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Ozanimod Approval Status

FDA Approved: No
Generic name: ozanimod
Company: Celgene Corporation
Treatment for: Multiple Sclerosis, Ulcerative Colitis

Ozanimod is an investigational selective sphingosine 1-phosphate (S1P) 1 and 5 receptor modulator in development for the treatment of patients with relapsing multiple sclerosis, and ulcerative colitis.

Development Status and FDA Approval Process for ozanimod

Mar 25, 2019Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis
May 22, 2017Celgene Announces Positive Results from RADIANCE, the Second Pivotal Phase III Trial of Oral Ozanimod in Patients with Relapsing Multiple Sclerosis
Sep 16, 2016Oral Ozanimod Efficacy and Safety Results at 2 Years from Phase 2 RADIANCE Trial of Patients with Relapsing Multiple Sclerosis Presented at 32nd ECTRIMS
Mar 18, 2016Oral Ozanimod Showed Histologic Improvements in Patients with Ulcerative Colitis in the Phase 2 TOUCHSTONE Trial
Feb 18, 2016Oral Ozanimod 72-Week Phase 2 Results From RADIANCE Trial in Relapsing Multiple Sclerosis Presented At ACTRIMS
Oct 19, 2015Phase 2 Maintenance Data from Oral Ozanimod TOUCHSTONE Study in Ulcerative Colitis Presented at ACG Plenary Session

Further information

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