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Lead program: Phase II
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Research, Drug Development & Manufacturing

Reset Pharma

Also known as: Reset Pharmaceuticals

Data updated

1 Drug Candidate

Reset Pharma is a US clinical-stage biotechnology company developing psilocybin-based treatments for patients with life-altering diseases. Its lead candidate RSTP1000 (oral psilocybin) targets demoralization syndrome in cancer patients — a condition with no approved treatments. In November 2023 the company received FDA IND clearance to initiate a Phase 2b multicenter, randomized, dose-ranging trial. The company holds an exclusive worldwide licence from NYU Langone Health and licenses drug supply from Filament Health Corp. Reset has raised $11.1M led by Merida Capital Partners.

Pipeline Intelligence

Developer Momentum

Programme tracker
Active candidates
1

All tracked candidates active

Active programmes
1

All tracked programmes active

Lead stage
Phase II

Current furthest stage

Forecast coverage
1 of 1

1 active programme with forecast fields

Latest sourced update

Reset Pharma focus page identifies proprietary RSTP-1000 for demoralization syndrome

Jun 26, 2026 - company-website - Reset Pharma - RSTP1000 (Oral Psilocybin, Botanical Source)

Next known catalyst

Phase II topline

Timing not specified - RSTP1000 (Oral Psilocybin, Botanical Source) / RSTP1000 Phase 2b Programme (Demoralization in Cancer) - Confidence: 55%

3 sources0 pipeline-linked trials0 pipeline-linked papers

Development Programmes

1

RSTP1000 (Oral Psilocybin, Botanical Source)

Psilocybin
Phase II
Palliative & End-of-Life Distress

Demoralization syndrome in cancer patients

Programme Tracker

Palliative & End-of-Life Distress

Primary: US (FDA)
Phase IIActive

Forecast

Phase II topline

FDA IND cleared November 2023 ("Safe to Proceed"); Phase 2b multicenter, randomized, dose-ranging, double-blind, parallel-group study; likely in site activation/early enrollment; quiet since IND clearance

Milestones

Licensing deal

Completed

Actual: Jul 7, 2021

Exclusive worldwide license from NYU Langone Health for psilocybin IP and clinical data in life-threatening diseases

Why it matters: NYU Langone produced seminal psilocybin-for-cancer-distress data (Griffiths/Ross et al.). This license gives Reset exclusive commercial rights to the most credible clinical dataset in psychedelic oncology. The NYU work demonstrated large, sustained anxiety/depression reductions in cancer patients at 6-month follow-up.

Reset Pharma Has Licensed Filament Botanical Psilocybin Drug Candidate(Press release)[Verified]

Funding milestone

Completed

Actual: Jun 1, 2022

$11.1M raised led by Merida Capital Partners

Why it matters: Merida Capital is a cannabis/psychedelic-focused fund with substantial portfolio. $11.1M positions Reset for Phase 2b trial execution.

Reset Pharma focus page identifies proprietary RSTP-1000 for demoralization syndrome(company-website)[Verified]

ind-filed

Completed

Actual: Nov 1, 2023

FDA "Safe to Proceed" notification for IND application for RSTP1000 Phase 2b in demoralization syndrome in cancer patients

Why it matters: FDA IND clearance for botanical-source psilocybin (via Filament Health) in demoralization is significant. Demoralization in cancer has NO FDA-approved treatment — this is an underserved indication with potential orphan-like regulatory positioning.

Reset Receives FDA Safe-to-Proceed Notice for RSTP1000 IND(Press release)[Verified]

Company milestone

Completed

Actual: Dec 1, 2023

Last public update; no enrollment milestones, site activations, or press releases since IND clearance

Why it matters: Over 2 years of silence post-IND is notable. Could indicate slow site activation (common for psychedelic trials requiring specialized therapist training) or funding/operational challenges. The trial is a complex multicenter design requiring site-level DEA licensing.

Watch next: Trial registration on ClinicalTrials.gov; first patient enrolled; site activation announcements

Reset Receives FDA Safe-to-Proceed Notice for RSTP1000 IND(Press release)[Verified]

Recorded Events

Dec 1, 2023: Company milestone

Nov 1, 2023: ind-filed

Jun 1, 2022: Funding milestone

Jul 7, 2021: Licensing deal

Evidence Links

Reset Pharma Has Licensed Filament Botanical Psilocybin Drug Candidate

Press release - Life Sciences BC / Filament Health - Aug 31, 2023 - Verified

Filament announced Reset licensed botanical psilocybin drug candidate PEX010/RSTP1000 for a Phase 2 trial in demoralization syndrome.

Reset Receives FDA Safe-to-Proceed Notice for RSTP1000 IND

Press release - Reset Pharma - Nov 1, 2023 - Verified

FDA safe-to-proceed notification allows Reset to conduct a Phase 2b dose-ranging trial of oral psilocybin RSTP1000 in patients with cancer and demoralization syndrome.

Reset Pharma focus page identifies proprietary RSTP-1000 for demoralization syndrome

company-website - Reset Pharma - Jun 26, 2026 - Verified

Company focus page reviewed June 26, 2026; page identifies RSTP-1000 as a proprietary psilocybin drug product for demoralization syndrome in cancer.

Similar Developers

Reference points selected from shared pipeline stage, indications, compounds, regulatory pathways, and evidence footprint.

View landscape
Diamond Therapeutics
Phase II1 active candidate2 trials
shared compound: Psilocybinsame indication: Palliative & End-of-Life DistressPhase II peersame regulator: US FDA
Psyence Biomedical
Phase II1 active candidate
shared compound: Psilocybinsame indication: Palliative & End-of-Life DistressPhase II peersimilar active pipeline size
Incannex Healthcare
Phase II1 active candidate
shared compound: PsilocybinPhase II peersame regulator: US FDAsimilar active pipeline size
Ceruvia Lifesciences
Phase II2 active candidates2 trials
shared compound: PsilocybinPhase II peersame regulator: US FDAsimilar active pipeline size

Quick Facts

Type
Private Biotech
Founded
2020
Lead Stage
Phase II
Website
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