Lead program: Phase II

Ceruvia Lifesciences

Data updated June 26, 2026

USA, United States

2 Drug Candidates2 Trials

Ceruvia Lifesciences is a US-based clinical-stage biopharmaceutical company founded in 2017 by philanthropist Carey Turnbull, focused on developing neurotransformational medicines for neurological and psychiatric disorders. The company was the world's first producer of cGMP-certified LSD and its non-hallucinogenic analogue BOL-148. Ceruvia is advancing SYNP-101 (synthetic psilocybin) through Phase 2 trials for OCD, alcohol use disorder, and migraine/headache disorders, and NYPRG-101 (BOL-148) for cluster headache. Collaborators include Yale University, the Heffter Research Institute, Usona Institute, NYU, and Clusterbusters.

Pipeline Intelligence

Developer Momentum

Programme tracker

Active candidates: 2
Active programmes: 3
Lead stage: Phase II
Forecast coverage: 3 of 3

Latest sourced update

Ceruvia Research - BOL-148 / NYPRG-101

Jun 26, 2026 - company-website - Ceruvia Lifesciences - NYPRG-101 (BOL-148)

Next known catalyst

Phase III started

Timing not specified - SYNP-101 (Synthetic Psilocybin) / SYNP-101 Phase 2 Programme (OCD) - Confidence: 40%

7 sources0 pipeline-linked trials0 pipeline-linked papers1 Phase II1 Phase I

Development Programmes

SYNP-101 (Synthetic Psilocybin)

Psilocybin

Phase II

Obsessive-Compulsive Disorder (OCD)Alcohol Use Disorder (AUD)Headache Disorders (Cluster & Migraine)

OCD / alcohol use disorder / cluster headache

Programme Tracker

Obsessive-Compulsive Disorder (OCD)

Primary: US (FDA)

Phase IIActive

Forecast

Phase III started

SYNP-101 has FDA IND clearance for a Phase 2 OCD trial and a related Frontiers in Psychiatry/Yale publication dated 2025-12-10. No public Phase 3 start, partnership, or sponsor status-changing update was found in the June 2026 sweep; keep as waiting-on-news pending new Ceruvia/Yale/B.More evidence.

Milestones

Phase II topline

Completed

Actual: Jun 1, 2025

Phase 2 RCT positive results — clinically significant OCD symptom reduction; SSRN preprint published 2025

Why it matters: Positive RCT data from Yale published as a preprint (2025) is the first double-blind evidence for psilocybin in treatment-resistant OCD, supporting progression to Phase 3.

Watch next: Peer-reviewed journal publication and Phase 3 design announcement

Frontiers in Psychiatry psilocybin OCD qualitative trial publication(Publication)[Verified]

Regulatory filing submitted

Completed

Actual: Jun 1, 2022

FDA IND cleared for SYNP-101 OCD programme

Why it matters: OCD affects ~1-2% of the population, and ~40% of patients fail to respond adequately to SSRIs or CBT. Ceruvia's Yale collaboration (Pittenger/Kelmendi lab) brings world-class OCD expertise. The double-blind RCT design (SYNP-101 vs niacin active placebo) will generate the highest-quality evidence base for psilocybin in OCD.

Ceruvia FDA IND approval for SYNP-101 OCD Phase 2 trial(Press release)[Verified]

Recorded Events

Jun 1, 2025: Phase II topline

Jun 1, 2022: Regulatory filing submitted

Alcohol Use Disorder (AUD)

Primary: US (FDA)

Phase IIActive

Phase 2b in planning; builds on Bogenschutz/NYU psilocybin AUD Phase 2a evidence

Milestones

Phase II started

In progress

Likely: Q2 2026

Why it matters: Ceruvia is supporting the next stage after Bogenschutz's landmark NYU psilocybin AUD trial (JAMA Psychiatry 2022). A powered Phase 2b would be a key step toward NDA filing for psilocybin in AUD.

Watch next: Trial registration and Phase 2b initiation announcement

B.More FDA IND approval for SYNP-101 AUD Phase 2b trial(Press release)[Verified]

Evidence Links

SSRN preprint for psilocybin OCD study

Publication - SSRN - Jan 1, 2026 - plausible

Ceruvia FDA IND approval for SYNP-101 OCD Phase 2 trial

Press release - Ceruvia Lifesciences / PRNewswire - Jun 27, 2022 - Verified

FDA cleared Ceruvia IND for a 105-participant Phase 2 OCD trial of synthetic psilocybin (SYNP-101).

Frontiers in Psychiatry psilocybin OCD qualitative trial publication

Publication - Frontiers in Psychiatry / Yale School of Medicine - Dec 10, 2025 - Verified

Related Yale/Ceruvia psilocybin OCD trial publication; article reports the randomized trial closed enrollment in May 2024 and cites clinically significant OCD symptom reductions at the 48-hour endpoint.

B.More FDA IND approval for SYNP-101 AUD Phase 2b trial

Press release - B.More / PRNewswire - Aug 25, 2022 - Verified

FDA cleared B.More IND for a 226-participant Phase 2b AUD trial of synthetic psilocybin (SYNP-101), with initiation planned for early 2023.

NYPRG-101 (BOL-148)

LSD

Phase I

Headache Disorders (Cluster & Migraine)

Migraine prevention / cluster headache

Programme Tracker

Headache Disorders (Cluster & Migraine)

Primary: US (FDA)

Phase IActive

Forecast

programme-status-update

IND submitted for NYPRG-101 migraine prevention in June 2022 and first participant dosed in Phase 1 in January 2023; no newer public trial registry or company status update found in this pass.

Milestones

Regulatory filing submitted

Completed

Actual: Jun 1, 2022

FDA IND submitted for NYPRG-101 Phase 1 single ascending dose study (migraine prevention)

Why it matters: NYPRG-101 (BOL-148, 2-bromo-LSD) is a non-hallucinogenic LSD analog that blocks 5-HT2A rather than activating it. Case reports and historical data suggest it aborts cluster headache attacks without psychedelic effects. Ceruvia's Phase 1 is the first systematic safety study of BOL-148 in modern GCP conditions.

Watch next: Phase 1 safety and tolerability results in healthy volunteers

Ceruvia Submits FDA IND for NYPRG-101 Migraine Prevention Programme(Press release)[Verified]

Recorded Events

Jun 1, 2022: Regulatory filing submitted