George Medicines presents long-term efficacy and safety data for single pill triple combination therapy for hypertension at American Heart Association’s Scientific Sessions 2025
George Medicines presents long-term efficacy and safety data for single pill triple combination therapy for hypertension at American Heart Association’s Scientific Sessions 2025
London, UK, Boston, MA, 9 November 2025 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, today presented long-term efficacy and safety data from a 52-week open-label extension of its pivotal Phase 3 study in treatment-naïve patients with hypertension. In this 52-week follow-up period of 50 subjects, treatment with GMRx2 (US tradename WIDAPLIKTM), demonstrated sustained blood pressure (BP) control out to one year, with good tolerability and low treatment discontinuation.
The data were presented in a moderated poster session, “Change is in the Air! New Discoveries in Hypertension Treatment”, at the American Heart Association’s (AHA) Scientific Sessions 2025, taking place in New Orleans, USA.
WIDAPLIK 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. By leveraging a multi-mechanism approach and lower doses, WIDAPLIK is formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the known safety profiles of existing antihypertensive medicines.
To evaluate the long-term efficacy and safety of WIDAPLIK-based treatment when used in usual clinical care, 50 participants from Sri Lanka and Nigeria sites of the placebo-controlled GMRx2_PCT study (NCT04518306), were enrolled into an open-label extension phase with GMRx2 treatment to one year. A total of 48 (96%) participants completed the study.
- Mean home and in-clinic blood pressures following 4-weeks of the core double blind study period entering into the open-label extension were 121/78 mmHg and 126/79 mmHg, respectively.
- Following 52-week open label dosing, mean home BP was maintained at 120/78 mmHg, as was in-clinic BP of 122/77 mmHg.
- Home BP control (<130/80 mmHg) was 56%, and clinic BP control (<140/90 mmHg) was 88% at the end of the open-label extension
- Tolerability was good, with no participants discontinuing treatment due to an adverse event.
Dr. Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, and Past President of the World Hypertension League, who presented the data at Scientific Sessions 2025, said: “These data reinforce the value of single pill triple combination therapy to effectively manage hypertension in the long term. With globally recognized treatment guidelines acknowledging the preferred use of single pill combinations, and the addition of triple combination antihypertensives to the WHO’s Model List of Essential Medicines, there is growing global recognition of their potential to improve blood pressure control and help patients to stay on therapy.”
Mark Mallon, Chief Executive Officer of George Medicines, said: “We are proud that the long-term data from our Phase 3 program of GMRx2 have been shared at AHA Scientific Sessions, one of the most prestigious global forums for cardiovascular science. These results reinforce the potential of GMRx2 to transform hypertension treatment by offering a single-pill combination, in lower doses than are currently available, enabling more patients to achieve sustained blood pressure control.”
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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 high blood pressure in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure may reduce the risk of having a stroke or heart attack.
IMPORTANT SAFETY INFORMATION FOR PATIENTS
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:
- Azurity Pharmaceuticals, Inc. at 1-800-461-7449; 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.
GMRx2 was approved by the US Food and Drug Administration (FDA) in June 2025 as WIDAPLIK™ (telmisartan, amlodipine and indapamide) for the treatment of hypertension 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.
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.
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