Key Takeaways
- FDA Approval: Widaplik is the first FDA-approved triple combination pill for initial hypertension treatment, addressing critical gaps in blood pressure management.
- Clinical Trial Success: Phase III studies demonstrated Widaplik’s superior efficacy and safety compared to placebo and dual therapies, supporting improved hypertension control rates.
- Market Impact: With a US commercial launch expected in Q4 2025, Widaplik positions George Medicines to significantly influence global hypertension treatment with a convenient single-pill option.
The FDA has approved George Medicines’ Widaplik (telmisartan, amlodipine, and indapamide), a novel single-pill triple combination therapy for hypertension in adults, including for initial treatment. Widaplik is a first-in-class triple combination medication that can be used as an initial therapy for patients likely to require multiple drugs to reach their blood pressure reduction goals. The approval was based on results from the Phase III GMRx2_PCT and GMRx2_ACT clinical trials, which compared the treatment to placebo as well as dual combinations of its components.1-3
What Makes Widaplik a Breakthrough in Hypertension Treatment?
“Data show that most patients with hypertension will require two or more medicines to bring their blood pressure under control,” said Mark Mallon, CEO, George Medicines, in a press release. “Widaplik can provide patients with hypertension, including those who are starting treatment, with a different approach to control their blood pressure. 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. 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.”
Phase III GMRx2_PCT Trial Demonstrates Early Efficacy and Safety
- The international, randomized, double-blind, placebo-controlled, parallel-group GMRx2_PCT trial enrolled 295 patients, randomly assigned in a 2:2:1 ratio to receive either a quarter dose of Widaplik, a half dose of Widaplik, or placebo.
- The primary endpoint of the trial was change in home systolic BP (SBP) from the time of randomization to week four, while the primary safety endpoint was treatment discontinuation due to adverse events (AEs).
- Results showed that at week four, 37% of participants in the placebo group achieved blood pressure control, compared to 65% and 70% in the quarter-dose and half-dose Widaplik groups, respectively.
- Serious AEs were reported in two patients in the placebo group and in none of the treatment groups.2
GMRx2_ACT Trial Confirms Superior Blood Pressure Reduction Versus Dual Therapies
- The international, randomized, double-blind, active-controlled GMRx2_ACT trial enrolled 1,385 participants, who were randomly assigned in a 2:1:1:1 ratio to receive either Widaplik, telmisartan–indapamide, telmisartan–amlodipine, or amlodipine–indapamide.
- The primary endpoint of the study was mean change in home SBP from baseline to week 12, and the primary safety outcome was withdrawal of treatment due to an AE from baseline to week 12.
- Key secondary endpoints included differences in clinic and home blood pressure levels and control rates.
Results show that at week 12, the mean home SBP in the Widaplik group was 126 mm Hg, which was significantly lower than all three dual combination therapies:
- 2.5 mm Hg lower than telmisartan–indapamide (95% CI –3.7 to –1.3, p<0.0001)
- 5.4 mm Hg lower than telmisartan–amlodipine (95% CI –6.8 to –4.1, p<0.0001)
- 4.4 mm Hg lower than amlodipine–indapamide (95% CI –5.8 to –3.1, p<0.0001)
- Additionally, there was a 74% clinic blood pressure control rate in the Widaplik group compared to the dual combination groups, which ranged from 53% to 61%.
- Two percent of participants in the Widaplik group withdrew due to AEs. One percent of patients from each of the other groups withdrew due to AEs, with no statistically significant differences between the groups.3
Expert Commentary on Widaplik’s Potential Impact
“I am very excited and pleased to have Widaplik approved for the treatment of hypertension in the US,” said Paul Whelton, chair, Show Chwan, global public health, Tulane University, in the press release. “Single pill combination antihypertensive therapy has great potential to improve hypertension control in the US and worldwide. 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 treatment.”
The commercial launch of Widaplik is expected in Q4 of this year.1
References
1. 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 10, 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. Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension. JACC. Accessed June 10, 2025. https://www.jacc.org/doi/full/10.1016/j.jacc.2024.08.025
3. Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomized, double-blind, active-controlled, international clinical trial. The Lancet. Accessed April 10, 2025. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01744-6/abstract
