AT1R antagonists(Angiotensin II Receptor Type 1 antagonists), L-type calcium channel blockers(Voltage-gated L-type calcium channel blockers), NCC inhibitors(Thiazide-sensitive sodium-chloride cotransporter inhibitors)

Therapeutic Areas

Cardiovascular DiseasesOther Diseases

Active Indication

HypertensionCerebral Hemorrhage

Inactive Indication

Cerebral Small Vessel DiseasesDementia, VascularHemorrhagic stroke

Originator Organization

The George Institute for Global Health

Active Organization

George Medicines UK Ltd.George Medicines Pty Ltd.

Inactive Organization

The George Institute for Global Health

License Organization

Bausch Health Cos., Inc.George Medicines UK Ltd.George Medicines PTY Limited

Drug Highest PhaseApproved

First Approval Date

United States (05 Jun 2025),

Hypertension

Regulation-

Structure/Sequence

Molecular FormulaC20H25ClN2O5

InChIKeyHTIQEAQVCYTUBX-UHFFFAOYSA-N

CAS Registry88150-42-9

View All Structures (3)

Clinical Trials associated with Amlodipine/Telmisartan/Indapamide

NCT04518293

/ CompletedPhase 3

Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Dual Combinations for the Treatment of Hypertension

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure (BP) control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to dual combinations.

Start Date09 Jul 2021

Sponsor / Collaborator

George Medicines UK Ltd.

NCT04518306

/ CompletedPhase 3

Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Placebo for the Treatment of Hypertension

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to placebo.

Start Date14 Jun 2021

Sponsor / Collaborator

George Medicines UK Ltd.

SLCTR/2021/007

/ CompletedPhase 3IIT

Efficacy and safety of GMRx2 (a single pill combination containing telmisartan/amlodipine/indapamide) compared to dual combinations for the treatment of hypertension: An international, multi-center, randomized, double-blind, active-controlled, parallel-group trial.

Start Date06 Mar 2021

Sponsor / Collaborator-

100 Clinical Results associated with Amlodipine/Telmisartan/Indapamide

100 Translational Medicine associated with Amlodipine/Telmisartan/Indapamide

100 Patents (Medical) associated with Amlodipine/Telmisartan/Indapamide

Literatures (Medical) associated with Amlodipine/Telmisartan/Indapamide

01 Dec 2024·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension

Article

Author: Spiering, Wilko ; Salam, Abdul ; Ranasinghe, Gotabhaya ; Schutte, Aletta E ; Lakshman, Poopalan ; Wang, Nelson ; Williams, Bryan ; Ojji, Dike B ; Schutte, Aletta E. ; Gutierez, Alexis ; Wright, Jackson T ; de Silva, H Asita ; Narkiewicz, Krzysztof ; Whelton, Paul ; de Silva, H. Asita ; Shanthakumar, Mathangi ; Cushman, William C. ; Liu, Xiaoqiu ; Gianacas, Chris ; Cushman, William C ; Schlaich, Markus P ; Poulter, Neil R ; Di Tanna, Gian Luca ; Wright, Jackson T. ; Ojji, Dike B. ; Sanni, Aliu ; Poulter, Neil R. ; Rodgers, Anthony ; McMullen, Deirdre ; Schlaich, Markus P. ; Oparil, Suzanne ; Grobbee, Diederick

BACKGROUND:

Single-pill combinations of 3 or more low-dose blood pressure (BP)-lowering drugs hold promise for initial or early treatment of hypertension.

OBJECTIVES:

The authors conducted a placebo-controlled trial of a new single-pill combination containing low doses of telmisartan, amlodipine, and indapamide in 2 dose options to assess efficacy and safety.

METHODS:

This international, randomized, double-blind, placebo-controlled, parallel-group trial enrolled adults with hypertension receiving 0 to 1 BP-lowering drugs. After a 2-week placebo run-in during which any BP-lowering medication was stopped, participants were eligible if home systolic BP (SBP) was 130 to 154 mm Hg. Participants were randomized in a 2:2:1 ratio to GMRx2 ¼ dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg), GMRx2 ½ dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg), or placebo. The primary efficacy outcome was difference in change in home SBP from randomization to week 4, and primary safety outcome was treatment discontinuation due to an adverse event.

RESULTS:

From June 14, 2021 to October 18, 2023, a total of 295 participants (mean age: 51 years; 56% female) were randomized and 96% completed the trial. Baseline mean home BP was 139/86 mm Hg and clinic BP was 138/86 mm Hg after placebo run-in. The placebo-corrected least square mean differences in home SBP at Week 4 were -7.3 mm Hg (95% CI: -4.5 to -10.2) for GMRx2 ¼ dose and -8.2 mm Hg (95% CI: -5.2 to -11.3) for GMRx2 ½ dose; reductions for clinic BP were 8.0/4.0 and 9.5/4.9 mm Hg. At Week 4, clinic BP control (<140/90 mm Hg) was 37%, 65%, and 70% for placebo, GMRx2 ¼ dose, and GMRx2 ½ dose, respectively (both doses P < 0.001 vs placebo). Placebo, GMRx2-triple ¼, and GMRx2 ½ treatment discontinuation due to an adverse event occurred in 1 (1.6%), 0, and 6 (5.1%), respectively; out of normal range serum sodium or potassium was observed in 4 (6.3%), 12 (10.6%), and 12 (10.1%), respectively, but no participant had a serum sodium <130/>150 mmol/L or potassium <3.0/>6.0 mmol/L. Serious adverse events were reported by 2 participants in the placebo and GMRx2 ½ groups and none in the GMRx2 ¼ group.

CONCLUSIONS:

In a population with mild-to-moderate BP elevation, both dose versions of the novel low-dose triple single-pill combination showed good tolerability and clinically relevant BP reductions compared with placebo. (Efficacy and Safety of GRMx2 Compared to Placebo for the Treatment of Hypertension: NCT04518306).

01 Oct 2024·LANCET

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 randomised, double-blind, active-controlled, international clinical trial

Article

Author: Salam, Abdul ; Spiering, Wilko ; Hay, P ; Schutte, Aletta E ; Wang, Nelson ; Uluwattage, W ; Williams, Bryan ; Ojji, Dike B ; Lakshman, P ; Gnanenthiran, Sonali R ; Gianacas, Chris ; de Silva, H Asita ; Wright, Jackson T ; Narkiewicz, Krzysztof ; Liu, Xiaoqiu ; Ranasinghe, G ; Shanthakumar, Mathangi ; Cushman, William C ; Schlaich, Markus P ; Poulter, Neil R ; Pereira, T ; Di Tanna, Gian Luca ; Grobbee, Diederick E ; Amarasena, N ; Rodgers, Anthony ; Oparil, Suzanne ; Whelton, Paul K

BACKGROUND:

Single-pill combinations (SPCs) of three low-dose antihypertensive drugs can improve hypertension control but are not widely available. A key issue for any combination product is the contribution of each component to efficacy and tolerability. This trial compared a new triple SPC called GMRx2, containing telmisartan, amlodipine, and indapamide, with dual combinations of components for efficacy and safety.

METHODS:

In this international, randomised, double-blind, active-controlled trial, we enrolled adults with hypertension receiving between zero and three antihypertensive drugs, with a screening systolic blood pressure (SBP) ranging from 140-179 mm Hg (on no drugs) to 110-150 mm Hg (on three drugs). Participants were recruited from Australia, the Czech Republic, New Zealand, Poland, Sri Lanka, the UK, and the USA. In a 4-week active run-in, existing medications were switched to GMRx2 half dose (telmisartan 20 mg, amlodipine 2·5 mg, and indapamide 1·25 mg). Participants were then randomly allocated (2:1:1:1) to continued GMRx2 half dose or to each possible dual combination of components at half doses (telmisartan 20 mg with amlodipine 2·5 mg, telmisartan 20 mg with indapamide 1·25 mg, or amlodipine 2·5 mg with indapamide 1·25 mg). At week 6, doses were doubled in all groups, unless there was a clinical contraindication. The primary efficacy outcome was mean change in home SBP from baseline to week 12, and the primary safety outcome was withdrawal of treatment due to an adverse event from baseline to week 12. Secondary efficacy outcomes included differences in clinic and home blood pressure levels and control rates. This study is registered with ClinicalTrials.gov, NCT04518293, and is completed.

FINDINGS:

The trial was conducted between July 9, 2021 and Sept 1, 2023. We randomly allocated 1385 participants to four groups: 551 to GMRx2, 276 to telmisartan-indapamide, 282 to telmisartan-amlodipine, and 276 to amlodipine-indapamide groups. The mean age was 59 years (SD 11), 712 (51%) participants self-reported as female and 673 (48·6%) male, and the mean clinic blood pressure at the screening visit was 142/85 mm Hg when taking an average of 1·6 blood pressure medications. Following the run-in on GMRx2 half dose, the mean clinic blood pressure level at randomisation was 133/81 mm Hg and the mean home blood pressure level was 129/78 mm Hg. At week 12, the mean home SBP was 126 mm Hg in the GMRx2 group, which was lower than for each of the dual combinations: -2·5 (95% CI -3·7 to -1·3, p<0·0001) versus telmisartan-indapamide, -5·4 (-6·8 to -4·1, p<0·0001) versus telmisartan-amlodipine, and -4·4 (-5·8 to -3·1, p<0·0001) versus amlodipine-indapamide. For the same comparisons, differences in clinic blood pressure at week 12 were 4·3/3·5 mm Hg, 5·6/3·7 mm Hg, and 6·3/4·5 mm Hg (all p<0·001). Clinic blood pressure control rate below 140/90 mm Hg at week 12 was superior with GMRx2 (74%) to with each dual combination (range 53-61%). Withdrawal of treatment due to adverse events occurred in 11 (2%) participants in the GMRx2 group, four (1%) in telmisartan-indapamide, three (1%) in telmisartan-amlodipine, and four (1%) in amlodipine-indapamide, with none of the differences being statistically significant.

INTERPRETATION:

A novel low-dose SPC product of telmisartan, amlodipine, and indapamide provided clinically meaningful improvements in blood pressure reduction compared with dual combinations and was well tolerated. This SPC provides a new therapeutic option for the management of hypertension and its use could result in a substantial improvement in blood pressure control in clinical practice.

FUNDING:

George Medicines.

14 Feb 2024·Global heart

Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension

Article

Author: Poulter, Neil ; Salam, Abdul ; Whelton, Paul ; Spiering, Wilko ; Ojji, Dike ; Gnanenthiran, Sonali R ; Williams, Bryan ; de Silva, Asita ; Schlaich, Markus P ; Di Tanna, Gian Luca ; Cushman, William ; Rodgers, Anthony ; Oparil, Suzanne ; Wright, Jackson T ; Schutte, Aletta E ; Narkiewicz, Krzysztof ; Grobbee, Diederick

Two recent large trials showed the potential of single pill combinations (SPCs) with ≥3 low-dose components among people with hypertension who were untreated or receiving monotherapy. In both trials, these 'hypertension polypills' were superior to usual care, achieving >80% BP control without increasing withdrawal due to side effects. However, there are no such products available for prescribers. To address this unmet need, George Medicines developed GMRx2 with telmisartan/amlodipine/indapamide in three strengths (mg): 10/1.25/0.625, 20/2.5/1.25; 40/5/2.5. Two pivotal trials are ongoing to support FDA submission for the treatment of hypertension, including initial treatment. These assess efficacy and safety of GMRx2 compared to: placebo, and each of the three possible dual combinations. Regulatory submissions are planned for 2024, with the aim of providing access to GMRx2 in developed and developing regions. Wider implementation of GMRx2-based treatment strategies will be guided by further research to inform access and appropriate scale up.

News (Medical) associated with Amlodipine/Telmisartan/Indapamide

09 Jun 2025

·www.fiercepharma.com

George Medicines opens new front in hypertension treatment with FDA nod for combo pill

George Medicines plans to launch its Widaplik in the U.S. in the fourth quarter of this year. A new era of hypertension treatment is on the horizon for U.S. patients with the FDA approval of George Medicines’ Widaplik, a three-in-one pill that can serve as an initial treatment to help lower blood pressure.The drug combines established high blood pressure meds telmisartan, amlodipine and indapamide and is the first triple-combination therapy to boast a label from the FDA that allows its use as an early treatment, helping patients who may need multiple drugs to achieve blood pressure goals with one fell swoop. Its three dosing options—one low dose and two standard doses—can deliver the benefits of a triple-combo approach “early in the treatment pathway with an established safety profile and good tolerability,” according to a June 9 press release from George Medicines.The drug is specifically approved for patients who are likely to need more than one medicine to achieve blood pressure goals.In late-stage trials, George Medicines weighed Widaplik against placebo and dual combinations of telmisartan, amlodipine and indapamide. The studies found that the triple combo bested the other cohorts by improving patients' blood pressure and control rates.The U.K.-based company is planning for a U.S. launch during the fourth quarter of this year, with additional regulatory submissions expected this year. About 119 million adults in the U.S. have high blood pressure, according to the FDA. Even though more than half of U.S. adults have hypertension, only about 1 in 4 have their blood pressure under control, according to the agency. This "silent killer" puts patients at a higher risk for heart disease, heart failure and strokes, even if no symptoms are apparent, according to the FDA.“Data show that most patients with hypertension will require two or more medicines to bring their blood pressure under control,” George Medicines’ CEO Mark Mallon said in a company press release. “Widaplik can provide patients with hypertension, including those who are starting treatment, with a different approach to control their blood pressure.”Widaplik will be sold with an FDA boxed warning urging patients to discontinue treatment “as soon as possible” after detecting pregnancy due to fetal toxicity. George Medicines, an independent spin-out company from global health inequity research organization The George Institute for Global Health, isn’t stopping at hypertension. The company looks to save “tens of thousands of lives a year” with Widaplik for patients who have had intracerebral hemorrhage, a severe stroke where bleeding occurs within the brain tissue. An ongoing phase 3 trial program has so far shown that the treatment combo can significantly improve patients' chances of survival without suffering major disabilities.

Drug ApprovalPhase 3

09 Jun 2025

·www.einpresswire.com

George Medicines announces FDA approval of WIDAPLIK™ (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment

Novel, single pill, triple combination with a standard dose and two lower doses that can deliver the efficacy benefits of combination therapy , with an established safety profile and good tolerability First and only triple combination for the initial treatment of hypertension Commercialization planning underway with US launch anticipated Q4 2025 London, UK, Boston, MA, 9 June 2025 – George Medicines, a late-stage biopharmaceutical company focused on addressing unmet needs in cardiometabolic disease, today announces that the US Food and Drug Administration (FDA) has approved WIDAPLIK™ (telmisartan, amlodipine and indapamide), formerly known as “GMRx2”, for the treatment of hypertension in adult patients, including as initial treatment, to lower blood pressure. WIDAPLIK is a proprietary single pill combination of three medicines: telmisartan, amlodipine and indapamide and is available in three doses: a standard dose and two low doses. It is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. WIDAPLIK, with its three different doses, can deliver the efficacy benefits of a triple mechanism approach early in the treatment pathway with an established safety profile and good tolerability. Globally recognized treatment guidelines now recommend the use of single pill combination therapy for most patients and acknowledge the benefit of early use of combination therapy. In the US, nearly half of adults have hypertension and only around one in four have their blood pressure under control. Hypertension is a major risk factor for coronary heart disease, stroke and heart failure and is estimated to cause 460,000 deaths in the US each year. Mark Mallon, Chief Executive Officer of George Medicines, said: “Data show that most patients with hypertension will require two or more medicines to bring their blood pressure under control. 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.” Dr. Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, and Past President of the World Hypertension League, said: “I am very excited and pleased to have WIDAPLIK approved for the treatment of hypertension in the US. 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 FDA approval is based on positive results from two international Phase 3 trials, which compared WIDAPLIK against placebo and against dual combinations of its component drugs . In both trials WIDAPLIK significantly improved blood pressure and control rates vs comparators. In clinical trials, the most common adverse event reported in patients treated with WIDAPLIK is symptomatic hypotension. WIDAPLIK is contraindicated in patients with anuria, known hypersensitivity to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs, or to any other component of this product. In patients with diabetes, WIDAPLIK is not to be co-administered with aliskiren. A boxed warning in the labeling informs physicians and patients to discontinue WIDAPLIK as soon as possible after pregnancy is detected due to fetal toxicity. For full Prescribing Information, visit here . The US commercial launch of WIDAPLIK is anticipated in Q4 2025. George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company’s WIDAPLIK development program built on earlier research by The George Institute, including the 700-patient TRIUMPH trial undertaken in Sri Lanka in 2016/17, which found that among patients with mild to moderate hypertension, treatment with a low-dose triple combination pill led to an increased proportion of patients achieving their target blood pressure goal versus usual care. George Medicines is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm. Ends About WIDAPLIK™ (GMRx2) WIDAPLIK is a combination tablet of telmisartan, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker and indapamide, a thiazide-like diuretic, available in three dosage forms – 10/1.25/0.625 mg; 20/2.5/1.25 mg and 40/5/2.5 mg. WIDAPLIK is indicated for the treatment of hypertension, including as initial treatment, to lower blood pressure. Its development is backed by a comprehensive clinical program, including two pivotal Phase 3 studies, published in 2024 in the Journal of the American College of Cardiology and The Lancet . In these trials the triple combination demonstrated significantly reduced blood pressure (BP) and improved BP control rates, when compared against dual therapy and against placebo. In both trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events. GMRx2 was investigated in the Nigerian VERONICA trial , which compared the triple combination with standard of care and reported better BP lowering among those receiving GMRx2, with good tolerability compared to the standard of care protocol. A global trial investigating the potential of GMRx2 for the prevention of stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) is ongoing. Please see full Prescribing Information including Boxed Warning for WIDAPLIK here . INDICATIONS WIDAPLIK TM is a prescription medicine used to treat high blood pressure (hypertension) in adults. WIDAPLIK may be used as the first medicine to lower your high blood pressure if your healthcare provider decides you are likely to need more than one medicine. Medicines that lower your blood pressure may lower your chances of having a stroke or heart attack. IMPORTANT SAFETY INFORMATION WARNING: WIDAPLIK™ can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue WIDAPLIK as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus. Talk with your doctor about other ways to lower blood pressure if you plan to become pregnant. Before taking WIDAPLIK, tell your doctor if you are breastfeeding or plan to breastfeed. Discuss with your doctor other ways to lower your blood pressure. Breastfeeding while taking WIDAPLIK is not recommended. Do not take WIDAPLIK if you make less urine because of kidney problems (anuria). Do not take aliskiren-containing products with WIDAPLIK if you have diabetes. Tell your doctor about all your medical conditions, including if you have heart problems, have gout, or have liver or kidney problems. Kidney problems may become worse in people that already have kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose or may need to stop treatment with WIDAPLIK. During treatment with WIDAPLIK, certain people who have severe heart failure, narrowing of the artery to the kidney, or who lose too much body fluid such as with nausea, vomiting, bleeding, or trauma, may develop sudden kidney failure. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other medicines to treat your high blood pressure or heart problem; water pills (diuretics); lithium; or digoxin. WIDAPLIK may cause serious side effects, including low blood pressure (hypotension) which may cause you to feel faint or dizzy. Vomiting and diarrhea, a low salt diet, sweating a lot, dialysis treatments, or not drinking enough fluid can also lead to low blood pressure. If you feel faint or dizzy, lie down and call your doctor right away. If you pass out (faint), have someone call your doctor or get medical help. Stop taking WIDAPLIK. If you have fluid and body salt (electrolyte) problems, tell your doctor if you experience any of the following symptoms: dry mouth, confusion, thirst, lack of energy (lethargic), weakness, drowsiness, passing very little urine or passing large amounts of urine, seizures, muscle pain/cramps, restlessness, muscle tiredness (fatigue), fast or abnormal heartbeat, nausea and vomiting, or constipation. People who have increased levels of uric acid in the blood may develop gout. If you already have gout, tell your doctor about worsening of your gout symptoms. In clinical studies, the most common side effects seen with WIDAPLIK were dizziness from low blood pressure, low blood sodium, or low blood potassium The Important Safety Information does not include all the information needed to use WIDAPLIK safely and effectively. For further information, please see accompanying complete Prescribing Information for WIDAPLIK. To report SUSPECTED ADVERSE REACTIONS contact either: George Medicines at: safety@george-medicines.com or call 1-888-508-2083; or FDA at: www.fda.gov/medwatch or call 1-800-FDA-1088 About George Medicines George Medicines is a late-stage biopharmaceutical company addressing unmet need in the treatment of cardiometabolic diseases with innovative single-pill combinations of existing treatments, designed for a balance of efficacy and safety, with the potential to improve patient adherence. Multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes with cardiometabolic disorders, including hypertension, each of which remain among the leading causes of premature death and disability worldwide. For more information, please visit www.george-medicines.com . Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to George Medicines’ financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential. In addition, this press release also contains forward looking statements relating to George Medicines’ growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including George Medicines’ ability to successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of drug candidates. Media contacts ICR Healthcare David Daley, Lindsey Neville, Tom Daniel georgemedicines@icrhealthcare.com ; Tel: +44 (0) 203 709 5700 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultDrug ApprovalPhase 3

13 Jan 2025

·www.globenewswire.com

George Medicines signs exclusive licensing agreement with Bausch Health to commercialize GMRx2 in Canada, Mexico, Columbia and Central America

George Medicines signs exclusive licensing agreement with Bausch Health to commercialize GMRx2 in Canada, Mexico, Columbia and Central America Bausch Health gains exclusive rights to single-pill triple combination therapy for hypertensionGeorge Medicines receives upfront milestone payment and is eligible for regulatory and commercial milestones, and a stepped royalty rate in licensed territoriesGMRx2 has potential to be the only triple combination approved for the treatment of hypertension including initial treatment London, UK, 13 January 2025 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, has entered into an exclusive licensing and supply agreement with Bausch Health Companies Inc. (NYSE/TSX: BHC) (‘Bausch Health’), a global, diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, granting Bausch Health exclusive rights to seek regulatory approval of, and to commercialize, GMRx2 in Canada, Mexico, Columbia and Central America. GMRx2, George Medicines’ lead pipeline candidate for the treatment of hypertension including initial treatment, is a proprietary single-pill combination of three best-in-class medicines: telmisartan, amlodipine and indapamide. Developed in ultra-low dose, low-dose, and standard-dose options, it has the potential to be the only triple combination approved for the initial treatment of hypertension. The innovative formulation is designed for optimal efficacy, safety and adherence. With a multi-mechanism approach and at lower dosing than today’s therapies, GMRx2 is designed to deliver the synergistic efficacy benefits of a triple therapy while maintaining tolerability. Under the terms of the licensing agreement, George Medicines receives an upfront milestone payment and is eligible for regulatory and commercial milestone payments, as well as a future recurring revenue stream through a stepped royalty rate on sales of GMRx2 in the licensed territories. In return, Bausch Health is granted a license to exclusively commercialize GMRx2, supplied by George Medicines, in Canada, Mexico, Columbia and Central America. Bausch Health is responsible for seeking regulatory approval of GMRx2, with support from George Medicines. Mark Mallon, Chief Executive Officer of George Medicines, said: “This announcement marks a significant milestone for George Medicines, and in Bausch Health we have secured a strong commercial partner who shares our belief in the potential of GMRx2 to enable more patients to achieve better blood pressure control and improve on current hypertension treatment approaches.” Cees Heiman, Senior Vice President, Europe and Canada, Bausch Health, said: “In Canada, seven and a half million people, about 1 in 4 adults, live with hypertension1, and too many do not have their condition under control. The clinically-proven efficacy of GMRx2 compared to dual combinations, coupled with its good tolerability, have the potential to address key challenges in current hypertension treatment approaches. This partnership with George Medicines underscores our commitment to deliver better health outcomes for patients.” Fernando Zarate, Vice President, Latin America, Bausch Health, said: “GMRx2 is a critical innovation that we believe can meaningfully advance cardiovascular care in Mexico, Colombia and Central America. While prevalence of hypertension remains high in the region, its treatment and control is low2. In GMRx2 we have an opportunity to change that.” Globally, many diagnosed hypertension patients are not currently achieving sufficient blood pressure (BP) control because they are on inadequate therapy, are not receiving the right combination of medicines at the right doses or are not taking their treatment as prescribed. With the latest professional guidelines from the European Society of Cardiology3 recommending lower target BP levels and early use of combination therapy, an effective, low-dose, single-pill triple combination with good tolerability provides an opportunity to significantly advance the management of hypertension. GMRx2 is backed by a comprehensive clinical development program, including two pivotal Phase III studies, published in 2024 in the Journal of the American College of Cardiology4 and The Lancet5, demonstrating GMRx2 significantly reduced BP and improved BP control rates, when compared against dual therapy and against placebo. The triple combination was also investigated in the Nigerian VERONICA trial6, which compared GMRx2 with existing, standard of care and reported better BP lowering and control among those receiving GMRx2. In all trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events. A global trial investigating the potential of GMRx2 for the prevention of stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) is ongoing7. GMRx2 has not received regulatory approval for commercial use in any country. A New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking US approval of GMRx2 for the treatment for hypertension, including initiation of treatment, is ongoing with a Prescription Drug User Fee Act (PDUFA) goal date of 5 June 2025. Regulatory submissions in other territories are anticipated in 2025. George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing 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. Ends References: Hypertension Canada Annual Report https://hypertension.ca/wp-content/uploads/2024/10/HC-2024-Annual-Report-Final.pdf)Prevalence, Awareness, Treatment, and Control of Hypertension in the Southern Cone of Latin America; Am J Hypertens; doi: 10.1093/ajh/hpw092 https://academic-oup-com.libproxy1.nus.edu.sg/ajh/article/29/12/1343/27082962024 ESC Guidelines for the management of elevated blood pressure and hypertension; European Heart Journal, Volume 45, Issue 38, 7 October 2024, Pages 3912–4018, https://doi-org.libproxy1.nus.edu.sg/10.1093/eurheartj/ehae178Rodgers A, Salam A, Schutte AE, . . .Whelton P. Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension. Journal of the American College of Cardiology. 2024;0(0). doi:10.1016/j.jacc.2024.08.025Efficacy and safety of a novel low-dose triple single-pill combination, compared with dual combinations for treatment of hypertension; The Lancet; doi: 10.1016/S0140-6736(24)01744-6Ojji DB, Salam A, Sani MU, . . .Rodgers A. Low-dose triple-pill vs standard-care protocols for hypertension treatment in Nigeria: a randomized clinical trial. doi:10.1001/jama.2024.18080. JAMA. 2024.10.1001/jama.2024.18080TRIDENT: Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial https://www.tridentstudy.org/ About George Medicines George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative combinations of best-in-class existing treatments, designed for optimal efficacy and safety. Combining best-in-class molecules from existing medicines in novel low-dose formulations, George Medicines is developing innovative and proprietary treatments to be more efficacious, safer and accessible than currently available treatment options. These multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes and therapy adherence in patients with cardiometabolic disorders, including hypertension and diabetes, each of which remain the leading causes of premature death and disability worldwide. For more information, please visit www.george-medicines.com. Media contacts ICR Healthcare David Daley, Lindsey Neville, Tom Daniel georgemedicines@icrhealthcare.com; Tel: +44 (0) 203 709 5700

Phase 3License out/inClinical Result

100 Deals associated with Amlodipine/Telmisartan/Indapamide

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	United States	George Medicines Pty Ltd.	05 Jun 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cerebral Hemorrhage	Phase 3	Australia	The George Institute for Global Health	27 Feb 2020
Cerebral Hemorrhage	Phase 3	Netherlands	The George Institute for Global Health	27 Feb 2020
Cerebral Small Vessel Diseases	Phase 3	Australia	The George Institute for Global Health	27 Feb 2020
Cerebral Small Vessel Diseases	Phase 3	Netherlands	The George Institute for Global Health	27 Feb 2020
Dementia, Vascular	Phase 3	Australia	The George Institute for Global Health	27 Feb 2020
Dementia, Vascular	Phase 3	Netherlands	The George Institute for Global Health	27 Feb 2020
Hemorrhagic stroke	Phase 3	Australia	The George Institute for Global Health	27 Feb 2020
Hemorrhagic stroke	Phase 3	Netherlands	The George Institute for Global Health	27 Feb 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04518293 (FDA_CDER) Manual	Phase 3	Hypertension	-	Widaplik 40 mg/5 mg/2.5 mg	qgludjgmak(cdhlqmhsri) = iojwcqbahn qzvizhkstu (zefruiogaw, 0.5) View more	Positive	05 Jun 2025
				Telmisartan/Indapamide 40 mg/2.5 mg	qgludjgmak(cdhlqmhsri) = rzrrwpxgyd qzvizhkstu (zefruiogaw, 0.5) View more
NCT04518306 (FDA_CDER) Manual	Phase 3	Hypertension	295	Widaplik 10 mg/1.25 mg/0.625 mg	qodyibxfua(wnhyluchwj) = fcxezxrxnl qxifpbupif (bklribenkt, 1.0) View more	Positive	05 Jun 2025
				Widaplik 20 mg/2.5 mg/1.25 mg	qodyibxfua(wnhyluchwj) = vybznkizvo qxifpbupif (bklribenkt, 1.3) View more
NCT04518306 (Efficacy and Safety of GRMx2, Pubmed \| J Am Coll Cardiol)	Phase 3	Hypertension	295	GMRx2 ¼ dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg)	xmfvyyncjn(orybzmaqia) = wxhzkuiwvr upjmyxwsxi (nenlechjen, -4.5 to -10.2) View more	Positive	01 Dec 2024
				GMRx2 ½ dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg)	xmfvyyncjn(orybzmaqia) = ewbqewimzp upjmyxwsxi (nenlechjen, -5.2 to -11.3) View more

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