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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular Psoriasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2026

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At a glance

  • Drugs Imsidolimab (Primary) ; Imsidolimab (Primary)
  • Indications Generalised pustular psoriasis
  • Focus Registrational; Therapeutic Use
  • Acronyms GEMINI1
  • Sponsors AnaptysBio

Most Recent Events

  • 25 Feb 2026 According to Vanda Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026.
  • 15 Dec 2025 According to Vanda Pharmaceuticals media release, the company has requested priority review for the BLA, citing GPP as a rare orphan disease. The priority review would establish a 6-month review cycle, with a potential FDA approval of imsidolimab for the treatment of GPP as early as mid-2026.
  • 15 Dec 2025 According to an Vanda Pharmaceuticals media release, the company has submitted the BLA for Imsidolimab to the USFDA to treat generalized pustular psoriasis (GPP). The BLA is supported by positive results from the global Phase 3 GEMINI-1 and GEMINI-2 studies.

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