Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ABCL635, an NK3R Monoclonal Antibody Antagonist for the Treatment of Vasomotor Symptoms: A Phase 1/2 Study
Nazarenko, N, et al. The Menopause Society (TMS), October 2026
This presentation describes top-line Phase 1/2 results of ABCL635, a novel, highly selective NK3R monoclonal antibody antagonist, administered via a subcutaneous (SC) injection. Safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical efficacy of ABCL635 were evaluated in a Phase 1/2 multicenter, randomized, double-blind, placebo-controlled study of postmenopausal women with moderate-to-severe VMS (VMSM-S).
In the Phase 1 single ascending dose (SAD) study, ABCL635 showed a favorable PK profile with PD effects supporting once monthly SC dosing.
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
In the Phase 1 SAD, multiple ascending dose (MAD), and Phase 2 cohorts, ABCL635 was well tolerated, with no gastrointestinal or liver signals.
Together, the data presented support the late-stage development of ABCL635 and highlight this as a potential best-in-class non-hormonal treatment for VMSM-S.
