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A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-1)

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Trial Profile

A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-1)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2026

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At a glance

  • Drugs Vidofludimus calcium (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ENSURE-1
  • Sponsors Immunic

Most Recent Events

  • 13 Aug 2026 This trial has been discontinued in Germany due to Investigator / Site related reason
  • 11 Aug 2026 According to an Immunic media release, if the Top-line data is positive then plans to submit a New Drug Application (NDA) in the United States in mid-2027, with a targeted potential regulatory approval date in 2028.
  • 27 May 2026 According to an Immunic media release, Mr. Erik Lundgren (Chief Executive Officer) will lead the company advances vidofludimus calcium through late-stage clinical development, including the pivotal phase 3 ENSURE program in relapsing multiple sclerosis (RMS) and the planned phase 3 program in primary progressive multiple sclerosis (PPMS), while also preparing for potential new drug application (NDA) filing, regulatory approval and commercialization.

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