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A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women With Moderate to Severe Endometriosis-Associated Pain Over a 12-Week Treatment Period

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Trial Profile

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women With Moderate to Severe Endometriosis-Associated Pain Over a 12-Week Treatment Period

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Dec 2025

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At a glance

  • Drugs BAY 1158061 (Primary)
  • Indications Endometriosis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Hope Medicine

Most Recent Events

  • 04 Dec 2025 According to a Hope Medicine media release, the company announced that HMI-115 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe pain associated with endometriosis.
  • 04 Dec 2025 According to a Hope Medicine media release, results of this proof-of-concept global Phase II clinical trial have been formally published in The Lancet Obstetrics, Gynaecology & Women's Health.
  • 01 Aug 2025 Status changed from recruiting to completed.

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