**George Medicines Presents Long-Term Data on WIDAPLIK™ for Hypertension at AHA Scientific Sessions 2025**
*London, UK & Boston, MA — 9 November 2025* — George Medicines, a late-stage biopharmaceutical company dedicated to 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 involving 50 subjects, treatment with GMRx2 (US tradename **WIDAPLIK™**) demonstrated sustained blood pressure (BP) control out to one year, with good tolerability and low treatment discontinuation rates.
The data were showcased in a moderated poster session titled *“Change is in the Air! New Discoveries in Hypertension Treatment”* at the American Heart Association’s (AHA) Scientific Sessions 2025, held in New Orleans, USA.
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### About WIDAPLIK™
WIDAPLIK™ is an innovative single-pill combination of three medicines: telmisartan, amlodipine, and indapamide, developed in three doses—including two lower doses than those currently available in single-pill combos. By leveraging a multi-mechanism approach at lower doses, WIDAPLIK™ aims to deliver the blood pressure-lowering benefits of triple combination therapy early in the treatment pathway, while maintaining the known safety profiles of existing antihypertensive medicines.
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### Study Design and Results
To evaluate the long-term efficacy and safety of WIDAPLIK™ in usual clinical care, 50 participants from sites in Sri Lanka and Nigeria enrolled in an open-label extension phase of the placebo-controlled GMRx2_PCT study (NCT04518306). Participants received GMRx2 treatment for one year, with 48 (96%) completing the study.
– **Baseline blood pressure following 4 weeks of double-blind treatment:**
– Mean home BP: 121/78 mmHg
– In-clinic BP: 126/79 mmHg
– **After 52 weeks of open-label dosing:**
– Mean home BP maintained at 120/78 mmHg
– In-clinic BP maintained at 122/77 mmHg
– Home BP control (<130/80 mmHg): 56%
- Clinic BP control (<140/90 mmHg): 88%
Tolerability was excellent, with zero participants discontinuing treatment due to adverse events.
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### Expert Commentary
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 the Scientific Sessions, remarked:
> “These data reinforce the value of single-pill triple combination therapy to effectively manage hypertension in the long term. With globally recognized treatment guidelines favoring single-pill combinations, and the inclusion of triple combination antihypertensives on the WHO’s Model List of Essential Medicines, there is growing recognition worldwide of their potential to improve blood pressure control and support patient adherence.”
Mark Mallon, Chief Executive Officer of George Medicines, added:
> “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 at lower doses than currently available, enabling more patients to achieve sustained blood pressure control.”
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### INDICATIONS
WIDAPLIK™ is a prescription medicine used to treat high blood pressure (hypertension) in adults. It may be used as the initial therapy in patients likely to require multiple drugs to reach blood pressure goals. Lowering blood pressure reduces the risk of stroke and heart attack.
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### IMPORTANT SAFETY INFORMATION FOR PATIENTS
**WARNING:** WIDAPLIK™ can cause fetal harm when administered to a pregnant woman. Discontinue immediately if pregnancy is detected. Drugs acting on the renin-angiotensin-aldosterone system may cause injury or death to a developing fetus.
– Discuss pregnancy plans and breastfeeding with your doctor, as breastfeeding while on WIDAPLIK™ is not recommended.
– Do **not** take WIDAPLIK™ if you have kidney problems that reduce urine output (anuria) or if you have diabetes and take aliskiren-containing products.
– Inform your doctor about all medical conditions—including heart problems, gout, liver or kidney issues—and all medicines you are taking.
– Low blood pressure (hypotension) may cause dizziness or fainting. Call your doctor if these symptoms occur.
– Report any signs of electrolyte imbalance such as dry mouth, confusion, weakness, seizures, muscle cramps, or changes in heartbeat.
– Those with high uric acid levels may develop gout; notify your doctor of any worsening symptoms.
The most common side effects observed in clinical studies included dizziness from low blood pressure, low blood sodium, or low blood potassium.
This summary does not include all safety information. For complete details, please refer to the full Prescribing Information for WIDAPLIK™.
To report suspected adverse reactions, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
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### About GMRx2
GMRx2 is a combination tablet containing telmisartan (angiotensin II receptor blocker), amlodipine (dihydropyridine calcium channel blocker), and indapamide (thiazide-like diuretic), available in three dosage strengths:
– 10/1.25/0.625 mg
– 20/2.5/1.25 mg
– 40/5/2.5 mg
Approved by the US Food and Drug Administration (FDA) in June 2025 as WIDAPLIK™, it is the first and only FDA-approved triple combination medication indicated for initial therapy in patients likely to need multiple medications for blood pressure control.
Further regulatory filings for GMRx2 are planned globally as George Medicines seeks to make this important medicine available worldwide.
**Contraindications:** Known hypersensitivity to telmisartan, amlodipine, indapamide, or sulfonamide-derived drugs.
**Boxed Warning:** Fetal toxicity—discontinue immediately upon pregnancy detection.
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### About George Medicines
George Medicines is a late-stage biopharmaceutical company focused on cardiometabolic diseases by developing innovative single-pill combinations of existing treatments designed to balance efficacy and safety, with potential to improve patient adherence.
Originating as an independent spin-out from The George Institute for Global Health—one of the world’s premier medical research institutes tackling 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](http://www.george-medicines.com).
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### Safe Harbor Statement
This press release contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially due to various factors, including but not limited to the successful commercialization of offerings, clinical development, regulatory approval outcomes, and market dynamics.
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### Media Contacts
ICR Healthcare
David Daley, Lindsey Neville, Tom Daniel
Email: [email protected]
Tel: +44 (0) 203 709 5700
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