[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of indapamide extended-release tablets in healthy volunteers under fasting and fed conditions

主要目的：考察空腹及餐后条件下，评价以吉林天衡英睿制药有限公司研制的吲达帕胺缓释片为受试制剂与施维雅(天津)制药有限公司持证的吲达帕胺缓释片（商品名：纳催离®）为参比制剂在中国健康受试者中的人体生物等效性。次要目的：评价吲达帕胺缓释片受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The primary objective was to evaluate the bioequivalence of the indapamide extended-release tablets (test formulation, developed by Jilin Tianheng Yingrui Pharmaceutical Co., Ltd.) and the reference formulation, in healthy Chinese volunteers under fasting and fed conditions. The secondary objective was to evaluate the safety of the test and reference formulations of indapamide extended-release tablets in healthy volunteers.

Start Date26 Aug 2025

Sponsor / Collaborator

Jilin Tianheng Yingrui Pharmaceutical Co., Ltd.

NCT07034677

/ RecruitingPhase 4IIT

Treatment With Indapamide in Patients With Post-Surgical Hypoparathyroidism

The aim of this study is to investigate the effect of daily treatment with Indapamide for 14 days on urinary calcium excretion in patients with post surgical hypoparathyroidisme.

Start Date01 Aug 2025

Sponsor / Collaborator

University of Aarhus

CTR20250503

/ CompletedNot Applicable

吲达帕胺缓释片在健康受试者中的随机、开放、两周期、双交叉空腹及餐后生物等效性预试验

[Translation] A randomized, open-label, two-period, double-crossover pilot study of the fasting and fed bioequivalence of indapamide sustained-release tablets in healthy subjects

主要目的：考察空腹及餐后条件下，初步评价吉林天衡英睿制药有限公司研制的吲达帕胺缓释片（规格：1.5mg）与施维雅(天津)制药有限公司持证的吲达帕胺缓释片（商品名：纳催离，规格：1.5mg）在中国健康受试者中的人体生物等效性，为正式试验的方案设计提供依据。次要目的：评价吲达帕胺缓释片受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main purpose: To investigate the human bioequivalence of indapamide sustained-release tablets (specification: 1.5 mg) developed by Jilin Tianheng Yingrui Pharmaceutical Co., Ltd. and indapamide sustained-release tablets (trade name: Nacuili, specification: 1.5 mg) certified by Servier (Tianjin) Pharmaceutical Co., Ltd. in healthy Chinese subjects under fasting and postprandial conditions, and to provide a basis for the design of the formal trial. Secondary purpose: To evaluate the safety of the test and reference preparations of indapamide sustained-release tablets in healthy subjects.

Start Date28 Feb 2025

Sponsor / Collaborator

Jilin Tianheng Yingrui Pharmaceutical Co., Ltd.

100 Clinical Results associated with Indapamide

100 Translational Medicine associated with Indapamide

100 Patents (Medical) associated with Indapamide

1,974

Literatures (Medical) associated with Indapamide

01 Apr 2026·ARCHIVES OF MEDICAL RESEARCH

Pharmacogenetic Drug Administration and Community Health: A Cross-Sectional Telecommunication-Based Study

Article

Author: Repin, Alexey N ; Anfinogenova, Nina D ; Kuznetsova, Alina D ; Chesalov, Nazary P ; Stepanov, Vadim A ; Popov, Sergey V

PURPOSE:

Drugs are considered pharmacogenetic (PGx) when genetic variants impact their efficacy, metabolism, or toxicity due to drug-gene interactions. This study aimed to elucidate PGx drug intake patterns in population samples.

METHODS:

The Short Message Service (SMS) invitations were sent to randomly selected adult clients of a telecommunication company. A total of 2,149 respondents were enrolled. The online questionnaire included questions on demographic, clinical, pharmacological, behavioral, and other factors. PharmGKB resources were used to identify PGx genes potentially involved in pharmacotherapy outcomes. Proneness to adverse drug reactions (ADRs) was assessed based on the ADR index (ADRi).

RESULTS:

Most respondents (68.45%) were taking pharmacotherapy (433 drugs) associated with 839 PGx genes. The top five PGx drugs included bisoprolol, aspirin, losartan, indapamide, and omeprazole. The five most important PGx gene families involved in pharmacotherapy were CYP, UGT, SLC, IL, and HLA. The top five PGx genes were: CYP3A5, ABCB1, CYP2D6, CYP2C9, and ACE. The number of PGx genes per drug ranged from 0 to 138. A high number of PGx genes associated with pharmacotherapy were observed in patients with coronary artery disease, diabetes mellitus, endocrine diseases, dyssomnia, and rheumatic diseases. PGx burden significantly correlated with health conditions, median ADRi values, health-related behavioral traits, and clinical-pharmacology characteristics (p <0.001).

CONCLUSION:

The high prevalence of PGx drug utilization encourages the implementation of pre-emptive PGx testing. In the meantime, medical history taking, dose adjustment, assessment of drug blood concentrations, and committing to medical minimalism may prevent PGx-triggered ADRs.

01 Feb 2026·DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY

Cyclodextrin-based inclusion complexes to enhance the solubility and oral bioavailability of indapamide: experimental and computational approaches

Article

Author: Al-Sou’od, Khaldoun A. ; Abu-El-Halawa, Rajab ; Al-Qudah, Gaith M.

OBJECTIVE:

Indapamide, a thiazide-like diuretic, exhibits very low aqueous solubility, which restricts its oral bioavailability and therapeutic efficacy. This study aimed to enhance its solubility and stability by forming inclusion complexes with various cyclodextrins.

SIGNIFICANCE:

Poor aqueous solubility remains a major challenge for oral delivery of many diuretics and other BCS class II drugs. Cyclodextrin inclusion offers a safe and pharmaceutically accepted strategy to overcome these limitations. By quantitatively bridging phase-solubility/van't Hoff thermodynamics (ΔG°, ΔH°, ΔS°) with molecular modeling metrics (ΔE, orientation Approach A vs B), this work provides a mechanistic explanation of host-guest recognition and stability that goes beyond prior indapamide-CD reports. The study identifies SBE-β-CD as superior on mechanistic grounds (synergistic electrostatic and H-bonding interactions consistent with enthalpy-driven binding; ΔE = -28.8 kcal·mol^-1; ∼8.7-fold solubility gain) and benchmarks preparation methods (freeze-drying > co-evaporation > kneading) while linking amorphization and HPLC retention shifts to complexation efficiency. Collectively, these advances yield a practical, generalizable decision framework for rational excipient and process selection in formulations of poorly water-soluble drugs.

METHODS:

Five cyclodextrins (α-CD, β-CD, γ-CD, hydroxypropyl-β-CD, and sulfobutylether-β-CD) were systematically evaluated using an integrated experimental-computational approach. Phase-solubility studies were performed to determine stoichiometry and stability constants, and thermodynamic parameters (ΔG°, ΔH°, ΔS°) were derived from van't Hoff analysis conducted over the temperature range of 293-313 K. Solid-state characterization was carried out using SEM, XRD, and HPLC. Molecular modeling with HyperChem was performed at the MM+ and PM3 levels to assess host-guest orientations, binding energies, and electronic properties.

RESULTS:

Phase solubility analysis confirmed the formation of 1:1 A_L-type complexes, with sulfobutylether-β-CD achieving the highest solubilization (∼8.7-fold), followed by hydroxypropyl-β-CD and γ-CD, while α-CD showed minimal effect. Thermodynamic evaluation revealed that the inclusion process was spontaneous, exothermic, and enthalpy-driven. SEM and XRD demonstrated transformation of indapamide from crystalline to amorphous state, and HPLC confirmed efficient encapsulation. Molecular modeling showed favorable host-guest interactions, with sulfobutylether-β-CD providing the most stable binding (ΔE = -28.8 kcal·mol^-1).

CONCLUSIONS:

The integrated findings highlight the superior potential of modified cyclodextrins, particularly sulfobutylether-β-CD, as excipients for improving solubility, dissolution, and oral bioavailability of indapamide. These results establish a mechanistic foundation for future formulation strategies targeting poorly water-soluble diuretics and related therapeutic agents.

01 Jan 2026·JOURNAL OF CHROMATOGRAPHY A

Stereoselective HPLC separation and configurational stability study of the N-nitrosamine impurity of indapamide

Article

Author: Panusa, Alessia ; Mammone, Francesca Romana ; Cirilli, Roberto ; Pierini, Marco

2-Methyl-1-nitroso-2,3-dihydro-1H-indole, known as impurity A in the European Pharmacopoeia, is a chiral nitrosamine impurity potentially related to the antihypertensive drug indapamide. Its chirality arises from a stereogenic center on the indoline ring. Additionally, the asymmetric substitution at the nitrogen atom and the partial double-bond character of the N-N bond give rise to E/Z stereoisomerism. This study aimed to achieve simultaneous HPLC separation of all four possible stereoisomers using polysaccharide-based chiral stationary phases under both normal and reversed-phase conditions. Optimal enantio‑ and diastereoselective separation was achieved using a chiral stationary phase consisting of amylose tris[(S)-α-methylbenzylcarbamate] immobilized onto 3 μm silica particles, operated at 5 °C with a 50:50 (v/v) acetonitrile-water mobile phase. The chromatographic profiles indicated on-column E/Z interconversion, as evidenced by dynamic chromatogram shapes. The energy barrier for interconversion was estimated, and the full stereochemical characterization of all isomers was accomplished by integrating theoretical calculations, HPLC data, and chiroptical analysis.

News (Medical) associated with Indapamide

25 Feb 2026

·www.biospace.com

George Medicines advances its global commercial strategy for GMRx2 with an exclusive licensing agreement with Orient EuroPharma in Southeast Asia

GMRx2 is an innovative single pill combination of three medicines designed to deliver the blood pressure-lowering benefits of triple combination therapy early in the treatment pathway, supported by an established safety profile George Medicines receives upfront licensing fee and is eligible for regulatory and commercial milestone payments, along with a future recurring revenue stream through stepped royalties in Southeast Asia Fourth licensing and supply agreement for GMRx2 reflects continued global partner interest, with further partnerships anticipated as George Medicines advances its strategy to expand global patient access London, UK, 25 February 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 Orient EuroPharma (“OEP”) (TWO: 4120), a leading multinational pharmaceutical company headquartered in Taiwan, granting OEP exclusive rights to seek regulatory approval of, and to commercialize, GMRx2 in Southeast Asia. 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. Its multi-mechanism approach and available doses are formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the safety pro established antihypertensive medications. Under the terms of the licensing agreement, George Medicines will receive an upfront licensing fee 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 territory. In return, OEP is granted a license to exclusively commercialize GMRx2, supplied by George Medicines. OEP is responsible for seeking regulatory approval of GMRx2, with support from George Medicines. Mark Mallon, Chief Executive Officer of George Medicines, said: “ This exclusive licensing and supply agreement with Orient EuroPharma marks another important step in the global expansion of GMRx2, adding Southeast Asia to our growing network of partners across the US, Canada, Mexico, Colombia, Central America and Brazil. Hypertension remains a major and growing health challenge across Southeast Asia, with high prevalence, and low control rates. GMRx2’s proven clinical efficacy, multiple dosing options, and established safety pro it well to address unmet need in hypertension management and we look forward to working with Orient EuroPharma to expand access to this important therapy across the region.” Calvin Tsai, Chief Executive Officer of Orient EuroPharma, said: “We are pleased to partner with George Medicines as part of the continued global expansion of GMRx2. This agreement reflects our shared commitment to improving cardiovascular outcomes and brings an innovative triple combination therapy to Southeast Asia. With our established regional presence and expertise in regulatory and commercial execution, we are well positioned to support the development and launch of GMRx2 and to help broaden patient access across Southeast Asia.” This agreement further strengthens George Medicines’ global commercialization strategy for GMRx2, following licensing and supply agreements with Azurity Pharmaceuticals in the US, Bausch Health in Canada, Mexico, Colombia and Central America, and Biolab Farmacêutica in Brazil. Together, these partnerships demonstrate growing global interest in GMRx2 and its potential to address unmet needs in hypertension treatment. Additional partnerships are anticipated as part of George Medicines’ commitment to bringing the benefits of GMRx2 to patients 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. Ends 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 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. 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 Orient EuroPharma Co., Ltd. Orient EuroPharma Co., Ltd. (OEP), established in 1982, has grown into a leading multinational pharmaceutical company headquartered in Taiwan. Listed on the Taipei Exchange (TPEx) since 2003. (4120.TW), OEP has built a strong presence across Southeast Asia, with extensive sales network in the region. OEP’s diversified portfolio spans prescription pharmaceuticals, oncology treatments, cosmeceuticals, and infant-to-adult nutrition and health products. The company also operates a dedicated subsidiary for innovative drug development and manufacturing. With integrated capabilities in pharmaceutical R&D, clinical trials, manufacturing, and regional marketing, OEP continues to advance healthcare solutions throughout Taiwan and the broader Asia-Pacific region. 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

License out/inPhase 3AHA

07 Nov 2025

·www.prnewswire.com

PRM Pharma Announces Nationwide Availability of HemiClor® (Chlorthalidone) 12.5 mg: The First FDA-Approved Low-Dose Chlorthalidone Tablet Aligned With Hypertension Guidelines

WEST CONSHOHOCKEN, Pa., Nov. 7, 2025 /PRNewswire/ -- PRM Pharma, LLC announces the nationwide availability of HemiClor® (chlorthalidone) 12.5 mg tablets, the first and only FDA-approved 12.5 mg formulation of chlorthalidone for the treatment of hypertension in adults ().1 This milestone comes as the newly released 2025 AHA/ACC Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults reemphasizes chlorthalidone's role as a long-acting, thiazide-like diuretic and recommends to "Maximize Diuretic Therapy" by replacing hydrochlorothiazide (HCTZ) with chlorthalidone 12.5 mg or 25 mg in patients with resistant hypertension. 2 Regarding resistant hypertension the 2025 AHA/ACC G uideline states: "Based on the current BP goal of <130/80 mmHg, the prevalence of resistant hypertension is approximately 8.5% to 20% among hypertensive U.S. adults." 2 "Patients with resistant hypertension are known to have at least a 50% higher risk of MI, stroke, end-stage kidney disease, and cardiovascular death than adults with hypertension without resistance to treatment." 2 "Antihypertensive drug therapy should start with a combination of an ACEi or ARB, a CCB, and a diuretic. Replacing thiazide-type diuretics (eg, HCTZ or bendroflumethiazide) with thiazide-like diuretics (eg, chlorthalidone and indapamide) may offer additional BP reduction and cardiovascular protection among patients with previous MI or stroke." 2 Chlorthalidone's long half-life and extensive cardiovascular outcome data have made it a cornerstone of hypertension management for more than 50 years. Landmark trials such as ALLHAT and SHEP (sponsored by the National Heart, Lung and Blood Institute) demonstrated that treatment regimens based on stepped-care therapy starting with once-daily 12.5 mg chlorthalidone significantly reduced cardiovascular events.3,4 Further, previous and current guidelines recommend initiating therapy with chlorthalidone at doses of 12.5 to 25 mg, once daily.2,5 "The evidence for the benefit of low-dose chlorthalidone spans over 30 years, but unfortunately we've lacked a commercially available product that enabled widespread use of the drug effectively in practice," said Michael Ernst, PharmD, AHSCP-CHC, Clinical Professor, Department of Pharmacy Practice and Science, College of Pharmacy; and Department of Family and Community Medicine, Carver College of Medicine, The University of Iowa, Iowa City, IA. "The availability of a low-dose formulation aligns with our contemporary understanding of how to optimize the benefit-risk when using the drug, and I'm excited for this new chapter in chlorthalidone's storied history." "Chlorthalidone has played a key role in hypertension treatment strategies for decades," said William B. White, MD, Professor Emeritus at the University of Connecticut School of Medicine and past president of the American Society of Hypertension. "Having access to a 12.5 mg dose in the U.S. may offer clinicians additional flexibility when initiating therapy and aligns with current treatment recommendations for many adult patients with stage 1 or stage 2 hypertension." HemiClor® was approved by the FDA on March 17, 2025, and is now available in pharmacies nationwide. Pharmacy Savings Programs, such as SaveHealth, GoodRx, SingleCare, and WellRx, may help provide important savings to eligible patients. Using SaveHealth, for example, patients may be able to purchase a 30-day supply of HemiClor® for as little as $12.15 (price subject to change; restrictions apply; see for details). Links to external sites are provided for patient convenience only; PRM Pharma does not control or endorse their content. Indication and Usage HemiClor® (chlorthalidone) is indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been demonstrated in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including chlorthalidone. Important Safety Information Contraindications: HemiClor® is contraindicated in patients with anuria or known hypersensitivity to chlorthalidone or sulfonamide-derived drugs. Adverse Reactions: Most common adverse reactions include electrolyte imbalance (particularly hypokalemia), dizziness, and gastrointestinal discomfort. Monitoring: Periodic monitoring of serum electrolytes is recommended. Drug Interactions: Chlorthalidone may potentiate the effects of other antihypertensive agents and may interact with lithium, antidiabetics, or NSAIDs. Please see Full Prescribing Information available at for complete efficacy and important safety information.1 To report suspected adverse reactions, contact PRM Pharma at 1-877-748-1970 or the FDA at or 1-800-FDA-1088. References: HEMICLOR® Prescribing Information. PRM Pharma, LLC. 2025. Jones OW, Ferdinand KC, Toler SJ, Johnson HM, et al. 2025 AHA/ ACC/ AANP/ AAPA/ABC/ ACCP/ ACPM/ AGS/ AMA/ ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. . Prevention of Stroke by Antihypertensive Drug Treatment in Older Patients with Isolated Systolic Hypertension Final Results at the Systolic Hypertension in the Elderly Program (SHEP). SHEP Cooperative Research Group. JAMA. 1991;265(1):3255-3264. ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to ACE inhibitor or calcium channel blocker vs diuretic. JAMA. 2002;288(23):2981-2997. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary. Hypertension. 2018;71(6):1269-1324. *Abbreviations: BP (Blood Pressure), HCTZ (hydrochlorothiazide), ACEi (Angiotensin-Converting Enzyme Inhibitor), ARB (Angiotensin Receptor Blocker), CCB (Calcium Channel Blocker), MI (Myocardial Infarction) About PRM Pharma, LLC PRM Pharma, LLC is a privately held specialty pharmaceutical company focused on developing low-dose therapies that align with clinical practice guidelines and advance patient care. Media Inquiries: PRM Pharma, LLC – Media Relations Email: [email protected] SOURCE PRM Pharma, LLC 21% more press release views with Request a Demo

Drug Approval

23 Oct 2025

·www.globenewswire.com

TRIDENT, a dedicated stroke outcomes trial in patients with a history of intracerebral hemorrhage (ICH), demonstrates the potential advantages of intensive blood pressure treatment with low-dose triple combination therapyTRIDENT, a dedicate

GMRx2 significantly reduced the risk of recurrent stroke when added to standard of care compared to placeboTrial results were presented during a plenary session of the World Stroke Congress 2025 in Barcelona London, UK, Boston, MA, 23 October 2025 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, today announced that positive results from the investigator-initiated TRIDENT trial have been shared at the World Stroke Congress in Barcelona. The study met the primary endpoint, with GMRx2 (a single pill low-dose combination therapy of telmisartan, amlodipine and indapamide) demonstrating a statistically significant and clinically meaningful reduction of recurrent stroke compared to matching placebo. The TRIDENT trial was conducted in patients with a history of acute stroke due to intracerebral hemorrhage (ICH) on standard of care treatment. 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. The safety profile of GMRx2 in the TRIDENT trial was generally consistent with the well-established safety profile of the medicine, and its individual components. Mark Mallon, Chief Executive Officer of George Medicines, said: “The TRIDENT trial represents an important step towards understanding how enhanced blood pressure management has the potential to reduce the risk of recurrent stroke after an intracerebral hemorrhage, the most severe type of stroke. Reducing the global burden of cardiovascular disease lies at the heart of our mission and we are proud that our single pill triple combination therapy demonstrated efficacy in this study.” Acute ICH accounts for at least 10 per cent of the 20 million new strokes in the world each year. ICH survivors are at high risk of recurrent stroke and other serious cardiovascular events. Numerous studies have indicated a benefit of stroke survivors reducing their risk of recurrent stroke through taking blood pressure-lowering medications. However, studies have also shown that many stroke survivors are either not receiving any blood pressure-lowering medication, or they are receiving inadequate control. TRIDENT is the first stroke outcomes trial with a low-dose single pill triple combination therapy for blood pressure treatment in adults with a history of ICH on top of standard of care. Full results from the trial will be submitted for publication in a peer-reviewed journal. Ends 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. About GMRx2GMRx2 is a combination tablet of telmisartan, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker and indapamide, a thiazide-like diuretic, developed in three dosage forms – 10/1.25/0.625 mg; 20/2.5/1.25 mg and 40/5/2.5 mg – for the treatment of hypertension. Its development is backed by a comprehensive clinical program, including two pivotal Phase III studies in hypertension, 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 and improved blood pressure 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 also investigated in the Nigerian VERONICA trial, which compared the triple combination with standard of care and reported better blood pressure lowering among those receiving GMRx2, with good tolerability compared to the standard of care protocol. 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 www.george-medicines.com. Safe Harbor StatementThis 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 3

100 Deals associated with Indapamide

External Link

KEGG	Wiki	ATC	Drug Bank
D00345	Indapamide	C03BA11	DB00808

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Essential Hypertension	Japan	Kyoto Pharmaceutical Industries Ltd.	23 Oct 1984
Hypertension	United States	Sanofi-Aventis U.S. LLC	06 Jul 1983

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	Ireland	Institut de Recherches Internationales Servier	02 Sep 2005
Vascular Diseases	Phase 3	Ireland	Institut de Recherches Internationales Servier	02 Sep 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESH2025	Not Applicable	Hypertension	834	Telmisartan 20 mg + Amlodipine 2.5 mg	ijehrsjyzc(stcrdkxtvy) = drngalezqb mowkrolimx (njzqszsgwc ) View more	Positive	23 May 2025
				Telmisartan 20 mg + Indapamide 1.25 mg	ijehrsjyzc(stcrdkxtvy) = kcmixjfljo mowkrolimx (njzqszsgwc ) View more
NCT03722524 (TRICOLOR, ESH2021)	Not Applicable	Hypertension	-	Perindopril/Indapamide/Amlodipine Triple Single-Pill Combination	itxfzwrbvh(jbbtbrgcke) = 14 adverse events were registered, including 7 drug-related adverse events (cough – 5, hypotension – 1, worsening of HTN – 1) and 1 case of lack of efficacy evfppkdvrp (ttvtjsmyya )	Positive	01 Apr 2021
ISRCTN67799751 (Pubmed \| Adv Ther)	Not Applicable	Hypertension	22	Perindopril arginine/indapamide single-pill combination (Pa/I SPC)	cflwdrxilh(hyltusmgzr) = rvzzirrpck cidcwetyvk (ihunmksqqf ) View more	-	01 Dec 2020
PP.07.21 (ESH2015)	Phase 3	Essential Hypertension	148	Perindopril 5 mg/Indapamide 1.25 mg/Amlodipine 5 mg (P/I/A) single pill	besijvlvoa(cjrbvarvoy) = ojydywxhmz tjnzrqrbtf (opqlblqkvx ) View more	Positive	01 Jun 2015
				Perindopril 5 mg/Indapamide 1.25 mg + Amlodipine 5 mg (P/I + A) free combination	besijvlvoa(cjrbvarvoy) = kqliwcgdli tjnzrqrbtf (opqlblqkvx ) View more
NCT00128518 (IDEAL Trial, Pubmed \| J Hum Hypertens)	Phase 4	Hypertension	112	Indapamide	clshlnskay(pxmsxbkvtr) = vlmsgnytfh cpaeldtvkq (cxyguimhxx )	-	01 Jan 2015
				Perindopril	clshlnskay(pxmsxbkvtr) = clukwmfffp cpaeldtvkq (cxyguimhxx )
NCT00122811 (HYVET, Pubmed \| Age Ageing)	Phase 4	Hypertension	-	Indapamide slow release 1.5mg ± perindopril 2-4 mg	xuhktcarie(fcggpawxzr) = sdfjcsnsly vjqcpxdcdd (tioemfdgmk )	-	01 Mar 2013
NCT00122811 (HYVET, Pubmed \| Age Ageing)	Phase 4	Hypertension	-	Thiazide-like diuretic (indapamide 1.5 mg SR) + ACE inhibitor (perindopril 2-4 mg)	grxghbvaks(ltfveofkjh): P-Value = 0.0498	-	01 Sep 2010
				Placebo
START STUDY (ESH2010)	Not Applicable	Essential Hypertension	714	Perindopril 2 mg / Indapamide 0.625 mg	hleulyvzgu(klgvzpslug) = aomrqwrjqk pysuogzgcr (warbpxwyjk )	Positive	01 Jun 2010
NCT00122811 (HYVET, Pubmed \| Lancet Neurol)	Phase 4	Hypertension \| Dementia	3,336	1.5 mg slow release indapamide + 2-4 mg perindopril	vkidwysefs(gdoolcwgyw) = piqiovthyw igskeglrbr (hjojkwtezo ) View more	Negative	01 Aug 2008
				Placebo	tjedxrffml(blbnegnudq) = qlzxsykhww bqyuofcddn (kxizyoznwr )
NCT00122811 (Pubmed \| N Engl J Med)	Phase 4	Hypertension	3,845	Indapamide (sustained release)	fjbngrxecr(vaqazanoyr): P-Value = 0.02 View more	Positive	01 May 2008
				Placebo

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