Ozanimod

Generic Name: Ozanimod

Brand Names: Zeposia, Zeposia 7-day Starter Pack, Zeposia Starter Kit

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₂₄N_₄O_₃

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: -

Clinical Trials

COVID-19 Ozanimod Intervention Study

Phase 2

Terminated

Conditions: COVID-19

Interventions: Drug: Ozanimod
Other: Standard of care

First Posted Date: 2020-05-28

Last Posted Date: 2024-02-20

Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Target Recruit Count: 43

Registration Number: NCT04405102

Locations: 🇨🇦
Hôpital Santa Cabrini Ospedale (CIUSSS EMTL), Montréal, Quebec, Canada
🇨🇦
Hôpital de la Cité-de-la-Santé (CISSS de Laval), Laval, Quebec, Canada
🇨🇦
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval, Québec, Canada

A Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Ozanimod

First Posted Date: 2019-12-26

Last Posted Date: 2021-03-25

Lead Sponsor: Celgene

Target Recruit Count: 24

Registration Number: NCT04211558

Locations: 🇨🇳
Capital Medical University - Beijing Anzhen Hospital, Beijing, China

Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Ozanimod
Drug: Cyclosporine

First Posted Date: 2019-11-04

Last Posted Date: 2020-08-24

Lead Sponsor: Celgene

Target Recruit Count: 40

Registration Number: NCT04149678

Locations: 🇺🇸
ICON Early Phase Services, San Antonio, Texas, United States

To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Phase 3

Active, not recruiting

Conditions: Colitis, Ulcerative

Interventions: Drug: Ozanimod
Other: Placebo

First Posted Date: 2019-04-16

Last Posted Date: 2024-01-05

Lead Sponsor: Celgene

Target Recruit Count: 195

Registration Number: NCT03915769

Locations: 🇯🇵
Local Institution - 122, Chikushino, Japan
🇯🇵
Local Institution - 119, Ogaki, Japan
🇯🇵
Local Institution - 139, Abiko, Japan

and more 64 locations

Drug-drug Interaction Study of Ozanimod With Tyramine to Evaluate the Effect on Pressor Response

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Phenelzine
Drug: Tyramine
Drug: Phenelzine placebo
Drug: ozanimod
Drug: ozanimod placebo

First Posted Date: 2018-10-03

Last Posted Date: 2019-07-19

Lead Sponsor: Celgene

Target Recruit Count: 92

Registration Number: NCT03694119

Locations: 🇺🇸
PPD Phase 1 Clinic, Austin, Texas, United States

Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites

Completed

Conditions: Healthy Volunteers

Interventions: Drug: ozanimod

First Posted Date: 2018-09-11

Last Posted Date: 2019-02-06

Lead Sponsor: Celgene

Target Recruit Count: 212

Registration Number: NCT03665610

Locations: 🇺🇸
PPD Phase 1 Clinic, Austin, Texas, United States
🇺🇸
ICON Early Phase Services, LLC, San Antonio, Texas, United States

Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Pressure and Heart Rate

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: ozanimod
Drug: ozanimod placebo
Drug: Pseudoephedrine

First Posted Date: 2018-08-23

Last Posted Date: 2019-05-30

Lead Sponsor: Celgene

Target Recruit Count: 54

Registration Number: NCT03644576

Locations: 🇺🇸
ICON Early Phase Services, San Antonio, Texas, United States

Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Ozanimod
Drug: Gemfibrozil
Drug: Itraconazole
Drug: Rifampin

First Posted Date: 2018-08-10

Last Posted Date: 2019-05-30

Lead Sponsor: Celgene

Target Recruit Count: 100

Registration Number: NCT03624959

Locations: 🇺🇸
PPD Phase 1 Clinic, Austin, Texas, United States

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Phase 3

Completed

Conditions: Crohn Disease

Interventions: Drug: Ozanimod

First Posted Date: 2018-03-16

Last Posted Date: 2024-11-26

Lead Sponsor: Celgene

Target Recruit Count: 854

Registration Number: NCT03467958

Locations: 🇺🇸
Holland Center for Family Health, Peoria, Arizona, United States
🇺🇸
Local Institution - 202, Scottsdale, Arizona, United States
🇺🇸
Local Institution - 026, North Little Rock, Arkansas, United States

and more 760 locations

A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Phase 3

Terminated

Conditions: Crohn Disease

Interventions: Drug: Ozanimod
Other: Placebo

First Posted Date: 2018-03-13

Last Posted Date: 2024-11-04

Lead Sponsor: Celgene

Target Recruit Count: 551

Registration Number: NCT03464097

Locations: 🇺🇸
Local Institution - 141, Middleburg Heights, Ohio, United States
🇺🇸
Holland Center for Family Health, Peoria, Arizona, United States
🇺🇸
Local Institution - 202, Scottsdale, Arizona, United States

and more 759 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy