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Second pivotal phase 3 clinical trial to investigate the efficacy, safety and tolerability of MTX-071 in patients with pain associated with osteoarthritis of the knee

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Trial Profile

Second pivotal phase 3 clinical trial to investigate the efficacy, safety and tolerability of MTX-071 in patients with pain associated with osteoarthritis of the knee

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2023

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At a glance

  • Drugs Resiniferatoxin (Primary)
  • Indications Musculoskeletal pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Grunenthal

    • Most Recent Events

    • 21 Jun 2023 According to a Grunenthal media release, the company announced that its investigational non-opioid medicine resiniferatoxin (RTX), currently undergoing clinical Phase III development, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for pain associated with osteoarthritis (OA) of the knee. The decision is based on clinical phase I and II data indicating significant pain relief and a favourable safety profile.
    • 22 May 2023 According to a Grunenthal media release, the company aims to submit first Marketing Authorization Application in 2025.
    • 18 Aug 2022 According to a Grunenthal media release, the company aims to submit a new drug application in 2024.
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