Drugs / ELVN-001
last change Jun 2026 re-read 3 minutes ago

ELVN-001

Developed for
chronic myeloid leukemia
Investigated by
Enliven Therapeutics

Trials 2

202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT06787144 Jan 2025 → Jan 2028 expected chronic myeloid leukemia Enliven Therapeutics Recruiting No outcome recorded
Phase 1 NCT05304377 May 2022 → Dec 2027 expected chronic myeloid leukemia Enliven Therapeutics Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 11

DateIssuerRelease
2026-06-11 Enliven Therapeutics Results Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components enliventherapeutics.com ↗
The updated data from the ENABLE trial are very promising and encouraging.
2026-05-12 Enliven Therapeutics Results Enliven Therapeutics Announces Oral Presentation at the EHA 2026 Congress Featuring Additional Positive Phase 1 Clinical Trial Data for ELVN-001 in CML enliventherapeutics.com ↗
2026-01-08 Enliven Therapeutics Results Enliven Reports Positive Initial Phase 1b Data for ELVN-001 in CML and Outlines 2026 Clinical Milestones enliventherapeutics.com ↗
Cumulative major molecular response (MMR) rate of 69% by 24 weeks, with 53% of patients achieving MMR by 24 weeks in ongoing randomized Phase 1b cohorts
2025-11-03 Enliven Therapeutics Results Enliven Therapeutics Announces Clinical Data in CML Patients with Atypical Fusion Transcripts at ASH 2025 Annual Meeting enliventherapeutics.com ↗
We observed encouraging anti-CML activity in the subset of patients with CML in the ENABLE study with atypical transcripts.
2025-08-13 Enliven Therapeutics Results Enliven Therapeutics Reports Second Quarter Financial Results and Provides a Business Update enliventherapeutics.com ↗
2025-06-13 Enliven Therapeutics Results Enliven Therapeutics Announces Updated Positive Data from Phase 1 Clinical Trial of ELVN-001 in CML at EHA 2025 Congress enliventherapeutics.com ↗
The data from ELVN-001 are encouraging, showing an efficacy, safety and tolerability profile that compare favorably to approved BCR::ABL1 inhibitors, despite being studied in a more heavily pretreated population.
2025-05-14 Enliven Therapeutics Results Enliven Therapeutics Reports First Quarter Financial Results and Provides a Business Update enliventherapeutics.com ↗
We are very pleased with the continued progress of ELVN-001 and the data that was just released in the EHA abstract.
2025-05-14 Enliven Therapeutics Results Enliven Therapeutics Announces Updated Positive Data from Phase 1 Clinical Trial of ELVN-001 in CML and Oral Presentation at the EHA 2025 Congress enliventherapeutics.com ↗
2024-09-28 Enliven Therapeutics Results Enliven Therapeutics Announces Positive Data Update from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia enliventherapeutics.com ↗
Additionally, ELVN-001 continues to be well-tolerated with no dose reductions and a median treatment duration of 20 weeks.
2024-05-14 Enliven Therapeutics Results Enliven Therapeutics Reports First Quarter Financial Results and Provides a Business Update enliventherapeutics.com ↗
2024-04-11 Enliven Therapeutics Results Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia enliventherapeutics.com ↗
Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage precision oncology company focused on the discovery and development of next-generation small molecule kinase inhibitors, today announced positive proof of concept data from the Phase 1 clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) who are relapsed, refractory, or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377).

All press releases naming this drug 14 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as ELVN-001 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06787144 ↗
1

NCT05304377 ↗

Route Oral “orally once or twice daily” NCT05304377 ↗