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Research, Drug Development & ManufacturingCompany-Led Drug Development & Commercialization
Lead program: Phase II

Reset Pharma

Also known as: Reset Pharmaceuticals

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.

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

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.

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.

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.

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

Recorded Events

Dec 1, 2023: Company milestone

Nov 1, 2023: ind-filed

Jun 1, 2022: Funding milestone

Jul 7, 2021: Licensing deal

Quick Facts

Type
Private Biotech
Founded
2020
Lead Stage
Phase II
Website
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