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Etrasimod, a selective sphingosine-1-phosphate (S1P) receptor modulator, has gained FDA and EMA approval for ulcerative colitis. This oral medication targets specific S1P subtypes, offering a new treatment for inflammatory disorders.

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Area of Science:

  • Immunology and Pharmacology
  • Gastroenterology

Background:

  • Etrasimod is an oral, small-molecule selective sphingosine-1-phosphate (S1P) receptor modulator.
  • It selectively targets S1P receptor subtypes S1P 1, S1P 4, and S1P 5, with minimal activity on S1P 3 and no activity on S1P 2.

Purpose of the Study:

  • To summarize the development milestones of etrasimod leading to its first approval.
  • To highlight the regulatory approvals for ulcerative colitis treatment.

Main Methods:

  • Review of clinical development and regulatory submissions for etrasimod.
  • Analysis of etrasimod's pharmacological profile and selectivity.

Main Results:

  • Etrasimod received US FDA approval in October 2023 for moderately to severely active ulcerative colitis in adults.
  • The European Medicines Agency recommended marketing authorisation in December 2023 for patients aged 16 years and older with inadequate response to existing therapies.

Conclusions:

  • Etrasimod represents a significant advancement in the treatment of ulcerative colitis.
  • Ongoing clinical development targets other immune-mediated inflammatory disorders, including Crohn's disease and atopic dermatitis.