FDA Approves New 3-in-1 Combo Pill for High Blood Pressure
June 11, 2025 – The FDA has approved a new pill for adults with high blood pressure (hypertension) that combines three medicines in one. Available in one regular and two lower doses, it offers a convenient option for treating hypertension, which affects nearly half of the adults in the U.S. and raises their risk of stroke and heart failure.
Sold as Widaplik, it is the first and only single pill to combine three previously FDA-approved drugs – telmisartan, amlodipine, and indapamide – offering a triple-action approach for people who would otherwise need multiple pills to manage their blood pressure. It works in three ways and is a safe, well-tolerated early treatment option.
Hypertension happens when your blood pushes too hard against your blood vessels, making the heart work harder and increasing the risk of heart problems, strokes, and other complications. It contributes to about 460,000 deaths annually in the U.S. and often goes undetected due to a lack of symptoms. With 1 in 3 Americans unaware they have it and only 1 in 4 managing it well, there's an urgent need for simpler, more effective treatments.
The approval was based on two large studies that showed using Widaplik helped lower blood pressure more than using just two medicines or a placebo, according to a news release from the company that makes it, George Medicines. People who took Widaplik didn't stop taking it more often because of side effects, which means it was generally easy for them to take.
Another trial showed that Widaplik was better at reducing blood pressure compared to standard care, while remaining well-tolerated. George Medicines stated that a global trial is underway to find out if the combo treatment can help prevent strokes in people who have previously had an intracerebral hemorrhage (sudden bleeding in the brain), the most serious type of stroke.
"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," Paul Whelton, MD, Show Chwan chair of global public health at Tulane University in New Orleans and past president of the World Hypertension League, said in a statement.
Widaplik is a medicine made of three drugs that work together to help lower blood pressure. Two of them, telmisartan and amlodipine, relax blood vessels so blood can flow more easily. The third, indapamide, helps your body get rid of extra water by making you pee more. Widaplik comes in three strengths: 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg.
Low blood pressure – which can make you feel faint or dizzy – was the most common side effect, the company said. Patients who pass out should stop taking the medication and consult their doctor.
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