London, UK, Boston, MA, USA, 11 September 2025 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, welcomes the decision by the World Health Organization (WHO) to add triple fixed-dose combination antihypertensive therapies to its Model List of Essential Medicines (EML).
The inclusion reflects growing global recognition of the clinical and public health value of triple-combination therapies in improving blood pressure control and patient outcomes. The WHO’s Expert Committee highlighted the favorable benefit–risk profile of triple combinations, their role in reducing systolic and diastolic blood pressure, and the potential to improve adherence compared with taking separate medicines.
Mark Mallon, Chief Executive Officer of George Medicines, said: “We are delighted that the WHO has recognized the importance of triple fixed-dose combinations for the treatment of hypertension by including them on its latest Essential Medicines List. The inclusion reflects strong evidence that triple combinations can improve blood pressure control, reduce cardiovascular risk, and help patients stay on therapy compared to taking separate medicines.”
George Medicines’ lead program, GMRx2, is an innovative single pill combination of three medicines, telmisartan, amlodipine and indapamide, for the treatment of hypertension, developed in three doses, including two doses that are lower than those currently available in single pill combinations. Its multi-mechanism approach and available doses are formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the safety profile of established antihypertensive medications.
GMRx2 was approved by the US Food and Drug Administration (FDA) in June 2025 as WIDAPLIK™ (telmisartan, amlodipine and indapamide), and is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Further regulatory filings for GMRx2 are anticipated across additional territories as part of George Medicines’ commitment to bring the value of this important medicine to patients globally.
In clinical trials, the most common adverse event reported in patients treated with WIDAPLIK is symptomatic hypotension. WIDAPLIK is contraindicated in patients with known hypersensitivity to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs. WIDAPLIK carries a Boxed Warning for fetal toxicity and should be discontinued as soon as pregnancy is detected. Please see full Prescribing Information and Important Safety Information, including Boxed Warning for WIDAPLIK here.
George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm.
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INDICATIONS
WIDAPLIKTM is a prescription medicine used to treat high blood pressure (hypertension) in adults. WIDAPLIK may be used as the first medicine to lower your high blood pressure if your healthcare provider decides you are likely to need more than one medicine. Medicines that lower your blood pressure may lower your chances of having a stroke or heart attack.
IMPORTANT SAFETY INFORMATION
WARNING: WIDAPLIK™ can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue WIDAPLIK as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus. Talk with your doctor about other ways to lower blood pressure if you plan to become pregnant.
- Before taking WIDAPLIK, tell your doctor if you are breastfeeding or plan to breastfeed. Discuss with your doctor other ways to lower your blood pressure. Breastfeeding while taking WIDAPLIK is not recommended.
- Do not take WIDAPLIK if you make less urine because of kidney problems (anuria).
- Do not take aliskiren-containing products with WIDAPLIK if you have diabetes.
- Tell your doctor about all your medical conditions, including if you have heart problems, have gout, or have liver or kidney problems. Kidney problems may become worse in people that already have kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose or may need to stop treatment with WIDAPLIK. During treatment with WIDAPLIK, certain people who have severe heart failure, narrowing of the artery to the kidney, or who lose too much body fluid such as with nausea, vomiting, bleeding, or trauma, may develop sudden kidney failure.
- Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other medicines to treat your high blood pressure or heart problem; water pills (diuretics); lithium; or digoxin.
- WIDAPLIK may cause serious side effects, including low blood pressure (hypotension) which may cause you to feel faint or dizzy. Vomiting and diarrhea, a low salt diet, sweating a lot, dialysis treatments, or not drinking enough fluid can also lead to low blood pressure.
- If you feel faint or dizzy, lie down and call your doctor right away. If you pass out (faint), have someone call your doctor or get medical help. Stop taking WIDAPLIK.
- If you have fluid and body salt (electrolyte) problems, tell your doctor if you experience any of the following symptoms: dry mouth, confusion, thirst, lack of energy (lethargic), weakness, drowsiness, passing very little urine or passing large amounts of urine, seizures, muscle pain/cramps, restlessness, muscle tiredness (fatigue), fast or abnormal heartbeat, nausea and vomiting, or constipation.
- People who have increased levels of uric acid in the blood may develop gout. If you already have gout, tell your doctor about worsening of your gout symptoms.
- In clinical studies, the most common side effects seen with WIDAPLIK were dizziness from low blood pressure, low blood sodium, or low blood potassium
The Important Safety Information does not include all the information needed to use WIDAPLIK safely and effectively.
For further information, please see accompanying complete Prescribing Information for WIDAPLIK.
To report SUSPECTED ADVERSE REACTIONS contact either:
- George Medicines at: safety@george-medicines.com or call 1-888-508-2083; or
- FDA at: www.fda.gov/medwatch or call 1-800-FDA-1088
About GMRx2
GMRx2 is a combination tablet of telmisartan, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker and indapamide, a thiazide-like diuretic, available in three dosage forms – 10/1.25/0.625 mg; 20/2.5/1.25 mg and 40/5/2.5 mg.
Its development is backed by a comprehensive clinical program, including two pivotal Phase III studies, published in 2024 in the Journal of the American College of Cardiology and The Lancet.
In these trials the triple combination demonstrated significantly reduced blood pressure (BP) and improved BP control rates, when compared against dual therapy and against placebo. In both trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events.
GMRx2 was investigated in the Nigerian VERONICA trial, which compared the triple combination with standard of care and reported better BP lowering among those receiving GMRx2, with good tolerability compared to the standard of care protocol.
A global trial investigating the potential of GMRx2 for the prevention of stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) is ongoing.
About George Medicines
George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative single-pill combinations of existing treatments, designed for a balance of efficacy and safety, with the potential to improve patient adherence. Multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes with cardiometabolic disorders, including hypertension, which remain among the leading causes of premature death and disability worldwide.
George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm.
For more information, please visit www.george-medicines.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to George Medicines’ financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential. In addition, this press release also contains forward looking statements relating to George Medicines’ growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including George Medicines’ ability to successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of drug candidates.
Media contacts
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