Helus Pharma
Phase III2 active candidates
shared compound: Psilocybinsame indication: Anxiety DisordersPhase III peer2 overlapping stages
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Lead program: Phase III
Categories
1 domain / 2 areas / 1 specialization
Reunion Neuroscience
Data updated
Toronto, Ontario, Canada, Canada
4 Drug Candidates
Reunion Neuroscience is a private, Toronto-based clinical-stage biopharmaceutical company focused on short-duration, serotonergic psychedelic therapies for postpartum depression, adjustment disorder, and anxiety. Spun out of Field Trip Health in 2022, the company raised a $103M Series A in May 2024 (co-led by Novo Holdings and MPM BioImpact) and went private under CEO Greg Mayes. Its lead asset RE104 (luvesilocin) — a subcutaneous prodrug of 4-OH-DiPT, a psilocybin-like 5-HT2A agonist with shorter duration than psilocybin — met the primary endpoint of its RECONNECT Phase 2 trial for PPD (Aug 2025) and received FDA Breakthrough Therapy Designation on February 23, 2026. A single pivotal Phase 3 trial is planned for 2026.
Pipeline Intelligence
Developer Momentum
- Active candidates
- 4
- Active programmes
- 4
- Lead stage
- Phase III
- Forecast coverage
- 4 of 4
All tracked candidates active
All tracked programmes active
Multiple active stages
4 active programmes with forecast fields
Latest sourced update
Reunion Neuroscience Programs - RE245
Jun 27, 2026 - company-website - Reunion Neuroscience - RE245
Next known catalyst
Phase III started
Q4 2026 - RE104 (luvesilocin) / RECONNECT — RE104 PPD Phase 2→Phase 3 - Confidence: 65%
11 sources0 pipeline-linked trials0 pipeline-linked papers1 Phase III2 Phase II1 Preclinical
Development Programmes
4RE104 (luvesilocin)
PsilocybinPhase III
RE104 (luvesilocin) is a subcutaneously administered prodrug of 4-OH-DiPT (a serotonin 2A agonist) producing a short psychedelic experience. Lead indication: postpartum depression (PPD). RECONNECT Phase 2 met its primary endpoint, FDA granted Breakthrough Therapy Designation in February 2026, and Reunion says it has aligned with FDA on a single pivotal Phase 3 path expected to start in 2026.
Programme Tracker
Peripartum
Primary: US (FDA)
Phase IIIActive
Forecast
Phase III started - Likely: Q4 2026 - Approval eventual: 50%
FDA granted Breakthrough Therapy Designation for luvesilocin in PPD on 2026-02-23 after positive RECONNECT Phase 2 data. Reunion says it has aligned with FDA on a registrational path and expects a single pivotal Phase 3 trial in 2026, with the next public watch item being trial registration or first-patient-in.
Milestones
Phase II started
CompletedActual: Jul 23, 2024
First patient dosed in RECONNECT Phase 2 (NCT06342310, 38 US sites, 84 patients)
Why it matters: Initiates the pivotal Phase 2 in an under-served indication (PPD affects ~1 in 7 women post-birth)
Watch next: Enrollment completion and topline results
Phase II topline
CompletedActual: Aug 18, 2025
RECONNECT Phase 2 topline results: statistically significant primary endpoint met — MADRS reduction 23.0 pts at Day 7 (30 mg arm) vs 17.2 pts (1.5 mg control; p=0.0094). Effects observed at Day 1, maintained through Day 28. No serious adverse events.
Why it matters: Clear proof-of-concept in PPD — a significant unmet need; rapid onset (Day 1) differentiates RE104 from standard antidepressants which take weeks
Watch next: EOP2 meeting with FDA and Phase 3 launch
Phase III started
PlannedLikely: Q3 2026
Phase 3 single pivotal trial planned for 2026; FDA indicated one additional Phase 3 trial is sufficient for potential NDA registration following positive EOP2 meeting (December 2025)
Why it matters: Single pivotal trial path minimises risk and cost; if successful, this could be the first psychedelic medicine approved for PPD
Watch next: Phase 3 ClinicalTrials.gov registration and first patient dosing
Regulatory review accepted
CompletedActual: Feb 23, 2026
FDA granted Breakthrough Therapy Designation to luvesilocin (RE104) for PPD
Why it matters: BTD accelerates development and provides intensive FDA guidance; validates luvesilocin's profile in PPD and strengthens Phase 3 design
Watch next: Phase 3 initiation (2026)
Recorded Events
Feb 23, 2026: Regulatory review accepted
Aug 18, 2025: Phase II topline
Jul 23, 2024: Phase II started
Evidence Links
NCT06342310 — RECONNECT Phase 2 (RE104 PPD)
clinical-trial-registry - ClinicalTrials.gov - May 14, 2026 - Verified
ClinicalTrials.gov registry for RECONNECT Phase 2 PPD study; last update posted 2026-05-14.
Reunion Neuroscience — 2026 Programme Updates and Milestones
Press release - Reunion Neuroscience - Jan 12, 2026 - Verified
RE104 (luvesilocin)
PsilocybinPhase II
RE104 (luvesilocin) for adjustment disorder (AjD) in adults with cancer and other serious medical illnesses. REKINDLE (NCT07002034) is a randomized, double-blind Phase 2 study; Reunion announced first patient dosed on 2025-09-30 and said topline results are anticipated in 2027.
Programme Tracker
Palliative & End-of-Life Distress
Primary: US (FDA)
Phase IIActive
Forecast
Phase II topline - Likely: Q1 2027
REKINDLE Phase 2 is recruiting in adjustment disorder related to cancer and other medical illnesses. ClinicalTrials.gov lists estimated primary completion in November 2026, and Reunion has guided to topline results in 2027.
Milestones
Phase II started
CompletedActual: Apr 7, 2025
REKINDLE Phase 2 (NCT07002034) presented at ADAA 2025; study evaluates RE104 in adjustment disorder in cancer and other serious illness
Why it matters: AjD in cancer patients is an under-served and sympathetic regulatory indication with precedent for expedited review
Watch next: Enrollment milestone and topline data
Recorded Events
Apr 7, 2025: Phase II started
Evidence Links
NCT07002034 — REKINDLE Phase 2 (RE104 Adjustment Disorder)
clinical-trial-registry - ClinicalTrials.gov - Jun 3, 2026 - Verified
ClinicalTrials.gov registry for REKINDLE Phase 2 AjD study; last update posted 2026-06-03.
RE104 (luvesilocin)
PsilocybinPhase II
RE104 (luvesilocin) for generalized anxiety disorder (GAD). RECLAIM (NCT07489651) is now registered as a Phase 2 study in adults with GAD; Reunion says Phase 2 data are expected in Q2 2027.
Programme Tracker
Anxiety Disorders
Primary: US (FDA)
Phase IIActive
Forecast
Phase II topline - Likely: Q2 2027
RECLAIM Phase 2 is recruiting for generalized anxiety disorder. ClinicalTrials.gov lists an actual study start in April 2026 and an estimated primary completion in February 2027; Reunion expects clinical data in Q2 2027.
Milestones
Phase II started
PlannedLikely: Q1 2026
RECLAIM Phase 2 in GAD planned; announced as an anticipated 2026 milestone in January 2026 programme update
Why it matters: GAD is a large indication; positive signal here combined with PPD Phase 3 data would significantly broaden RE104's commercial potential
Watch next: ClinicalTrials.gov registration and first patient dosing
Evidence Links
ClinicalTrials.gov NCT07489651 - RE104 in Generalized Anxiety Disorder
clinical-trial-registry - ClinicalTrials.gov - Jun 26, 2026 - Verified
ClinicalTrials.gov registry for RECLAIM Phase 2 GAD study; refreshed on 2026-06-26 during source review.
Reunion Announces Program Updates and 2026 Milestones
Press release - Reunion Neuroscience - Jan 12, 2026 - Verified
Reunion said it was on track to initiate the Phase 2 RECLAIM trial of RE104 in generalized anxiety disorder in Q1 2026.
Reunion to Present Full RECONNECT Data at ASCP and APA
Press release - Reunion Neuroscience - May 11, 2026 - Verified
May 2026 update says Reunion is enrolling the Phase 2 RECLAIM trial in patients with GAD.
RE245
Preclinical
RE245 is a non-psychedelic, orally bioavailable serotonin 2A (5-HT2A) agonist neuroplastogen designed for chronic treatment paradigms. Structurally related to classic psychedelics but engineered to deliver 5-HT2A-mediated neuroplasticity without hallucination or cardiotoxicity. IND-enabling studies planned 2025; IND application targeted 2026.
Programme Tracker
Depressive Disorders
Primary: US (FDA)
Pre-clinicalActive
Forecast
Regulatory filing submitted - Likely: Q4 2026
RE245 remains Reunion's lead non-psychedelic discovery-stage 5-HT2A agonist. Reunion reiterated in February, May, and June 2026 that it plans to file an IND in 2026; no IND submission or clearance announcement was found in this pass.
Milestones
Discovery completed
CompletedActual: Jan 6, 2025
RE245 preclinical programme disclosed publicly; non-psychedelic 5-HT2A agonist for chronic oral dosing paradigm
Why it matters: Non-psychedelic profile could address a much larger patient population who cannot or will not access supervised psychedelic therapy
Watch next: IND-enabling study completion and IND submission
Recorded Events
Jan 6, 2025: Discovery completed
Evidence Links
Reunion Neuroscience Programs - RE245
company-website - Reunion Neuroscience - Jun 27, 2026 - Verified
Programmes page describes RE245 as a discovery-stage, orally bioavailable non-psychedelic 5-HT2A agonist.
Reunion Announces Program Updates and 2026 Milestones
Press release - Reunion Neuroscience - Jan 12, 2026 - Verified
Reunion states it advanced RE245 from its non-psychedelic discovery programme and plans to file an IND in 2026.
Reunion to Present RECONNECT Phase 2 Data
Press release - Reunion Neuroscience - May 11, 2026 - Verified
May 2026 update repeats RE245 IND-plan language while focusing on Reunion clinical-stage pipeline progress.
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Quick Facts
- Type
- Private Biotech
- Founded
- 2020
- Lead Stage
- Phase III
- HQ
- Toronto, Ontario, Canada, Canada
- Website
- Visit