Etrasimod Arginine API Suppliers & Bulk Manufacturers

Available Forms: API (drug substance)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Velsipity

Category: Active Pharmaceutical Ingredient

Etrasimod, traded as its L-arginine salt, is an oral S1P receptor modulator for ulcerative colitis. It is sourced by formulation developers, CDMOs and R&D teams.

Product Description:

Etrasimod is a sphingosine 1-phosphate (S1P) receptor modulator that acts on S1P receptor subtypes 1, 4 and 5 and holds lymphocytes back in lymphoid tissue, which reduces their movement into the gut. It is approved for adults with moderately to severely active ulcerative colitis (reference brand: Velsipity).

Specification at a glance

Regulatory files and timing

The FDA list of Drug Master Files (third quarter 2026) shows 3 active Type II API DMFs for this molecule. Few filings usually means few qualified sources, so early contact with suppliers pays off. For Europe, ask whether the supplier holds a CEP or an EU ASMF and, for imports into the EU, a written confirmation.

Generic or biosimilar entry. United States: Patent expiry; entry not confirmed (2030 (2035 if pending PTE granted)). European Union: Protected beyond 2033 (2034).

Handling and quality points

S1P receptor modulators act at low doses and affect heart rate and lymphocyte counts, so etrasimod is generally handled with containment and good personal protection during powder work. Specify the arginine content and salt ratio, enantiomeric purity and the solid form. A nitrosamine risk assessment and residual solvent data are standard requests.

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Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.