PT150 · program

PT150 (Org 34517) for Alcohol use disorder

Phase 1ActivePop 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 alcohol use disorder, on the hypothesis that blocking stress-hormone (GR) signalling reduces stress-induced drinking and the behavioural effects of alcohol. Clinical work so far is Phase 1. Two ethanol-interaction studies in healthy, alcohol-experienced volunteers at the Michael E. DeBakey VA Medical Center (NCT03548714, completed 2019; NCT04331288, completed 2023) found no significant pharmacokinetic interaction between PT150 900 mg/day and ethanol in either direction, and no serious adverse events or clinically significant ECG abnormalities (J Addict Med 2025). A Phase 1 human laboratory study in people with AUD (NCT06712602), started February 2025 and recruiting, tests 225 mg and 450 mg twice daily before alcohol-administration and cold-pressor stress sessions. Estimated primary completion is July 2028.

Data current as of

Development timeline

Phase 1Sept 2018 – Jul 2028
  1. UpcomingClinicalTrials.gov estimated primary completion of the PT150 human laboratory study in alcohol use disorder (NCT06712602): July 2028.
  2. metPhase 1 ethanol-interaction study of PT150: no significant pharmacokinetic interaction with alcohol and no serious adverse events (J Addict Med, 2025).↗
  3. Phase 1 human laboratory study in alcohol use disorder NCT06712602 started (NIAAA-funded, 34 participants estimated); recruiting as of its 2026-09-16 registry update.
  4. Trial startedPhase 1 human laboratory study of PT150 in alcohol use disorder begins
  5. Trial (portion) completedPhase 1 ethanol pharmacokinetic-interaction study of PT150 completes
  6. Phase 1 ethanol pharmacokinetic-interaction study NCT04331288 started (completed 2023-10-27; results published J Addict Med 2025: no significant PK interaction, no serious adverse events).
  7. First Pop Test Oncology study of PT150 with alcohol (NCT03548714) started, a Phase 1 safety study of PT150 taken concurrently with alcohol; completed 2019-07-15.

Readouts

  • July 2028AnticipatedRegistry resultsNCT06712602

    ClinicalTrials.gov estimated primary completion of the PT150 human laboratory study in alcohol use disorder (NCT06712602): July 2028.

  • 2025-08-11ReportedFull resultsmetNCT04331288

    Phase 1 ethanol-interaction study of PT150: no significant pharmacokinetic interaction with alcohol and no serious adverse events (J Addict Med, 2025). ↗

Clinical trials in Alcohol use disorder

NCT0671260290580Phase 1Recruitingn=34

Selective Glucocorticoid Receptor Antagonism in Alcohol Use Disorder: A Human Laboratory Study

Started Feb 2025· Primary completion Jul 2028· 📍 1 site across 1 country (United States)

NCT04331288AS140026-A3cPhase 1Completedn=10

Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517) (PT150 PK Study)

Started Nov 2021· Primary completion Oct 2023· 📍 1 site across 1 country (United States)

metprimaryPharmacokinetic interaction between PT150 (900 mg/day) and ethanol (Cmax, tmax, t1/2, AUC)

No statistically significant effect of ethanol on PT150 pharmacokinetics, or of PT150 on ethanol pharmacokinetics; no clinically significant abnormal ECGs or serious adverse events. Authors conclude the data support evaluating PT150 in future AUD trials.

NCT03548714AS140026-A3.bPhase 1Completedn=10

Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol

Started Sept 2018· Primary completion Jul 2019· 📍 1 site 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. NCT03548714 (AS140026-A3.b) — Safety of PT150 (Formerly ORG34517) When Taken Concurrently With Alcohol (Phase 1, completed) — ClinicalTrials.gov (U.S. National Library of Medicine)
  3. NCT04331288 (AS140026-A3c) — Effects of Ethanol on the Pharmacokinetics of PT-150 (Formerly ORG34517) (Phase 1, completed) — ClinicalTrials.gov (U.S. National Library of Medicine)
  4. NCT06712602 (90580) — Selective Glucocorticoid Receptor Antagonism in Alcohol Use Disorder: A Human Laboratory Study (Phase 1, recruiting) — ClinicalTrials.gov (U.S. National Library of Medicine)
  5. 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
  6. 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
  7. Vaughan A, Mensah CK, Pennycuff J, et al. Pharmacokinetic Interactions Between Ethanol and PT150, a Selective Glucocorticoid Receptor Antagonist, in Healthy Volunteers. J Addict Med. 2025 (epub 2025-08-11). doi:10.1097/ADM.0000000000001557 — Journal of Addiction Medicine / PubMed