Psilocybin is under clinical development by Ceruvia Lifesciences and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Psilocybin’s likelihood of approval (LoA) and phase transition for Cluster Headache Syndrome (Cluster Headache) took place on 25 Aug 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Psilocybin Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Psilocybin overview

Psilocybin is under investigation for the treatment of obsessive compulsive disorder, cluster headache syndrome, major depressive disorder, nicotine dependence, lyme disease, alcohol use disorder (AUD) and migraine headache. The drug candidate is formulated as capsule and administered by oral route. It is a tryptamine alkaloid which is a psychedelic compound acts by targeting 5hydroxy tryptamine 1A and 2A.

Ceruvia Lifesciences overview

Ceruvia Lifesciences is engaged in research, development and commercialization of neuro transformational medicines to treat neurological and psychiatric disorders. The company is investigating its pipeline programs including NYPRG-101, a non-hallucinogenic analog of LSD against migraine, cluster headache, opioid and alcohol use disorders; and SYNP-101, a synthetic form of psilocybin for the treatment of obsessive compulsive disorder (OCD). It also produces GMP LSD and supply to academic research sites and GMP BOL-148. Ceruvia Lifesciences provide treatments for patients, caregivers, payers and health care providers. The company works in collaboration with Yale University, Usona Institute, The Heffter Research Institute, Clusterbusters and New York University (NYU). Ceruvia Lifesciences is headquartered in Greenwich, Connecticut, the US.

Quick View Psilocybin LOA Data

Report Segments
  • Innovator
Drug Name
  • Psilocybin
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Infectious Disease
Key Developers
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.