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
- -
Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod
- First Posted Date
- 2024-07-31
- Last Posted Date
- 2024-11-08
- Lead Sponsor
- University of Colorado, Denver
- Target Recruit Count
- 24
- Registration Number
- NCT06529406
- Locations
- 🇺🇸
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
🇺🇸Cleveland Clinic, Cleveland, Ohio, United States
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
- Conditions
- Interventions
- First Posted Date
- 2024-05-10
- Last Posted Date
- 2024-11-28
- Lead Sponsor
- Celgene
- Target Recruit Count
- 194
- Registration Number
- NCT06408259
- Locations
- 🇷🇴
Local Institution - 0088, Bucharest, București, Romania
🇺🇸Local Institution - 0130, Sacramento, California, United States
🇺🇸UCSF Benioff Children's Hospital San Francisco, San Francisco, California, United States
Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS
- First Posted Date
- 2024-03-27
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- The University of Texas at Dallas
- Registration Number
- NCT06334094
- Locations
- 🇺🇸
Center for Brain Health, Dallas, Texas, United States
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants
- Conditions
- Interventions
- First Posted Date
- 2023-11-15
- Last Posted Date
- 2023-11-15
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 2961
- Registration Number
- NCT06133049
- Locations
- 🇺🇸
OptumInsight Life Sciences Inc, Eden Prairie, Minnesota, United States
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants
- Conditions
- Interventions
- First Posted Date
- 2023-11-13
- Last Posted Date
- 2024-10-01
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 2828
- Registration Number
- NCT06126835
- Locations
- 🇺🇸
OptumInsight Life Sciences Inc, Eden Prairie, Minnesota, United States
A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea
- First Posted Date
- 2023-10-10
- Last Posted Date
- 2024-08-22
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 3000
- Registration Number
- NCT06073873
- Locations
- 🇰🇷
Bristol-Myers Squibb YH, Seoul, Korea, Republic of
Define Predictors of Response to Ozanimod in UC Discovering Biomarkers in the Management of Ulcerative Colitis
- First Posted Date
- 2023-04-12
- Last Posted Date
- 2023-04-18
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Target Recruit Count
- 20
- Registration Number
- NCT05809583
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
- Conditions
- Interventions
- First Posted Date
- 2023-01-27
- Last Posted Date
- 2023-12-06
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Target Recruit Count
- 240
- Registration Number
- NCT05702879
- Locations
- 🇨🇭
University Hospital Bern Inselspital, Bern, Switzerland
A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
- Conditions
- Interventions
- First Posted Date
- 2023-01-18
- Last Posted Date
- 2023-10-13
- Lead Sponsor
- Biogen
- Target Recruit Count
- 1178
- Registration Number
- NCT05688436
- Locations
- 🇺🇸
OptumInsight, Eden Prairie, Minnesota, United States
A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)
- First Posted Date
- 2022-12-09
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 130
- Registration Number
- NCT05644665
- Locations
- 🇨🇳
Local Institution - 0012, Hefei, Anhui, China
🇨🇳Local Institution - 0013, Wuhu, Anhui, China
🇨🇳Local Institution - 0052, Beijing, Beijing, China
Drug Development Updates
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