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A phase IIB/III pivotal study of KAND567

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Trial Profile

A phase IIB/III pivotal study of KAND567

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs KAND-567 (Primary) ; KAND-567 (Primary)
  • Indications Myocardial infarction
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms FRACTIVE

Most Recent Events

  • 05 Jun 2025 According to kancera media release, the company's non-clinical data package and planned activities are sufficient for initiating a phase III study. the proposed dosing regimen for the phase IIb study, as well as the general dosing strategy for the phase III study, appear reasonable, however, it is recommended to evaluate an additional dose in the phase IIb study to better characterize the exposure-response relationship to support dose selection for phase III.
  • 05 Jun 2025 According to kancera media release, the company has completed pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration (FDA) and received positive feedback on the planned clinical development program for KAND567 in ST-elevation myocardial infarction.
  • 20 May 2025 According to kancera media release, the company has submitted a pre-IND application with the US regulatory agency FDA, with the objective to receive formal feedback on the planned phase IIb study design and the overall clinical development plan up until market approval. The company expects to present the FDA feedback before the end of the second quarter 2025.

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