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A randomized, double-blind, placebo-controlled, parallel-arm Phase III trial of tesofensine in patients with obesity

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Trial Profile

A randomized, double-blind, placebo-controlled, parallel-arm Phase III trial of tesofensine in patients with obesity

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Jul 2021

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At a glance

  • Drugs Tesofensine (Primary)
  • Indications Obesity
  • Focus Registrational; Therapeutic Use
  • Acronyms Viking
  • Sponsors Medix

    • Most Recent Events

    • 25 Jun 2021 According to a Saniona media release, discussions with the committee may delay the anticipated final approval decision from COFEPRIS into 2022.
    • 25 Jun 2021 According to a Saniona media release, the tesofensine application was reviewed by a COFEPRIS technical committee and was unable to provide a favorable opinion and cited the need for additional information regarding certain topics, including weight loss maintenance. The company ill gather the requested information and continue discussions with the committee as soon as possible.
    • 23 Dec 2019 According to a Saniona media release, company has submitted a new drug application to the Mexican food and drug administration for approval of tesofensine for the treatment of patients with obesity.

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