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Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Dual Combinations for the Treatment of Hypertension

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Trial Profile

Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Dual Combinations for the Treatment of Hypertension

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jan 2025

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At a glance

  • Drugs Amlodipine/indapamide/telmisartan-George Medicines (Primary) ; Amlodipine/telmisartan; Indapamide/amlodipine
  • Indications Hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms GMRx2_ACT
  • Sponsors George Medicines

    • Most Recent Events

    • 13 Jan 2025 According to a George Medicines media release, a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking US approval of GMRx2 for the treatment for hypertension, including initiation of treatment, is ongoing with a Prescription Drug User Fee Act (PDUFA) goal date of 5 June 2025. Regulatory submissions in other territories are anticipated in 2025.
    • 18 Oct 2024 Results presented in the George Medicines Media Release.
    • 31 Aug 2024 According to a George Medicines media release, data from both GMRx2 clinical development program will support additional global regulatory filings.

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