This is a Phase 1 clinical trial designed to evaluate the safety and tolerability of amlodipine, a calcium channel blocker, in adults with Myotonic Dystrophy Type 1 (DM1). Amlodipine is being studied to see if it can improve muscle strength, reduce stiffness (myotonia), and improve function by modifying calcium flow in muscle cells. All participants will receive amlodipine starting at 2.5 mg daily for 2 weeks, then 5 mg for 4 weeks. After that, participants will be randomly assigned to continue on 5 mg or increase to 10 mg for an additional 4 weeks. The main goals are to assess changes in blood pressure and any adverse events to determine whether the drug is safe in this population. The study will also explore how amlodipine affects muscle strength, mobility, fatigue, and daily function using clinical tests and questionnaires. Findings will inform a future phase 2 trial.

Start Date07 Dec 2026

Sponsor / Collaborator

University of Rochester

TCTR20260126004

/ Not yet recruitingPhase 1IIT

A Bioequivalence Study of Open-label, Randomized, Single Oral Dose, Two-way Crossover Design of Two Fixed Dose Combination of Generic Amlodipine Besylate 10 mg and Olmesartan Medoxomil 40 mg Film-coated Tablets and Reference Product (NORMETECTM 10/40) in Healthy Thai Subjects under Fasting Conditions

Start Date09 Mar 2026

Sponsor / Collaborator-

ChiCTR2600116323

/ Not yet recruitingNot ApplicableIIT

Pathogenesis, Molecular Targets and Intervention Strategies of High-Altitude Heart Disease

Start Date07 Jan 2026

Sponsor / Collaborator-

100 Clinical Results associated with Amlodipine Besylate

100 Translational Medicine associated with Amlodipine Besylate

100 Patents (Medical) associated with Amlodipine Besylate

5,527

Literatures (Medical) associated with Amlodipine Besylate

01 Mar 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Selective and sensitive determination of amlodipine in binary mixtures using a nanomaterial-assisted molecularly imprinted electrochemical sensor

Article

Author: Budak, Fatma ; Bekmez, Berfu ; Cetinkaya, Ahmet ; Ozkan, Sibel A

Cardiovascular disease, one of the leading causes of death in developing countries, is mainly caused by the combination of arterial hypertension and dyslipidemia as major risk factors. Amlodipine (AML) is a calcium channel blocker that inhibits extracellular calcium influx across the membranes of myocardial and vascular smooth muscle cells, thereby reducing contraction and dilating coronary and systemic arteries. This study aimed to design a nanoparticle-supported molecularly imprinted polymer (MIP)-based electrochemical sensor with selective and sensitive sensitivity for the quantitative analysis of both binary drug mixtures and AML. The modified sensor was produced by the electropolymerization (EP) method in the presence of 4-aminobenzoic acid (4-ABA) as the functional monomer, pyrrole (Py) as the copolymerization monomer, and the target molecule AML. The incorporation of silver nanoparticles (AgNPs) into the MIP-based electrochemical sensor increased its active surface area and porosity. The AML/4-ABA-co-Py@AgNPs/MIP-GCE sensor was characterized both electrochemically (electrochemical impedance spectroscopy (EIS) and cyclic voltammetry (CV)) and by surface morphology (scanning electron microscopy (SEM)). The quantification of AML was performed using differential pulse voltammetry (DPV) with the direct method in a 5.0 mM [Fe(CN)₆]^3-/4 solution, yielding a linear range of 0.1-1.0 pM. The applicability and accuracy of the sensor were evaluated by recovery studies in tablet forms containing binary mixtures. In addition, to demonstrate the sensor's selectivity, a selectivity study was performed in the presence of components with chemical structures similar to those of AML, and its high selectivity was confirmed by the relative suppression factors for AML. In conclusion, this newly developed sensor for AML offers many advantages, such as selective, sensitive, fast, and inexpensive analysis.

01 Feb 2026·Green synthesis and catalysis

Mild and green thioacylation with dithiocarboxylates via photoredox catalysis

Author: Zhou, Rong ; Li, Wei ; Zhang, Juan ; Gao, Wen-Chao ; Chang, Hong-Hong

A photocatalysis process-enabled thioacylation of amines has been developed with eco-friendly feedstock potassium dithiocarboxylates as green thioacyl sources and water as the reaction solvent.The key to the success of this transformation is the light-induced generation of active dithioacyl disulfides as thioacyl donors.This green methodol. has been successfully employed for the late-stage thioacylation of various amino compounds including drugs, hormones, amino acids and peptides under mild conditions.

01 Feb 2026·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Fabrication and characterization of taste-masked core-shell nanofibre mats for dual drug delivery of antihypertensives in pediatrics

Article

Author: Craig, Duncan Q M ; Ubani-Ukoma, Uloma N ; Faiyaz, Mahmood ; Li, Xiunan ; Abdelhakim, Hend E ; Parhizkar, Maryam

Drug adherence in pediatrics can be challenging due to bitter drug taste, dysphagia and polypharmacy. With pediatric hypertension on the rise worldwide, this study investigated the use of electrospinning to create a novel taste-masked, fixed-dose combination of lisinopril dihydrate (LIS) and amlodipine besylate (AML) for paediatric use. Electrospun nanofibres of the antihypertensives were formulated as core-shell fibres with polyvinylpyrrolidone (PVP), and Eudragit® EPO (EEPO) by applying an electrical charge to a viscous mixture of the drugs, polymers and solvents. The drug loading, release kinetics, morphology, thermal analysis, physical and solid-state characterization of the fibre mats were evaluated. Taste-masking was investigated in vitro by electronic-tongue analysis. Scanning electron microscopy (SEM) and transmission electron microscopy (TEM) analyses showed smooth, non-beaded core-shell fibres with diameters in the nanorange. Fourier transform infra-red (FTIR) spectroscopy and x-ray diffraction (XRD) studies confirmed the drugs were amorphously dispersed within the fibres and thermal analysis studies showed acceptable stability profile of the formulations. Both drugs were over 90 % released in 15 mins consistent with immediate release formulations. The e-tongue mean sensor response plot showed the nanofibre mats achieved a statistically significant enhanced taste-masking (p < 0.0001) compared to raw amlodipine which registered a high bitterness reading of 87 mV. This study therefore indicates that coaxial electrospinning may be used to produce a fixed-dose taste masked nanofibre mat of LIS and AML that can potentially be used to improve adherence in children.

News (Medical) associated with Amlodipine Besylate

23 Apr 2026

·www.biospace.com

George Medicines: New England Journal of Medicine publishes global stroke outcomes trial that demonstrated reduction of risk for recurrent stroke by almost 40% with GMRx2 in patients with previous intracerebral hemorrhage

Significant lowering of systolic blood pressure of 9mmHg on top of background treatment maintained with GMRx2 over an average follow-up of 3 years Safety findings similar to previous studies of GMRx2 London, UK, Boston, MA, 22 April 2026 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, today announced that results from the global, investigator-initiated TRIDENT trial have been published in the New England Journal of Medicine 1 . The trial met its primary endpoint with GMRx2, George Medicines’ single pill low-dose combination therapy of telmisartan, amlodipine and indapamide, and demonstrated a statistically significant and clinically meaningful reduction of recurrent stroke events in patients with intracerebral hemorrhage (ICH). The international study randomized 1,670 patients with a recent ICH event who were on standard of care treatment and had stable systolic blood pressure (SBP) of 130-160mmHg. Patients received either GMRx2 (telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg) or a placebo, plus standard of care for blood pressure and comorbid cardiovascular conditions. During an average duration of follow-up of 3 years, stroke occurred in 4.6% of patients receiving GMRx2 compared to 7.4% in the placebo group, equating to a 39% relative risk reduction for recurrent stroke in patients receiving GMRx2. The GMRx2 group achieved better blood pressure (BP) control, with mean SBP levels 9mmHg lower than the placebo group, a result that was maintained during the course of the study. The safety pro GMRx2 was generally consistent with the established safety profiles of the medicine and its individual components. Serious adverse events were comparable between the two groups, affecting 23.8% of patients in the GMRx2 group and 26.8% in the placebo group. Dr. Kevin Sheth, MD. Professor of Neurology and Neurosurgery, Vice Chair for Clinical and Translational Research, and Director of the Center for Brain & Mind Health at Yale School of Medicine, said: “ For patients who have survived an intracerebral hemorrhage, the risk of a second stroke remains high. This trial showed that a structured, intensive blood pressure-lowering approach using a single-pill triple combination can translate into meaningful reductions in recurrent stroke risk. This finding has the potential to directly address the long-standing challenges of under-treatment, adherence issues prominent for this patient population, and therapeutic inertia that stand in the way of a safe and effective preventative treatment that can improve outcomes for patients .” Around 100 million people worldwide have experienced a stroke, with ICH recognized as the most serious form, and 12 million new cases occur each year 2 . Recurrent strokes represent between 25-30% of all cases 3 . In the US alone, each year more than 795,000 people have a stroke, with nearly 1 in 4 occurring in people who have had a previous stroke 4 . The only treatment with the demonstrated potential to prevent ICH and its recurrence is effective BP reduction 5,6 . However, the benefits of intensive BP-lowering and the optimal approach to treatment are uncertain. Although most stroke survivors are discharged from hospital on BP-lowering therapy, long-term BP control is generally thought to be inadequate due to the potential combination of factors such as uncertainty surrounding the degree of benefit, varying guideline recommendations, insufficient up-titration of medicines, poor adherence and therapeutic inertia 7-12 . Dr. Amy Carroll, PhD. Senior Vice President of Medical Affairs, George Medicines, said: “ TRIDENT is the first stroke outcomes trial of its kind and the largest secondary prevention trial in survivors of ICH. The study employed a triple-therapy, multi–mechanism-based strategy to evaluate whether GMRx2 could reduce the risk of recurrent stroke following prior ICH through effective blood pressure control. We are enthusiastic about the results, and the significant treatment effect shown in this study reinforces what we have learned from prior indirect evidence of the benefits of intensive blood pressure-lowering in this patient group with the highest unmet need for stroke recurrence.” GMRx2 was approved by the US Food and Drug Administration (FDA) in June 2025 as WIDAPLIK TM (telmisartan, amlodipine and indapamide) for the treatment of hypertension and 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. Azurity Pharmaceuticals has exclusive rights to commercialize WIDAPLIK in the United States. 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. References Anderson CS et al. Three Low-Dose Antihypertensive Agents in a Single Pill after Intracerebral Hemorrhage. N Engl J Med 2026;394:1571-82. DOI: 10.1056/NEJMoa2515043 Feigin VL et al . World Stroke Organization: Global Stroke Fact Sheet 2025. Int J Stroke. 2025. Hankey GJ. Secondary stroke prevention. Lancet Neurol . 2014. (13)70255-2 . US Centers for Disease Control and Prevention, Stroke Facts, October 2024. . Steiner T, Purrucker JC, de Sousa DA, European Stroke Organisation (ESO) and European Association of Neurosurgical Societies (EANS) guideline on stroke due to spontaneous intracerebral hemorrhage. Eur Stroke J 2025; 0(0). doi:10.1177/23969873251340815 . Greenberg SM, Ziai WC, Cordonnier C, et al. 2022 Guideline for the management of patients with spontaneous intracerebral hemorrhage: a guideline from the American Heart Association / American Stroke Association. Stroke 2022; 53: e282–e361. Zhou B, Carrillo-Larco RM, Danaei G, et al. Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet 2021; 398: 957-980. Zhang M, Shi Y, Zhou B, et al. Prevalence, awareness, treatment, and control of hypertension in China, 2004-18: findings from six rounds of a national survey. BMJ 2023; 380: e071952. McGurgan IJ, Kelly PJ, Turan TN, Rothwell PM. Long-term secondary prevention: management of blood pressure after a transient ischemic attack or stroke. Stroke 2022; 53: 1085-1103. Biffi A, Anderson CD, Battey TW, et al. Association between blood pressure control and risk of recurrent intracerebral hemorrhage. JAMA 2015; 314: 904-912. Bonello K, Nelson APK, Moullaali TJ, Al-Shahi Salman R. Prescription of blood pressure lowering treatment after intracerebral haemorrhage: prospective, population-based cohort. Eur Stroke J 2021; 6: 44-52. Zahuranec DB, Wing JJ, Edwards DF, et al. Poor long-term blood pressure control after intracerebral hemorrhage. Stroke 2012; 43: 2580-2585. Ends 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 high blood pressure in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure may reduce the risk of having a stroke or heart attack. IMPORTANT SAFETY INFORMATION FOR PATIENTS WARNING: WIDAPLIK TM 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: Azurity Pharmaceuticals, Inc. at 1-800-461-7449 ; or FDA at: or call 1-800-FDA-1088 About TRIDENT TRIDENT was a multicenter, international, double-blind, placebo-controlled, parallel-group, randomized controlled trial in patients with a history of ICH designed to evaluate the effect of GMRx2 (telmisartan 20 mg/ amlodipine 2.5mg/ indapamide 1.25mg), compared with placebo, given once daily in addition to standard of care. The primary outcome was the time to first occurrence of recurrent stroke. The trial was led by The George Institute for Global Health and funded by the National Health and Medical Research Council (NHMRC) Australia and the Brazilian Ministry of Health, with study medication provided by George Medicines. About GMRx2 GMRx2 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. Its development is backed by a comprehensive clinical program, including two pivotal Phase III 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 led by The George Institute for Global Health and funded by the National Health and Medical Research Council (NHMRC) Australia and the Brazilian Ministry of Health, investigating the potential of GMRx2 to significantly reduce the risk of recurrent stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) completed in 2025. The study met the primary endpoint, with GMRx2 demonstrating a statistically significant and clinically meaningful reduction of recurrent stroke compared to matching placebo. About George Medicines George Medicines is a late-stage biopharmaceutical company addressing significant 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, which remain among the leading causes of premature death and disability worldwide. 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. For more information, please visit . 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

Clinical ResultPhase 3Drug Approval

15 Apr 2026

·www.businesswire.com

Pangea Pharmaceuticals Announces U.S. Launch of Sdamlo™, the First and Only FDA-Approved, Amlodipine Powder for Oral Solution

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Pangea Pharmaceuticals, a U.S.-based, patient-centered pharmaceutical company focused on bringing differentiated, clinically relevant products to market, today announced the U.S. launch of Sdamlo™ (amlodipine for oral solution), the first and only FDA-approved, patent-pending amlodipine powder formulation. Sdamlo™ is the first and only FDA-approved amlodipine powder for oral solution designed for precise, easy administration. Sdamlo introduces a differentiated approach to one of the most widely prescribed cardiovascular therapies, offering a prescription-strength powdered oral solution designed to support ease of administration, precision dosing, and improved patient experience across a range of care settings. Amlodipine remains a cornerstone treatment for hypertension and cardiovascular disease, yet traditional tablet and existing liquid formulations present challenges for certain patient populations. Sdamlo is designed to address these gaps with a novel unit-dose oral solution format that eliminates the need for swallowing tablets and simplifies medication administration for patients and caregivers. “Sdamlo reflects our commitment to creating better products from proven molecules and bringing them to market in a way that always puts patients first,” said Tony LaViola, CEO and Co-Founder of Pangea Pharmaceuticals. “We are focused on identifying meaningful gaps in care and delivering solutions that improve access, simplify administration, and support better outcomes. This launch is an important step as we continue to build a differentiated portfolio of life-enhancing products.” Sdamlo is well-suited for patients who have difficulty swallowing solid dosage forms, including pediatric, geriatric, and dysphagic populations. It is particularly beneficial for tube-fed patients, where traditional medications often require crushing and mixing, increasing the risk of dosing variability and tube clogging. Its ready-to-administer liquid format enables precise, consistent enteral delivery. It is also ideal for institutional settings such as hospitals and long-term care facilities, where efficiency, accuracy, and ease of administration are critical. Differentiated Formulation Designed for Real-World Use Sdamlo’s powder for oral solution formulation utilizes a patent-pending lyophilization process to freeze-dry the active ingredient, supporting uniform distribution, enhanced stability, and reliable therapeutic performance. The product offers several key advantages: Easy-to-swallow format eliminating the need for tablets and reducing aspiration risk Precision unit-dose delivery with no measuring, shaking, or stirring required Alcohol-free, preservative-free, and sucralose-free formulation , enhancing suitability for sensitive populations No refrigeration required , supporting flexibility across care settings “No guess” dosing , designed to ensure patients receive the exact prescribed amount every time Together, these attributes support treatment adherence, caregiver confidence, and improved patient experience, particularly in complex care environments. Supporting Clinical and Operational Needs Sdamlo’s unit-dose format is designed to provide value beyond the patient experience, supporting pharmacy workflow efficiency and consistency of administration. In institutional and clinical settings, the product may help reduce preparation complexity and eliminate variability associated with alternative liquid preparation methods, offering a more streamlined and reliable option for healthcare providers. Partnership and Platform Growth Sdamlo is commercialized in partnership with Brillian Pharma, reflecting a shared commitment to bringing differentiated and clinically relevant products to market. “We are proud to partner with Pangea Pharmaceuticals on the U.S. commercialization of Sdamlo, a product based on Brillian’s proprietary platform technology,” said Dr. Nolan Wang, Co-Founder and Chief Technology Officer of Brillian Pharma. “This collaboration reflects a shared commitment to advancing differentiated formulations of widely prescribed therapies while addressing challenges associated with traditional solid oral dosage forms. Sdamlo provides a more flexible option for patients who have difficulty swallowing, including pediatric and geriatric populations.” The launch represents a broader milestone for Pangea Pharmaceuticals as the company continues to build a selective and growing pipeline of products designed to improve access and enhance patient care. Pangea is focused on creating a commercial ecosystem that connects product innovation with efficient market execution, and is actively evaluating additional opportunities to collaborate with partners seeking to bring differentiated products to market. “We are building a thoughtful and intentional portfolio centered on solutions that make a meaningful difference in patients’ lives,” added LaViola. “Sdamlo is an early example of what this platform can deliver, and we see a significant opportunity to expand our pipeline through strategic partnerships and continued growth.” Sdamlo will be available in multiple strengths, with initial availability beginning in March and additional strengths expected to launch in the coming months. For more information on Sdamlo, visit www.sdamlorx.com, and to learn more about Pangea Pharmaceuticals, visit www.pangeapharm.com. About Sdamlo™ Sdamlo™ (amlodipine for oral solution) is the first and only FDA-approved, patent-pending amlodipine powder formulation. Designed as a prescription-strength oral solution, Sdamlo supports ease of administration, precision dosing, and improved patient experience across pediatric, geriatric, dysphagic, and tube-fed populations. The product is alcohol-free, preservative-free, sucralose-free, requires no refrigeration, and is available in convenient unit-dose containers. About Pangea Pharmaceuticals Pangea Pharmaceuticals is a U.S.-based, patient-centered pharmaceutical company focused on bringing differentiated, clinically relevant products to market through thoughtful product strategy and strong commercial execution. The company is building a selective and expanding portfolio of products designed to improve patient access, enhance quality of life, and address meaningful gaps in care through strategic partnerships and innovation in delivery and formulation. Learn more at www.pangeapharm.com.

Drug Approval

16 Mar 2026

·www.biospace.com

George Medicines extends global commercialization of GMRx2 into Australia and New Zealand with Arrotex licensing agreement

Arrotex gains exclusive rights in Australia and New Zealand to innovative single pill combination of three hypertension medicines, including two doses that are lower than those currently available in single pill combinations GMRx2 is designed to deliver blood pressure-lowering benefits of triple combination therapy early in the treatment pathway, with an established safety profile George Medicines receives upfront licensing fee and is eligible for commercial milestone payments, as well as a future recurring revenue stream through a tiered royalty rate on sales in Australia and New Zealand Arrotex to seek regulatory approval of GMRx2 in Australia and New Zealand London, UK, 16 March 2026 – 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 Arrotex Pharmaceuticals (“Arrotex”), a leading Australian pharmaceutical company and Australia’s largest supplier of medicines by prescription volume, granting Arrotex exclusive rights to seek regulatory approval of, and to commercialize, GMRx2 in Australia. GMRx2 is an innovative single pill combination of three medicines, telmisartan, amlodipine and indapamide, for the treatment of hypertension, developed in three doses, including two doses that are lower than those currently available in single pill combinations. By leveraging a multi-mechanism approach and lower doses, GMRx2 is formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the known safety profiles of existing antihypertensive medicines. Under the terms of its licensing agreement, George Medicines will receive an upfront licensing fee and is eligible for commercial milestone payments, as well as a future recurring revenue stream through a tiered royalty rate on sales of GMRx2 in the licensed territory. In return, Arrotex is granted a license to exclusively commercialize GMRx2, supplied by George Medicines. Arrotex is responsible for seeking regulatory approval of GMRx2, supported by George Medicines, with upcoming applications to Australia’s Therapeutic Goods Administration and the New Zealand Medicines and Medical Devices Safety Authority. Mark Mallon, Chief Executive Officer of George Medicines, said: “This latest partnership in our global commercialization strategy for GMRx2 signals our commitment to extend the reach of this triple combination product to all corners of the globe. The George Institute for Global Health, which founded George Medicines, was established in Australia and so it is a significant moment for us to bring GMRx2 one step closer to people living with hypertension in the Institute’s home country. As Australia's largest pharmaceutical provider, and with its significant commercial capabilities, Arrotex is an ideal partner to support us in delivering on the potential of GMRx2 to help address key challenges in current hypertension treatment approaches.” Monique Jonson, General Manager, Innovation, at Arrotex Pharmaceuticals, said: “Our partnership with George Medicines reflects Arrotex’s ongoing commitment to bringing innovative, life-changing therapies to Australia and New Zealand. Through our unprecedented operational and commercial capabilities, we are well placed to facilitate access for patients and look forward to working with the George Medicines team on our upcoming regulatory submissions for GMRx2.” Around one in three adults in Australia (6.8 million) are living with high blood pressure with only half of those aware of their condition and receiving treatment. More than a million of those diagnosed and treated do not have their blood pressure effectively controlled 1 . In New Zealand, the prevalence of hypertension in adults is 31% (968,000), and only around a quarter have the condition effectively controlled 2 . Most patients with hypertension will require two or more medicines to bring their blood pressure under control, and globally recognized treatment guidelines acknowledge the preferred use of single pill combination therapy and the benefit of their early use. 3,4,5 To date, George Medicines has granted licensing and supply agreements for GMRx2 in Brazil, Cananda, Mexico, Colombia and Central America, and the United States, with further collaborations anticipated as part of the Company’s commitment to bring the value of this important medicine to patients globally. 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 National Hypertension Taskforce Australia 2 WHO Hypertension New Zealand 2023 country profile 3 European Heart Journal, Volume 45, Issue 38, 7 October 2024, Pages 3912–4018, 4 Guideline for the pharmacological treatment of hypertension in adults. Geneva: World Health Organization ; 2021 5 CMAJ May 26, 2025 197 (20) E549-E564; About GMRx2 GMRx2 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. Its development is backed by a comprehensive clinical program, including two pivotal Phase III 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 led by The George Institute for Global Health and funded by the National Health and Medical Research Council (NHMRC) Australia and the Brazilian Ministry of Health, investigating the potential of GMRx2 to significantly reduce the risk of recurrent stroke in people who have had intracerebral hemorrhage (the most severe type of stroke) completed in 2025. The study met the primary endpoint, with GMRx2 demonstrating a statistically significant and clinically meaningful reduction of recurrent stroke compared to matching placebo. About George Medicines George Medicines is a late-stage biopharmaceutical company addressing significant 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, which remain among the leading causes of premature death and disability worldwide. For more information, please visit . About Arrotex Pharmaceuticals Arrotex Pharmaceuticals is the largest and most diversified pharmaceutical company in Australia, offering the most extensive range of prescription products across the spectrum of therapeutic areas. Proudly Australian-owned and part of DBG Health, Arrotex has over 15 years of proven success in representing branded medicines and has become the Australian partner of choice for pharmaceutical companies seeking to grow and protect their brands while enhancing patient access to medicines for Australians. 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

Clinical ResultLicense out/inPhase 3

100 Deals associated with Amlodipine Besylate

External Link

KEGG	Wiki	ATC	Drug Bank
D00615	Amlodipine Besylate	C08CA01	DBSALT001054

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Deglutition Disorders	Canada	Pendopharm, Inc.	11 Jan 2019
Angina Pectoris	United Kingdom	Pfizer Inc.	01 Jan 1990
Angina Pectoris, Variant	United Kingdom	Pfizer Inc.	01 Jan 1990
Angina, Stable	United Kingdom	Pfizer Inc.	01 Jan 1990
Coronary Artery Disease	United Kingdom	Pfizer Inc.	01 Jan 1990
Hypertension	United Kingdom	Pfizer Inc.	01 Mar 1989

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Resistant hypertension	Phase 3	Belgium	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Canada	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Denmark	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Finland	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	France	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Netherlands	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Norway	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	Philippines	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	South Africa	Boehringer Ingelheim GmbH	01 Oct 2007
Resistant hypertension	Phase 3	South Korea	Boehringer Ingelheim GmbH	01 Oct 2007

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04434664 (BLOCK HFpEF, CTgov)	Phase 4	Heart failure with normal ejection fraction \| Hypertension	50	Amlodipine Besylate (Amlodipine Besylate)	quswqdafeg(abarjavdao) = gdcqipjrxo liscbrgbto (keaofskbcf, 12.4) View more	-	30 Jan 2026
				Metoprolol Succinate (Metoprolol Succinate)	quswqdafeg(abarjavdao) = yzlfbqftlz liscbrgbto (keaofskbcf, 17.2) View more
NCT06395194 (Pubmed \| Am J Hypertens)	Phase 3	-	13,903	Valsartan	kougzkspkf(ejnkuuopoz): HR = 0.442 (95.0% CI, 0.196 - 1.0), P-Value = 0.05 View more	Positive	17 Nov 2025
				Amlodipine
NCT02373163 (INTERVENCION Trial \| INTERVENCION, CTgov)	Phase 4	Hypertension	166	Hydrochlorothiazide (Diuretic)	yjipfpvwwx(yasdoydoaq) = ogwaiqydwr mnsitswjit (lsmmwhxkxn, 8.4) View more	-	29 Jul 2025
				Amlodipine (Calcium-channel Blocker)	yjipfpvwwx(yasdoydoaq) = wutgcbusat mnsitswjit (lsmmwhxkxn, 9.2) View more
ESH2025	Not Applicable	Hypertension	120	Olmesartan (Masked hypertension + Target organ damage)	nbmcwogdcx(qwkqzifhky) = vezhufjiki eciemremfx (uawnhfqfyx, 37.8 - 53.6)	Positive	23 May 2025
				Placebo (Masked hypertension + Target organ damage)	nbmcwogdcx(qwkqzifhky) = qlerymnrhp eciemremfx (uawnhfqfyx, 18.9 - 31.9)
ESH2025	Not Applicable	Hypertension	834	Telmisartan 20 mg + Amlodipine 2.5 mg	zpcjkbpqcf(zgpxuwglle) = npofomjisz pyuewdhlne (yowcfcxhhb ) View more	Positive	23 May 2025
				Telmisartan 20 mg + Indapamide 1.25 mg	zpcjkbpqcf(zgpxuwglle) = novjtsvfbb pyuewdhlne (yowcfcxhhb ) View more
AD-209 (ESH2025)	Phase 2	Hypertension	221	AD-209; telmisartan 20 mg/amlodipine 2.5 mg/chlorthalidone 6.25 mg	onhpzrgofp(aautssqwyx) = xcymujljcb cajadvahiy (xigtosryyk ) View more	Positive	23 May 2025
				AD-209-1A; telmisartan 20 mg/amlodipine 2.5 mg	uvnxuzpfmp(ozrqgiumko) = apgajtffgr eihuhtmlph (jgtcjrskde )
NCT04179019 (CCB-PA, CTgov)	Phase 2	Bartter Syndrome	15	Amlodipine	ganqpbrhoh(pfigajgnsg) = gkiflvpyjk edfleiucxc (ixyftxlqkl, 4.94) View more	-	15 Apr 2025
NCT03683069 (CTgov)	Phase 4	Hypertension	90	Eplerenone+Amlodipine	bsgadrkbzw(dxvymilrro) = hcdlewuydg zmjvixsszc (trupljeftv, 10.5) View more	-	19 Mar 2025
NCT04692467 (Pubmed \| AIDS)	Phase 2	Prehypertension	250	Amlodipine 5mg	eyzjoxgnfd(uggyhjauwb) = lvqtvhbpcm tmprmtuyoz (wabfsdqqvw, -8.8 to -3.0) View more	Positive	01 Mar 2025
				Control (No Amlodipine)	byejnkkfgw(afiybbrtdh) = tkvzzjvxec jsslfemkzp (hklpesiubb )
NCT05513937 (Botticelli, CTgov)	Phase 4	Hypertension	301	Nebivolol+Amlodipine (Combination Therapy Phase Nebivolol 5mg/Amlodipine 5 or 10 mg)	bxvknjgcsy(fgxqkbazfl) = hxtabvexhj oxhgxykfhn (dnmcrkcyip, 8.32)	-	04 Feb 2025
				Nebivolo (Nebivolo 5 mg MONOTHERAPY PERIOD)	izgepaieps(xqozoadjgk) = sbomfqldgm qbdzqawdws (niowusnmws, pdgfxrrsna - qklkajdaim) View more

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