Etrasimod FDA Approval Opens New Chapter in Ulcerative Colitis Treatment

Ulcerative colitis patients in the United States just gained access to a promising new treatment option. Pfizer, in partnership with Everest Medicines, has secured U.S. FDA approval for VELSIPITY™ (etrasimod), marking a significant breakthrough for patients struggling with moderately to severely active disease.

Why This Matters for Patients

The approval addresses a critical unmet need. Approximately one million UC patients are expected to be diagnosed in China by 2030—more than double the 2019 figures—reflecting a rapidly growing disease burden across Asia and beyond. Many of these patients require alternatives when conventional treatments and biologics fail or cause intolerance.

Etrasimod stands apart from competing S1P receptor modulators with a notable advantage: its label eliminates the requirement for dose titration at treatment initiation. For patients seeking convenience, this oral once-daily formulation offers a meaningful improvement over more complex dosing schedules.

Clinical Evidence Demonstrates Efficacy

The FDA’s decision rested on robust data from the ELEVATE UC clinical trial program, which included two pivotal Phase 3 studies (ELEVATE UC 52 and ELEVATE UC 12). These trials enrolled patients who had already failed or couldn’t tolerate conventional therapies, biologics, or JAK inhibitors—a challenging population requiring effective new options.

Results were compelling:

Week 12 outcomes: Clinical remission reached 27.0% of etrasimod-treated patients versus 7.0% receiving placebo, yielding a 20.0 percentage point advantage (P<.001).

Week 52 outcomes: The benefit persisted and strengthened, with 32.0% achieving remission on etrasimod compared to 7.0% on placebo—a 26.0 percentage point differential (P<.001).

Notably, nearly two-thirds of trial participants had received no prior biologic or JAK inhibitor therapy. The ELEVATE UC program was also the first advanced therapy trials to include patients with isolated proctitis, broadening the relevant patient population.

Safety remained favorable and consistent with earlier etrasimod studies, supporting the drug’s benefit-risk profile.

Asia’s Path Forward

Everest Medicines holds exclusive development and commercialization rights for etrasimod across Greater China and South Korea. The company’s Asia Phase 3 clinical trial has completed patient enrollment, positioning the organization to pursue New Drug Applications as quickly as possible in these strategic markets.

“We congratulate our partner for achieving this significant milestone,” said Rogers Yongqing Luo, CEO of Everest Medicines. “Etrasimod represents an advanced treatment with proven efficacy and a favorable safety profile—exactly what UC patients need as incidence rises across the region.”

The etrasimod development story traces back to Arena Pharmaceuticals, which created the molecule before Pfizer’s 2022 acquisition brought the asset into the company’s portfolio. Everest’s 2017 licensing agreement positioned it to capitalize on this breakthrough in key Asian markets where UC prevalence is accelerating.

With FDA approval now achieved, the focus shifts to completing regulatory pathways in China and other Asian countries—bringing this effective new treatment option to millions of patients facing this chronic inflammatory condition.