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A Phase 2A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of ACER-801 for Treatment of Moderate to Severe Vasomotor Symptoms (VMS) Associated With Menopause

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Trial Profile

A Phase 2A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of ACER-801 for Treatment of Moderate to Severe Vasomotor Symptoms (VMS) Associated With Menopause

Status: Suspended
Phase of Trial: Phase II

Latest Information Update: 09 Aug 2024

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At a glance

  • Drugs Osanetant (Primary)
  • Indications Vasomotor symptoms
  • Focus Adverse reactions; Pharmacokinetics; Proof of concept
  • Sponsors Acer Therapeutics

Most Recent Events

  • 17 Mar 2023 Topline results presented in an Acer Therapeutics media release.
  • 16 Mar 2023 According to an Acer Therapeutics media release, company intends to conduct a comprehensive analysis of totality of clinical trial data-including pharmacokinetic data, which has not yet been analyzed-which will inform path forward for the program.
  • 16 Mar 2023 According to an Acer Therapeutics media release, ACER-801 did not achieve statistical significance when evaluating its ability to decrease frequency or severity of hot flashes in postmenopausal women. As a result, company is pausing ACER-801 program until company has conducted a thorough review of the full data set.

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