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Last update 26 Oct 2025

Telmisartan

Last update 26 Oct 2025

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'-[(1,7'-dimethyl-2'-propyl-1H,3'H-2,5'-bibenzimidazol-3'-yl)methyl]biphenyl-2-carboxylic acid, Telmisartan

+ [69]

Target

AT1R

Action

antagonists

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

Teva Pharmaceuticals Europe BVBoehringer Ingelheim Pty Ltd.Actavis Group PTC ehf

+ [9]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (10 Nov 1998),

Hypertension

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC33H30N4O2

InChIKeyRMMXLENWKUUMAY-UHFFFAOYSA-N

CAS Registry144701-48-4

351

Clinical Trials associated with Telmisartan

NCT07207057

/ RecruitingPhase 3IIT

Edmond J Safra, Accelerating Clinical Trials in Parkinson's Disease (EJS ACT-PD) - a Multi-arm Multi-stage Platform Trial for Potential Disease Modifying Approaches.

Parkinson's disease (PD) is currently the fastest-growing neurological condition globally. It is projected to affect 172,000 people in the UK by 2030,with the current annual cost to the country being
£3.6 billion. The disease progressively impairs physical abilities, leading to increased disability, falls, and difficulties with speech, swallowing, mood, thinking, and memory. While existing treatments can alleviate some symptoms, their effectiveness diminishes over time, and they can cause severe side effects. This trial uses a Multi-Arm,Multi-Stage (MAMS) design where multiple treatments are tested simultaneously in separate groups, called "arms." Each treatment is compared against a placebo, a dummy treatment with no active ingredients, to evaluate its effectiveness and safety. Throughout the trial, each treatment undergoes periodic reviews, known as interim analyses, to assess its safety and potential benefits. If a treatment shows promise, it continues in the trial until a final assessment determines its overall effectiveness. Treatments that do not show positive results are discontinued and replaced with new candidates. This approach reduces the number of participants needed to obtain reliable results and is more cost-effective and faster than conducting separate trials for each treatment. The treatments selected for this trial were chosen based on careful consideration of existing evidence regarding their safety and effectiveness. To choose the treatments we want to test, we carefully considered evidence for safety and effectiveness. The trial will start with two treatment arms (telmisartan and terazosin) and one placebo arm, with a third treatment arm added after one year. We can identify new treatments to add to the trial each year. Participants will be followed up for up to 36 months. After an in-person screening visit, all remaining visits at 3 months,6 months and then every 6 months after, for a total of up to 36 months can be completed remotely. The visits will include questionnaires, assessment of Parkinson's symptoms and discussions about any side effects. Participants will informed of trial progress. Results will be shared via the trial website and published in a medical journal.

Start Date12 Sep 2025

Sponsor / Collaborator

University College London

[+5]

ChiCTR2500108026

/ Not yet recruitingNot ApplicableIIT

Efficacy and safety of Ambrisentan on idiopathic membranous nephropathy----a prospective, multi-center, randomized and controlled study

Start Date01 Sep 2025

Sponsor / Collaborator

The Second Military Medical University

[+1]

NCT06815497

/ Not yet recruitingPhase 2IIT

Phase II Non-Randomized, Unblinded, Single-Center Trial of Telmisartan in Combination With Cytotoxic Regimens in Platinum-Resistant Ovarian Cancer Versus Historical Best Supportive Care

The primary study objective is to assess progression-free survival in patients with ovarian cancer receiving telmisartan plus selected standard of care chemotherapy regimens versus historical controls.

Start Date14 Aug 2025

Sponsor / Collaborator

Dartmouth-Hitchcock Medical Center

[+1]

100 Clinical Results associated with Telmisartan

100 Translational Medicine associated with Telmisartan

100 Patents (Medical) associated with Telmisartan

4,101

Literatures (Medical) associated with Telmisartan

01 Dec 2025·JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

LC–MS/MS-based simultaneous quantification of chlorthalidone and cilnidipine in rat plasma: Pharmacokinetic evaluation, green analytical assessment, and DoE-driven optimization

Article

Author: Gandu, Sravanthi ; Gandla, Kumaraswamy ; Repudi, Lalitha

A highly sensitive and reproducible liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was systematically developed and optimized using a Quality by Design (QbD) framework for the simultaneous quantification of chlorthalidone and cilnidipine in rat plasma. Critical method variables-organic phase composition, flow rate, and mobile phase pH-were identified through risk assessment and subsequently optimized via Box-Behnken Design to ensure analytical robustness. Optimal chromatographic conditions comprised 20 % organic content, a flow rate of 1.0 mL/min, and a mobile phase pH of 3.0, facilitating efficient resolution of both analytes. Detection was achieved in positive electrospray ionization mode using multiple reaction monitoring, with transitions of m/z 339.8909 → 85.0951 for chlorthalidone, m/z 493.5237 → 300.1587 for cilnidipine, and m/z 515.6423 → 342.6158 for telmisartan, employed as the internal standard. Method validation, performed in accordance with European Medicines Agency (EMA) guidelines, demonstrated excellent linearity (r² > 0.998), accuracy, and precision, with coefficient of variation consistently <10 %. The method exhibited strong analyte stability and was successfully applied to the pharmacokinetic evaluation of both drugs in Wistar rats. This DoE-optimized LC-MS/MS platform offers a selective, reliable, and environmentally conscious analytical solution for the preclinical assessment of chlorthalidone and cilnidipine.

01 Dec 2025·JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY A-CHEMISTRY

Aquatic photochemistry and transformations of multiclass emerging organic contaminants in environmental water matrices

Author: Bajt, Oliver ; Kravos, Aleksander ; Prosen, Helena

This study shows a comprehensive assessment of the photodegradation of 18 multiclass contaminants of emerging concern (CECs) in simulated river and marine aquatic compartments.Degradation trends, mineralization, and defluorination of the target CECs were monitored in model matrixes, artificial and real seawater, with and without aeration.Each model matrix contained a natural abiotic factor of interest, i.e., chloride, nitrate, humic acid, lignosulfonate, and iron, all naturally present in surface water.Transformation pathways were investigated by UHPLC-MS/MS and for the identified transformation products (TPs), their ecotoxicities were predicted in silico.Only 8 out of 18 selected CECs were found to be significantly photolabile, especially rosuvastatin.Direct photolysis was their primary degradation route, while abiotic factors either accelerated or suppressed the degradation depending on the type of CEC.Real and artificial seawater mostly acted inhibitory.Oxygen aeration mostly accelerated degradation showing the effect of singlet oxygen.Low mineralization and defluorination were in most cases linked to the formation of stable and relatively more toxic TPs, which were characteristic for rosuvastatin.Main identified TPs were screened in real river water and seawater (North Adriatic Sea water basin, Slovenia, Europe).Rosuvastatin′s TP ROS-349 was detected with a high confidence level for the first time, which may raise environmental concerns.Overall, advanced assessment of aquatic photochem. is achieved by using low concentrations, mixtures of multiclass CECs, UV light above 300 nm, more realistic matrixes, as well as by identifying, ranking, and analyzing the TPs in actual aquatic environment.

01 Nov 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Integrated network pharmacology and in vivo experimental approaches unveil the modulatory effect of telmisartan on autophagy in a rat model of nonalcoholic steatohepatitis

Article

Author: Abdel-Ghany, Rasha H ; Alsemeh, Amira Ebrahim ; Zakaria, Esraa M ; Elgharbawy, Atef S ; Metwally, Sami S ; Mohsen, Mohamed

Defective autophagy contributes to the progression of various diseases, including nonalcoholic steatohepatitis (NASH). While telmisartan's hepatoprotective effects are well established, its impact on hepatic autophagy in NASH remains unclear. This study employed network pharmacology combined with in vivo experiments to predict and validate telmisartan's effects on hepatic autophagy in a rat model of NASH. Additionally, we investigated whether telmisartan could augment pioglitazone's protective effects. Network pharmacology identified 97 common molecular targets shared by telmisartan and NASH. Key targets included Signal Transducer and Activator of Transcription 3 (STAT3), B-cell lymphoma 2 (Bcl2), and Nuclear Factor kappa-light-chain-enhancer of activated B cells (NF-κB), regulators of cellular autophagy, suggesting telmisartan's potential interaction with autophagy-related pathways. To validate these findings, NASH was induced in adult male rats via an 18-week high fructose, fat, and salt diet, with telmisartan, pioglitazone, or their combination administered orally during the final 10 weeks. Blood pressure, glycemic, lipid, and liver function parameters were quantified in serum. Besides, hepatic markers of autophagy (Beclin1, LC3, and p62), inflammation, oxidative stress, fibrosis, and apoptosis were measured. Moreover, liver histology and collagen deposition were examined. Telmisartan significantly enhanced hepatic autophagy more than pioglitazone. Furthermore, combination therapy synergistically increased autophagy beyond the effects of either drug alone. Both drugs similarly ameliorated hepatic inflammation and oxidative stress markers. These results demonstrate that telmisartan's hepatoprotective effects are partly mediated by restoration of hepatic autophagy. Moreover, the data suggest that combined telmisartan and pioglitazone therapy may provide enhanced benefit in NASH treatment, warranting further clinical investigation.

News (Medical) associated with Telmisartan

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

03 Oct 2025

·www.globenewswire.com

George Medicines strengthens global commercialization strategy for GMRx2 with exclusive Biolab Farmacêutica licensing agreement in Brazil

Biolab Farmacêutica gains exclusive rights in Brazil to GMRx2, an innovative single pill combination of three medicines, including two doses that are lower than those currently available in single pill combinations, designed to deliver the 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 regulatory and commercial milestone payments, as well as a future recurring revenue stream through a stepped royalty rate on sales in Brazil Third licensing agreement for GMRx2 follows deals with Bausch Health in Canada, Mexico, Colombia and Central America, and with Azurity Pharmaceuticals in the US 2 October 2025 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, has entered into an exclusive licensing and supply agreement with Biolab Farmacêutica (“Biolab”), one of Brazil’s largest pharmaceutical companies, granting Biolab exclusive rights to seek regulatory approval of, and to commercialize, GMRx2 in Brazil. 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 profile of established antihypertensive medications. 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.1,2,3 Mark Mallon, Chief Executive Officer of George Medicines, said: “This partnership in Brazil further strengthens our global commercial strategy for GMRx2 and follows on swiftly from the product’s regulatory approval in the US and licensing agreements covering the US, Canada, Mexico, Colombia and Central America markets. The clinically-proven efficacy of this triple combination product, with its multiple dosing options including two doses that are lower than those currently available in single pill combinations, coupled with its established safety profile, has the potential to address key challenges in current hypertension treatment approaches. Through our partnership with Biolab we have an opportunity with GMRx2 to meaningfully advance cardiovascular care in Brazil.” Fabio Amorosino, Chief Executive Officer of Biolab Farmacêutica, said: “The partnership with George Medicines for the exclusive commercialization of GMRx2 reinforces Biolab’s strategic presence in the cardiovascular segment. The medication, which will undergo regulatory approval in Brazil, represents a significant innovation in hypertension treatment. With a solid infrastructure and strong medical presence, we are well prepared to expand access to effective and safe healthcare solutions for the population.” 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, Biolab Farmacêutica is granted a license to exclusively commercialize GMRx2, supplied by George Medicines. Biolab is responsible for seeking regulatory approval of GMRx2, with support from George Medicines. This is George Medicines’ third licensing and supply agreement for GMRx2, following the agreement established with Bausch Health in January 2025 granting exclusive rights in Canada, Mexico, Colombia and Central America, and with Azurity Pharmaceuticals in July 2025 granting exclusive rights in the US. Further collaborations are anticipated as part of George Medicines’ 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. 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. 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. Promoting a future with better quality of life requires a relentless pursuit of safe and innovative treatments. That’s why Biolab, a Brazilian pharmaceutical company founded in 1997 with international presence, invests in research and strategic partnerships to overcome the growing challenges in healthcare. With nearly 4,000 employees and one of the largest sales forces in the country, Biolab stands out among Brazil’s leading pharmaceutical companies. In 2025, it was recognized in LinkedIn’s Top Companies ranking as one of the 15 best companies to work for in Brazil, based on criteria such as growth opportunities, skill development, diversity, and stability. Biolab operates across multiple specialties, including dermatology, gynecology, orthopedics, gastroenterology, pediatrics, general medicine, and central nervous system treatments, and is a leader in cardiology. Its business units—Biolab Genéricos, Avert Humana, and Avert Biolab Saúde Animal—contribute to a portfolio of over 500 products. Biolab is in constant growth. It has three production units and is building a state-of-the-art manufacturing complex. And it doesn’t stop there: in Canada, Biolab became the first Brazilian pharmaceutical company to establish a research center and acquired Exzell Pharma to expand its global footprint. 1 European Heart Journal, Volume 45, Issue 38, 7 October 2024, Pages 3912–4018, https://doi.org/10.1093/eurheartj/ehae178 2 Guideline for the pharmacological treatment of hypertension in adults. Geneva: World Health Organization; 2021 3 CMAJ May 26, 2025 197 (20) E549-E564; https://doi.org/10.1503/cmaj.241770 The content above comes from the network. if any infringement, please contact us to modify.

License out/inClinical Result

29 Aug 2025

·www.einpresswire.com

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

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	European Union	Actavis Group PTC ehf	29 Sep 2010
Cardiovascular Diseases	Iceland	Actavis Group PTC ehf	29 Sep 2010
Cardiovascular Diseases	Liechtenstein	Actavis Group PTC ehf	29 Sep 2010
Cardiovascular Diseases	Norway	Actavis Group PTC ehf	29 Sep 2010
Essential Hypertension	European Union	Bayer AG	11 Dec 1998
Essential Hypertension	Iceland	Bayer AG	11 Dec 1998
Essential Hypertension	Liechtenstein	Bayer AG	11 Dec 1998
Essential Hypertension	Norway	Bayer AG	11 Dec 1998
Hypertension	United States	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	Germany	Bayer AG	01 Nov 2007
Metabolic Syndrome	Phase 3	Germany	Bayer AG	01 Nov 2007
Hypercholesterolemia	Phase 3	United States	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	Czechia	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	France	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	Germany	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	Hong Kong	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	Netherlands	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	Russia	Boehringer Ingelheim GmbH	01 Apr 2006
Hypercholesterolemia	Phase 3	Slovakia	Boehringer Ingelheim GmbH	01 Apr 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02373163 (INTERVENCION Trial \| INTERVENCION, CTgov)	Phase 4	Hypertension	166	Hydrochlorothiazide (Diuretic)	uwcgdibonf(nckbqhwnpr) = mbgyckddkv lmpkvwkghb (dzmeuhlmfm, 8.4) View more	-	29 Jul 2025
				Amlodipine (Calcium-channel Blocker)	uwcgdibonf(nckbqhwnpr) = qeahactkyi lmpkvwkghb (dzmeuhlmfm, 9.2) View more
NCT04518293 (GMRx2, Pubmed \| Lancet)	Phase 3	Hypertension	1,385	GMRx2 (telmisartan 20 mg, amlodipine 2·5 mg, and indapamide 1·25 mg)	krrohpdfqf(jltzgvizas) = stkxnmaanq dbsrxubhaz (nlbsgezzft )	Positive	01 Oct 2024
NCT02471833 (HEART, CTgov)	Phase 1/2	Alzheimer Disease	61	Telmisartan 20mg (Telmisartan 20mg)	llfwdzxgzk(xudggqucjj) = lonsaxaqet kwvrdooqif (uyitkcdglj, 1425.34) View more	-	23 May 2024
				Telmisartan 40mg (Telmisartan 40mg)	llfwdzxgzk(xudggqucjj) = aturcpyhii kwvrdooqif (uyitkcdglj, 1509.02) View more
NCT02338232 (CTgov)	Not Applicable	Acute Graft Versus Host Disease	32	Telmisartan	uvbotnjqcd = iwuvxbpffu prmqvtvrcy (evzfamfjjx, livpeqrpeh - ddckdayiud) View more	-	01 May 2024
NCT04360551 (CTgov)	Phase 2	COVID-19 \| Complication	24	Telmisartan 40mg (Telmisartan)	tixlialfyh(tlnxpqwfgp) = mozlcmkwiu lttimwtpti (yliyihavws, tukrxxrhim - grwvigzcra) View more	-	21 Aug 2023
				Placebo (Placebo)	tixlialfyh(tlnxpqwfgp) = cpppnkfeao lttimwtpti (yliyihavws, causikwivp - wyfwgoucdq) View more
NCT04736329 (TRIUMF trial, Pubmed \| Egypt Heart J)	Not Applicable	Heart failure with reduced ejection fraction	107	Telmisartan	ohpcimsvaf(mdfmojcgwi) = ltmttebmen qutcxtziev (remnlfoyps ) View more	Positive	08 Aug 2023
				Enalapril	ohpcimsvaf(mdfmojcgwi) = glyfxffadj qutcxtziev (remnlfoyps ) View more
NCT04736329 (TRIUMF trial, ESC2023)	Not Applicable	Heart failure with reduced ejection fraction	107	Telmisartan	toamxlnufb(nyllaxfmvf) = gcyosvoltw ftxaewmfwo (slateqvchc ) View more	-	20 May 2023
				Enalapril	toamxlnufb(nyllaxfmvf) = kipglfpuuk ftxaewmfwo (slateqvchc ) View more
NCT02593110 (TELEX, CTgov)	Not Applicable	Peripheral Arterial Disease	114	Supervised Treadmill Exercise Therapy+Telmisartan (Telmisartan + Supervised Treadmill Exercise Therapy)	xariodtjvw(jnhpkzyvpc) = rcuhdxiwlm tljaplucsh (sfnejpbfhb, 67.21) View more	-	11 Jan 2023
				"No exercise" control group+Telmisartan (Telmisartan + "No Exercise" Control Group)	xariodtjvw(jnhpkzyvpc) = ikijvqbggf tljaplucsh (sfnejpbfhb, 47.33) View more
NCT02593110 (Pubmed \| JAMA)	Not Applicable	Peripheral Arterial Disease	114	Telmisartan plus exercise	qddhsnluvk(ewewuqizzn) = vzkezhcvan rjunwwezav (nucdcajfxe )	Negative	04 Oct 2022
				Placebo plus exercise	qddhsnluvk(ewewuqizzn) = ovrxyouiqb rjunwwezav (nucdcajfxe )
NCT03868839 (CTgov)	Phase 2	Schizoaffective disorder \| Schizophrenia, Treatment-Resistant	6	Telmisartan Pill	qjqyptcfkj(bggiluhauz) = nomgoybwld snczxokqqc (gskkhdtihz, 0.2377) View more	-	02 Mar 2022

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