Top-line Results of a Phase 2 Study of ABCL635, a First-in-Class NK3R Monoclonal Antibody for the Treatment of Vasomotor Symptoms
Nazarenko, N, et al. International Menopause Society (IMS), October 2026
This presentation describes the top-line Phase 2 results of ABCL635, a novel, long-acting, highly selective NK3R monoclonal antibody antagonist, administered via a subcutaneous (SC) injection. Safety and efficacy of ABCL635 were evaluated in a Phase 2 multicenter, randomized, double-blind, placebo-controlled study of postmenopausal women with moderate-to-severe VMS (VMSM-S).
In the Phase 2 study at 4 weeks, ABCL635:
- Significantly reduced frequency and severity of VMSM-S after a single dose of 600 mg SC
- Meaningfully improved sleep and symptom burden
- Was well tolerated, with no gastrointestinal or liver signals
Together, the data presented show that ABCL635 is a potential best-in-class non-hormonal treatment option to women with VMSM-S.
Further Reading