Enliven announces FDA alignment on relcobatinib Phase 3 trial design
Published in Drugs development & discovery.
Publication date: October 7, 2026.
Enliven Therapeutics reported on October 6, 2026 that it had reached alignment with the U.S. FDA on the final design of ENABLE-2, a planned pivotal Phase 3 trial of investigational relcobatinib (ELVN-001) in previously treated chronic myeloid leukemia.
The randomized study is expected to enroll approximately 450 adults who have received at least one tyrosine kinase inhibitor. Participants will receive either relcobatinib 80 mg once daily or investigator-selected dasatinib, nilotinib or bosutinib.
The primary endpoint is major molecular response at Week 24; a key secondary endpoint assesses that response at Week 96. The company expects to initiate the study before the end of 2026.
Agreement on trial design is a development milestone, not marketing approval or evidence of superiority. ENABLE-2 will need to test the candidate’s benefit and risks against its comparator treatments.