PT150 · program

PT150 (Org 34517) for Post-traumatic stress disorder

Phase 2ActivePop Test Oncology LLC (dba Palisades Therapeutics)

Indications for PT150: Post-traumatic stress disorder · Phase 2 Major depressive disorder · Discontinued Alcohol use disorder · Phase 1

PT150, an oral glucocorticoid receptor antagonist, for post-traumatic stress disorder in U.S. veterans. On 2026-02-19 Pop Test Oncology (dba Palisades Therapeutics) announced that the FDA had granted permission to proceed with a Phase 2a trial, 'Efficacy and Safety of PT150 in U.S. Veterans with Post Traumatic Stress Disorder (PTSD)': a dual-site, double-blind, placebo-controlled study funded by the Department of Defense Congressionally Directed Medical Research Programs, enrolling 120 veterans at VA medical centers in San Diego and Houston, with a primary endpoint of change in PTSD symptoms from baseline to 4 weeks post-treatment. The registered study (NCT07187011, sponsored by San Diego Veterans Healthcare System) titrates PT150 150-900 mg over 7 days against placebo. As of its last registry update (2025-12-23) it was not yet recruiting, with an estimated start of April 2026 and estimated primary completion in March 2029. This is PT150's most advanced active indication.

Data current as of

Development timeline

Phase 2Sept 2025 – Mar 2029
  1. UpcomingClinicalTrials.gov estimated primary completion of the Phase 2 PT150 PTSD trial in veterans (NCT07187011): March 2029.
  2. Company announced FDA permission to proceed with the Phase 2a PTSD trial in U.S. veterans (DoD-funded, 120 veterans, San Diego and Houston VA medical centers).↗
  3. IND/CTA clearanceFDA clears Phase 2a trial of PT150 in U.S. veterans with PTSD↗
  4. Phase 2 PTSD trial NCT07187011 first posted on ClinicalTrials.gov (submitted 2025-09-15), status not yet recruiting.
  5. Trial registeredPhase 2 trial of PT150 in veterans with PTSD registered on ClinicalTrials.gov

Readouts

  • March 2029AnticipatedRegistry resultsNCT07187011

    ClinicalTrials.gov estimated primary completion of the Phase 2 PT150 PTSD trial in veterans (NCT07187011): March 2029.

Clinical trials in Post-traumatic stress disorder

NCT07187011H250195Phase 2Activen=120

Initial Study Testing Efficacy and Tolerability of PT150 for PTSD in Veterans

Started Apr 2026· Primary completion Mar 2029· 📍 2 sites across 1 country (United States)

Formulations

FormulationRouteRegimenPharmacokinetics
PT150 oral (150 mg capsules)
Organon Phase 2 (Protocol 28130): 150 mg capsules, 300 mg or 900 mg once daily in the evening with dinner for 2 weeks (900 mg arm titrated 300 -> 600 -> 900 mg over Days 1-3). Ethanol-interaction Phase 1: 900 mg/day. AUD human laboratory study NCT06712602: 225 mg then 450 mg twice daily for 5 days before each session. PTSD Phase 2 NCT07187011: 150-900 mg titrated over 7 days, 900 mg target dose.
Oral——

Mechanism of action (compound-wide)

Competitive antagonist of the glucocorticoid receptor (GR, NR3C1), a ligand-activated nuclear receptor. In AtT20 pituitary cells Org 34517 blocked corticosterone-induced GR nuclear translocation without inducing translocation itself (unlike mifepristone), and was described as a true competitive GR antagonist without partial agonist activity. In rats it occupied GR in the anterior pituitary and brain without occupying the mineralocorticoid receptor, and did not cause episodic HPA-axis activation on chronic dosing. The current sponsor describes PT150 as a modulator of both GR and the androgen receptor (AR): predominantly systemic GR antagonism in vivo, with direct AR down-regulation and minor GR agonism at the cellular level. In patients with psychotic depression it produced a dose-dependent rise in salivary cortisol, consistent with central GR blockade. The clinical hypothesis in PTSD and alcohol use disorder is that blocking GR signalling normalizes stress (HPA-axis) responses that drive symptoms, craving and stress-induced drinking.

TargetActionAffinity
Glucocorticoid receptorprimaryNR3C1Antagonist—ⓘ
Androgen receptorARModulator—ⓘ

← Full PT150 compound page (identity, identifiers, all indications)

Sources

  1. Differential effects of the new glucocorticoid receptor antagonist ORG 34517 and RU486 (mifepristone) on glucocorticoid receptor nuclear translocation in the AtT20 cell line. Ann N Y Acad Sci. 2008. doi:10.1196/annals.1410.072 — Annals of the New York Academy of Sciences / PubMed
  2. NCT07187011 (H250195) — Initial Study Testing Efficacy and Tolerability of PT150 for PTSD in Veterans (Phase 2, not yet recruiting) — ClinicalTrials.gov (U.S. National Library of Medicine)
  3. Organon N.V. Clinical Trial Report synopsis, Protocol 28130 — dose-finding study of Org 34517 (300 mg / 900 mg) as adjunctive therapy in psychotic major depression (EudraCT results attachment; copyright Merck Sharp & Dohme) — EU Clinical Trials Register (EMA) / Merck Sharp & Dohme
  4. Palisades Therapeutics Receives FDA Clearance to PROCEED with Phase 2a PTSD Trial of PT150 in U.S. Veterans (2026-02-19) — Pop Test Oncology LLC dba Palisades Therapeutics (via EIN Presswire)
  5. Theise ND, Arment AR, Chakravarty D, et al. Clinical stage molecule PT150 is a modulator of glucocorticoid and androgen receptors with antiviral activity against SARS-CoV-2. Cell Cycle. 2020. doi:10.1080/15384101.2020.1859752 — Cell Cycle (Taylor & Francis) / PubMed