Safety and Efficacy of Asimadoline (TP0052) in Patients With Vasomotor Symptoms (VMS).

This Randomized Clinical Trial entitled Safety and Efficacy of a Peripherally Restricted Selective Kappa Agonist for Moderate to Severe Menopausal Symptoms in Midlife Women is a Phase 2a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of asimadoline TP0052 for the treatment of moderate to severe menopausal vasomotor symptoms (VMS). The design includes: 2 weeks of daily recording of VMS prior to drug treatment; 8 weeks of double-blind treatment with the peripherally restricted kappa agonist (PRKA), asimadoline TP0052, or placebo; and a safety telephone follow-up post-treatment; after the initial 8-week double-blinded follow-up, all patients undergo treatment with Asimadoline in an open label format for 4 weeks.

NCT Number	NCT07042516
Lead Sponsor	Tioga Pharmaceuticals
Conditions	Vasomotor Symptoms
Enrollment	120 participants
Start Date	2025-08-13
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-02-20 (estimated)
Updated on ClinicalTrials.gov	2025-09-09