Ozanimod has been approved by the US Food and Drug Administration (FDA) for use in adults with moderately to severely active ulcerative colitis (UC).

Ozanimod is administered orally, once daily, and is the first sphingosine-1-phosphate (S1P) receptor modulator that has been approved for UC. In March last year, the drug was approved by the FDA for adults with relapsing forms of multiple sclerosis. 

The approval of the drug in UC comes from data from a phase 3 placebo-controlled trial that assessed induction therapy with ozanimod over 10 weeks in 645 adults who had moderately to severely active UC, followed by maintenance therapy over 42 weeks. During induction at week 10, the primary end point was met and significantly more patients taking ozanimod attained clinical remission compared to patients who were given placebo (18% vs 6%). The primary endpoint of clinical remission was also met during maintenance at week 52 (37% vs 19%)... (Medscape)