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
-

Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Phase 3
Completed
Conditions
Interventions
First Posted Date
2018-02-22
Last Posted Date
2024-12-05
Lead Sponsor
Celgene
Target Recruit Count
606
Registration Number
NCT03440385
Locations
🇫🇮

Local Institution - 614, Turku, Finland

🇺🇸

Local Institution - 202, Scottsdale, Arizona, United States

🇺🇸

Ucsd Medical Center, La Jolla, California, United States

and more 365 locations

Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2018-02-22
Last Posted Date
2024-11-18
Lead Sponsor
Celgene
Target Recruit Count
625
Registration Number
NCT03440372
Locations
🇲🇽

Local Institution - 525, Monterrey, Nuevo León, Mexico

🇮🇳

Local Institution - 443, Jaipur, Rajasthan, India

🇲🇽

Local Institution - 532, Monterrey, Nuevo León, Mexico

and more 405 locations

Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

First Posted Date
2014-11-19
Last Posted Date
2020-11-25
Lead Sponsor
Celgene
Target Recruit Count
1346
Registration Number
NCT02294058
Locations
🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

Neurological Research Institute Inc, Columbus, Ohio, United States

🇺🇸

The Polyclinic, Seattle, Washington, United States

and more 220 locations

Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

First Posted Date
2014-01-28
Last Posted Date
2021-02-11
Lead Sponsor
Celgene
Target Recruit Count
1320
Registration Number
NCT02047734
Locations
🇺🇸

Neurostudies Inc, Port Charlotte, Florida, United States

🇵🇱

RESMEDICA Spolka z o.o., Kielce, Poland

🇵🇱

Receptos Study Site 402, Olsztyn, Poland

and more 296 locations

Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-07-23
Last Posted Date
2021-05-19
Lead Sponsor
Celgene
Target Recruit Count
199
Registration Number
NCT01647516
Locations
🇸🇰

Slovak Research Center, Ilava, Slovakia

🇧🇬

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD, Sofia, Bulgaria

🇧🇬

University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia, Sofia, Bulgaria

and more 85 locations

Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-06-26
Last Posted Date
2021-02-11
Lead Sponsor
Celgene
Target Recruit Count
258
Registration Number
NCT01628393
Locations
🇧🇪

Centre Hospitalier Chretien Clinique Saint Joseph, Montegnee, Belgium

🇧🇪

Clinique Saint-Pierre, Ottignies, Belgium

🇧🇪

Cliniques Universitaires St-Luc, Brussels, Belgium

and more 55 locations
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