Ceruvia Lifesciences
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.
Development Programmes
2SYNP-101 (Synthetic Psilocybin)
PsilocybinOCD / alcohol use disorder / cluster headache
Programme Tracker
Obsessive-Compulsive Disorder (OCD)
Phase 2 RCT at Yale University (NCT03356483, PIs: Kelmendi and Pittenger); FDA IND cleared June 2022; 105 participants
Milestones
Phase II topline
CompletedActual: 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
Regulatory filing submitted
CompletedActual: 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.
Recorded Events
Jun 1, 2025: Phase II topline
Jun 1, 2022: Regulatory filing submitted
Alcohol Use Disorder (AUD)
Phase 2b in planning; builds on Bogenschutz/NYU psilocybin AUD Phase 2a evidence
Milestones
Phase II started
In progressLikely: 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
NYPRG-101 (BOL-148)
LSDMigraine prevention / cluster headache
Programme Tracker
Headache Disorders (Cluster & Migraine)
Phase 1 SAD study in healthy volunteers; FDA IND submitted June 2022 for migraine prevention
Milestones
Regulatory filing submitted
CompletedActual: 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
Recorded Events
Jun 1, 2022: Regulatory filing submitted
Quick Facts
- Type
- Private Biotech
- Founded
- 2017
- Lead Stage
- Phase II
- HQ
- USA, United States
- Website
- Visit