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SearchAbout VELSIPITYAbout VELSIPITYUncontrolled DiseasePatient ProfilesVELSIPITY OverviewMOAEfficacyEfficacyTrial DesignEfficacy DataSafetySafetyELEVATE UCENLIGHT UCStarting TreatmentAccess & SupportAccess & SupportVelsipityForMe Patient SupportEnrollment ResourcesResourcesResourcesRequest a RepEventsMaterialsVideos
Prescribing InformationMedication GuideIndication Patient SiteRequest Samples
VELSIPITY is indicated for adults with moderately to severely active UCVELSIPITY in the middle: after conventional therapy but before biologics or JAKi*VELSIPITY in the middle: after conventional therapy but before biologics or JAKi*
ELEVATE UC trials included both moderate and severe patients, where 36% of UC-1 and 42% of UC-2 patients had mMS 5-6 and 64% of UC-1 and 58% of UC-2 patients had mMS 7-91
VELSIPITY was studied in patients with moderately to severely active ulcerative colitis who had an inadequate response, loss of response, or intolerance to oral aminosalicylates, corticosteroids, thiopurines, Janus kinase (JAK) inhibitors, or biologic therapies.2Co-primary endpoints: Proportion of patients achieving clinical remission at week 12 and at week 52. Clinical remission was defined as a stool frequency (SF) subscore of 0 or 1, a rectal bleeding (RB) subscore of 0, and an endoscopy score (ES) ≤1 (excluding friability). Clinical remission: UC-1: At week 12, 27% (74/274) vs 7% (9/134) with placebo. At week 52, 32% (88/274) vs 7% (9/134) with placebo. UC-2: At week 12, 26% (57/221) vs 15% (17/112) with placebo.2Explore their clinical historyMonica – Moderately Active UC

Monica

Moderately Active UC

28-year-old female school teacher with moderate UC, diagnosed 1 year ago

Treatment Profile
Current treatment Oral 5-ASA
Symptom burden Frequent bowel movements; occasional blood in stool
Treatment considerations Oral treatment
Patient request Considering steroids to relieve symptoms

Clinical Profile

Biologic/JAKi exposure Naive
mMS score 5*
fCAL level 1,000 µg/g†
Extent of disease Left-sided colitis (proctosigmoiditis)
Scroll left to view table
Like Monica, 59% of patients in ELEVATE UC-1 and UC-2 were identified with left-sided colitis (proctosigmoiditis)1
Learn more about VELSIPITY Loading*Stool frequency (SF) subscore of 2, rectal bleeding (RB) subscore of 1, and a Mayo endoscopic score (MES) of 2.3
†Normal range: <150-200 µg/g.4
fCAL=fecal calprotectin; mMS=modified Mayo score.Fred – Severely Active UC

Fred

Severely Active UC

42-year-old male construction worker with severe UC, diagnosed 2 years ago

Treatment Profile
Current treatment Rectal 5-ASA; multiple rounds of steroids
Symptom burden Frequently waking up to go to the bathroom; blood in stool regularly
Treatment considerations Not interested in biologic treatment; dislike of needles
Patient request Asking for another round of steroids for symptom relief

Clinical Profile

Biologic/JAKi exposure Naive
mMS score 8*
fCAL level 1,600 µg/g†
Extent of disease Pancolitis
Scroll left to view table
Like Fred, 64% of patients in ELEVATE UC-1 and 58% of patients in ELEVATE UC-2 had an mMS of 7-91
Learn more about VELSIPITY Loading*Stool frequency (SF) subscore of 2, rectal bleeding (RB) subscore of 3, and a Mayo endoscopic score (MES) of 3.3
†Normal range: <150-200 µg/g.4
fCAL=fecal calprotectin; mMS=modified Mayo score.

Do you see patients with UC who have isolated proctitis?

VELSIPITY is the first advanced therapy‡ to include moderate to severe UC patients with isolated proctitis in UC clinical trials5

8% of patients (n=56) in the VELSIPITY clinical trial program had isolated proctitis confirmed by centrally read colonoscopy or proctosigmoidoscopy at baseline.1,2

‡Advanced therapies include S1P receptor modulators, biologics, and JAKi.5
Patient with Isolated Proctitis
“I had an accident last week while out with friends. It’s embarrassing. I wish I had another way to manage my UC symptoms.” 
Max, 22Max – Patient with Isolated Proctitis

Max

Patient with Isolated Proctitis

22-year-old male student with moderate UC diagnosed with isolated proctitis 2.5 years ago

Treatment Profile
Current treatment Oral 5-ASA, rectally administered steroid
Symptom burden Stool frequency, blood in stool
Treatment considerations Embarrassed to use rectal treatment in shared dorm bathroom
Patient request Asking for another course of steroids

Clinical Profile

Biologic/JAKi exposure Naive
mMS score 5*
fCAL level 930 µg/g†
Extent of disease Isolated proctitis
Scroll left to view table
Learn more about VELSIPITY Loading*Stool frequency (SF) subscore of 2, rectal bleeding (RB) subscore of 1, and a Mayo endoscopic score (MES) of 2.3
†Normal range: <150-200 µg/g.4
fCAL=fecal calprotectin; mMS=modified Mayo score.
Hear from an expert discussing which of your patients
may be appropriate for VELSIPITY.
 Watch Video LoadingAsk your appropriate patients with moderate to severe UC if they would prefer an oral therapy, and talk to them about VELSIPITY—one pill, once daily, no injections or infusions2Data

View data from the clinical trials in moderate to severe UC, which included patients with isolated proctitis.

 Explore Efficacy Data LoadingmMS=modified Mayo score.VELSIPITY (etrasimod) is indicated for adults with moderately to severely active ulcerative colitis.2References:Data on file. Pfizer Inc.VELSIPITY [prescribing information]. New York, NY: Pfizer Inc.; August 2025.Ulcerative Colitis: Developing Drugs for Treatment. Guidance for Industry. U.S. Department of Health and Human Services. Food and Drug Administration. April 2022.Rubin DT, Ananthakrishnan AN, Siegel CA, Barnes EL, Long MD. ACG clinical guideline update: ulcerative colitis in adults. Am J Gastroenterol. 2025;120(6):1187-1224.Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies [published correction appears in Lancet. 2023;401(10381):1000]. Lancet. 2023;401(10383):1159-1171.About VELSIPITY
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IndicationVELSIPITY® (etrasimod) is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.
Important Safety Information Contraindications
  • Patients in the last 6 months who experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure
  • Patients with 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
Infections 

VELSIPITY may increase the susceptibility to infections. Life-threatening and rare fatal infections have been reported in association with other sphingosine 1-phosphate (S1P) receptor modulators. Before starting VELSIPITY, obtain a recent (i.e., within 6 months) CBC, including lymphocyte count. Delay initiation of VELSIPITY in patients with an active infection until the infection is resolved. Consider interruption of treatment with VELSIPITY if a patient develops a serious infection. Continue monitoring for infections up to 5 weeks after discontinuing VELSIPITY.

  • Progressive multifocal leukoencephalopathy (PML) is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and usually leads to death or severe disability. PML has been reported in multiple sclerosis (MS) patients treated with S1P receptor modulators and has been associated with risk factors and duration of use. Longer treatment duration (≥18 months) increases the risk of PML. VELSIPITY is not indicated in MS. If PML is suspected, suspend VELSIPITY and discontinue if PML is confirmed by appropriate diagnostic evaluation. Immune reconstitution inflammatory syndrome (IRIS) has been reported in patients with MS treated with S1P receptor modulators who developed PML and discontinued treatment. Clinical decline may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic MRI changes. Onset was generally within a few months after S1P receptor modulator discontinuation. Monitoring for IRIS should be undertaken.
  • Herpes simplex encephalitis, varicella zoster meningitis, and localized herpes viral infections have been reported with S1P receptor modulators. In UC-1, herpes zoster was reported in 0.7% of subjects treated with VELSIPITY and in none of the subjects who received placebo. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating VELSIPITY. A full course of VZV vaccination for antibody-negative patients is recommended prior to commencing treatment with VELSIPITY.
  • Cases of fatal cryptococcal meningitis (CM) and disseminated cryptococcal infections have been reported with S1P receptor modulators. VELSIPITY treatment should be suspended until a cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.
  • VELSIPITY has not been studied in combination with anti-neoplastic, immune-modulating, or non-corticosteroid immunosuppressive therapies. Avoid concomitant administration of these therapies with VELSIPITY. 
  • Update immunizations according to current guidelines prior to VELSIPITY treatment. Avoid the use of live attenuated vaccines during and for 5 weeks after treatment with VELSIPITY. If live attenuated vaccine immunizations are required, administer at least 4 weeks prior to initiation of VELSIPITY.
Bradyarrhythmia and Atrioventricular (AV) Conduction Delays
Initiation of VELSIPITY may result in a transient decrease in heart rate and AV conduction delays. Before starting VELSIPITY, obtain an ECG to assess for preexisting cardiac conduction abnormalities. Seek advice of a cardiologist for patients with: significant QT prolongation; arrhythmia requiring treatment with Class Ia or Class III anti-arrhythmic drugs or QT prolonging drugs; unstable ischemic heart disease, Class I or Class II heart failure, history of cardiac arrest, cerebrovascular disease, or uncontrolled hypertension; resting HR<50bpm; history of symptomatic bradycardia, recurrent cardiogenic syncope, or severe untreated sleep apnea; history of Mobitz type I second-degree AV block in the absence of a functioning pacemaker.

Liver Injury
Elevations of aminotransferases may occur in patients receiving VELSIPITY. Obtain transaminase and bilirubin levels, if not recently available (i.e., within the last 6 months), before initiation of VELSIPITY or in patients who develop symptoms suggestive of hepatic dysfunction. Discontinue VELSIPITY if significant liver injury is confirmed. Use of VELSIPITY in patients with severe hepatic impairment is not recommended.

Macular Edema
S1P receptor modulators have been associated with an increased risk of macular edema. Obtain baseline evaluation of the fundus, including the macula near the start of VELSIPITY treatment. Periodically assess the fundus, including the macula, during treatment or if there is a change in vision. Consider discontinuing VELSIPITY if macular edema develops. 

Increased Blood Pressure 
VELSIPITY patients in clinical trials had average increases of 1 to 4 mm Hg systolic and 1 to 2 mm Hg diastolic blood pressure (BP). Increases were first detected after 2 weeks of treatment and remained within the specified average range of BP increases throughout treatment. Monitor BP during treatment with VELSIPITY and manage appropriately.

Fetal Risk
Based on animal studies, VELSIPITY may cause fetal harm. Advise pregnant females and females of reproductive potential of the potential risk to a fetus and to use effective contraception to avoid pregnancy during and for one week after stopping VELSIPITY. Pregnant females exposed to VELSIPITY are encouraged to contact the pregnancy registry by calling 1-800-616-3791.

Cutaneous Malignancies
Risk of cutaneous malignancies is increased in patients treated with S1P receptor modulators in clinical trials and cutaneous malignancies have been reported in the postmarketing setting. Skin examinations are recommended prior to or shortly after the start of treatment and periodically thereafter for all patients, particularly those with risk factors for skin cancer. Monitor for suspicious skin lesions. Limit UV exposure including phototherapy.

Posterior Reversible Encephalopathy Syndrome
Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving S1P receptor modulators. If a patient develops neurological or psychiatric symptoms/signs or any symptom/sign suggestive of an increase of intracranial pressure, or accelerated neurological deterioration, complete a physical and neurological examination promptly and consider an MRI. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, discontinue treatment with VELSIPITY.

Respiratory Effects
VELSIPITY may cause a decline in pulmonary function. Spirometric evaluation should be conducted during therapy if clinically indicated.

Unintended Additive Immune System Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs
When switching to VELSIPITY from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

Immune System Effects After Stopping VELSIPITY
After stopping VELSIPITY, lymphocyte counts returned to the normal range in 90% of subjects within 4 to 5 weeks. Use of immunosuppressants within this period may lead to an additive effect on the immune system, and therefore monitor patients receiving concomitant immunosuppressants for infectious complications up to 5 weeks after the last dose of VELSIPITY.

Most Common Adverse Reactions
Most common adverse reactions reported in ≥ 2% of subjects and at a higher rate than placebo included: headache, elevated liver tests, dizziness, arthralgia, nausea, hypertension, bradycardia, UTI, hypercholesterolemia, and herpes viral infection.

Please see full Prescribing Information, including Medication Guide.Indication

VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.