Indapamide/Amlodipine Besylate/Telmisartan

Significant lowering of systolic blood pressure of 9mmHg on top of background treatment maintained with GMRx2 over an average follow-up of 3 years Safety findings similar to previous studies of GMRx2 London, UK, Boston, MA, 22 April 2026 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, today announced that results from the global, investigator-initiated TRIDENT trial have been published in the New England Journal of Medicine 1 . The trial met its primary endpoint with GMRx2, George Medicines’ single pill low-dose combination therapy of telmisartan, amlodipine and indapamide, and demonstrated a statistically significant and clinically meaningful reduction of recurrent stroke events in patients with intracerebral hemorrhage (ICH). The international study randomized 1,670 patients with a recent ICH event who were on standard of care treatment and had stable systolic blood pressure (SBP) of 130-160mmHg. Patients received either GMRx2 (telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg) or a placebo, plus standard of care for blood pressure and comorbid cardiovascular conditions. During an average duration of follow-up of 3 years, stroke occurred in 4.6% of patients receiving GMRx2 compared to 7.4% in the placebo group, equating to a 39% relative risk reduction for recurrent stroke in patients receiving GMRx2. The GMRx2 group achieved better blood pressure (BP) control, with mean SBP levels 9mmHg lower than the placebo group, a result that was maintained during the course of the study. The safety pro GMRx2 was generally consistent with the established safety profiles of the medicine and its individual components. Serious adverse events were comparable between the two groups, affecting 23.8% of patients in the GMRx2 group and 26.8% in the placebo group. Dr. Kevin Sheth, MD. Professor of Neurology and Neurosurgery, Vice Chair for Clinical and Translational Research, and Director of the Center for Brain & Mind Health at Yale School of Medicine, said: “ For patients who have survived an intracerebral hemorrhage, the risk of a second stroke remains high. This trial showed that a structured, intensive blood pressure-lowering approach using a single-pill triple combination can translate into meaningful reductions in recurrent stroke risk. This finding has the potential to directly address the long-standing challenges of under-treatment, adherence issues prominent for this patient population, and therapeutic inertia that stand in the way of a safe and effective preventative treatment that can improve outcomes for patients .” Around 100 million people worldwide have experienced a stroke, with ICH recognized as the most serious form, and 12 million new cases occur each year 2 . Recurrent strokes represent between 25-30% of all cases 3 . In the US alone, each year more than 795,000 people have a stroke, with nearly 1 in 4 occurring in people who have had a previous stroke 4 . The only treatment with the demonstrated potential to prevent ICH and its recurrence is effective BP reduction 5,6 . However, the benefits of intensive BP-lowering and the optimal approach to treatment are uncertain. Although most stroke survivors are discharged from hospital on BP-lowering therapy, long-term BP control is generally thought to be inadequate due to the potential combination of factors such as uncertainty surrounding the degree of benefit, varying guideline recommendations, insufficient up-titration of medicines, poor adherence and therapeutic inertia 7-12 . Dr. Amy Carroll, PhD. Senior Vice President of Medical Affairs, George Medicines, said: “ TRIDENT is the first stroke outcomes trial of its kind and the largest secondary prevention trial in survivors of ICH. The study employed a triple-therapy, multi–mechanism-based strategy to evaluate whether GMRx2 could reduce the risk of recurrent stroke following prior ICH through effective blood pressure control. We are enthusiastic about the results, and the significant treatment effect shown in this study reinforces what we have learned from prior indirect evidence of the benefits of intensive blood pressure-lowering in this patient group with the highest unmet need for stroke recurrence.” GMRx2 was approved by the US Food and Drug Administration (FDA) in June 2025 as WIDAPLIK TM (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. Azurity Pharmaceuticals has exclusive rights to commercialize WIDAPLIK in the United States. 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. References Anderson CS et al. Three Low-Dose Antihypertensive Agents in a Single Pill after Intracerebral Hemorrhage. N Engl J Med 2026;394:1571-82. DOI: 10.1056/NEJMoa2515043 Feigin VL et al . World Stroke Organization: Global Stroke Fact Sheet 2025. Int J Stroke. 2025. Hankey GJ. Secondary stroke prevention. Lancet Neurol . 2014. (13)70255-2 . US Centers for Disease Control and Prevention, Stroke Facts, October 2024. . Steiner T, Purrucker JC, de Sousa DA, European Stroke Organisation (ESO) and European Association of Neurosurgical Societies (EANS) guideline on stroke due to spontaneous intracerebral hemorrhage. Eur Stroke J 2025; 0(0). doi:10.1177/23969873251340815 . Greenberg SM, Ziai WC, Cordonnier C, et al. 2022 Guideline for the management of patients with spontaneous intracerebral hemorrhage: a guideline from the American Heart Association / American Stroke Association. Stroke 2022; 53: e282–e361. Zhou B, Carrillo-Larco RM, Danaei G, et al. Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet 2021; 398: 957-980. Zhang M, Shi Y, Zhou B, et al. Prevalence, awareness, treatment, and control of hypertension in China, 2004-18: findings from six rounds of a national survey. BMJ 2023; 380: e071952. McGurgan IJ, Kelly PJ, Turan TN, Rothwell PM. Long-term secondary prevention: management of blood pressure after a transient ischemic attack or stroke. Stroke 2022; 53: 1085-1103. Biffi A, Anderson CD, Battey TW, et al. Association between blood pressure control and risk of recurrent intracerebral hemorrhage. JAMA 2015; 314: 904-912. Bonello K, Nelson APK, Moullaali TJ, Al-Shahi Salman R. Prescription of blood pressure lowering treatment after intracerebral haemorrhage: prospective, population-based cohort. Eur Stroke J 2021; 6: 44-52. Zahuranec DB, Wing JJ, Edwards DF, et al. Poor long-term blood pressure control after intracerebral hemorrhage. Stroke 2012; 43: 2580-2585. Ends INDICATIONS WIDAPLIK TM 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 TM 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: or call 1-800-FDA-1088 About TRIDENT TRIDENT was a multicenter, international, double-blind, placebo-controlled, parallel-group, randomized controlled trial in patients with a history of ICH designed to evaluate the effect of GMRx2 (telmisartan 20 mg/ amlodipine 2.5mg/ indapamide 1.25mg), compared with placebo, given once daily in addition to standard of care. The primary outcome was the time to first occurrence of recurrent stroke. The trial was led by The George Institute for Global Health and funded by the National Health and Medical Research Council (NHMRC) Australia and the Brazilian Ministry of Health, with study medication provided by George Medicines. 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 led by The George Institute for Global Health and funded by the National Health and Medical Research Council (NHMRC) Australia and the Brazilian Ministry of Health, investigating the potential of GMRx2 to significantly reduce the risk of recurrent stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) completed in 2025. The study met the primary endpoint, with GMRx2 demonstrating a statistically significant and clinically meaningful reduction of recurrent stroke compared to matching placebo. 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 . 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 ICR Healthcare David Daley, Lindsey Neville, Tom Daniel georgemedicines@icrhealthcare.com ; Tel: +44 (0) 203 709 5700