Ozanimod
- Generic Name
- Ozanimod
- Brand Names
- Zeposia, Zeposia 7-day Starter Pack, Zeposia Starter Kit
- Drug Type
- Small Molecule
- Chemical Formula
- C23H24N4O3
- CAS Number
- 1306760-87-1
- Unique Ingredient Identifier
- Z80293URPV
- Background
Ozanimod is a once-daily sphingosine 1-phosphate receptor modulator for the treatment of relapsing Multiple Sclerosis (MS) and inflammatory bowel disease. It was developed by Celgene (now acquired by Bristol-Myers Squibb) and was approved by the FDA on March 26, 2020. The US approval was followed by the approval in Canada on October 2, 2020. In November 202...
- Indication
Ozanimod is a sphingosine 1-phosphate receptor modulator 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. It is also used to treat moderately to severely active ulcerative colitis (UC) in adults.
- Associated Conditions
- Clinically Isolated Syndrome (CIS), Moderately to Severely Active Ulcerative Colitis, Progressive Multiple Sclerosis (PMS), Relapsing Multiple Sclerosis (RMS), Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS)
- Associated Therapies
- -
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
- First Posted Date
- 2022-07-22
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 5
- Registration Number
- NCT05470985
- Locations
- 🇺🇸
Local Institution - 0008, Seattle, Washington, United States
🇺🇸Local Institution - 0010, Garden Grove, California, United States
🇺🇸Local Institution - 0071, Lebanon, New Hampshire, United States
A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis
- First Posted Date
- 2022-05-19
- Last Posted Date
- 2022-06-30
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 380
- Registration Number
- NCT05382715
- Locations
- 🇩🇪
Local Institution - 0001, Berlin, Germany
An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice
- First Posted Date
- 2022-05-11
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 415
- Registration Number
- NCT05369832
- Locations
- 🇺🇸
Local Institution - 0048, Dothan, Alabama, United States
🇺🇸Local Institution - 0206, Chandler, Arizona, United States
🇺🇸Local Institution - 0216, Gilbert, Arizona, United States
Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients
- Conditions
- Interventions
- First Posted Date
- 2022-04-08
- Last Posted Date
- 2022-04-22
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 40
- Registration Number
- NCT05319093
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
- First Posted Date
- 2021-10-13
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 120
- Registration Number
- NCT05076175
- Locations
- 🇩🇪
Local Institution - 0097, Leipzig, Sachsen, Germany
🇺🇸Local Institution - 0041, Phoenix, Arizona, United States
🇺🇸University of Arizona, Tucson, Arizona, United States
Taste Assessment of Ozanimod
- First Posted Date
- 2021-08-11
- Last Posted Date
- 2023-06-18
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 7
- Registration Number
- NCT05001152
- Locations
- 🇺🇸
Senopsys LLC, Woburn, Massachusetts, United States
🇺🇸Local Institution - 0001, Woburn, Massachusetts, United States
Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants
- Conditions
- Interventions
- First Posted Date
- 2021-07-27
- Last Posted Date
- 2023-08-31
- Lead Sponsor
- Celgene
- Target Recruit Count
- 128
- Registration Number
- NCT04978298
- Locations
- 🇺🇸
Local Institution - 001, Anaheim, California, United States
Relationship Between Oral DMT Burden and Adherence in MS
- First Posted Date
- 2020-12-19
- Last Posted Date
- 2022-08-31
- Lead Sponsor
- Monash University
- Target Recruit Count
- 323
- Registration Number
- NCT04676204
- Locations
- 🇦🇺
Monash University, Melbourne, Victoria, Australia
A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod
- First Posted Date
- 2020-11-20
- Last Posted Date
- 2022-06-14
- Lead Sponsor
- Celgene
- Target Recruit Count
- 26
- Registration Number
- NCT04639115
- Locations
- 🇺🇸
The Texas Liver Institute, San Antonio, Texas, United States
🇺🇸University of Miami Miller School of Medicine, Miami, Florida, United States
🇺🇸Orlando Clinical Research Center OCRC, Orlando, Florida, United States
A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects
- First Posted Date
- 2020-08-27
- Last Posted Date
- 2021-09-20
- Lead Sponsor
- Celgene
- Target Recruit Count
- 56
- Registration Number
- NCT04528290
- Locations
- 🇺🇸
PPD Phase 1 Clinic, Austin, Texas, United States
Drug Development Updates
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