Ozanimod

Overview

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 2021, ozanimod was also approved by the European Commission for the treatment of adults with relapsing remitting multiple sclerosis. MS is a devastating inflammatory disease that often progresses and causes severe neurological, physical, and cognitive effects. Inflammatory bowel disease also a chronic inflammatory condition and can cause persistent abdominal pain, diarrhea, bloody stools, and vomiting. In clinical trials, Ozanimod has been shown to be well-tolerated and has resulted in a higher decrease in the rate of MS relapses than with intramuscular interferon beta-1a, a current standard in MS therapy. Studies involving patients with inflammatory bowel disease have also shown promising results.

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)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Ozanimod in Patients With Alzheimer's Disease	2025/03/07	NCT06862960	Phase 2	Not yet recruiting	ChenXiaoChun
Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod	2024/07/31	NCT06529406	Phase 4	Recruiting	University of Colorado, Denver
Determine PK Profiles of Ozanimod and Its' Major Metabolites in Healthy Subjects	2024/07/30	NCT06528665	N/A	Recruiting	Corium Innovations, Inc.
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis	2024/05/10	NCT06408259	Phase 3	Recruiting	Celgene
A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis	2024/05/02	NCT06396039	Phase 4	Active, not recruiting	Bristol-Myers Squibb
Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS	2024/03/27	NCT06334094	Phase 4	Withdrawn	The University of Texas at Dallas
Ulcerative Colitis Leukocyte TRAfficking After Treatment With Zeposia: the ULTRAZ Study	2024/01/03	NCT06188637	Phase 4	Withdrawn	Geert D'Haens
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants	2023/11/15	NCT06133049	N/A	Active, not recruiting	Bristol-Myers Squibb
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants	2023/11/13	NCT06126835	N/A	Active, not recruiting	Bristol-Myers Squibb
A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea	2023/10/10	NCT06073873	N/A	Recruiting	Bristol-Myers Squibb

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ZEPOSIA	Celgene Corporation	59572-820	ORAL	0.92 mg in 1 1	6/20/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Zeposia	Bristol-Myers Squibb Pharma EEIG,Plaza 254,Blanchardstown Corporate Park 2,Dublin 15,D15 T867,Ireland	Authorised	5/20/2020

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ZEPOSIA CAPSULES 0.92 MG	Celgene International Sàrl	SIN16786P	CAPSULE	0.92 mg	5/17/2023
ZEPOSIA CAPSULES TREATMENT INITIATION PACK	Celgene International Sàrl	SIN16785P	CAPSULE	0.46 mg and 0.23 mg	5/17/2023

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ZEPOSIA ozanimod 230 microgram and 460 microgram capsules blister wallet composite pack	318801	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	7/17/2020
ZEPOSIA ozanimod 920 microgram capsules blister pack	318800	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	7/17/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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