Breakthrough in Hypertension Treatment: FDA Approves First Triple-Combination Pill
Breakthrough in Hypertension Treatment: FDA Approves First Triple-Combination Pill
June 9, 2025
The U.S. Food and Drug Administration (FDA) has granted approval to Widaplik (formerly GMRx2), marking the first-ever single-pill triple-combination therapy for hypertension. This novel formulation combines telmisartan (ARB), amlodipine (CCB), and indapamide (diuretic), designed to simplify and enhance blood pressure (BP) management in adults—even as initial therapy by prescription. Pharmacy TimesDrugs.comWikipedia
Composition & Dosage Options
Widaplik is available in three dosage strengths allowing for tailored therapy:
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10/1.25/0.625 mg (low dose)
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20/2.5/1.25 mg (intermediate)
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40/5/2.5 mg (standard) Drugs.comFDA Access Data
Its triple-mechanism targets vascular resistance, calcium-channel effects, and fluid balance—offering a broad-spectrum approach to BP reduction.
Clinical Efficacy: Phase 3 Trials
GMRx2_ACT (Active-Controlled Trial)
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Compared Widaplik against dual combos: telmisartan+amlodipine, telmisartan+indapamide, amlodipine+indapamide.
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At 12 weeks, mean home systolic BP (SBP) reduction was significantly greater for Widaplik—from baseline to ~126 mm Hg—versus all dual therapies (differences ranging from –2.5 to –5.4 mm Hg; P<0.0001).
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Clinical BP control achieved in 74% of Widaplik patients vs 53–61% with dual therapies. Pharmacy Times
GMRx2_PCT (Placebo-Controlled Trial)
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Evaluated low-dose (¼ dose) and mid-dose (½ dose) formulations versus placebo.
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At 4 weeks, BP control (<140/90 mm Hg) reached 37% with ¼ dose and 65% with ½ dose, significantly outperforming placebo (P<0.001).
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Adverse-event discontinuation was rare: none in ¼ dose; 5.1% in ½ dose; similar to placebo. Pharmacy Times
Safety & Contraindications
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Most common adverse event: symptomatic hypotension. HCP LiveDrugs.com
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Contraindications: anuria; hypersensitivity to any component, including sulfonamide-derived drugs; coadministration with aliskiren in diabetic patients.
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Boxed warning: fetal toxicity mandates immediate discontinuation upon pregnancy detection. Drugs.comFDA Access Data
Global Impact & Public Health Potential
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Prevalence: Nearly 50% of U.S. adults have hypertension, yet only about 25% achieve control. Simplified regimens like Widaplik are poised to significantly improve adherence and outcomes. Drugs.comThe Educated Patient
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Expert Endorsement:
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“Single-pill combination antihypertensive therapy has great potential to improve hypertension control... including as initial treatment.” — Dr. Paul Whelton Pharmacy TimesDrugs.com
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Mark Mallon, CEO of George Medicines, highlights matched efficacy, safety, and good tolerability in a single regimen that “addresses key challenges in current hypertension treatment” and points to upcoming global rollout. Drugs.comtctmd.com
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Summary Table
| Feature | Details |
|---|---|
| FDA Approval | June 9, 2025; first FDA-approved triple-combo pill for hypertension |
| Drug Components | Telmisartan, Amlodipine, Indapamide |
| Dosage Variants | Three strengths for individualized titration |
| Efficacy | Superior BP reduction vs dual therapies and placebo |
| Safety | Well tolerated; watch for hypotension; fetal toxicity warning applies |
| Public Health Fit | Enhances adherence; aligns with modern guidelines favoring single-pill combos |
Conclusion
Widaplik represents a pivotal advancement in cardiovascular care. Its once-daily triple-combination formulation offers superior BP control, streamlined administration, and holds great promise to improve adherence, particularly for patients requiring multiple agents from therapy initiation.
References:
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FDA approval announcement and trial summaries Pharmacy TimesDrugs.com+1tctmd.comHCP LiveEndocrinology AdvisorFDA Access DataWikipediaThe Educated Patient
