GMRx2 FDA Approval Status

Last updated by Judith Stewart, BPharm on Aug 14, 2024.

FDA Approved: No
Brand name: GMRx2
Generic name: amlodipine, indapamide and telmisartan
Company: George Medicines
Treatment for: High Blood Pressure

GMRx2 (amlodipine, indapamide and telmisartan) is a single pill, triple combination of existing medicines in development for the treatment for hypertension, including initiation of treatment.

• Hypertension (high blood pressure) occurs when the force of blood flowing through the blood vessels is too high (≥140/90 mmHg).
• Globally recognized treatment guidelines recommend the use of fixed dose combination therapy for most patients with hypertension, including for first-line treatment, as most patients require two or more medicines to achieve control.
• GMRx2 is a combination of low doses of amlodipine (a calcium channel blocker), indapamide (an indoline antihypertensive/diuretic), and telmisartan (an angiotensin II receptor blocker) that potentially work together to deliver rapid and effective blood pressure control with a favourable tolerability profile.
• The New Drug Application for GMRx2 for the treatment of hypertension was supported by the results of the Company’s two Phase III studies where it was shown to achieve all primary efficacy and safety endpoints. Study 1 was 4 weeks in duration with 295 subjects receiving GMRx2 or placebo. Study 2 involved a 4-week active run-in period, during which 2,244 subjects received GMRx2 followed by a 12-week randomized period in which 1385 subjects received GMRx2 or one of the three component two-drug combinations. The two studies are expected to be published by the end of 2024.

Development timeline for GMRx2

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer