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First-in-Class: FDA OKs Triple Therapy to Treat Hypertension

Time:2025-10-11 Views:0
       Recently, George Medicines announced that its new drug Widaplik® (containing telmisartan, amlodipine, and indapamide, previously known as GMRx2) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension in adult patients, including as initial therapy to lower blood pressure (BP). This marks the world’s first triple-combination drug approved for initial hypertension treatment.

Hypertension, one of the most common chronic conditions, significantly increases the risk of cardiovascular diseases when poorly controlled. Current treatment guidelines recommend single-pill combination therapies for most patients to achieve effective BP management. Such combination drugs must balance efficacy with safety in clinical use.Widaplik is a fixed-dose combination tablet comprising three antihypertensive agents: telmisartan, amlodipine, and indapamide. These components work synergistically through distinct mechanisms to reduce peripheral vascular resistance and lower blood pressure:

Telmisartan, an angiotensin II receptor blocker (ARB), selectively inhibits the binding of angiotensin II to AT1 receptors, suppressing vasoconstriction and aldosterone release, thereby dilating blood vessels and reducing BP.

Amlodipine, a dihydropyridine calcium channel blocker (CCB), blocks calcium influx into vascular smooth muscle cells, relaxing vascular tone and directly dilating peripheral arterioles to reduce vascular resistance.

Indapamide, a thiazide-like diuretic, exerts both diuretic and vasodilatory effects.

Widaplik is available in three dosage strengths: 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg. Its triple-mechanism action provides synergistic efficacy early in treatment, with clinical data confirming favorable safety and tolerability.

SZEB  specializes in providing high-quality reference standards for telmisartan, amlodipine, and indapamide-related impurities. These products support comprehensive impurity analysis and quality control, ensuring drug safety and compliance. For more information, visit our official website: www.ex-biotech.com or contact us by E-mail:sales@ex-biotech.com .

 
    

News Source:‘George Medicines announces FDA approval of WIDAPLIK™ (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment’.