FDA Approves First Triple-Drug Polypill for Initial Hypertension Treatment

The FDA has approved Widaplik, a polypill combining telmisartan, amlodipine, and indapamide, for the treatment of hypertension in adults, including as initial therapy. This is the first triple-combination pill approved for first-line treatment in patients likely to require multiple medications to reach blood pressure targets.

WIDAPLIK is a proprietary single pill combination of three medicines: telmisartan, amlodipine and indapamide and is available in three doses: a standard dose and two low doses. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. WIDAPLIK, with its three different doses, can deliver the efficacy benefits of a triple mechanism approach early in the treatment pathway with an established safety profile and good tolerability.

Globally recognized treatment guidelines now recommend the use of single pill combination therapy for most patients and acknowledge the benefit of early use of combination therapy.

In the US, nearly half of adults have hypertension and only around one in four have their blood pressure under control. Hypertension is a major risk factor for coronary heart disease, stroke and heart failure and is estimated to cause 460,000 deaths in the US each year.

Mark Mallon, Chief Executive Officer of George Medicines, said: “Data show that most patients with hypertension will require two or more medicines to bring their blood pressure under control. WIDAPLIK can provide patients with hypertension, including those who are starting treatment, with a different approach to control their blood pressure. With its triple combination efficacy, established safety profile, good tolerability and its availability in a single pill, WIDAPLIK has the potential to address key challenges in current hypertension treatment approaches. With planning underway for the upcoming US commercial launch of WIDAPLIK, and further regulatory submissions in other territories anticipated during 2025, George Medicines is well-positioned to positively impact the global burden of hypertension.”

Dr. Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, and Past President of the World Hypertension League, said: “I am very excited and pleased to have WIDAPLIK approved for the treatment of hypertension in the US. Single pill combination antihypertensive therapy has great potential to improve hypertension control in the US and worldwide. Most patients with hypertension need multiple therapies to achieve their blood pressure goals. The new dose options available with WIDAPLIK offer a treatment regimen that could benefit a broad range of patients, including those just starting treatment.”

The FDA approval is 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. In clinical trials, the most common adverse event reported in patients treated with WIDAPLIK is symptomatic hypotension. WIDAPLIK is contraindicated in patients with anuria, known hypersensitivity to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs, or to any other component of this product. In patients with diabetes, WIDAPLIK is not to be co-administered with aliskiren. A boxed warning in the labeling informs physicians and patients to discontinue WIDAPLIK as soon as possible after pregnancy is detected due to fetal toxicity. For full Prescribing Information, visit here.

The US commercial launch of WIDAPLIK is anticipated in Q4 2025.

George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company’s WIDAPLIK development program built on earlier research by The George Institute, including the 700-patient TRIUMPH trial undertaken in Sri Lanka in 2016/17, which found that among patients with mild to moderate hypertension, treatment with a low-dose triple combination pill led to an increased proportion of patients achieving their target blood pressure goal versus usual care.