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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jun 2025

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At a glance

Most Recent Events

  • 09 Jun 2025 According to a George Medicines media release, based on positive results from two phase III studies (NCT04518293 and NCT04518306), the US Food and Drug Administration (FDA) has approved WIDAPLIK for the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure.
  • 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.
  • 13 Jan 2025 According to a George Medicines media release, data from this study published in 2024 in the Journal of the American College of Cardiology.

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