Ozanimod hydrochloride is under clinical development by Bristol-Myers Squibb and currently in the Phase III 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 Ozanimod hydrochloride’s likelihood of approval (LoA) and phase transition for Crohn’s Disease (Regional Enteritis) took place on 31 May 2021, 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 Ozanimod hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ozanimod hydrochloride overview

Ozanimod hydrochloride (Zeposia) is an immunomodulatory agent. It is formulated as hard gelatin capsules for oral route of administration. Zeposis indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and also indicated for  the treatment moderate to severe ulcerative colitis Zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or were intolerant to either conventional therapy or a biologic agent.


Ozanimod (RPC-1063) is under development for the treatment of Coronavirus disease 2019 (COVID-19),  moderate to severe ulcerative colitis and Crohn’s disease in pediatrics and adults. It is a new chemical entity. The drug candidate is administered orally as a capsule. It is the second generation S1P1 receptor modulator. The drug candidate is based on GPCR structure-based drug design platform.

Bristol-Myers Squibb overview

Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in New York City, New York, the US.

Quick View Ozanimod hydrochloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Ozanimod hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Gastrointestinal
  • Infectious Disease
Key Developers
Highest Development Stage
  • Marketed

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.