Drugs / PP-01
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT05494437 | Oct 2022 → Aug 2023 | substance withdrawal syndrome | PleoPharma, Inc. | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT07644052 | Jun 2026 → Jun 2027 expected | substance withdrawal syndrome | PleoPharma, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-08-28 | PleoPharma, Inc. | Results Proof‐of‐concept trial of PP‐01 for mitigating cannabis withdrawal syndrome in participants with cannabis use disorder pleopharma.com ↗
PP-01 Reduced Symptoms of Cannabis Withdrawal in a Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Clinical Trial |
| 2025-06-19 | PleoPharma, Inc. | Results PLEOPHARMA, INC. Presents Positive Cannabis Withdrawal Clinical Trial Results at The College on Problems of Drug Dependence Annual Meeting pleopharma.com ↗
PP-01 significantly reduced Cannabis Withdrawal Scores compared to placebo (P value < 0.02). |
| 2025-02-13 | PleoPharma, Inc. | Regulatory FDA GRANTS FAST TRACK DESIGNATION TO PLEOPHARMA, INC's INVESTIGATIONAL NEW DRUG, PP-01, FOR THE MITIGATION OF CANNABIS WITHDRAWAL SYMPTOMS IN PATIENTS WITH CANNABIS USE DISORDER: pleopharma.com ↗
PleoPharma, Inc., a privately held company focused on finding treatments for cannabis related health issues, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, its lead asset, for the mitigation of Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder. |
| 2024-11-18 | PleoPharma, Inc. | Results PLEOPHARMA, INC. Presents Positive Cannabis Withdrawal Clinical Trial Results at AAAP Annual Meeting pleopharma.com ↗
Compared to placebo, PP-01 administered once daily significantly reduced mean CWS ratings beginning 4 hours post first dose of PP-01 (first measured timepoint). |
| 2024-09-05 | PleoPharma, Inc. | Results PLEOPHARMA, INC. REPORTS POSITIVE PHASE 2b CLINICAL TRIAL DATA FOR MITIGATION OF CANNABIS WITHDRAWAL: A POTENTIAL FIRST IN CLASS TREATMENT pleopharma.com ↗
Participants in the study demonstrated statistically significant reductions in cannabis withdrawal symptoms with PP-01 vs. Placebo. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PP-01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05494437 ↗ |
| Action | Activate | “Cannabinoid-1 (CB1) partial agonist” NCT05494437 ↗ |
| Route | Oral | “Oral PP-01 High Dose tapered/titrated over 34 days” NCT05494437 ↗ |