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Velsipity (ETRASIMOD)
Velsipity works by binding to and modulating the activity of certain immune cells in the body.
At a glance
| Generic name | ETRASIMOD |
|---|---|
| Sponsor | Pfizer |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
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.
Approved indications
- moderately to severely active ulcerative colitis (UC)
Common side effects
- Headache
- Elevated liver tests
- Dizziness
- Arthralgia
- Hypertension
- Urinary tract infection
- Nausea
- Hypercholesterolemia
- Herpes viral infection
- Bradycardia
- Ophthalmologic Findings
Drug interactions
- Class Ia anti-arrhythmic drugs (e.g., quinidine, procainamide)
- Class III anti-arrhythmic drugs (e.g., amiodarone, sotalol)
- QT prolonging drugs
- Beta blockers
- Calcium channel blockers
- Anti-neoplastic, immune-modulating, or non-corticosteroid immunosuppressive therapies
- Moderate to strong inhibitors of CYP2C9 and CYP3A4 (e.g., fluconazole)
- CYP2C9 poor metabolizers using moderate to strong inhibitors of CYP2C8 or CYP3A4
- Rifampin
- Moderate to strong inhibitors of CYP2C8 or CYP3A4
- Other drugs that may decrease heart rate
- Class III anti-arrhythmic drugs (e.g., amiodarone, sotalol)
Key clinical trials
- A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis (PHASE2)
- A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
- An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis (PHASE3)
- Etrasimod as Prevention of Pouchitis (PHASE2)
- A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis (PHASE2)
- An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis
- Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
- Etrasimod for Immune Checkpoint Inhibitor Diarrhea and Colitis (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Velsipity CI brief — competitive landscape report
- Velsipity updates RSS · CI watch RSS
- Pfizer portfolio CI