Key takeaways
The FDA approved Widaplik, a triple combination medication, to treat high blood pressure in adults.
It can also be used as an initial treatment for hypertension in patients who might otherwise need several medications to control their blood pressure.
Widaplik comes in three doses: one standard dose and two lower doses.
The U.S. Food and Drug Administration (FDA) has approved Widaplik, a new triple combination medication designed to treat high blood pressure in adults. Widaplik is the first single pill containing three different drugs approved as an initial treatment for hypertension. It’s a huge win for people who would otherwise likely need several different prescriptions to optimize their cardiovascular health.
What is Widaplik?
Manufactured by George Medicines, Widaplik is a combination tablet that contains three medications that work together to reduce blood pressure and lower the risk of heart attack or stroke:
- Telmisartan, an angiotensin receptor blocker (ARB), treats high blood pressure
- Amlodipine, a calcium channel blocker, treats high blood pressure and angina (chest pain) caused by coronary artery disease
- Indapamide, a diuretic (also known as a water pill), helps eliminate excess salt and water from the body
Widaplik comes in one standard dose and two lower doses:
- 40 mg telmisartan/5 mg amlodipine/2.5 mg indapamide
- 20 mg telmisartan/2.5 mg amlodipine/1.25 mg indapamide
- 10 mg telmisartan/1.25 mg amlodipine/0.625 mg indapamide
The recommended initial therapy is one of the two lower doses once daily. However, after two weeks, your healthcare provider may increase the dose if additional blood pressure control is needed.
How does Widaplik work?
The FDA’s approval was based in part on the results of the two double-blind randomized trials published in The Lancet and the Journal of the American College of Cardiology, which showed that Widaplik reduced systolic blood pressure by 7-8 mm Hg compared to placebo (inactive treatment) and compared to the dual therapy of its component drugs.
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What are the side effects of Widaplik?
The most common side effects of Widaplik include:
- Low blood sodium
- Low blood potassium
- Low blood pressure, which may cause dizziness
The package insert cautions that taking non-steroidal anti-inflammatory drugs (NSAIDs) could lead to an increased risk of kidney problems and the possible loss of the medication’s antihypertensive effect. The risk is higher in older adults, people with kidney problems, and people who are dehydrated.
It may also be necessary for individuals 65 years and older to start with a lower dose of this medication, due to the possibility of experiencing low blood sodium, or hyponatremia, along with low potassium levels, or hypokalemia, when taking indapamide, which is one of the three medications contained in Widaplik.
People who are pregnant or breastfeeding should not take this medication. Also, people who have anuria, which is when you do not produce urine, should not take Widaplik. People who are allergic to any ingredient in the drug or to sulfa drugs should not take Widaplik. People with diabetes who take aliskiren should not take Widaplik.
Who could a triple-combination hypertension medication help?
Nearly 120 million people in the U.S. (almost half of all adults) have hypertension, but only about 1 in 4 adults actually have their hypertension under control.
While everyone diagnosed with hypertension is advised to make lifestyle changes to help them lower their blood pressure, most adults need to take a prescription medication to meet their goals.
Currently, the available classes of medications to help treat high blood pressure include:
- ACE inhibitors
- Alpha blockers
- Alpha-2 receptor agonists
- Angiotensin II receptor blockers (ARBs)
- Beta-blockers
- Calcium channel blockers
- Diuretics
- Vasodilators
Many people have to eventually increase the dosage of their current medication to achieve blood pressure control. It’s also not uncommon for some people to need more than one medication to help them manage their high blood pressure.
“Single pill combination antihypertensive therapy has great potential to improve hypertension control in the U.S. and worldwide,” said Dr. Paul Whelton, MD, chair of global public health at Tulane University and the past president of the World Hypertension League, in the manufacturer’s statement. “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.”
How much will Widaplik cost?
George Medicines has not yet announced pricing for Widaplik.
When will Widaplik be available?
Widaplik should be commercially available during the fourth quarter of 2025.
- Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomised, double-blind, active-controlled, international clinical trial, The Lancet (2024)
- Efficacy and safety of a novel low-dose triple single-pill combination compared with placebo for initial treatment of hypertension, Journal of the American College of Cardiology (2024)
- Estimated hypertension prevalence, treatment, and control among U.S. adults, Million Hearts
- 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 Medicines (2025)
- Types of blood pressure medications, American Heart Association (2024)
- What is high blood pressure?, National Heart, Lung, and Blood Institute (2024)