In a milestone development for hypertension care, the U.S. Food and Drug Administration (FDA) has approved WIDAPLIK, the first and only triple-combination medicine approved as initial therapy for patients anticipated to require multiple medications to achieve their blood pressure targets. WIDAPLIK is a once-daily oral medication that includes telmisartan (an angiotensin II receptor blocker), amlodipine (a calcium channel blocker), and indapamide (a thiazide-like diuretic) and is available in three dosage strengths: 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg.
WIDAPLIK has been developed to provide the benefits of a triple mechanism approach early in the treatment pathway, with excellent blood pressure control, safety, and tolerability. The therapy supports globally endorsed guidelines, which promote that single-pill combination therapy should be the foundation and first-line therapy in most hypertension cases. Such an approach simplifies regimens, promotes adherence, and may help patients reach target blood pressure levels.
The urgency for better treatment options has never been more apparent. In the United States, nearly 50% of adults are living with hypertension, and only one in four has it well under control. Hypertension continues to be a significant contributor to cardiovascular events (heart attack, stroke, heart failure), with an estimated 460,000 deaths in the U.S. each year linked to hypertension. Studies have shown that most patients will need two or more medications to lower their blood pressure sufficiently. With this unmet patient need, the opportunity for WIDAPLIK is clear.
Dr. Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University and former president of the World Hypertension League, praised the approval. “I am very excited and pleased to have WIDAPLIK approved for the treatment of hypertension in the U.S. Single pill combination antihypertensive therapy will help improve hypertension control both in the U.S. and worldwide”, he said. “The new dose formulations available with WIDAPLIK provide a treatment regimen that will reach a wider variety of patients, including patients who are starting treatment.”
The FDA approval is based on a large clinical development program that incorporated two pivotal Phase 3 studies. WIDAPLIK produced a greater reduction in blood pressure compared to dual therapy and placebo, and achieved a statistically significant improvement in blood pressure control compared to both treatment groups, yielding promising results for full approval. WIDAPLIK, used in both studies, resulted in good tolerability with no meaningful added withdrawal effects due to adverse reactions, with the most frequently observed adverse event relating to symptomatic hypotension.
Other global studies support the efficacy and safety of WIDAPLIK. For example, in the VERONICA trial conducted in Nigeria, WIDAPLIK was compared to standard care and reported more blood pressure reduction and good tolerability. Additionally, there is a global study currently examining GMRx2 (where WIDAPLIK is the active component) to determine whether GMRx2 can prevent stroke in patients with intracerebral hemorrhage (one of the most severe forms of stroke).
WIDAPLIK is contraindicated in patients with anuria or known hypersensitivity to any of its components, including telmisartan, amlodipine, indapamide, or other sulfonamide-derived drugs. It is also contraindicated in patients with diabetes who are taking aliskiren. The labeling has a boxed warning indicating that the drug should be discontinued immediately if pregnancy is detected, which is due to the risk of fetal toxicity.
While a commercial launch of WIDAPLIK in the U.S. is anticipated, more regulatory submissions are expected globally in 2025. The developer of WIDAPLIK is strategically positioned to make a significant contribution to the fight against hypertension. By providing patients with simpler and effective treatment for a disease affecting millions, WIDAPLIK could have a positive impact on the management of blood pressure worldwide.
References: George Medicines. George Medicines announces FDA approval of WIDAPLIK™ (telmisartan, amlodipine, and indapamide), a new single-pill combination treatment for hypertension in adults, including initial treatment. Published  9 June 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 – George MedicinesÂ
