Is Etrasimod approved by the US FDA?

Drugs@FDA lists 1 application product line for Etrasimod, including VELSIPITY (Prescription).

Is Etrasimod authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Etrasimod: Velsipity.

Are there safety signals or safety updates for Etrasimod?

US FDA: 1 entry (latest 2024-06-05).

Active substance

Etrasimod

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VELSIPITY	EQ 2MG BASE	tablet · oral	PFIZER	Prescription	12 Oct 2023

EMA European Union — centrally authorised medicines

Velsipity Pfizer Europe MA EEIG · Authorised · authorised 16 Feb 2024 · ATC L04AE05

Therapeutic indication (EMA)

Velsipity is indicated for the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VELSIPITY	02544903	2 MG	TABLET · ORAL	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 5 Jun 2024 VELSIPITY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for etrasimod →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.