NCT07042516

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

Safety and Efficacy of Asimadoline (TP0052), a Peripherally Restricted Selective Kappa Agonist, for the Treatment of Moderate to Severe Menopausal Symptoms in Midlife Women.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tioga Pharmaceuticals · Industry
• Sex: Female
• Age: 40 Years – 62 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Vasomotor Symptoms

Interventions

Type	Name	Description
DRUG	Asimadoline	Asimadoline TP0052 2.5 mg two (2) tablets bid (two on awakening and two before bed), total of four (4) tablets daily (10 mg) for 8 weeks.

Timeline

• Start date: 2025-08-13
• Primary completion: 2026-12-31
• Completion: 2027-02-20
• First posted: 2025-06-29
• Last updated: 2025-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study