Revive TherapeuticsCSE: RVV
Canadian biotech developing psilocybin formulations for substance use disorders and neurological conditions. Lead programme is an oral psilocybin thin-film strip in a Phase I/II clinical trial for methamphetamine use disorder, with approximately 50% enrolment completed. Also conducting preclinical research on psilocybin for stroke recovery and inflammation.
Development Programmes
2Bucillamine
Oral thiol-based drug with anti-inflammatory, antioxidant, and antiviral properties. Used in Japan/South Korea for rheumatoid arthritis for 30+ years. 16x more potent as thiol donor than NAC. Strategic pivot (Sep 2024) to focus on: (1) Long COVID — FDA Type C meeting Jun 2024, Phase 2 planned; (2) Nerve agent exposure — DRDC study nearing completion, Five Eyes stockpiling opportunity; (3) Ischemia-reperfusion injury in liver transplant — FDA Orphan Drug Designation (Feb 2022). Also exploring cancer (solid tumors), pandemic influenza (next-gen lyophilized formulation with Univ. of Waterloo), and TBI.
Programme Tracker
Neurological Injury
Phase 2 Long COVID study planned. FDA Type C meeting (Jun 2024) recommended new IND with cross-reference to prior COVID-19 IND (NCT04504734, Phase 3, terminated by DSMB). IND submission targeted Q1 2025; FDA approval of protocol expected Q2 2025. No confirmation IND has been filed. Extremely limited cash ($14,560 as of Jun 2025).
Milestones
Trial start
CompletedActual: Nov 1, 2020
Phase 3 clinical trial (NCT04504734) initiated for bucillamine in acute COVID-19 (mild-moderate). ~1,000+ patients enrolled across multiple sites.
Why it matters: Largest clinical trial for bucillamine in a novel indication. Although terminated by DSMB (primary endpoint unlikely to be met), secondary data showed 29.1% improvement in oxygen saturation normalisation for patients with baseline SpO2 <96% and zero deaths in treatment arm.
Company milestone
CompletedActual: Sep 1, 2024
Strategic pivot: Revive announces primary focus on bucillamine for infectious diseases and medical countermeasures. Psilocybin, CBD, and other programs deprioritised.
Why it matters: Concentrates limited resources on the most commercially viable programme. Bucillamine has 30+ years of safety data from RA use in Japan/South Korea — de-risks new indication development.
ip-milestone
CompletedActual: Mar 10, 2026
Canadian Patent No. 3,172,170 granted — "Use of Bucillamine in the Treatment of Infectious Diseases." Expires March 2041. US + Canadian patent applications filed for nerve agent exposure treatment (PCT/CA2024/000008).
Why it matters: IP protection for bucillamine in infectious diseases secured through 2041. Nerve agent patent filing positions for Five Eyes government procurement contracts.
Recorded Events
Mar 10, 2026: ip-milestone
Sep 1, 2024: Company milestone
Nov 1, 2020: Trial start
Neurological Injury
Research study with Defence R&D Canada (DRDC) — Suffield Research Centre nearing completion (targeted Sep 2025). Bucillamine for nerve agent-induced brain injury (sarin, soman, tabun, VX). Health Canada approval for strategic stockpiling targeted 2026. Five Eyes procurement opportunity (Canada, US, UK, Australia, NZ).
Milestones
data-readout
In progressActual: Jun 26, 2025
DRDC nerve agent countermeasure study nears completion. Results pending DRDC authorisation for publication. Health Canada approval for strategic stockpiling targeted 2026.
Why it matters: Government medical countermeasure contracts represent a potentially large revenue source not dependent on traditional pharma financing. Five Eyes procurement could be significant if efficacy confirmed.
Recorded Events
Jun 26, 2025: data-readout
Evidence Links
company-website - Revive Therapeutics - Verified
Psilocybin (Multiple Formulations)
Multiple psilocybin formulations acquired via Psilocin Pharma Corp. ($2.75M, Mar 2020): oral capsules, sublingual spray, gel cap, effervescent tablets, breath strips. Novel delivery: oral thin film (OTF) strip with Univ. of Wisconsin-Madison/WARF; MicroDose-MN™ biodegradable microneedle patch with PharmaTher. Phase 1/2 trial for methamphetamine use disorder (NCT05322954) actively recruiting at UW-Madison (12 pts, ~50% enrolled Apr 2024). DEPRIORITISED in Sep 2024 strategic pivot to bucillamine, but MUD trial continues under investigator-initiated IND. Also exploring TBI (FDA ODD application filed Apr 2021) and stroke (preclinical pub in BMC Neuroscience Nov 2024).
Programme Tracker
Substance Use Disorders (SUD)
Phase 1/2 open-label trial actively recruiting at University of Wisconsin-Madison (PI: Dr. Christopher Nicholas). Investigator-initiated IND. Target 12 participants; ~50% enrolled as of April 2024. Initial efficacy "encouraging" per company. Continues despite Sep 2024 bucillamine pivot — runs under academic IND, not company-sponsored.
Milestones
Trial start
CompletedActual: Mar 1, 2023
First patient enrolled in Phase 1/2 psilocybin trial for methamphetamine use disorder (NCT05322954) at University of Wisconsin-Madison.
Why it matters: One of the first clinical trials studying psilocybin specifically for methamphetamine use disorder. MAUD has zero approved treatments. Academic IND means trial can continue even as Revive deprioritises psilocybin internally.
Recorded Events
Mar 1, 2023: Trial start
Evidence Links
Press release - GlobeNewswire - Nov 12, 2024 - Verified
Quick Facts
- Type
- Public Biotech
- Ticker
- CSE: RVV
- Lead Stage
- Phase II
- Website
- Visit