TELMISARTAN
TELMISARTAN is indicated for the treatment of Hypertension.
How TELMISARTAN Works
Telmisartan works by selectively blocking the binding of angiotensin II to the AT1 receptor in tissues such as vascular smooth muscle and the adrenal gland. This blockade inhibits the vasoconstrictor and aldosterone-secreting effects of angiotensin II. Unlike ACE inhibitors, telmisartan does not inhibit the enzyme responsible for angiotensin II synthesis or the degradation of bradykinin, and it does not bind to other hormone receptors or ion channels involved in cardiovascular regulation.
Details
- Status
- Prescription
- First Approved
- 2014-01-08
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TELMISARTAN Approval History
What TELMISARTAN Treats
1 indicationsTELMISARTAN is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertension
TELMISARTAN Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue telmisartan as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue telmisartan as soon as possi...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue telmisartan as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue telmisartan as soon as possible ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 )
TELMISARTAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TELMISARTAN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TELMISARTAN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TELMISARTAN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
43 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04356495 COVERAGEFrance | CHUBX 2020/12 2020-001435-27 | Ph 2, Ph 3 | completed | Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation |
| NCT07370506 | 2467R4 | Ph 1, Ph 2 | not yet recruiting | Telmisartan for Prevention of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients |
| NCT06815497 | STUDY02002599 24WIL599 | Ph 2 | recruiting | Telmisartan in Combination With Cytotoxic Regimens in Platinum-Resistant Ovarian Cancer |
| NCT07207057 EJS ACT-PD | ND002 ISRCTN17799294 | Ph 3 | recruiting | Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease: A Multiarm Multi-stage Platform Trial |
| NCT06168487 | STUDY02002057 NCI-2024-07041 | Ph 1 | recruiting | Telmisartan in Prostate Cancer |
| NCT02373163 INTERVENCION results posted | INTERVENCION Trial | Ph 4 | completed | INTERVENCION Trial |
| NCT02085265 SARTAN-AD | 148-2013 | Ph 2 | terminated | Telmisartan vs. Perindopril in Mild-Moderate Alzheimer's Disease Patients |
| NCT06431477 | B115_02HT/DN2201 | Ph 4 | recruiting | Efficacy and Safety of Telmisartan Compared With Losartan |
| NCT04510662 STAR-COVID | CI/HRAEZ2020/05 | Ph 2 | completed | Telmisartan in Respiratory Failure Due to COVID-19 |
| NCT04606563 ARBs CORONA II | H20-01984 | Ph 3 | terminated | Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection? |
| NCT04359953 COVID-Aging | 7747 | Ph 3 | terminated | Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19 |
| NCT01928927 TRAFIC results posted | ACTG A5317 UM1AI068636 | Ph 2 | completed | Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study) |
| NCT04218552 | AD-209P2 | Ph 2 | completed | Determining the Optimal Dose of AD-209 in Patients With Essential Hypertension |
| NCT04158076 | ROZETELA RCT | Ph 3 | completed | Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine |
| NCT03267329 | YMC023 | Ph 4 | completed | Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension |
| NCT03872232 | ROZETEL_RCT | Ph 3 | completed | Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan |
| NCT01683084 TEDY | DAL0041ARG 22647 | Ph 4 | completed | Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms |
| NCT02170246 SEARCH018 | 1401013214 1R01NS084911-01, W81XWH-11-2-0174 | Ph 1 | completed | Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection |
| NCT01202721 BAV results posted | BAV-15JUNE2010 | Ph 3 | terminated | Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study) |
| NCT01088295 MATH results posted | MATH | Ph 2 | completed | HIV and Fat Accumulation |
| NCT03705533 | PTL-P3-923 | Ph 1 | completed | Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State |
| NCT03504566 ROTATE-2 | H-17013487 | Ph 4 | withdrawn | Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation (ROTATE-2) |
| NCT03566316 | ID-TAR-301 | Ph 3 | completed | Efficacy/Safety of Telmisartan/Amlodipine/Rosuvastatin in Hypertensive Patients With Hyperlipidemia |
| NCT00981526 results posted | 2008-P-000790 | Ph 4 | completed | Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia |
| NCT02079805 results posted | 279/NRP-001 U1111-1151-7168, AZI-P4-004 | Ph 4 | completed | A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R |
| NCT02933658 | DW-1501-P101 | Ph 1 | completed | Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers |
| NCT02579356 | SI-1307 | Ph 1 | completed | To Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers |
| NCT02358824 CKD-828 | 130BE15002 | Ph 1 | completed | CKD-828 (80/5mg) Pharmacokinetic Study |
| NCT02250833 | 130HPS14006 | Ph 1 | completed | CKD-828 (80/5mg) Pharmacokinetic Study |
| NCT02233218 | YH22189-101 | Ph 1 | completed | The Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers |
| NCT01578772 results posted | miFMD | Ph 2 | completed | A Clinical Trial for People HIV+ Age > 50 at Risk for Heart Disease |
| NCT02152969 | YH22162-101 | Ph 1 | completed | Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone) |
| NCT02276391 | 502.571 | Ph 1 | completed | Bioequivalence of Telmisartan as Telmisartan 80 mg/HCTZ 12.5 mg Fixed-dose Combination Tablet or as Two Telmisartan 40 mg Tablets in Healthy Male Volunteers |
| NCT01914432 | YH16410-301 | Ph 3 | completed | Efficacy and Safety Study of YH16410 Versus Rosuvastatin and Telmisartan Monotherapies in Patients With Hypertension and Hyperlipidemia |
| NCT00926289 results posted | 502.550 2008-007711-32 | Ph 4 | completed | Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension |
| NCT01222520 results posted | 1235.36 | Ph 3 | completed | Telmisartan 80mg Non-responder Trial |
| NCT00860262 results posted | 1235.20 2008-000873-40 | Ph 3 | completed | Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension |
| NCT01344629 results posted | 1235.28 | Ph 1 | completed | Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use |
| NCT01224860 COSTANT | COSTANT 2008-000822-38 | Ph 2 | completed | Telmisartan Versus Losartan in Kidney Transplantation |
| NCT00538486 HOT-ACME | HOT-ACME 1 | Ph 4 | completed | A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients |
| NCT01830530 HIGHCARE-A | 09F102 | Ph 4 | completed | HIGH Altitude CArdiovascular REsearch in the ANDES |
| NCT00865020 ASSERTIVE results posted | CSPP100A2408 | Ph 4 | completed | Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal |
| NCT01128322 | 128HT09K | Ph 2 | completed | CKD-828 Primary Hypertension Trial(Dose-selection) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TELMISARTAN FDA Label Details
Indications & Usage
FDA Label (PDF)TELMISARTAN is indicated for the treatment of Hypertension.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue telmisartan as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Pr...
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MICARDIS
Full clinical data, patents, trials, and competitive landscape for telmisartan.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.