George Medicines Reports Sustained Blood Pressure Control with WIDAPLIK Triple Combination Therapy in 52-Week Extension Study
Key Insights
George Medicines (search) presented 52-week extension data for WIDAPLIK (search) (GMRx2) showing sustained blood pressure control in treatment-naïve hypertension patients at AHA Scientific Sessions 2025.
The study demonstrated maintained home blood pressure at 120/78 mmHg and clinic blood pressure at 122/77 mmHg after one year of treatment.
WIDAPLIK (search) achieved 88% clinic blood pressure control rate with good tolerability and no treatment discontinuations due to adverse events.
George Medicines (search) presented compelling long-term efficacy and safety data for its FDA-approved triple combination hypertension therapy WIDAPLIK (search) (GMRx2) at the American Heart Association's Scientific Sessions 2025 in New Orleans. The 52-week open-label extension study demonstrated sustained blood pressure control in treatment-naïve patients, reinforcing the therapeutic potential of this innovative single-pill combination approach.
Study Design and Patient Population
The extension study enrolled 50 participants from Sri Lanka and Nigeria sites of the placebo-controlled GMRx2_PCT study (NCT04518306), evaluating long-term efficacy and safety when used in usual clinical care. A total of 48 participants (96%) completed the full 52-week treatment period, demonstrating strong patient retention.
Sustained Blood Pressure Control
The data revealed maintained blood pressure control throughout the one-year treatment period. Mean home and in-clinic blood pressures at the start of the open-label extension were 121/78 mmHg and 126/79 mmHg, respectively. Following 52 weeks of treatment, mean home blood pressure was maintained at 120/78 mmHg, while in-clinic blood pressure remained stable at 122/77 mmHg.
Blood pressure control rates at the end of the extension period showed clinically meaningful outcomes, with home blood pressure control (<130/80 mmHg) achieved in 56% of patients and clinic blood pressure control (<140/90 mmHg) in 88% of participants.
Safety and Tolerability Profile
The extension study demonstrated favorable tolerability, with no participants discontinuing treatment due to adverse events. This safety profile aligns with the known characteristics of the individual components and supports the potential for improved patient adherence with the combination approach.
Clinical Significance and Expert Perspective
Dr. Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University and Past President of the World Hypertension League, who presented the data, emphasized the clinical value: "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."
WIDAPLIK's Unique Positioning
WIDAPLIK (search) represents an innovative approach to hypertension management, combining three established antihypertensive mechanisms in a single pill: telmisartan (angiotensin II receptor blocker), amlodipine (dihydropyridine calcium channel blocker), and indapamide (thiazide-like diuretic). The therapy is available in three dosage forms: 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg.
The FDA approved WIDAPLIK (search) in June 2025 as the first and only triple combination medication for use as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. This approval represents a significant advancement in hypertension treatment, offering lower doses than currently available single pill combinations while maintaining efficacy.
Commercial and Development Outlook
Mark Mallon, Chief Executive Officer of George Medicines (search), highlighted the significance of the data presentation: "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."
George Medicines (search) plans additional regulatory filings across multiple territories as part of its commitment to bring this therapy to patients globally. The company, a spin-out from The George Institute for Global Health, focuses on addressing significant unmet needs in cardiometabolic diseases through innovative single-pill combinations designed to balance efficacy and safety while potentially improving patient adherence.