FDA OKs New Single Pill Combination for HTN Treatment: Daily Dose
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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
On June 10, 2025, we reported on the US FDA approval of a fixed-dose triple combination pill containing telmisartan, amlodipine and indapamide (Widaplik, formerly GMRx2; George Medicines) for treating hypertension (HTN) in adults, including as initial treatment.
The approval
The triple combination pill is the first combination medication that will be available for initial therapy in individuals with HTN who will likely require multiple drugs to achieve blood pressure (BP) goals.
The FDA’s decision was supported by safety and efficacy data from 2 international phase 3 trials that compared the fixed dose triple combination to placebo and against all possible dual combinations of its component agents. The first trial evaluated 2 doses of the polypill against placebo among 295 adults with HTN receiving either no treatment or 1 medication. The study found that compared with just 30% of the placebo-treated group, 65% of participants assigned to the ultra-low dose and 70% assigned to the low-dose polypill achieved in-office BP of less than 140/90 mm Hg at follow-up.
For the second trial, after 12 weeks of treatment, BP was assessed as controlled in nearly three-quarters (74%) of participants receiving the triple combination. Smaller proportions achieved control among those assigned to any of the dual combination comparators (amlodipine/telmisartan, 54%; amlodipine/indapamide, 61%; telmisartan/indapamide, 61%).
The medication's safety profile reflects its established component drugs. In clinical trials the most common adverse event among polypill-treated participants was symptomatic hypotension.
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