George Medicines Receives FDA Approval for WIDAPLIK™, a New Single-Pill Combination Treatment for Hypertension in Adults
Monday, June 09, 2025
George Medicines, a biopharmaceutical company focused on cardiometabolic conditions, has received approval from the US Food and Drug Administration (FDA) for WIDAPLIK™ (telmisartan, amlodipine and indapamide). This single-pill treatment is designed to manage hypertension in adults and can be used as an initial therapy.
WIDAPLIK combines three antihypertensive agents and is available in three dosing options—standard and two low-dose variants. It is the first triple-combination therapy approved by the FDA for initial use in patients who are likely to need more than one medication to reach their target blood pressure. The treatment aims to offer early, effective control with a proven safety profile and tolerability.
Clinical guidance now increasingly supports the use of fixed-dose combination therapies, especially in early treatment stages. In the United States, around half of the adult population has high blood pressure, with only a quarter managing to keep it under control. Hypertension remains a major contributor to heart disease, stroke, and heart failure, and is estimated to cause about 460,000 deaths annually in the US.
The FDA’s approval was based on two Phase 3 global clinical studies, which demonstrated that WIDAPLIK significantly improved blood pressure levels and control rates compared to placebo and dual-combination treatments. The most commonly reported side effect was symptomatic hypotension. WIDAPLIK is not suitable for patients with anuria, known allergies to its components, or those who are pregnant. It should also not be used alongside aliskiren in diabetic patients.
Commercial launch in the US is expected in the fourth quarter of 2025. Regulatory submissions in other markets are planned for 2025.
WIDAPLIK was developed by George Medicines, an independent company spun out of The George Institute for Global Health. The treatment builds on earlier clinical research, including the TRIUMPH trial in Sri Lanka, which showed improved blood pressure outcomes using a low-dose triple therapy.
George Medicines is supported by George Health and Brandon Capital, one of Australia's prominent life sciences investment firms.
Source: globenewswire.com
