TRIDENT, a dedicated stroke outcomes trial in patients with a history of intracerebral hemorrhage (ICH), demonstrates the potential advantages of intensive blood pressure treatment with low-dose triple combination therapyTRIDENT, a dedicate
- GMRx2 significantly reduced the risk of recurrent stroke when added to standard of care compared to placebo
- Trial results were presented during a plenary session of the World Stroke Congress 2025 in Barcelona
London, UK, Boston, MA, 23 October 2025 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, today announced that positive results from the investigator-initiated TRIDENT trial have been shared at the World Stroke Congress in Barcelona. The study met the primary endpoint, with GMRx2 (a single pill low-dose combination therapy of telmisartan, amlodipine and indapamide) demonstrating a statistically significant and clinically meaningful reduction of recurrent stroke compared to matching placebo.
The TRIDENT trial was conducted in patients with a history of acute stroke due to intracerebral hemorrhage (ICH) on standard of care treatment. 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.
The safety profile of GMRx2 in the TRIDENT trial was generally consistent with the well-established safety profile of the medicine, and its individual components.
Mark Mallon, Chief Executive Officer of George Medicines, said: “The TRIDENT trial represents an important step towards understanding how enhanced blood pressure management has the potential to reduce the risk of recurrent stroke after an intracerebral hemorrhage, the most severe type of stroke. Reducing the global burden of cardiovascular disease lies at the heart of our mission and we are proud that our single pill triple combination therapy demonstrated efficacy in this study.”
Acute ICH accounts for at least 10 per cent of the 20 million new strokes in the world each year. ICH survivors are at high risk of recurrent stroke and other serious cardiovascular events. Numerous studies have indicated a benefit of stroke survivors reducing their risk of recurrent stroke through taking blood pressure-lowering medications. However, studies have also shown that many stroke survivors are either not receiving any blood pressure-lowering medication, or they are receiving inadequate control.
TRIDENT is the first stroke outcomes trial with a low-dose single pill triple combination therapy for blood pressure treatment in adults with a history of ICH on top of standard of care.
Full results from the trial will be submitted for publication in a peer-reviewed journal.
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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.
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, developed in three dosage forms – 10/1.25/0.625 mg; 20/2.5/1.25 mg and 40/5/2.5 mg – for the treatment of hypertension.
Its development is backed by a comprehensive clinical program, including two pivotal Phase III studies in hypertension, 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 and improved blood pressure 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 also investigated in the Nigerian VERONICA trial, which compared the triple combination with standard of care and reported better blood pressure lowering among those receiving GMRx2, with good tolerability compared to the standard of care protocol.
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
ICR Healthcare
David Daley, Lindsey Neville, Tom Daniel
georgemedicines@icrhealthcare.com; Tel: +44 (0) 203 709 5700
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