Ctrl+Alt+Del

Developing a physiological approach to PTSD

Phase III-Candidate Biopharmaceutical Company

PTSD has a physiological dimension. CAD Therapeutics is developing an investigational approach designed to study it there.

CAD Therapeutics is developing Clonicaine™, an investigational product candidate for PTSD being studied through a physician-administered sympathetic-block procedure. Clonicaine™ is investigational and is not FDA-approved.

Phase III candidate
IND in preparation under a planned 505(b)(2) strategy
Lead PTSD program with expansion potential
PTSD lead program; VMS and additional indications remain preclinical.
Patents issued
Issued patents and pending claims related to CAD's product candidates and methods
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

A capital‑efficient path to pivotal evidence

Most PTSD treatment today relies on psychiatric management — SSRIs, SNRIs, or talk therapy — carrying real trade‑offs in cognitive and motor function, sleep, and, in some cases, suicidal ideation risk.

CAD Therapeutics takes a different starting point. Our lead candidate, Clonicaine™, is being developed as an investigational approach focused on the physiological dimension of PTSD through a physician-administered sympathetic-block procedure.

The company is led by a team spanning clinical anesthesiology, FDA regulatory strategy, development operations, and biotech intellectual property, with additional diligence materials available only to qualified parties under appropriate confidentiality arrangements.

IndicationsPTSD · VMS · additional
Clinical trial stagePhase III Candidate
Regulatory pathway505(b)(2)
FDA engagementPre-IND meeting completed
IP estateIssued patents + pending IP portfolio
Development stageIND in preparation
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

A physiological PTSD hypothesis under controlled clinical evaluation

Independent literature has explored whether physician-administered sympathetic-block procedures may affect physiological features associated with PTSD. CAD is developing Clonicaine™ as an investigational product candidate 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 public patents, and third-party literature background. Detailed scientific and development materials are reserved for FDA submissions and confidential diligence channels.

Published Evidence

Independent literature informs CAD's development rationale

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.

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.
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

Lead PTSD program with preclinical expansion opportunities

CAD's pipeline is built around Clonicaine™, an investigational product candidate being developed for physician-administered sympathetic-block procedures. 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 prep / Phase III planned
Clonicaine™ — Vasomotor symptoms (VMS / hot flashes) PatentedPreclinical sympathetic-block development program
Preclinical
Clonicaine™ — Additional indications (undisclosed)Preclinical programs; details undisclosed
Preclinical
Clonicaine™ — Early platform expansion Under evaluationEarly-stage platform work; details undisclosed
Discovery

The PTSD program is a Phase III candidate under a 505(b)(2) strategy (FDA pre-IND meeting completed; IND in preparation) — no Phase III trial is currently active or enrolling. Any trial initiation is subject to FDA IND clearance, IRB approval, and informed consent. Beyond PTSD, platform expansion remains preclinical and undisclosed except as reflected in issued/public IP and future company updates. Full qualifiers ›

Development roadmap — lead PTSD program

CAD's near-term program is sequenced around FDA engagement and clinical-development readiness, with detailed program materials shared only through appropriate regulatory or confidential diligence channels.

2026 H1

Pre-IND Engagement

FDA pre-IND meeting completed; IND package in preparation under a planned 505(b)(2) regulatory strategy.

2026 H2

Type D Clinical Meeting Package / IND Preparation

Type D clinical meeting package submitted to FDA; package contents and FDA-facing details are not summarized publicly.

Following Clearance

Phase III Activation

Potential trial 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.

Leadership & Strategic Partners

Built on clinical, regulatory, and IP depth

Founders & Board

Sorina Buri

Sorina Buri

Founder & Board Member

Founder, CAD Therapeutics. Managing Partner at Park South Capital. 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.

Christopher J. Teas

Christopher J. Teas

Co-Founder & CEO · Board Member

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.

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 diligence.
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 a pre-IND meeting and is preparing its IND package under a planned 505(b)(2) strategy. No Phase III trial is currently active or enrolling.

2026 · H2

Type D clinical meeting package submitted

CAD submitted a Type D clinical meeting package to FDA. The package contents and FDA-facing details are not summarized publicly.

2026 · H2

IND in preparation

CAD is preparing its IND package and related clinical-development readiness activities, ahead of potential Phase III activation 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 Phase III-candidate 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 U.S. patents owned by CAD.

What is Clonicaine™?

Clonicaine™ is CAD's proprietary, patent-protected investigational product candidate 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.

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 shared only through appropriate FDA, clinical, partner, or qualified-investor diligence channels under confidentiality arrangements.

Where can qualified parties review technical diligence?

Qualified parties may request access to diligence materials through CAD. Those materials are reviewed through appropriate confidentiality, investor-qualification, regulatory, and legal processes; they are not distributed through this public 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. 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, qualified partners, and qualified investors or strategic parties under appropriate confidentiality arrangements. 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. A pre-IND meeting has been completed, and an IND is in preparation; 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 and a broader intellectual-property portfolio. As with any early-stage intellectual property, 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 Phase III Clinical Trial?

CAD is preparing a controlled Phase III clinical program to evaluate Clonicaine™ for PTSD. 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, investor, or media inquiries, please reach us through the Contact section.

Investor & Strategic Partner Information

A capital-efficient, IP-protected Phase III-candidate program

Lead programClonicaine™ for post-traumatic stress disorder (PTSD)
StatusPhase III candidate; pre-IND meeting completed; Type D clinical meeting package submitted; IND in preparation. No Phase III trial is currently active or enrolling.
Near-term milestonesFDA interaction, IND submission, FDA clearance, IRB approval, and clinical-development readiness
Development strategy505(b)(2) strategy, subject to FDA review, IND clearance, and potential modifications
DifferentiatorsInvestigational Phase III-candidate program; issued and pending intellectual property; a base of independent third-party sympathetic-block literature. These are development attributes, not claims of safety or efficacy.

Diligence materials

Available to qualified parties under NDA:

  • Clinical and regulatory diligence materials
  • Technical diligence materials
  • Intellectual-property diligence materials
  • Budget / use-of-proceeds model
  • Capitalization table
  • Clinical & regulatory timeline

Request diligence access ›

Information for prospective investors is available only to qualified parties through appropriate diligence materials. Nothing on this website is an offer to sell, or a solicitation of an offer to buy, securities.

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. Sertraline (Zoloft), U.S. FDA Drugs@FDA, NDA 019839 — FDA-approved for PTSD.
  19. Paroxetine (Paxil), U.S. FDA Drugs@FDA, NDA 020031 — FDA-approved for PTSD.
  20. Quetiapine (Seroquel), U.S. FDA Drugs@FDA, NDA 020639 — boxed warnings and metabolic effects.
  21. Monahan et al. “Quetiapine withdrawal: a systematic review.” Aust N Z J Psychiatry, 2021.
  22. “Quetiapine for primary insomnia: consider the risks.” Cleveland Clinic Journal of Medicine, 2021.
  23. Esketamine (Spravato), U.S. FDA Drugs@FDA, NDA 211243 — approved for treatment-resistant depression, not PTSD.
  24. “Ketamine and Esketamine in Clinical Trials.” PMC review, 2025.
  25. VA/DoD Clinical Practice Guideline for the Management of PTSD.
Safety Profile — Full Disclosure

‹ Back to summary

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.