Data updated: May 26, 2026
MICARDIS (telmisartan)
Trial Activity: Declining 6 active trials
Cardiovascular
Approved 1998-11-10
Development Insights
Boehringer Ingelheim conducting 6 trials (13%)
45 indications explored (Broad Platform)
→ hypertension (16 trials)
→ hypercholesterolemia (2 trials)
→ bioequivalence (2 trials)
2
Indications
--
Phase 3 Trials
27
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1998-11-10
- Routes
- ORAL
- Dosage Forms
- TABLET
MICARDIS Approval History
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
66 FDA actions from 1998 to 2022 · 1 indication expansions
Aug 2015 SUPPL
Mfg · Manufacturing (CMC)
Feb 2015 SUPPL
Mfg
Oct 2000 SUPPL
Mfg
Apr 2000 SUPPL
Mfg
Dec 1999 SUPPL
Mfg
Oct 1999 SUPPL
Mfg
What MICARDIS Treats
2 FDA approvalsOriginally approved for its first indication in 1998 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
44 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 |
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
| 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) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
MICARDIS FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment