Psilocybin is under clinical development by Ceruvia Lifesciences and currently in Phase II for Smoking Cessation. According to GlobalData, Phase II drugs for Smoking Cessation does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Psilocybin LoA Report. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Psilocybin overview

Psilocybin is under investigation for the treatment of obsessive compulsive disorder, cluster headache syndrome, 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.

It was also under development for major depressive disorder.

Ceruvia Lifesciences overview

Ceruvia Lifesciences carries out the 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 the obsessive-compulsive disorder (OCD). It also produces GMP LSD and supplies it to academic research sites and GMP BOL-148. Ceruvia Lifesciences provides 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.

For a complete picture of Psilocybin’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.