George Medicines has achieved a significant regulatory milestone with the US FDA approval of WIDAPLIK™ (telmisartan, amlodipine, and indapamide), a proprietary single-pill, triple-combination medication for the treatment of hypertension in adults. This approval is particularly noteworthy as WIDAPLIK is the first and only FDA-approved triple combination medication indicated for use as an initial therapy in patients likely to require multiple drugs to achieve their blood pressure goals.
This approval addresses a critical unmet need, as nearly half of US adults have hypertension, and only about one in four have it under control – a major risk factor for heart disease, stroke, and heart failure. The FDA's decision is supported by robust positive results from two international Phase 3 trials that demonstrated WIDAPLIK's significant superiority in blood pressure reduction and control rates compared to both placebo and dual combinations of its components, all while maintaining an established safety profile and good tolerability. George Medicines, an independent spin-out from The George Institute for Global Health, plans to commercially launch WIDAPLIK in the US in Q4 2025, with further global regulatory submissions anticipated in 2025.