Etrasimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. It is available as tablets for oral use. MedsAcross supplies Etrasimod for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. VELSIPITY is a sphingosine 1-phosphate receptor modulator indicated for the treatment of moderately to severely active ulcerative colitis in adults.
Source: US FDA prescribing information
Etrasimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1, 4, and 5 (S1P 1,4,5 ). Etrasimod has minimal activity on S1P 3 (25-fold lower than C max at the recommended dose) and no activity on S1P 2. Etrasimod partially and reversibly blocks the capacity of lymphocytes to egress from lymphoid organs, reducing the number of lymphocytes in peripheral blood. The mechanism by which etrasimod exerts therapeutic effects in UC is unknown but may involve the reduction of lymphocyte migration into the intestines.
Source: US FDA prescribing information
• Assessments are required prior to initiating VELSIPITY. • The recommended dosage is 2 mg orally once daily. Assessments, Medications, and Vaccinations Prior to First Dose of VELSIPITY Before initiation of treatment with VELSIPITY, assess the following: Complete Blood Count Obtain a recent (i.e., within the last 6 months or after discontinuation of prior UC therapy) complete blood count (CBC), including lymphocyte count. Cardiac Evaluation Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present. In patients with certain preexisting conditions, advice from a cardiologist should be sought. Liver Function Tests Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels. Ophthalmic Assessment Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with VELSIPITY.
Source: US FDA prescribing information
VELSIPITY is contraindicated in patients who: • In the last 6 months, have experienced a myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure. • Have a history or presence of Mobitz type II second-degree or third-degree AV block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker. • In the last 6 months, experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure.
Source: US FDA prescribing information
• Infections: May increase the risk of infections. Obtain a complete blood count (CBC) before initiation of treatment. Monitor for infection during treatment and for 5 weeks after discontinuation. Consider interruption of treatment if a serious infection develops. Avoid use of live attenuated vaccines during and for up to 5 weeks after treatment. • Bradyarrhythmia and Atrioventricular Conduction Delays: May result in a transient decrease in heart rate and AV conduction delays. Obtain an electrocardiogram (ECG) to assess for preexisting cardiac conduction abnormalities before starting treatment. Consider cardiology consultation for conduction abnormalities or concomitant use with other drugs that decrease heart rate. • Liver Injury: Elevations of aminotransferases may occur. Obtain transaminase and bilirubin levels before initiating VELSIPITY.
Source: US FDA prescribing information
The following serious adverse reactions are described elsewhere in the labeling: • Infections • Bradyarrhythmia and Atrioventricular Conduction Delays • Liver Injury • Macular Edema • Increased Blood Pressure • Fetal Risk • Cutaneous Malignancies • Posterior Reversible Encephalopathy Syndrome • Respiratory Effects • Unintended Additive Immune System Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs • Immune System Effects After Stopping VELSIPITY Most common adverse reactions (incidence ≥5%) are: headache, elevated liver tests, and dizziness.
Source: US FDA prescribing information
Etrasimod is primarily metabolized by CYP2C8, CYP2C9, and CYP3A4. Table 3 includes drugs with clinically important drug interactions when administered concomitantly with VELSIPITY and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information. The effect of concomitant use of VELSIPITY with a combination of separate drugs that are moderate to strong inhibitors or inducers of either CYP2C8, CYP2C9, or CYP3A4 is unknown. However, based on the information below, a similar clinically significant change in exposure cannot be ruled out when two or more metabolic pathways are affected. Table 3: Drugs That Affect VELSIPITY CYP-Mediated Metabolic Pathways Anti-Arrhythmic Drugs and QT Prolonging Drugs Clinical Impact A transient decrease in heart rate and AV conduction delays may occur when initiating VELSIPITY.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Etrasimod, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Velsipity 2 mg tabletOral | Pfizer Laboratories | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Etrasimod and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Etrasimod, including Velsipity.
Yes. The US FDA first approved Etrasimod on 12 October 2023, according to Drugs@FDA.
Yes. Etrasimod has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Etrasimod is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Etrasimod is classified under ATC code L04AE05 (Etrasimod).
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