Ctrl+Alt+Del

Rebooting the brain without losing your hard drive

Clinical-Stage Biopharmaceutical Company

Many conditions share a common physiological pathway. CAD Therapeutics is developing investigational therapies to study that pathway across multiple indications.

CAD Therapeutics is developing a platform of investigational therapies — led by Clonicaine™, a fixed-dose formulation, and including additional proprietary formulations and adjuvants — addressing conditions associated with sympathetic (autonomic) nervous system activity. Its lead programs are post-traumatic stress disorder (PTSD) and vasomotor symptoms (VMS), both studied through a physician-administered sympathetic-block procedure. CAD’s product candidates are investigational and are not FDA-approved.

Two lead programs — PTSD & VMS
PTSD in a combined, adaptive Phase 2b/3 under a 505(b)(2) NDA pathway (Phase 3 stage designed as a potential registrational trial); VMS advancing as the second lead program.
One platform, multiple indications
A portfolio of proprietary, novel investigational formulations and a shared development approach, spanning PTSD, VMS, and additional indications identified by code.
Patents & 510(k) filings
Multiple issued and pending U.S. patents covering methods for PTSD and VMS, plus 510(k) filings, with applications extending coverage across additional indications.
See the Science ›

Clonicaine™ is an investigational product candidate. It is not approved by the FDA for any indication, has not been established as safe or effective, is not commercially available, and may be studied only under authorized clinical investigations.

Company Snapshot

Novel formulations. A platform of indications.

Many common conditions — from PTSD to menopausal vasomotor symptoms (VMS) — involve the sympathetic (autonomic) nervous system, yet are managed today with unrelated drug classes that each carry their own trade-offs. PTSD care often relies on psychiatric management — SSRIs, SNRIs, or talk therapy — with real impacts on cognition, sleep, and, in some cases, suicidal-ideation risk.

CAD Therapeutics takes a different starting point. Our lead candidate, Clonicaine™, is a proprietary investigational fixed-dose formulation being developed to study that shared physiological pathway — led by programs in PTSD and VMS. Beyond Clonicaine™, CAD is developing additional novel formulations and adjuvants directed at further indications, supported by a growing patent estate. The lead programs are delivered through a physician-administered sympathetic-block procedure.

Because these programs are built on a shared platform, development approach, and clinical capability — and because their clinical endpoints are objective and read out over weeks rather than years — the platform is designed to be capital-efficient, advancing several independent opportunities from a shared base. Each program is a distinct, binary clinical question; none depends on another to proceed.

The company is led by a team spanning clinical anesthesiology, FDA regulatory strategy, development operations, and biotech intellectual property.

IndicationsPTSD · VMS · additional filed indications (coded)
Lead clinical stagePTSD: combined, adaptive Phase 2b/3 (planned); VMS: development-stage
Platform logicProprietary novel formulations; objective, near-term clinical endpoints
Regulatory pathway505(b)(2) NDA
FDA engagementMultiple FDA meetings completed; IND submission anticipated near-term
IP estateMultiple issued & pending U.S. patents (PTSD & VMS), plus 510(k) filings, across additional indications
Development stageIND submission in preparation; study not yet open or enrolling
Clonicaine™ is investigational. It is not approved by the FDA for any indication; safety and efficacy have not been established. Clonicaine™ is not commercially available. Any future access would occur only through an authorized clinical investigation, subject to IND clearance, IRB approval, eligibility criteria, and informed consent.
Scientific Rationale

One physiological pathway, studied across multiple conditions

Independent literature has explored whether physician-administered sympathetic-block procedures may affect physiological features associated with PTSD — and, separately, with vasomotor symptoms and other conditions tied to the sympathetic (autonomic) nervous system. CAD is developing Clonicaine™ as an investigational product candidate across these indications and does not publish nonpublic formulation, dosing, procedural, protocol, or internal mechanistic details on this website.

Disclosure posture

Public materials are intentionally limited to company overview, regulatory status, issued and pending patents, and third-party literature background. Detailed scientific and development materials are reserved for FDA submissions and are not published on this website.

One pathway, multiple conditions

The premise behind CAD’s platform is that a number of conditions managed by unrelated medical specialties — among them PTSD and menopausal vasomotor symptoms — share involvement of the sympathetic (autonomic) nervous system. Independent, peer-reviewed literature has proposed a unifying mechanism by which a stellate ganglion block can produce prolonged effects across conditions as different as PTSD, menopausal hot flashes, and complex regional pain syndrome (CRPS).33

CAD’s strategy applies its proprietary formulations — led by Clonicaine™ — to that shared pathway, one indication at a time. This literature is independent of CAD, does not study Clonicaine™, and does not establish that Clonicaine™ is safe or effective for any condition; it informs CAD’s development rationale only.

A different mechanism from neuroplasticity-based therapies

A question that comes up often is how CAD’s approach compares with the neuroplasticity-based therapies now being studied for PTSD — agents such as ketamine, MDMA, psilocybin, cannabinoids, and ibogaine. In published literature, those agents are understood to act centrally, inside the brain, largely through mechanisms associated with neuroplasticity: serotonergic and monoamine signaling, NMDA-receptor modulation, endocannabinoid activity, or multi-target receptor effects.

CAD’s investigational approach sits in a different mechanistic category. Published literature and Dr. Eugene Lipov’s model33 describe a peripheral, autonomic pathway — trauma-associated nerve growth factor (NGF) signaling, sympathetic nerve sprouting, and norepinephrine overproduction — and propose that a stellate ganglion block acts on that pathway outside the brain. Clonicaine™ adds clonidine, an alpha-2 agonist understood to lower sympathetic norepinephrine release. The table below summarizes where each approach is understood to act.

CENTRAL — INSIDE THE BRAIN KetamineMDMAPsilocybinCannabinoidsIbogaineTMS Neuroplasticity & brain-stimulation mechanisms:serotonergic, NMDA, endocannabinoid, multi-target, or cortical. outside the brain PERIPHERAL · AUTONOMIC — OUTSIDE THE BRAIN SGB CAD / Clonicaine™ (SGB) Targets NGF-driven sympathetic sprouting & norepinephrine (NE ↓).
Schematic, not to scale. Shows mechanistic category drawn from published literature and Dr. Lipov’s model only; not a claim that Clonicaine™ is safe, effective, superior, or of therapeutic benefit. Sources for each mechanism are listed in the references. Clonicaine™ is investigational; its safety and efficacy have not been established.
ApproachHow it is understood to actWhere it actsActs on NGF / NE?*
CAD / Clonicaine™ (SGB)33Local anesthetic plus clonidine (alpha-2 agonist) at the cervical sympathetic chainPeripheral · autonomic (outside the brain)Hypothesized to lower NGF-driven signaling and norepinephrine
MDMAMonoamine / serotonergic releaser associated with neuroplasticityCentral (brain)Associated with increased NE release
Psilocybin385-HT2A (serotonergic) agonist associated with neuroplasticityCentral (brain)Not identified
Ketamine39NMDA-receptor antagonistCentral (brain)Not identified
Cannabinoids (e.g., marijuana / THC)Endocannabinoid (CB1 / CB2) receptor activityCentral (brain)Not identified
Ibogaine40Multi-target receptor activityCentral (brain)Not established in humans
Brain stimulation (e.g., TMS)41Magnetic stimulation of the cortical surfaceCentral (cortex)Not identified

* “NGF / NE” = nerve growth factor and norepinephrine. These descriptions are drawn from published literature and Dr. Lipov’s model and describe mechanistic category only. They are not a claim that Clonicaine™ is safe, effective, or superior to any other approach. Each of the other therapies is being studied for PTSD on its own merits; Clonicaine™ is investigational and its safety and efficacy have not been established.
Sources: SGB / Dr. Lipov’s model33; psilocybin38; ketamine39; ibogaine40; TMS41. MDMA (monoamine / norepinephrine release) and cannabinoid (CB1 / CB2) pharmacology are described per standard published literature.

Published Evidence

Independent literature informs CAD's development rationale

The independent, peer-reviewed literature on stellate ganglion block (SGB) for PTSD now spans more than 40 publications, including two sham/placebo-controlled randomized trials, alongside multiple registered clinical trials — all independent of CAD and not studies of Clonicaine™. CAD references selected third-party literature on sympathetic-block procedures and PTSD as public scientific background. These publications are independent of CAD's planned clinical program and do not disclose CAD's nonpublic formulation, dosing, protocol, manufacturing, or internal development materials.

Independent literature also supports the scientific rationale for CAD’s second indication. Stellate ganglion block has been studied for vasomotor symptoms (VMS / hot flashes) in peer-reviewed publications — including randomized and sham-controlled trials and a clinical review — all conducted by groups unaffiliated with CAD.343536 These studies are not studies of Clonicaine™ and do not establish its safety or efficacy.

2008
Early clinical literature1Peer-reviewed case-report literature
Third-party publication; not a CAD-sponsored clinical trial.
2009
Published scientific hypothesis2Third-party literature background
Publicly available literature; CAD's internal scientific rationale is not published here.
2014
Published clinical experience5Peer-reviewed third-party publication
Independent literature; not evidence of Clonicaine™ safety or efficacy.
2019
Randomized clinical literature7Third-party PTSD research
Independent study; not a CAD-sponsored clinical trial.
2022
Retrospective clinical literature8Peer-reviewed third-party publication
Retrospective, non-CAD data; hypothesis-generating only.
2023
Ongoing independent research17ClinicalTrials.gov listing
Independent study; not sponsored by CAD.
2024
Peer-reviewed review
Independent review of SGB mechanisms, efficacy, and safety; not a CAD-sponsored study.
2025
Recent mechanistic research
Independent, third-party publication; not evidence of Clonicaine™ safety or efficacy.

Independent literature — SGB for vasomotor symptoms (VMS)

Selected third-party, peer-reviewed publications. Independent of CAD; not studies of Clonicaine™.

2014
VMS — randomized, sham-controlled trial34Menopause · postmenopausal women
Independent trial; not a CAD-sponsored study; not evidence of Clonicaine™ safety or efficacy.
2022
VMS — clinical review36Cleveland Clinic Journal of Medicine
Third-party review; notes that long-term randomized data remain limited.
2023
VMS — randomized controlled trial35Frontiers in Endocrinology · perimenopausal women
Independent, single-center study; authors call for larger and longer trials.
The literature summarized here is third-party, publicly available, and not CAD-sponsored. These publications are scientific background only and should not be interpreted as evidence that Clonicaine™ is safe or effective. CAD's planned controlled clinical program is intended to evaluate Clonicaine™ specifically.
Safety Profile

A well‑characterized procedure, with risks patients should understand

Sympathetic-block procedures have been used in clinical practice for decades and have a well-characterized risk profile, but they remain invasive procedures with known risks, including rare serious and life-threatening complications. Clonicaine™ remains investigational, and safety and efficacy have not been established. Potential effects would be addressed through physician review and informed consent in any authorized clinical investigation.18,19

Full safety & risk disclosure ›

Standard of Care Today

Current options leave a significant unmet need

Psychiatric management

SSRIs & SNRIs20–24

Sertraline and paroxetine remain the only two drugs FDA-approved specifically for PTSD — both over two decades old. They typically take 6–8 weeks to show effect, benefit an estimated 40–60% of patients, and are commonly associated with sexual dysfunction, weight gain, and emotional blunting.

Antipsychotics are also used off-label for PTSD-related insomnia and agitation despite limited evidence. Quetiapine (Seroquel®), not FDA-approved for PTSD, carries boxed warnings for increased mortality in elderly dementia patients and for suicidality in youth, plus metabolic risks — weight gain, elevated blood sugar and diabetes, and high cholesterol. It requires tapering, since abrupt stopping can cause withdrawal.

Emerging psychotropics

Ketamine & MDMA25,26

MDMA-assisted therapy earned FDA Breakthrough Therapy designation for PTSD (though the FDA later declined approval), and ketamine — whether intravenous, oral, or the intranasal esketamine spray (Spravato, Johnson & Johnson) — is used off-label for PTSD. None are FDA-approved for PTSD: racemic ketamine is approved only as an anesthetic, and esketamine (Spravato) is approved for treatment-resistant depression, not PTSD. Both remain psychotropic compounds with their own profile of potential adverse effects and administration requirements.

Behavioral therapy

CPT & CBT27

Effective for many patients, but demand sustained engagement over months, and access to trained clinicians remains limited relative to patient need.

Pipeline

One formulation across a pipeline of indications

CAD is developing Clonicaine™ as a platform: a portfolio of proprietary investigational formulations — led by Clonicaine™ — applied program by program to conditions that share a sympathetic–autonomic basis. The lead programs are PTSD and vasomotor symptoms (VMS), followed by additional filed indications identified below by code. Clonicaine™ is investigational and is not approved by the FDA for any indication.

Program
DiscoveryPreclinicalPhase 1Phase 2Phase 3
Clonicaine™ — PTSD PatentedPhysician-administered sympathetic-block development program
IND submission / Phase 2b/3 planned
Clonicaine™ — Vasomotor symptoms (VMS / hot flashes) PatentedSecond lead program; informed by independent published SGB–VMS literature
Development-stage
CAD platform — additional therapeutic programs CodedMultiple additional indications under filed IP (undisclosed)
Discovery–preclinical
CAD platform — additional route-of-administration program CodedDifferentiated route of administration (undisclosed)
Discovery

CAD’s lead PTSD program is a combined, adaptive Phase 2b/3 under a 505(b)(2) NDA pathway, with the Phase 3 stage designed as a potential registrational trial (multiple FDA meetings completed; IND submission anticipated in the near term) — the study is not yet open or enrolling. Any trial initiation is subject to FDA IND clearance, IRB approval, and informed consent. VMS is CAD’s next lead program and remains development-stage; the additional filed indications are early-stage and are listed separately below. Full qualifiers ›

Platform strategy — proprietary formulations, sequential indications

CAD’s strategy is to establish Clonicaine™ first in PTSD, then apply its platform to additional indications that share a sympathetic–autonomic basis. Follow-on programs may use Clonicaine™ or other proprietary formulations, and more than one route of administration. VMS is the first of these follow-on programs; beyond it, CAD’s platform includes additional novel formulations and adjuvants directed at further indications.

VMS is a logical second indication: the stellate-ganglion-block approach has been studied for vasomotor symptoms in independent, peer-reviewed literature — including randomized and sham-controlled trials conducted by groups unaffiliated with CAD (see Published Evidence). That literature is independent of CAD, does not study Clonicaine™, and does not establish its safety or efficacy; it informs CAD’s development rationale only.

Each program is pursued under the 505(b)(2) pathway using known, well-characterized components, and each is designed around objective endpoints that read out over weeks rather than years. Because the programs share a common platform, development approach, and clinical capability, they can be sequenced capital-efficiently — giving the platform several independent opportunities rather than a single all-or-nothing outcome. Each program is nonetheless a distinct clinical question; success in one does not predict or ensure success in another. CAD believes the resulting opportunity is broadly consistent with comparable clinical-stage programs at similar stages of development — strengthened by several independent “shots on goal” advanced by a single team and clinical capability.

CAD’s intellectual property, developed with specialist patent counsel, includes issued U.S. patents covering methods of treatment for PTSD and vasomotor symptoms, together with pending applications intended to extend coverage across the additional filed indications shown below. Pending applications have not issued and may not issue; issued claims remain subject to validity and enforceability limitations.

Additional development programs

Beyond PTSD and VMS, CAD has filed intellectual property across multiple additional indications. CAD identifies these programs by code and general description; specific indications, formulations, and technical development details remain undisclosed. Several employ a differentiated route of administration; the specific routes, formulations, and delivery details remain undisclosed.

Program codeGeneral description
CAD-104Neuropsychiatry indication A
CAD-105Neuropsychiatry indication B
CAD-106Neuropsychiatry indication C
CAD-107Neurology indication A
CAD-108Neurology indication B
CAD-201Women’s health indication
CAD-202Adjacent-market program

Program codes are company development identifiers. They do not establish IND clearance, clinical success, or marketing approval. CAD's investigational product candidates are not approved for any indication and are not commercially available.

Development roadmap — lead PTSD program

CAD's near-term program is sequenced around FDA engagement and clinical-development readiness, with detailed program materials reserved for FDA and regulatory submissions.

2026 H1

Pre-IND Engagement

Multiple FDA meetings completed under a 505(b)(2) NDA pathway.

2026 H2

FDA Feedback Incorporated

FDA interactions completed and reflected in the combined Phase 2b/3 design. Specific FDA-facing details are not summarized publicly.

Following Clearance

Study Activation

Combined Phase 2b/3 initiation subject to FDA IND clearance, IRB approval, and operational readiness.

Pivotal Path

Readout & Filing Prep

If the planned trial is authorized, completed, and successful, continued regulatory interaction and filing preparation would follow.

Policy & regulatory context

Independent of CAD, the broader environment for stellate ganglion block (SGB) in PTSD has been developing. Bipartisan federal legislation — the TREAT PTSD Act (H.R. 1947, 119th Congress) — would direct the U.S. Department of Veterans Affairs and the Department of Defense to furnish SGB to veterans and service members diagnosed with PTSD who elect it.37 Related appropriations language directing attention to SGB has been taken up by the U.S. House in recent cycles, and the VA/DoD has conducted a sham-controlled SGB study.

A recurring theme across this public record is the call for a completed, standardized efficacy trial. CAD’s strategy is to develop Clonicaine™ as a standardized, FDA-regulated fixed-dose product evaluated in exactly that kind of controlled trial, under the 505(b)(2) pathway.

These developments concern the SGB procedure generally. They are not an FDA approval, an endorsement of Clonicaine™, or a determination of its safety or efficacy, and nothing here states or implies that CAD, Clonicaine™, or any CAD program is endorsed, funded, or approved by any government body. Legislative outcomes are uncertain and pending bills may not become law.

Leadership & Strategic Partners

Built on clinical, regulatory, and IP depth

Christopher J. Teas

Christopher J. Teas

F / C / B

Chief Executive Officer, CAD Therapeutics. Managing Partner at Park South Capital. Christopher has 38 years of experience across banking, capital markets, private equity, and company-building. His background includes control-equity and operating-platform experience, including companies in biotech and other regulated sectors. He has built, bought, financed, and led companies through multiple market cycles, and has board and governance experience. His charitable work includes mental health, U.S. veterans, cancer research, and other causes. He is a passionate fly fisherman and golfer.

Sorina Buri

Sorina Buri

F / B

More than three decades of experience across global capital markets, hedge funds, alternatives, institutional asset management, and operating-company investment. Her background includes derivatives-market experience, hedge-fund formation and management, senior investment-management leadership, and board/governance roles across public, private, health, technology, and cultural organizations. She is active in philanthropy focused on mental health, cancer research, U.S. veterans, the arts, and related causes.

Clinical, Scientific, Regulatory, CMC & IP Leaders & Advisors

CAD Therapeutics is led by its founders and supported by named clinical, scientific, biostatistics, regulatory, clinical-operations, legal, and IP advisors across the planned PTSD program. The profiles below identify each person’s current role or relationship to CAD, including company officers, planned clinical-program leadership, and external advisors or consultants. Role descriptions reflect CAD’s current clinical, scientific, advisory, consulting, or program-support relationships, as applicable. Employment, fiduciary, board, or corporate-officer status should not be inferred unless expressly stated in definitive company documents.

Clinical & Safety

Dr. Eugene Lipov
Dr. Eugene Lipov, MD Clinical LeadChief Medical Officer — Stella PTSD lead; 29 years in anesthesia; 48 published PTSD / pain articles.
Dr. Ken Candido
Dr. Ken Candido, MD InvestigatorPrincipal Investigator, Planned PTSD Clinical Program — anesthesiology and surgery; 100+ clinical-trial experience.
Amanda Kube Jotte
Amanda Kube Jotte, PhD BiostatisticianBiostatistician / clinical biostatistics — University of Chicago Statistics & Data Science; PhD, Computational and Data Sciences.
Dr. Richard Isbrucker
Dr. Richard Isbrucker, PhD Scientific LeadChief Science Officer — WHO and Health Canada toxicology / safety review.

FDA & Regulatory

Heidi Nelson-Keherly
Heidi Nelson-Keherly, PhD ConsultantRegulatory Advisor (QNova) — 300+ programs; 80+ Phase I–IV trials.
Jeremiah J. Kelly
Jeremiah J. Kelly, Esq. ConsultantRegulatory Advisor, Faegre Drinker — former Chief, FDA Regulatory Law Division (USAMRDC).
Justin A. Coen
Justin A. Coen, Esq. ConsultantRegulatory Advisor — FDA engagement, GxP, expedited pathways, and labeling.

Development & CMC

Patrick C. McCarthy
Patrick C. McCarthy, Esq. ConsultantClinical Development Advisor, Validcare CEO — real-world-evidence platform; Phase I–III trials; 30+ years.
Robert Kaufmann
Robert Kaufmann, MD ConsultantValidcare CMO / Director of Research — clinical research lead; CBD liver-safety study lead.
Diane Markesich
Diane Markesich, PhD ConsultantTranslational Research, QNova — drug development, CMC, and pharmacodynamics.
Louis H. Junker
Louis H. Junker, PhD ConsultantCMC Advisor — 30 years commercialization; prior Amgen, AstraZeneca, Novartis.
Janice Cattano
Janice Cattano, RN, MSN ConsultantMedical devices & clinical operations — medical-device and clinical-operations readiness support.

IP & Patent Estate

Gregory W. Mitchell
Gregory W. Mitchell, Esq. ConsultantLife-Sciences IP Counsel, Faegre Drinker — former USPTO examiner / patent agent.
Dylan J. Kahl
Dylan J. Kahl, PhD ConsultantPatent Advisor — pharma / biotech portfolios and financing matters.
Jane Chen
Jane Chen, PhD ConsultantBiotech IP — biologics, CRISPR / mRNA / gene-editing; freedom-to-operate.
Dan Keller
Dan Keller, Esq. ConsultantPatent & Trademark Counsel, PNK Law — U.S. and Canadian patent and trademark agent.

The CAD Therapeutics Board is currently comprised of Sorina Buri and Christopher Teas, with Board of Directors expansion planned.

Milestones

Program milestones

Key milestones in CAD's development of Clonicaine™. Company announcements and press releases will be posted here as the program advances.

2026 · H1

FDA pre-IND meeting completed

CAD completed its pre-IND (Type B) meeting under a 505(b)(2) NDA pathway. The study is not yet open or enrolling.

2026 · H2

FDA Type D written responses received

CAD received FDA’s written responses to its Type D clinical questions (October 2026), informing the combined Phase 2b/3 design. Details are not summarized publicly.

2026 · H2

IND submission in preparation

CAD is preparing its IND submission and clinical-development readiness, ahead of a combined Phase 2b/3 study subject to FDA IND clearance and IRB approval.

Ongoing

Clinical program readiness

Clinical-development planning remains in progress with CAD's clinical and biostatistics advisors.

Frequently Asked Questions

What people ask us

Company & Clonicaine

Who is CAD Therapeutics?

CAD Therapeutics is a privately held, U.S.-based clinical-stage biotechnology company developing Clonicaine™ for PTSD. "CAD" stands for Ctrl-Alt-Del — the guiding idea is to evaluate a physiological approach to PTSD in a controlled clinical-development setting. Clonicaine™ is supported by issued and pending U.S. patents and applications owned by CAD.

What is Clonicaine™?

Clonicaine™ is CAD's proprietary investigational product candidate, supported by issued and pending patents, being developed for PTSD through a physician-administered sympathetic-block procedure. Detailed formulation, dosing, and protocol information is not published on this website. If the planned clinical program is authorized, completed, and successful, CAD may seek FDA approval, subject to FDA requirements and review.

Is Clonicaine™ FDA-approved?

No. Clonicaine™ is an investigational drug. It is not approved by the FDA for PTSD or any other indication; safety and efficacy have not been established. Clonicaine™ is not commercially available. Any future access would occur only through an authorized clinical investigation, subject to IND clearance, IRB approval, eligibility criteria, and informed consent.

What are CAD's additional development programs?

Beyond Clonicaine™ for PTSD and VMS, CAD has filed intellectual property across multiple additional indications, evaluated as coded early-stage programs. The pipeline listing provides the current program codes and general descriptions. A program code does not indicate IND clearance or FDA approval. Specific indications, formulations, and technical details are not publicly disclosed.

Is CAD a single-product company, or a platform?

CAD is building a platform of proprietary, novel investigational drug formulations. Its lead formulation, Clonicaine™, is being applied across PTSD and VMS, and CAD is developing additional novel formulations and adjuvants directed at further indications identified by code. Because the programs share a common platform, development approach, and clinical capability, they are designed to be pursued capital-efficiently; however, each is a separate clinical question, and success in one does not predict or ensure success in another. All product candidates are investigational and not FDA-approved.

Why are detailed scientific materials not posted here?

CAD keeps nonpublic scientific, formulation, dosing, manufacturing, and protocol details out of the public website. Public pages are limited to high-level company, regulatory-status, patent, and third-party literature background. Detailed materials are reserved for FDA and clinical regulatory use and are not published on this website.

Understanding PTSD

What is PTSD, and what causes it?

PTSD is a condition that can develop after exposure to traumatic events such as combat, assault, serious accidents, or disaster. It is characterized by intrusive memories, nightmares, hypervigilance, avoidance, and disrupted mood and sleep. PTSD is estimated to affect about 5% of U.S. adults — roughly 13 million — in a given year, with particularly high prevalence among military veterans and first responders.

Source: PTSD definition, symptoms, and prevalence — National Center for PTSD, U.S. Dept. of Veterans Affairs (adults, veterans).

What treatments are currently approved for PTSD, and what are their limitations?

As of 2026, only two drugs remain FDA-approved specifically for PTSD — sertraline (Zoloft, 1999) and paroxetine (Paxil, 2001), both SSRIs. They typically take 6–8 weeks to show effect, benefit an estimated 40–60% of patients, and are commonly associated with sexual dysfunction, weight gain, and emotional blunting. They generally require ongoing daily use, with relapse common on discontinuation, and they modulate neurotransmitter levels rather than targeting the underlying physiology of PTSD. No new PTSD medication has been approved in more than two decades — recent attempts were declined by the FDA, including MDMA-assisted therapy (Lykos) in August 2024 and the brexpiprazole-plus-sertraline combination (Otsuka/Lundbeck) in September 2025 — underscoring how difficult the prevailing pharmacologic approach has been to improve upon.

Source: U.S. FDA prescribing information for Zoloft (sertraline) and Paxil (paroxetine), the only two agents FDA-approved specifically for PTSD; Otsuka/Lundbeck, FDA Complete Response Letter for brexpiprazole + sertraline in PTSD (Sept 20, 2025; advisory committee voted 10–1 against on July 18, 2025); FDA Complete Response Letter for MDMA-assisted therapy (Aug 2024).

How does this approach differ from SSRIs, ketamine, or talk therapy?

Clonicaine™ is being developed as a physician-administered investigational approach, which differs from daily oral medication or psychotherapy-based care. CAD does not claim comparative superiority to approved medicines, psychotherapy, ketamine, MDMA-assisted approaches, or any other intervention. Where it differs is in mechanistic category: CAD’s approach targets a peripheral, autonomic pathway (NGF signaling and norepinephrine) rather than the central, neuroplasticity-based mechanisms attributed to agents such as ketamine, MDMA, psilocybin, cannabinoids, and ibogaine — see the Science section for details. Safety and efficacy have not been established.

Source: PTSD treatment background — VA/DoD Clinical Practice Guideline for PTSD.

What about complex PTSD (C-PTSD)?

C-PTSD develops from prolonged or repeated trauma and includes core PTSD symptoms plus difficulties in emotion regulation, self-concept, and relationships. CAD's current development focus is PTSD. Any potential relevance to C-PTSD would require separate clinical evaluation and should not be inferred from this website.

The SGB Procedure

What is a Stellate Ganglion Block (SGB)?

SGB is a physician-administered sympathetic-block procedure used in pain medicine and studied in independent PTSD literature. CAD does not publish procedural technique, product-candidate, dosing, or protocol details on this website.

Source: Background on SGB history and use in pain medicine — StatPearls, “Stellate Ganglion Blocks” (NCBI). SGB has been in clinical use since about 1925 — Summers & Nevin, Current Psychiatry Reports (2015).

What is the history of SGB in medicine?

SGB has a long history in pain medicine, and independent researchers have studied its potential relevance to trauma-related disorders. CAD references this public literature as background only; Clonicaine™ remains investigational, and CAD's specific development materials are not published on this website.

Source: SGB’s clinical history and its first reported use for PTSD (Lipov, 2008) — Summers & Nevin, Current Psychiatry Reports (2015); Lipov EG et al., “Cervical Sympathetic Blockade in a Patient with PTSD: A Case Report,” Annals of Clinical Psychiatry (2008).

How is SGB thought to work for PTSD?

Published literature has proposed several hypotheses for why sympathetic-block procedures may affect PTSD-related symptoms. CAD's specific product candidate, protocol assumptions, and internal scientific rationale remain investigational and are not disclosed on this website.

Source: Selected public literature is cited below. These sources are third-party publications and are not CAD-sponsored studies of Clonicaine™.

Why doesn't CAD publish full formulation or dosing details?

CAD does not publish nonpublic formulation, dosing, procedural, or protocol details on its public website. Those materials are reserved for FDA submissions and clinical and regulatory use and are not published on this website. Public patent materials remain available through official patent-office records.

Note: Nothing on this website should be read as disclosure of nonpublic formulation, manufacturing, dosing, or protocol information.

How long do the effects last?

Reported duration varies considerably by individual. Durability for Clonicaine™ has not been established. CAD's planned controlled clinical program is intended to evaluate efficacy and durability in a defined study setting.

Source: Selected public literature is cited below. These sources are third-party publications and are not CAD-sponsored studies of Clonicaine™.

Safety

What are the common, temporary side effects?

Published literature describes generally temporary effects that may include eye or facial changes, voice or swallowing changes, congestion, arm symptoms, soreness, bruising, lightheadedness, or blood-pressure and heart-rate changes. Any authorized clinical investigation would include physician review, eligibility screening, informed consent, and safety monitoring.

What serious complications are possible?

Serious adverse events are uncommon in the published literature but can be severe. Reported risk varies by study, setting, patient population, and technique. Appropriate physician judgment, patient selection, and monitoring are important risk-mitigation practices.

Who typically cannot receive SGB?

Eligibility and exclusion criteria would be defined in the final protocol and assessed by qualified clinicians. This website does not provide medical screening guidance, and no person should rely on it to determine whether any investigational procedure is appropriate.

Evidence

What does the published research show?

Independent, peer-reviewed studies have evaluated SGB and related sympathetic-block procedures in PTSD populations. These are third-party publications, not completed CAD-sponsored trials, and should not be interpreted as evidence that Clonicaine™ is safe or effective. Clonicaine™'s efficacy and durability remain to be evaluated in CAD's planned controlled clinical program.

Who has SGB been studied in?

Published SGB research includes multiple PTSD populations. These are third-party studies of procedures other than Clonicaine™; whether any individual is an appropriate candidate for any intervention is a medical decision for a qualified clinician.

Regulatory & Access

Is SGB for PTSD FDA-approved?

No. SGB for the treatment of PTSD is not FDA-approved. CAD's planned clinical program is intended to study Clonicaine™ specifically for the PTSD indication, subject to FDA review, IND clearance, IRB approval, and potential modification.

What is CAD's regulatory pathway?

CAD plans to develop Clonicaine™ under the FDA's 505(b)(2) framework. CAD has completed multiple FDA meetings, and an IND submission is anticipated in the near term; the planned clinical program remains subject to FDA review, IND clearance, IRB approval, and potential modifications. Clonicaine™ remains investigational and is not approved by the FDA.

Is the treatment covered by insurance?

Coverage varies by insurer and plan. Because PTSD is currently an off-label use, coverage is inconsistent and often requires prior authorization; military and veterans' systems (TRICARE and VA) have increasingly recognized SGB for PTSD. Coverage for investigational or off-label uses is limited today and may evolve over time depending on the treatment's regulatory status and the supporting evidence.

How will Clonicaine™ be manufactured?

CAD expects any investigational clinical supply to be produced in the United States under appropriate pharmaceutical quality systems. Manufacturing plans remain subject to final agreements, regulatory review, and potential modification. Nonpublic manufacturing details are not disclosed on this website.

Is the treatment protected by intellectual property?

CAD's product candidates and development methods are supported by issued U.S. patents — including patents covering methods of treatment for PTSD and vasomotor symptoms — together with pending applications intended to extend coverage across additional indications. CAD has also made 510(k) filings with the FDA. As with any intellectual property or regulatory filing, applications may be pending and unpublished, may not issue, and, if issued, may be challenged, narrowed, or invalidated. Nothing here is a representation regarding the scope, validity, or enforceability of any intellectual property.

Clinical Trial

What is CAD’s planned clinical trial?

CAD is preparing a combined, adaptive Phase 2b/3 clinical program to evaluate Clonicaine™ for PTSD, with the Phase 3 stage designed as a potential registrational trial. Final design and timing remain subject to regulatory review, IND clearance, IRB approval, and trial registration.

Who can enroll in the trial?

Eligibility criteria will be defined in the final protocol and, if the trial is authorized, posted through appropriate trial-registration channels. The planned trial is not active or enrolling.

Is it a paid study?

Participant compensation, if any, will be determined by the final protocol and IRB-approved study materials. Participation is voluntary, and the planned trial is not active or enrolling.

How can I receive treatment or learn more?

Clonicaine™ is not commercially available. Any future access would occur only through an authorized clinical investigation, subject to IND clearance, IRB approval, eligibility criteria, and informed consent. For general or media inquiries, please reach us through the Contact section.

Contact CAD Therapeutics

General

Company Inquiries

Questions about CAD Therapeutics, our programs, or our approach to PTSD treatment.

info@cadtherapeutics.com
Published Evidence & Citations

References

The independent, peer-reviewed literature on stellate ganglion block (SGB) for PTSD, together with the regulatory and drug-label sources cited across this site. These are third-party publications; they are not CAD-sponsored trials of Clonicaine™, and they do not establish that Clonicaine™ is safe or effective.

  1. Lipov EG, et al. “Cervical sympathetic blockade in a patient with PTSD: a case report.” Annals of Clinical Psychiatry, 2008.
  2. Lipov EG, et al. “A unifying theory linking the prolonged efficacy of SGB…” Medical Hypotheses, 2009.
  3. Hickey AH, Navaie M, Stedje-Larsen ET, Lipov EG, McLay RN. “Stellate Ganglion Block for the Treatment of PTSD.” Psychiatric Annals 43(2):87–92, 2013.
  4. Lipov EG, Navaie M, Brown PR, Hickey A, et al. “SGB Improves Refractory PTSD and Associated Memory Dysfunction: A Case Report and Systematic Literature Review.” 2013.
  5. Mulvaney SW, Lynch JH, Hickey MJ, et al. SGB and combat-related PTSD. Military Medicine, 2014.
  6. Alkire MT. Neuroimaging study related to SGB and PTSD. 2015.
  7. Rae Olmsted KL, et al. “Effect of SGB Treatment on PTSD Symptoms: A Randomized Clinical Trial.” JAMA Psychiatry, 2020. (RTI International / Psychological Health Center of Excellence.)
  8. Lipov EG, Jacobs R, Springer S, Candido KD, et al. Retrospective analysis of sympathetic-block procedures and PTSD. Pain Physician, 2022.
  9. Kirkpatrick K, Khan MH, Deng Y, et al. “A Review of SGB as an Adjunctive Treatment Modality.” 2023.
  10. Lynch J, Mulvaney SW, Bryan C, Hernandez D. SGB and anxiety symptoms. 2023.
  11. Prasad S, Jain N, Umar TP, et al. “Sympathetic Nerve Blocks for PTSD: An Evidentiary Review for Future Clinical Trials.” 2023.
  12. Blakey SM, Rae Olmsted KL, Hirsch S, et al. Secondary analysis of SGB and PTSD symptoms. 2024.
  13. Springer S, Whitmer P, Steinlin M, Gray L, Blankfield J. SGB and trauma-informed care. 2024.
  14. Hasoon J, Sultana S, Malik A, et al. Review article on SGB and PTSD. 2024.
  15. Niraj G, Karanth V, Niraj S, Charan N. “SGB in Disparate Treatment-Resistant Mental Health Disorders: A Case Series.” 2025.
  16. Wang Z, Liu Z, Yu Y, et al. “SGB Diminishes Consolidation of Conditioned Fear Memory in Mice…” 2025.
  17. Independent registered PTSD study. NYU Langone · ClinicalTrials.gov NCT05391971.
  18. Lipov EG, et al. “Possible Reversal of PTSD-Related DNA Methylation by Sympathetic Blockade.” Journal of Molecular Neuroscience, 2017.
  19. Wang W, et al. “Stellate ganglion block attenuates chronic stress-induced depression in rats.” PLoS One, 2017;12:e0183995.
  20. Summers MR, Nevin RL. “Stellate Ganglion Block in the Treatment of Post-Traumatic Stress Disorder: A Review of Historical and Recent Literature.” Pain Practice, 2017.
  21. Marchi M, et al. “Clonidine for post-traumatic stress disorder: a systematic review of the current evidence.” European Journal of Psychotraumatology, 2024.
  22. Lipov E, et al. “Ketamine plus cervical sympathetic block versus cervical sympathetic block alone for PTSD.” Anesthesia & Pain Research, 2024.
  23. Sertraline (Zoloft), U.S. FDA Drugs@FDA, NDA 019839 — FDA-approved for PTSD.
  24. Paroxetine (Paxil), U.S. FDA Drugs@FDA, NDA 020031 — FDA-approved for PTSD.
  25. Quetiapine (Seroquel), U.S. FDA Drugs@FDA, NDA 020639 — boxed warnings and metabolic effects.
  26. Monahan et al. “Quetiapine withdrawal: a systematic review.” Aust N Z J Psychiatry, 2021.
  27. “Quetiapine for primary insomnia: consider the risks.” Cleveland Clinic Journal of Medicine, 2021.
  28. Esketamine (Spravato), U.S. FDA Drugs@FDA, NDA 211243 — approved for treatment-resistant depression, not PTSD.
  29. “Ketamine and Esketamine in Clinical Trials.” PMC review, 2025.
  30. VA/DoD Clinical Practice Guideline for the Management of PTSD.
  31. Lipov EG, et al. “A unifying theory linking the prolonged efficacy of the stellate ganglion block for the treatment of chronic regional pain syndrome (CRPS), hot flashes, and posttraumatic stress disorder (PTSD).” Medical Hypotheses, 2009.
  32. Walega DR, et al. “Effects of stellate ganglion block on vasomotor symptoms: findings from a randomized controlled clinical trial in postmenopausal women.” Menopause, 2014;21(8):807–814.
  33. Li et al. “Effects of stellate ganglion block on perimenopausal hot flashes: a randomized controlled trial.” Frontiers in Endocrinology, 2023.
  34. Lee JH, et al. “Stellate ganglion block as a treatment for vasomotor symptoms: Clinical application.” Cleveland Clinic Journal of Medicine, 2022;89(3):147–153.
  35. TREAT PTSD Act, H.R. 1947, 119th Congress (2025) — “Treatment and Relief through Emerging and Accessible Therapy for PTSD Act.” Congress.gov.
  36. Madsen MK, et al. “Psychedelic effects of psilocybin correlate with serotonin 2A receptor occupancy and plasma psilocin levels.” Neuropsychopharmacology, 2019.
  37. Li N, et al. “mTOR-dependent synapse formation underlies the rapid antidepressant effects of NMDA antagonists.” Science, 2010. (Ketamine mechanism.)
  38. Marton S, et al. “Ibogaine administration modifies GDNF and BDNF expression in brain regions involved in mesocorticolimbic and nigral dopaminergic circuits.” Frontiers in Pharmacology, 2019.
  39. Kozel FA, et al. “Repetitive TMS to augment cognitive processing therapy in combat veterans with PTSD: A randomized clinical trial.” J Affect Disord, 2018.
Safety Profile — Full Disclosure

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A well‑characterized procedure, with risks patients should understand

Sympathetic-block procedures have been used in clinical practice for decades and have a well-characterized risk profile, but they remain invasive procedures with known risks, including rare serious and life-threatening complications. Clonicaine™ remains investigational, and its safety and efficacy have not been established. The information below reflects published literature on the procedure and is not a substitute for physician review or informed consent.

Source: Published literature on sympathetic-block procedure risks and the regulatory sources listed in the Legal & Disclosures section.

Potential temporary effects

Published literature describes generally temporary procedure-related effects, which may include local discomfort, bruising, eye or facial changes, voice or swallowing changes, congestion, arm symptoms, lightheadedness, or blood-pressure and heart-rate changes. Frequency and severity vary by patient, setting, and clinical circumstances.

Potential serious risks

Rare but serious procedure-related or medication-related complications have been reported in the medical literature. These can include neurologic, cardiovascular, respiratory, bleeding, infectious, allergic, or other serious events, including life-threatening events in rare circumstances.

NOTE:Risk depends on patient-specific factors, clinical judgment, procedure technique, operator experience, and monitoring. Any authorized clinical investigation would include physician review, eligibility screening, IRB-approved informed consent, and appropriate safety monitoring. This summary reflects published literature and is not a substitute for a full discussion with a qualified clinician.

Important Safety Disclosure

The effects and complications described above are only some of the potential adverse events, side effects, and complications that may be associated with sympathetic-block procedures and with Clonicaine™, an investigational product candidate. The lists on this website are not exhaustive and do not describe every possible risk, side effect, adverse reaction, drug interaction, warning, precaution, or complication.

Clonicaine™ is investigational and has not been approved by the U.S. Food and Drug Administration (FDA) for any use; its safety and effectiveness have not been established. Its proposed use for post-traumatic stress disorder (PTSD) is investigational and constitutes an unapproved use. Individual results vary, and no particular outcome, benefit, durability, or degree of symptom relief is or can be promised or guaranteed.

Serious — and, in rare cases, life-threatening — adverse events are possible, including but not limited to neurologic, cardiovascular, respiratory, bleeding, infectious, allergic, or other procedure-related or medication-related events, and, very rarely, death. Any investigational therapy may interact with other prescription and non-prescription medicines, supplements, alcohol, and central-nervous-system depressants, and may be unsafe or contraindicated in patients with certain cardiac, pulmonary, neurologic, ophthalmologic, hepatic, renal, bleeding, or other medical conditions, in pregnancy or while breastfeeding, or at certain ages.

Please consult a qualified, licensed physician in advance of any treatment for a complete description of the potential risks, benefits, contraindications, warnings, precautions, and drug–drug interactions associated with any procedure or investigational therapy. A complete assessment requires individualized evaluation by a licensed healthcare provider. The information on this website is provided for general informational purposes only, is not medical advice, and is not a substitute for professional medical evaluation, diagnosis, or treatment; it does not create a physician–patient relationship. Clonicaine™ is not commercially available. Any future access would occur only through an authorized clinical investigation, subject to IND clearance, IRB approval, eligibility criteria, and informed consent. Nothing on this website is an offer to sell, or a solicitation of an offer to buy, any security.