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Phase 3 trial of Risvodetinib

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Trial Profile

Phase 3 trial of Risvodetinib

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 30 May 2025

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At a glance

  • Drugs Risvodetinib (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 30 May 2025 New trial record
  • 21 May 2025 According to an Abli therapeutics media release, The Company proposed to use the change in the MDS-UPDRS Part 2 as the primary outcome measure for its planned Phase 3 trial, consistent with the Agency view of the most clinically meaningful outcome for patients. The Agency encouraged continued use of Patient and Clinical Severity scales as was done in the Phase 2 trial to complement MDS-UPDRS and SEADL measures.
  • 21 May 2025 According to an Abli therapeutics media release, company completed an End of Phase 2 (EOP2) meeting with the Food and Drug Administration (FDA) to discuss outcomes of the 201 Trial in untreated Parkinson disease and to review plans for the Phase 3 program. The primary purpose of the meeting was to discuss endpoints to be used in a Phase 3 program and to define what tangential clinical and pre-clinical experiments may be necessary for a potential filing of a New Drug Application (NDA.)

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