FDA

Triple combination pill OK’d for hypertension

June 11, 2025

Brand name: Widaplik

Generic name: telmisartan, amlodipine and indapamide

Manufacturer: George Medicines

Approval date: June 9, 2025

FDA approved Widaplik (telmisartan, amlodipine and indapamide), formerly known as GMRx2, for the treatment of hypertension in adult patients, including as initial treatment, to lower BP.

According to a manufacturer press release, Widaplik is the first and only FDA-approved triple combination therapy for use as an initial therapy in patients likely to need multiple agents to achieve BP goals.

Efficacy

Approval was based on data from two international phase 3 trials (Study 1: NCT04518306; Study 2: NCT04518293), which compared Widaplik against placebo and against dual combinations of its component drugs.

In both trials Widaplik significantly improved BP and control rates vs. comparators.

Safety

In clinical trials, the most common adverse event reported in patients treated with Widaplik was 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.

Recommended dose

For initial treatment of hypertension, start with Widaplik (10 mg/1.25 mg/0.625 mg) or Widaplik (20 mg/2.5 mg/1.25 mg) orally once daily. Titrate up to a maximum dose of Widaplik (40 mg/5 mg/2.5 mg) orally once daily. Dosage may be increased after 2 weeks to a maximum dose of 40 mg/5 mg/2.5 mg orally once daily to achieve more rapid control.

Sources:

Widaplik (telmisartan, amlodipine and indapamide) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219423s000lbl.pdf Accessed June 10, 2025.

George Medicines announces FDA approval of Widaplik™ (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment. [News release]. 2025. https://george-medicines.com/george-medicines-announces-fda-approval-of-widaplik-telmisartan-amlodipine-and-indapamide-a-new-single-pill-combination-treatment-for-hypertension-in-adults-including-initial-treatment/