Last update 24 Dec 2024

Telmisartan

Last update 24 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

4'-((1,4'-dimethyl-2'-propyl(2,6'-bi-1H-benzimidazol)-1'-yl)methyl)-(1,1'-biphenyl)-2-carboxylic acid, 4'-((4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl)methyl)-2-biphenylcarboxylic acid, 4'-[(1,4'-dimethyl-2'propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid

+ [69]

Target

AT1R

Mechanism

AT1R antagonists(Angiotensin II Receptor Type 1 antagonists)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Cardiovascular DiseasesEssential HypertensionHypertension

Inactive Indication

Diabetes MellitusDiabetes Mellitus, Type 2Diabetic Nephropathies+ [6]

Originator Organization

Boehringer Ingelheim GmbH

Active Organization

Boehringer Ingelheim International GmbHNippon Boehringer Ingelheim Co., Ltd.Teva Pharmaceuticals Europe BV

+ [7]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (10 Nov 1998),

Hypertension

RegulationPriority Review (CN)

Structure

Molecular FormulaC33H30N4O2

InChIKeyRMMXLENWKUUMAY-UHFFFAOYSA-N

CAS Registry144701-48-4

321

Clinical Trials associated with Telmisartan

TCTR20241006001 / Not yet recruitingPhase 3

A Randomized, Double-blind, Multi-center, Active-controlled, Phase 3 clinical trial to Evaluate the Efficacy and Safety of Combination Therapy of THP-00101, THP-00102, and THP-00103 in Subjects with T2DM and Essential Hypertension

Start Date31 Dec 2024

Sponsor / Collaborator

THPharm

NCT06647745 / Not yet recruitingPhase 3

A Randomized, Double-blind, Multi-center, Active-controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of THP-00101, THP-00102, and THP-00103 in Subjects With T2DM and Essential Hypertension

[Primary Objective] To demonstrate the superiority of the change in mean sitting systolic blood pressure (MSSBP) and hemoglobin A1c (HbA1c)on week 12 of the combination therapy of THP-00101 (dapagliflozin 10 mg) and THP-00102 (telmisartan 80 mg) compared to THP-00101 or THP-00102 monotherapy among subjects with type 2 diabetes mellitus accompanied by essential hypertension. [Secondary Objective] To comparatively evaluate secondary efficacy and safety in the THP-00101 monotherapy group, THP-00102 monotherapy group, THP-00101 and THP-00102 combination therapy group, and THP-00101 and THP-00103 (telmisartan 40 mg) combination therapy group among subjects with type 2 diabetes mellitus accompanied by essential hypertension.

Start Date01 Dec 2024

Sponsor / Collaborator

THPharm

CTRI/2024/07/069868 / Not yet recruitingPhase 2IIT

Open label randomised controlled trial of Telmisartan in Raynauds phenomenon associated with Systemic Lupus Erythematosus and Rheumatoid Arthritis - NIL

Start Date01 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Telmisartan

100 Translational Medicine associated with Telmisartan

100 Patents (Medical) associated with Telmisartan

2,699

Literatures (Medical) associated with Telmisartan

01 Feb 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Circumventing Imatinib resistance in CML: Novel Telmisartan-based cell death modulators with improved activity and stability

Article

Author: Gust, Ronald ; Salcher, Stefan ; Gebhart, Maximilian ; Alilou, Mostafa

Drug resistance presents a significant challenge in cancer therapy, which has led to intensive research in resistance mechanisms and new therapeutic strategies. In chronic myeloid leukemia (CML), the introduction of Imatinib, the first tyrosine kinase inhibitor (TKI), drastically changed the outcome for patients. However, complete remission still cannot be achieved in a large number of patients in the long term. Therefore, there is a great interest in the design of new drugs to target TKI-resistant cancer cells. A promising approach to enhance the efficacy of Imatinib is the simultaneous application of cell death modulators derived from the Angiotensin II type 1 receptor blocker Telmisartan. The methyl ester (3a) of 4'-((2-propyl-1H-benzo[d]imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-carboxylic acid (LEAD-acid (4)), which is the structural core of Telmisartan, has already been shown to abolish the resistance of Imatinib in TKI-insensitive CML cells at a concentration of 5 μM. As the ester was expected to be unstable in a biological environment, this study attempted to increase the stability through structural modifications. The methyl group was exchanged for longer (3b (ethyl), 3c (propyl), 3d (butyl) and branched (3e (isopropyl), 3f (tert-butyl)) alkyl chains as well as a phenyl (3g) and 4-phenoxyphenyl (3h) group. Furthermore, the esters were bioisosterically replaced with a respective substituted carboxamide (5a-h). The LEAD-amides (5a-h) showed high stability against esterases, while amidases cleaved only the carboxamides with short alkyl chains to a small extent. Esterases hydrolyzed the LEAD-alkylesters (3a-d) dependent on the chain length with τ_½ = 55-82 min. Esters with branched alkyl chains were stable and introduction of the aromatic rings mentoined above increased the half-life to τ_½ = 280 min and 360 min. In cell culture medium, only 3a-d degraded to 67-78 % after 72 h. However, the uptake studies showed that approximatly 80 % of the esters accumulated in the cell within the first 1-3 h of incubation. Therefore, it can be concluded that the intact LEAD-esters and LEAD-amides caused the biological effects. The compounds were non-cytotoxic and efficiently sensitized KD225 (K562-resistant) CML cells to Imatinib at a half-maximal sensitizing concentration (SC₅₀) of 1.5-2.9 μM (ester derivatives) and 1.3-11.2 μM (amide derivatives).

01 Feb 2025·ANALYTICAL BIOCHEMISTRY

Specialized greenness sustainability tools for evaluation of the spectrophotometric methodologies greenness: Spectral signal manipulation for resolving the interfering telmisartan and metoprolol succinate spectra in their bulk and pharmaceutical formulation

Article

Author: Abd El-Hay, Soad S. ; Abd El-Hay, Soad S ; Fawzy, Michael Gamal ; Mostafa, Alaa Ahmed ; Metias, Youstina Mekhail

Hypertension is a leading cause of cardiovascular mortality, often accompanied by complications such as arrhythmia and stroke. This silent killer requires a multifaceted pharmacological approach for effective management. This article presents new, environmentally friendly spectrophotometric methods for simultaneous quantification of telmisartan (TER) and metoprolol succinate (MTR) in laboratory prepared mixtures and pharmaceutical formulations. The suggested methodologies include the following: area under the curve method (AUC) utilizing area at specific wavelength ranges 228-233 nm (λ₁ - λ₂) and 240-245 nm (λ₃ - λ₄) for each analyte and Fourier self-deconvolution method (FD) depending on built-in function to address spectral interferences. In addition, the induced dual wavelength method (IDWL) employing equality factors to obtain absorbance differences at designated wavelengths, ratio difference method (RD) utilizing divisor-based ratio spectra where the utilized divisors were TER 40 μg/mL and MTR 90 μg/mL, and ratio derivative method (RDV) generating spectra through first derivative application that was measured at 266 nm and 246 nm for TER and MTR, respectively. These methods offer green alternatives for the accurate and precise determination of TER and MTR with exceptional linearity of 3-45, and 15-200 μg/mL for TER and MTR, respectively. Furthermore, the methods showed a coefficient of determination exceeding 0.9995 and good detection and quantification levels. A comprehensive greenness assessment, employing five distinct evaluation tools, confirmed the reduced environmental impact of the proposed methods in terms of waste generation, chemical consumption, and instrument safety. Successful analysis of pharmaceutical formulations and laboratory prepared mixtures containing different TER and MTR ratios confirmed the validity of the proposed methods. Standard addition studies further supported these findings, and the statistical results were comparable to those obtained using a reference method.

01 Jan 2025·BRAIN RESEARCH

Involvement of Renin-Angiotensin system (RAS) components in mild traumatic brain injury

Article

Author: Lúcio Teixeira, Antônio ; Miranda Kangussu, Lucas ; Simões E Silva, Ana Cristina ; de Barros Fernandes, Heliana ; Kangussu, Lucas Miranda ; Guimarães, Pedro Pires Goulart ; de Brito Toscano, Eliana Cristina ; de Barros, João Luís Vieira Monteiro ; Fernandes, Heliana de Barros ; Machado, Caroline Amaral ; da Silva Oliveira, Bruna ; Cristina Simões e Silva, Ana ; Silva de Miranda, Aline ; Amaral Machado, Caroline ; Luís Vieira Monteiro de Barros, João ; Oliveira, Bruna da Silva ; de Miranda, Aline Silva ; Cristina de Brito Toscano, Eliana ; Teixeira, Antonio Lucio ; Pires Goulart Guimarães, Pedro

The Renin Angiotensin System (RAS) plays a pathophysiological role in traumatic brain injury (TBI) but the evidence of its involvement in mild TBI (mTBI) is still limited. We aimed at investigating the levels of components from both the classical and counter-regulatory axis of the RAS in a mTBI animal model. Mice with mTBI displayed enhanced ACE/Ang II/AT₁R axis ipsilateral- and contralaterally to the trauma in the hippocampus and prefrontal cortex during acute (24 and 72 h) and later (30 days) timepoints. Increase in Ang-(1-7) levels alongside reduction in Mas receptor expression in hippocampus and prefrontal cortex was also observed after injury. Conversely, mTBI-mice presented higher expression of AT₂ receptor in the contralateral hippocampus and the ipsilateral prefrontal cortex. Importantly, treatment with telmisartan, an AT₁R blocker, and perindopril, an ACE inhibitor, were able to prevent mTBI-associated locomotor activity impairment and anxiety-like behavior, corroborating the involvement of RAS in the pathophysiology of mTBI. We provided original evidence that components of classical and alternative RAS axes undergo alterations in key brain areas following a mTBI in a time and hemisphere dependent manner. Our findings also open new avenues for investigating the therapeutic potential of RAS components in mTBI.

News (Medical) associated with Telmisartan

18 Oct 2024

·www.globenewswire.com

Phase III trial results of novel triple combination pill for hypertension published in The Lancet

Phase III trial results of novel triple combination pill for hypertension published in The Lancet Novel combination pill significantly reduced blood pressure and improved control rates vs dual therapy, with good tolerability and no increase in adverse event related withdrawalsTriple combination approach aligns with latest European Society of Cardiology hypertension guidelines recommending increased use of combination therapies Subject to regulatory review, following New Drug Application (NDA) filed with FDA in August, GMRx2 would be the first triple combination approved for initial treatment of hypertension London, UK, 18 October 2024 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease treatment, today announced that The Lancet has published results from its pivotal Phase III clinical trial of GMRx2. A proprietary combination of three best-in-class medicines, telmisartan, amlodipine and indapamide, developed in an ultra-low dose (triple quarter-dose), low-dose (triple half-dose), and triple standard-dose options, GMRx2 was compared with dual combinations, for the treatment of hypertension (high blood pressure), including initiation of treatment. The triple combination’s multi-mechanism approach is designed to deliver optimal efficacy and safety while promoting patient adherence. The research, “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”, is published in the 19 October issue of The Lancet. The international trial, conducted in seven countries, met all primary efficacy and safety endpoints: GMRx2 was more effective than each dual therapy, significantly reducing both home- and clinic-measured blood pressure (BP) and improving BP control rates, with both standard- and half-dose forms.GMRx2 half-dose achieved 63% clinic BP control <140/90 mmHg, which rose to 74% at the end of follow-up on GMRx2 standard-dose – superior to all three dual combinations at standard-dose (53-61%).Assessed against more stringent BP control rates of <130/80 mmHg, GMRx2 standard dose achieved 56% control rates, again clinically and statistically superior to all three dual combinations (33-44%).Tolerability was good, with no increase in withdrawal from treatment due to adverse events. This treatment approach aligns with recently updated European Society of Cardiology (ESC) guidelines for hypertension management1, which recommend lower blood pressure levels to begin treatment among those at raised risk and greater use of combination therapy, starting off with dual low-dose followed by a triple low -dose therapy. Chair of the trial’s steering committee, Dr. Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, and President of the World Hypertension League, commented: “This trial, conducted across seven countries and diverse populations, demonstrates that GMRx2 provides significantly better blood pressure control compared to dual combinations, while maintaining an excellent safety profile. The findings are particularly noteworthy as they show efficacy at lower blood pressure levels, aligning with the latest guideline recommendations. This new single-pill combination has the potential to address the critical need for more effective and tolerable treatment options to achieve and maintain blood pressure control in the many patients who remain uncontrolled on current therapies.” Dr. Anthony Rodgers, Chief Medical Officer of George Medicines, and Professorial Fellow at The George Institute for Global Health, said: “These findings, now published in The Lancet, provide robust evidence for the potential of GMRx2 to transform hypertension management. The superior efficacy of this triple combination therapy compared to dual combinations, coupled with its good tolerability, addresses key challenges in current hypertension treatment approaches and directly supports recent guideline recommendations. Subject to regulatory approval, we believe GMRx2 could play a crucial role in addressing the global burden of hypertension and improving patient outcomes.” These results, along with data from other recent trials, including the VERONICA trial in Nigeria, funded by the National Health and Medical Research Council (NHMRC) of Australia, supported by The George Institute for Global Health and recently published in JAMA, and a placebo-controlled Phase III study recently published in the Journal of the American College of Cardiology, provide a comprehensive body of evidence supporting the efficacy and safety of GMRx2 across various patient populations and dosing regimens. In August 2024 George Medicines announced its submission to the US Food and Drug Administration (FDA) of a New Drug Application (NDA) for GMRx2. Data from GMRx2’s clinical development program will support additional global regulatory filings. 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. The Company’s GMRx2 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. Ends About the clinical trialA Phase III trial among 1,385 patients in Australia, Czech Republic, New Zealand, Poland, Sri Lanka, UK and the US, standard- and half-dose forms of GMRx2 were tested against dual combinations of its component drugs. The trial’s primary efficacy outcome was the difference between GMRx2 and its comparators in home blood pressure change from randomization to week 12. The head-to-head trial provides the first large scale comparison of a low- and standard-dose triple combination pill and its dual combinations at the same doses. It assessed the safety and efficacy of the triple combination among patients with starting blood pressure levels that were considerably lower than those in previous trials. About hypertension (high blood pressure)Globally, more than one billion adults have hypertension2. Many diagnosed patients aren’t achieving sufficient blood pressure control because they are on inadequate therapy, aren’t receiving the right combination of medicines at the right doses or aren’t taking their treatment as prescribed or continuing their treatment in the long term. The major, globally recognized treatment guidelines3 recommend the use of fixed dose combination therapy for most patients with hypertension, including for first-line treatment and yet, in practice, newly diagnosed patients will often still be prescribed monotherapy treatment. This is despite a broad evidence base indicating that, individually, blood pressure medicines are only modestly effective at reducing blood pressure, even at high doses, and most patients will require two or more medicines to achieve control. As dosage of hypertension drugs is increased, so too are side effects, which can preclude the use of high doses for many patients. These side effect challenges, alongside the management of multiple hypertension medicines being taken together with treatments for other conditions, can significantly impact treatment compliance and adherence, including failure to take medications as prescribed and to persist on long-term therapy. 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. The Company’s lead candidate, GMRx2, has completed a Phase III development program for the treatment of hypertension, including first-line therapy, and a global trial focused on the prevention of recurrent intracerebral hemorrhage (the most severe type of stroke) is underway. 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. References 2024 ESC Guidelines for the management of elevated blood pressure and hypertension https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Elevated-Blood-Pressure-and-HypertensionWorld Health Organization Hypertension factsheet https://www.who.int/news-room/fact-sheets/detail/hypertension2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA 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 Task Force on Clinical Practice Guidelines https://www.ahajournals.org/doi/10.1161/HYP.0000000000000065; WHO Guideline for the pharmacological treatment of hypertension in adults https://iris.who.int/bitstream/handle/10665/344424/9789240033986-eng.pdf; 2024 ESC Guidelines for the management of elevated blood pressure and hypertension https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Elevated-Blood-Pressure-and-Hypertension Media contacts ICR Consilium David Daley, Lindsey Neville, Isabelle Abdou georgemedicines@consilium-comms.com; Tel: +44 (0) 203 709 5700

Phase 3Clinical ResultNDA

24 Sep 2024

·www.globenewswire.com

Potential of George Medicines’ novel, low-dose, triple combination pill to transform management of hypertension highlighted at global congress

London, UK 24 September 2024 – George Medicines, a late-stage, biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic disease, today announced the presentation of positive clinical trial results investigating GMRx2, its novel, multi-mechanism triple combination candidate for the treatment of hypertension, including initiation of treatment, at the recent 30th Congress of the International Society of Hypertension, held in Cartagena, Colombia, 19-22 September. GMRx2 contains best-in-class medicines, telmisartan, amlodipine and indapamide, in proprietary, triple quarter-dose (ultra-low dose), triple half-dose (low-dose) and triple standard-dose options. Designed for optimal efficacy, safety and adherence, GMRx2’s low-dose, multi-mechanism approach, delivers the synergistic efficacy benefits of a triple therapy while maintaining tolerability. Professor Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, President of the World Hypertension League and Chair of the steering committee for the Phase III clinical trial program shared an overview of recent positive clinical data from three recent trials: George Medicines’ pivotal Phase III trial testing GMRx2 against dual combinations of its component drugs, which determined that GMRx2 was more effective than dual therapy, significantly reducing blood pressure (BP) and improving BP control rates, with both standard- and half-dose forms.A second Phase III trial, recently published in the Journal of the American College of Cardiology, comparing GMRx2 against a placebo pill, in which GMRx2 significantly improved BP and BP control rates, in both half- and quarter-doses.The VERONICA trial in Nigeria, led by Professor Dike Ojji at University of Abuja, funded by the National Health and Medical Research Council (NHMRC) of Australia, supported by The George Institute for Global Health and recently published in JAMA, which compared GMRx2-based treatment protocol with existing, standard care protocol and reported significant reductions in BP among those receiving GMRx2. In all trials, tolerability was good, with no increase in withdrawal from treatment due to adverse events. Mark Mallon, Chief Executive Officer of George Medicines, said: “We’re pleased that the clinical and global health significance of our research findings for GMRx2 are being shared with the international hypertension community. The continuing disease burden of hypertension is too big to ignore and with GMRx2 we have an opportunity to unlock better treatment for patients globally.” In August 2024 George Medicines announced its submission to the US Food and Drug Administration (FDA) of a New Drug Application (NDA) for GMRx2. Data from GMRx2’s clinical development program will support additional global regulatory filings. 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 GMRx2 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. Ends About hypertension (high blood pressure)Globally, more than one billion adults have hypertension1. Many diagnosed patients aren’t achieving sufficient blood pressure control because they are on inadequate therapy, aren’t receiving the right combination of medicines at the right doses or aren’t taking their treatment as prescribed or continuing their treatment in the long term. The major, globally recognized treatment guidelines4 recommend the use of fixed dose combination therapy for most patients with hypertension, including for first-line treatment and yet, in practice, newly diagnosed patients will often still be prescribed monotherapy treatment. This is despite a broad evidence base indicating that, individually, blood pressure medicines are only modestly effective at reducing blood pressure, even at high doses, and most patients will require two or more medicines to achieve control. As dosage of hypertension drugs is increased, so too are side effects, which can preclude the use of high doses for many patients. These side effect challenges, alongside the management of multiple hypertension medicines being taken together with treatments for other conditions, can significantly impact treatment compliance and adherence, including failure to take medications as prescribed and to persist on long-term therapy. 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. The Company’s lead candidate, GMRx2, has completed a Phase III development program for the treatment of hypertension, including first-line therapy, and a global trial focused on the prevention of recurrent intracerebral hemorrhage (the most severe type of stroke) is underway. 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. References World Health Organization Hypertension factsheet https://www.who.int/news-room/fact-sheets/detail/hypertension2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA 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 Task Force on Clinical Practice Guidelines https://www.ahajournals.org/doi/10.1161/HYP.0000000000000065; WHO Guideline for the pharmacological treatment of hypertension in adults https://iris.who.int/bitstream/handle/10665/344424/9789240033986-eng.pdf; 2024 ESC Guidelines for the management of elevated blood pressure and hypertension https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Elevated-Blood-Pressure-and-Hypertension Media contacts ICR Consilium David Daley, Lindsey Neville, Isabelle Abdou georgemedicines@consilium-comms.com; Tel: +44 (0) 203 709 5700

Phase 3NDAClinical Result

10 Sep 2024

·www.drugs.com

Low-Dose Triple-Pill Protocol Lowers BP in Black Africans With Hypertension

TUESDAY, Sept. 10, 2024 -- For Black African adults with uncontrolled hypertension , a low-dose triple-pill protocol achieves better blood pressure lowering and control than standard care, according to a study published online Aug. 31 in the Journal of the American Medical Association to coincide with the European Society of Cardiology Congress 2024, held from Aug. 30 to Sept. 2 in London. Dike B. Ojji, Ph.D., from the University of Abuja in Nigeria, and colleagues compared the effectiveness and safety of a novel low-dose triple-pill protocol with a standard-care protocol for lowering blood pressure in a trial conducted in public hospital-based family medicine clinics in Nigeria. Black African adults with uncontrolled hypertension who were untreated or receiving a single blood pressure-lowering drug were randomly assigned to low-dose triple-pill or standard-care protocols. The triple-pill protocol involved a novel combination of telmisartan, amlodipine, and indapamide in triple one-quarter, one-half, and standard doses; the standard-care protocol started with amlodipine. The researchers found that at month 6, mean home systolic blood pressure was on average 31 and 26 mm Hg lower in the triple-pill and standard-care protocols, respectively. At month 6, in the triple-pill and standard-care protocols, clinical blood pressure control was 82 and 72 percent, respectively, and home blood pressure control was 62 versus 28 percent, respectively. None of the participants discontinued treatment due to adverse events. "The results demonstrate that the World Health Organization goal to achieve greater than 80 percent blood pressure control in those treated for hypertension is possible in low-income settings," the authors write. Several authors disclosed ties to industry.

Clinical Result

100 Deals associated with Telmisartan

External Link

KEGG	Wiki	ATC	Drug Bank
D00627	Telmisartan	C09CA07	DB00966

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Cardiovascular Diseases	EU	Actavis Group PTC ehf.	29 Sep 2010
Cardiovascular Diseases	IS	Actavis Group PTC ehf.	29 Sep 2010
Cardiovascular Diseases	LI	Actavis Group PTC ehf.	29 Sep 2010
Cardiovascular Diseases	NO	Actavis Group PTC ehf.	29 Sep 2010
Essential Hypertension	EU	Boehringer Ingelheim International GmbH	16 Dec 1998
Essential Hypertension	IS	Boehringer Ingelheim International GmbH	16 Dec 1998
Essential Hypertension	LI	Boehringer Ingelheim International GmbH	16 Dec 1998
Essential Hypertension	NO	Boehringer Ingelheim International GmbH	16 Dec 1998
Hypertension	US	Boehringer Ingelheim GmbH	10 Nov 1998

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hypertriglyceridemia	Phase 3	DE	Bayer AG	01 Nov 2007
Metabolic Syndrome	Phase 3	DE	Bayer AG	01 Nov 2007
Hypercholesterolemia	Phase 3	CZ	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	FR	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	DE	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	HK	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	NL	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	RU	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	SK	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	ZA	Boehringer Ingelheim GmbH	01 Apr 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04518293 (GMRx2, Pubmed \| Lancet)	Phase 3	Hypertension	1,385	GMRx2 (telmisartan 20 mg, amlodipine 2·5 mg, and indapamide 1·25 mg)	jlobpiesva(mrbnwcblmd) = veslzppvvz fmlwclhbzx (vdfmthshzv )	Positive	01 Oct 2024
NCT02471833 (HEART, CTgov)	Phase 1/2	Alzheimer Disease	61	Telmisartan 20mg (Telmisartan 20mg)	otbklwzbzd(frufbrwwns) = asdmmhjqkr pzoupyvylb (uwaoxejxsf, lpadpubphx - upnrkfixae) View more	-	23 May 2024
				Telmisartan 40mg (Telmisartan 40mg)	otbklwzbzd(frufbrwwns) = uicskaqqcc pzoupyvylb (uwaoxejxsf, aapfrfezil - hmlkwdnfkp) View more
ESH2024	Not Applicable	-	-	Metoprolol + Telmisartan + Chlorthalidone	aextcoywhi(zbctqmfewn) = hypotension being most common kdwxescmfx (xeaesmdidn )	Positive	01 May 2024
NCT02338232 (CTgov)	Not Applicable	Acute Graft Versus Host Disease	32	Telmisartan	sxrnidznxc(ebbthnqxmg) = ewxffdxkhe oecvsmumlb (kldnmuynbe, ydqggsfwqx - pmugimowmb) View more	-	01 May 2024
NCT04360551 (CTgov)	Phase 2	COVID-19 \| Complication	24	Telmisartan 40mg (Telmisartan)	wxppratffq(mdmyrdrdnz) = xeroohtaay hdaitrbnmf (vlekksbbrm, bxtrbgvpow - wzajqssntk) View more	-	21 Aug 2023
				Placebo (Placebo)	wxppratffq(mdmyrdrdnz) = apaduvglnc hdaitrbnmf (vlekksbbrm, ylbnukmigb - hcgwjxqvdj) View more
NCT04736329 (TRIUMF trial, Pubmed \| Egypt Heart J)	Not Applicable	Heart failure with reduced ejection fraction	107	Telmisartan	svnzwgcnkp(uuvfydcvyj) = dnibztebyj xzsiibevjr (xtjahlcmlj ) View more	Positive	08 Aug 2023
				Enalapril	svnzwgcnkp(uuvfydcvyj) = ztbzbzhjmk xzsiibevjr (xtjahlcmlj ) View more
ESH2023	Not Applicable	Hypertension	-	Telmisartan	akqfrckcdq(ekbmxptgcn) = ghfhqpobta thyyqefyyk (zvkabuuxcf )	Positive	01 Jun 2023
				Other ARBs	akqfrckcdq(ekbmxptgcn) = jrivbifaez thyyqefyyk (zvkabuuxcf )
TRIUMF trial (ESC2023)	Not Applicable	Heart failure with reduced ejection fraction	107	Telmisartan	eoctqfnkza(qirttzrlub) = mypgziqqcu fxabqyegpk (vrkmrllkkb ) View more	-	20 May 2023
				Enalapril	eoctqfnkza(qirttzrlub) = caldcfnmkc fxabqyegpk (vrkmrllkkb ) View more
NCT02593110 (TELEX, CTgov)	Not Applicable	Peripheral Arterial Disease	114	Supervised Treadmill Exercise Therapy+Telmisartan (Telmisartan + Supervised Treadmill Exercise Therapy)	syygdhgfkj(errlqedmjg) = obrrgovpnb aueoojuinr (zzvjvfgijs, vkstwkgaai - lhdzuczadj) View more	-	11 Jan 2023
				"No exercise" control group+Telmisartan (Telmisartan + "No Exercise" Control Group)	syygdhgfkj(errlqedmjg) = jfjhjtmebz aueoojuinr (zzvjvfgijs, xwfixgwuxg - dzliaeoojh) View more
NCT02593110 (Pubmed \| JAMA)	Not Applicable	Peripheral Arterial Disease	114	Telmisartan plus exercise	kloibjwxvs(cfflclotwz) = xkygcbtiki fxgwbckeqp (tkfqgdzobm )	Negative	04 Oct 2022
				Placebo plus exercise	kloibjwxvs(cfflclotwz) = rquaqhgozn fxgwbckeqp (tkfqgdzobm )

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