OBJECTIVE: To review the pharmacological and clinical profile of ozanimod in the 
treatment of ulcerative colitis (UC).
DATA SOURCES: A PubMed search was conducted from inception to July 2021 using 
the keywords ozanimod, ulcerative colitis, and sphingosine 1-phosphate receptor 
modulator. Information was also extracted from published abstracts and the 
package insert.
STUDY SELECTION AND DATA EXTRACTION: Phase 2 and 3 studies and relevant 
literature on ozanimod pharmacological and clinical profiles were reviewed.
DATA SYNTHESIS: Ozanimod approval was based on True North, a phase 3 trial 
evaluating ozanimod's efficacy and safety in the treatment of moderate to severe 
UC. Compared with placebo, ozanimod led to clinical remission in a significantly 
higher proportion of patients in both the induction and maintenance phase. 
Additionally, for secondary end points of clinical response, endoscopic 
improvement, corticosteroid-free remission, and mucosal healing, ozanimod 
performed significantly better than placebo. Common adverse events included 
infections, headaches, hypertension, bradycardia, and liver enzyme elevations.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Ozanimod is the first 
sphingosine 1-phosphate modulator to be approved for UC and is administered 
orally. Its efficacy profile is comparable with other UC medications. However, 
its safety profile is unique, requiring extensive assessments prior to 
initiation of and during treatment. Thus, it is unclear how ozanimod will be 
positioned in UC treatment.
CONCLUSION: Ozanimod is another option in the growing arsenal of UC treatment. 
Although it offers a novel mechanism of action and is administered orally, there 
are important safety, dosing, and pharmacokinetic factors to consider prior to 
initiation and use.