October 7, 2026
Enliven remains on track to initiate ENABLE-2 before year-end 2026
BURLINGAME, Calif., Oct. 7, 2026 /PRNewswire/ — Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced that it has reached alignment with the U.S. Food and Drug Administration (FDA) on the final design of the ENABLE-2 pivotal trial, a Phase 3 trial of relcobatinib (ELVN-001) in patients with previously treated chronic myeloid leukemia (CML).
United States Adopted Names (USAN) Council has adopted relcobatinib as the nonproprietary name for ELVN-001. Relcobatinib is an investigational, potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver of CML.
“We are pleased to have reached alignment with the FDA on the design of the ENABLE-2 pivotal Phase 3 trial, providing a clear path to initiate the trial before year-end,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “ENABLE-2 is designed to directly compare relcobatinib to the second-generation TKIs and evaluate its potential to be the best-in-class ATP-competitive inhibitor for patients with CML. We are encouraged by the enthusiasm from physicians and the broader CML community as we prepare to initiate the trial.”
ENABLE-2 Phase 3 Trial Design: A 2L+ Pivotal Trial for Patients with CML
ENABLE-2 is a planned randomized 2L+ phase 3 trial expected to enroll approximately 450 adults with CML previously treated with one or more tyrosine kinase inhibitors (TKIs). Participants will be randomized 1:1 to receive either relcobatinib 80 mg once daily or an investigator-selected second-generation TKI (dasatinib, nilotinib, or bosutinib). The primary endpoint is major molecular response (MMR) at Week 24, with the key secondary endpoint of MMR at Week 96.
With approximately 450 patients, the trial is designed such that an improvement in MMR rate of at least 10 percentage points over the control arm would be sufficient to demonstrate statistical superiority. We believe this difference would represent a clinically meaningful improvement over currently available second-generation TKIs.
The Company remains on track to initiate ENABLE-2 before year-end 2026.
