Widaplik FDA Approval History

Last updated by Judith Stewart, BPharm on June 10, 2025.

FDA Approved: Yes (First approved June 5, 2025)
Brand name: Widaplik
Generic name: amlodipine, indapamide and telmisartan
Dosage form: Tablets
Previous Name: GMRx2
Company: George Medicines
Treatment for: High Blood Pressure

Widaplik (amlodipine, indapamide and telmisartan) is a single pill, triple combination therapy for the treatment of 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.
• Widaplik 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 work together to deliver rapid and effective blood pressure control.
• FDA approval was based on positive results from two international Phase 3 trials, which compared Widaplik against placebo and against dual combinations of its component drugs. In both trials Widaplik significantly improved blood pressure and control rates vs comparators.
• Widaplik tablets are administered orally, once daily.
• The Widaplik product label carries a Boxed Warning for fetal toxicity. Warnings and precautions associated with Widaplik include hypotension, electrolyte and glucose imbalances, impaired renal function, acute angle closure glaucoma, and hyperuricemia.
• The most common adverse reaction is symptomatic hypotension.

Development timeline for Widaplik

Further information

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