Clinical trials

This Phase 2a randomized, double-blind, placebo-controlled study evaluates the safety and efficacy of asimadoline (TP0052), a peripherally restricted selective kappa-opioid receptor agonist, for moderate to severe menopausal vasomotor symptoms (VMS) in women aged 40-62 years. Following screening and baseline VMS diary collection, eligible participants are randomized 1:1 to oral asimadoline 5 mg twice daily or matching placebo for 8 weeks. Following the double-blind treatment period, all participants receive 4 weeks of open-label asimadoline, with a safety telephone assessment at approximately Week 12. Participants enrolled following implementation of Protocol Version 3.0 may elect to undergo optional noninvasive vascular assessments at Baseline and Week 8. These include brachial artery flow-mediated dilation (FMD), digital pulse amplitude tonometry (PAT), carotid-femoral pulse wave velocity (PWV), and radial pulse-wave analysis, including augmentation index normalized to a heart rate of 75 beats per minute (AIx@75). These exploratory assessments evaluate endothelial function, arterial stiffness, and central hemodynamics. Participation is voluntary, and participants may decline or discontinue the vascular assessments without affecting eligibility for or continued participation in the main study.