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A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

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Trial Profile

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jun 2026

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At a glance

  • Drugs Fostamatinib (Primary)
  • Indications Idiopathic thrombocytopenic purpura
  • Focus Registrational; Therapeutic Use
  • Acronyms FIT1
  • Sponsors Rigel Pharmaceuticals

Most Recent Events

  • 27 May 2026 According to Knight Therapeutics media release, the company has submitted TAVALISSE for regulatory approval in Colombia, Argentina and Paraguay.
  • 27 May 2026 According to Knight Therapeutics media release, based on results form FIT-1 and FIT-2 trial results, the company received approval for TAVLESSE in Mexico in 2024 and has launched TAVALISSE (fostamatinib disodium hexahydrate) in Mexico, for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
  • 08 May 2026 According to Knight Therapeutics media release, the company announced today that its Brazilian affiliate, United Medical Ltda., received regulatory approval from ANVISA for TAVALISSE for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The company expect the launch of TAVALISSE in Brazil in the second half of 2026. The approval was supported by FIT-1 and FIT-2 and the open-label FIT-3 extension.

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