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First head-to-head pivotal trial of ELVN-001

Trial Profile

First head-to-head pivotal trial of ELVN-001

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2026

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At a glance

  • Drugs ELVN-001 (Primary)
  • Indications Chronic myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ENABLE-2
  • Sponsors Enliven Therapeutics

Most Recent Events

  • 11 Jun 2026 According to an Enliven Therapeutics media release, Additional details of the Phase 3 trial design are expected to be finalized following further discussions with the FDA, including at a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026.
  • 08 Jan 2026 According to an Enliven Therapeutics media release, the company is preparing for upcoming regulatory interactions with the FDA to align on dose selection and support initiation of this Phase 3 trial in 2H 2026. Initiation of ENABLE-2, this Phase 3 clinical trial of ELVN-001 is also expected in 2H 2026
  • 07 Jan 2026 According to an Enliven Therapeutics media release, the company advance ELVN-001 into a pivotal Phase 3 trial in patients with chronic myeloid leukemia later this year.

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