Zeposia FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 2, 2024.
FDA Approved: Yes (First approved March 25, 2020)
Brand name: Zeposia
Generic name: ozanimod
Dosage form: Capsules
Company: Bristol-Myers Squibb Company
Treatment for: Multiple Sclerosis, Ulcerative Colitis
Zeposia (ozanimod) is a sphingosine 1-phosphate receptor modulator used for the treatment of multiple sclerosis and ulcerative colitis.
- Zeposia is 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.
- moderately to severely active ulcerative colitis (UC) in adults. - Zeposia is sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5, blocking the capacity of lymphocytes to egress from lymph nodes and reducing the number of lymphocytes in peripheral blood. The mechanism by which Zeposia works in the treatment of multiple sclerosis and ulcerative colitis is unknown, but is thought to involve the reduction of lymphocyte migration into the central nervous system for multiple sclerosis and the reduction of lymphocyte migration into the intestines for ulcerative colitis.
- Zeposia is administered orally, usually once a day.
- Warnings and precautions associated with Zeposia include an increased risk of infections, progressive multifocal leukoencephalopathy, a transient decrease in heart rate, liver injury, fetal risk, increased blood pressure, decline in pulmonary function, increased risk of macular edema, and cutaneous malignancies.
- Common adverse reactions:
- in people with multiple sclerosis include upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.
- in people with ulcerative colitis include increased liver function test values, upper respiratory infection, and headache.
Development timeline for Zeposia
Further information
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