FDA Approves Triple Combination Drug GMRx2 (WIDAPLIK) for Hypertension Treatment

The US Food and Drug Administration (FDA) has approved GMRx2 (WIDAPLIK) for the treatment of hypertension in adult patients, as announced by London-based parent company George Medicines on June 9th, 2025. A US commercial launch is expected in the 4th quarter of 2025.1

GMRx2 is a novel, single-pill combination of telmisartan, amlodipine, and indapamide, and is available in 3 doses: a standard dose and 2 lower doses. GMRx2 is also the only FDA-approved triple combination medication for use as an initial therapy in patients who will likely need multiple drugs to achieve blood pressure targets.1

Nearly half of all adults in the US have hypertension, but only 1 in 4 have blood pressure under control. Treatment guidelines recognized globally currently recommend the use of single-pill combination therapy for the majority of patients, acknowledging the benefit of combination therapy’s early usage.1

“I am very excited and pleased to have WIDAPLIK approved for the treatment of hypertension in the US,” Paul Whelton, MD, MSc, Show Chwan Chair of Global Public Health at Tulane University in Louisiana, said. “Most patients with hypertension need multiple therapies to achieve their blood pressure goals. The new dose options available with WIDAPLIK offer a treatment regimen that could benefit a broad range of patients, including those just starting treatments.”1

Veristat, a leading global clinical research organization and a significant partner in the development and approval process for GMRx2, expressed their congratulations on 16 June 2025.2

“This approval underscores the power of true collaboration in advancing science and improving lives,” said Robert Bliss, PhD, Vice President of Strategic Consulting at Veristat. “We are proud to have supported George Medicines on their journey, and we remain committed to helping biopharmaceutical innovators bring transformative therapies to patients around the world.”2

This approval is based on 2 international phase 3 trials, which compared GMRx2 against placebo and dual combinations of its components, respectively. Both trials saw GMRx2 significantly improve blood pressure and control rates versus comparators. Investigators also noted that tolerability was good across both trials, with no increase in treatment withdrawal due to adverse events.1

Additionally, GMRx2 was investigated in the VERONICA trial, which compared it with standard of care and resulted in better BP lowering in patients receiving GMRx2. This trial also indicated good tolerability compared to standard of care.1

The most common adverse event in the latter trial was symptomatic hypotension; this has led to its contraindication in patients with anuria, known hypersensitivity to telmisartan, amlodipine, indapamide, or other sulfonamide-derived drugs.1

A global trial investigating GMRx2’s potential to prevent stroke in patients with prior intracerebral hemorrhage – the most severe type of stroke – is currently underway.1

“With its triple combination efficacy, established safety profile, good tolerability and its availability in a single pill, WIDAPLIK has the potential to address key challenges in current hypertension treatment approaches,” Mark Mallon, Chief Executive Officer of George Medicines, said. “With planning underway for the upcoming US commercial launch of WIDAPLIK, and further regulatory submissions in other territories anticipated during 2025, George Medicines is well-positioned to positively impact the global burden of hypertension.”1

References

1. George Medicines. George Medicines announces FDA approval of WIDAPLIK (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment. GlobeNewswire. June 9, 2025. Accessed June 16, 2025. https://www.globenewswire.com/news-release/2025/06/09/3095734/0/en/George-Medicines-announces-FDA-approval-of-WIDAPLIK-telmisartan-amlodipine-and-indapamide-a-new-single-pill-combination-treatment-for-hypertension-in-adults-including-initial-treat.html

2. Veristat. Veristat congratulates George Medicines on FDA Approval of WIDAPLIK. Businesswire. June 16, 2025. Accessed June 16, 2025. https://www.businesswire.com/news/home/20250616203834/en/Veristat-Congratulates-George-Medicines-on-FDA-Approval-of-WIDAPLIK