Helus Pharma
Phase III2 active candidates
shared compound: Psilocybinsame indication: Major Depressive Disorder (MDD)Phase III peersame regulator: US FDA
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Lead program: Phase III
Categories
1 domain / 3 areas / 2 specializations
Usona Institute
Data updated
2800 Woods Hollow Rd., Madison, WI, United States
2 Drug Candidates23 Trials
Usona Institute is a US-based 501(c)(3) non-profit medical research organisation headquartered in Madison, Wisconsin. Usona develops and supports clinical research on psilocybin and other consciousness-expanding medicines with a mission-driven access model.
Its psilocybin programme received FDA Breakthrough Therapy Designation for major depressive disorder in 2019. After completing the Phase 2 PSIL201 study, Usona launched the Phase 3 uAspire trial in 2024, a 240-participant randomised, double-blind multicentre study of 25 mg psilocybin with psychosocial support for adults with MDD. In April 2026, industry reporting said Usona confirmed it had received an FDA Commissioner National Priority Voucher for psilocybin in MDD, potentially shortening review if an NDA is filed and accepted. Usona is also exploring 5-MeO-DMT in early-stage research.
Manufacturing Snapshot
Research-Led (Partner Manufacturing)Scope & Capabilities
Regulatory / CMC SupportAnalytical / QC Testing
Supply Use Cases
Clinical TrialsResearch Use
GxP / Compliance
General GxP
Facilities & Access
Non-profit research model coordinating investigational drug supply through regulated development pathways.
Manufacturing DetailsSupported Substances
Psilocybin investigational supply and quality/CMC coordination in support of clinical trial programs.
Manufacturing Sources
Pipeline Intelligence
Developer Momentum
- Active candidates
- 2
- Active programmes
- 2
- Lead stage
- Phase III
- Forecast coverage
- 2 of 2
All tracked candidates active
All tracked programmes active
Multiple active stages
2 active programmes with forecast fields
Latest sourced update
Usona Institute 5-MeO-DMT Program
Jun 26, 2026 - company-website - Usona Institute - 5-MeO-DMT
Next known catalyst
nda-submission
Q4 2026 - Psilocybin (25 mg) / uAspire (PSIL301) — Psilocybin MDD Phase 3 - Confidence: 65%
9 sources2 pipeline-linked trials0 pipeline-linked papers1 Phase III1 Preclinical
Development Programmes
2Psilocybin (25 mg)
PsilocybinPhase III
Synthetic psilocybin (25 mg oral, single dose) for major depressive disorder, administered with psychosocial support. FDA Breakthrough Therapy Designation was granted in 2019. Phase 3 uAspire (PSIL301, NCT06308653) is ongoing. In April 2026, industry reporting said Usona confirmed receipt of an FDA Commissioner National Priority Voucher for psilocybin in MDD.
Programme Tracker
Major Depressive Disorder (MDD)
Primary: US (FDA)
Phase IIIActive
Forecast
nda-submission - Likely: Q4 2026 - Approval eventual: 55%
uAspire (NCT06308653) remains the active Phase 3 MDD study. Usona has an official Phase 3 sponsor statement on uAspire, and industry reporting in April 2026 said Usona confirmed receipt of an FDA Commissioner National Priority Voucher for psilocybin in MDD.
Milestones
Phase II topline
CompletedActual: Sep 5, 2023
Phase 2 PSIL201 results published in JAMA: single 25 mg psilocybin dose produced rapid, sustained antidepressant effect vs active placebo over 6 weeks (n=104)
Why it matters: JAMA publication provides the strongest evidence base for the Phase 3 programme; high-profile journal validates the clinical approach
Watch next: Phase 3 uAspire enrolment and completion
Phase III started
CompletedActual: Mar 19, 2024
Phase 3 uAspire study (PSIL301, NCT06308653) launched — ~240 adults, multi-site including VA, 6-week double-blind + 12-month follow-up
Why it matters: Pivotal study required for NDA submission; Usona's non-profit model means results will inform regulatory submissions without commercial licensing barriers
Watch next: Enrollment completion, topline results, NDA submission
Regulatory review accepted
CompletedActual: Nov 22, 2019
FDA granted BTD to Usona's psilocybin programme for MDD — one of the first psilocybin BTDs granted
Why it matters: BTD provides expedited development pathway and closer FDA collaboration; signals FDA recognition of unmet need in MDD
Watch next: Phase 2 results and Phase 3 launch
Recorded Events
Mar 19, 2024: Phase III started
Sep 5, 2023: Phase II topline
Nov 22, 2019: Regulatory review accepted
Evidence Links
NCT06308653 — uAspire Phase 3 Study (Psilocybin MDD)
trial-registry - ClinicalTrials.gov - Jun 1, 2026 - Verified
Usona Institute — Drug Development
company-website - Usona Institute - Apr 29, 2022 - Verified
5-MeO-DMT
5-MeO-DMTPreclinical
Synthetic 5-MeO-DMT (designated MEO201) for a planned Phase 2 efficacy study. GMP active and placebo drug product manufactured; analytical testing, initial stability, method validation, compendial testing, CMC documentation, draft MEO201 protocol, vendor selection, and study start-up processes were reported in Usona Impact 2025. No public Phase 2 launch registration was found in the June 2026 sweep.
Programme Tracker
Depressive Disorders
Primary: US (FDA)
Pre-clinicalActive
Forecast
Phase II started - Likely: Q4 2026
Usona reports completed CMC, manufacturing, protocol, vendor-selection, and study start-up work positioning MEO201 to move into Phase 2 efficacy studies. No public Phase 2 launch registration or first-patient announcement was found in the June 2026 sweep, so this remains a waiting-on-news Phase 2-start watch item.
Milestones
Pre-clinical completed
CompletedActual: Dec 1, 2024
GMP manufacturing of 5-MeO-DMT drug product complete; CMC documentation for IND finalized; Type B FDA meeting completed under BTD
Why it matters: IND-enabling package readies Usona for regulatory submission to initiate Phase 2
Watch next: IND submission and Phase 2 first patient dosing
Phase II started
PlannedLikely: Q4 2026
Original mid-2025 Phase 2 target is now stale; Usona 2025 reporting supports Phase 2 readiness but not public launch.
Why it matters: Would be Usona's second clinical-stage programme; non-profit access model for 5-MeO-DMT distinct from commercial competitors
Watch next: Phase 2 efficacy-study registry, site activation, first-patient dosing, or Usona launch announcement.
Recorded Events
Dec 1, 2024: Pre-clinical completed
Evidence Links
Usona Institute 5-MeO-DMT Program
company-website - Usona Institute - Jun 26, 2026 - Verified
Usona page says all dosing sessions were completed for its Phase 1 first-in-human 5-MeO-DMT study.
ClinicalTrials.gov NCT05698095 - Intramuscular 5-MeO-DMT
clinical-trial-registry - ClinicalTrials.gov - Nov 30, 2023 - Verified
Phase 1 randomized study of intramuscular 5-MeO-DMT safety, pharmacokinetics, and tolerability in healthy volunteers.
Usona Impact - Drug Development 2025
company-report - Usona Institute - Jan 1, 2025 - Verified
Usona 2025 report says CMC/manufacturing milestones position the 5-MeO-DMT programme to move into Phase 2 efficacy studies.
Similar Developers
Reference points selected from shared pipeline stage, indications, compounds, regulatory pathways, and evidence footprint.
Reunion Neuroscience
Phase III4 active candidates
shared compound: Psilocybinsame indication: Depressive DisordersPhase III peer2 overlapping stages
Otsuka Pharmaceutical
Phase III2 active candidates
shared compound: Psilocybinsame indication: Major Depressive Disorder (MDD)Phase III peersame regulator: US FDA
Biomind Labs
Phase II2 active candidates3 trials
shared compound: 5-MeO-DMTsame indication: Major Depressive Disorder (MDD)also active in Preclinicalsame regulator: US FDA
Quick Facts
- Type
- Non-Profit
- Founded
- 2014
- Lead Stage
- Phase III
- HQ
- 2800 Woods Hollow Rd., Madison, WI, United States
- Website
- Visit