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Drug

Telmisartan

Established medicine
ClassType-1 angiotensin II receptor antagonistResearchActive indication expansion
Also known as 4'-((4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl)methyl)-2-biphenylcarboxylic acid, Micardis, Micardis HCT, Micardis-HCT+5 more

4'-((4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl)methyl)-2-biphenylcarboxylic acid, Micardis, Micardis HCT, Micardis-HCT, Semintra, Twynsta, Widaplik, Hydrochlorothiazide-Telmisartan, 4'-((1,4'-dimethyl-2'-propyl(2,6'-bi-1H-benzimidazol)-1'-yl)methyl)-(1,1'-biphenyl)-2-carboxylic acid.

RxNorm73494ChEMBLCHEMBL1017ATCC09CA07UNIIU5SYW473RQ
6
Active clinical trials
Type-1 angiotensin II receptor
Primary target
15
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: TELMISARTAN (ANDA203171)

Regulatory2026-10-08FDA

Label change: TELMISARTAN (ANDA203171)

Regulatory2026-10-08FDA

Supplemental approval: TELMISARTAN AND AMLODIPINE (ANDA205234)

Regulatory2026-09-22FDA

Phase I Non-Randomized, Unblinded, Single-Center Trial of Oral Telmisartan Alone or Combined With Selected Standard of Care Therapies for Prostate Cancer

Clinical trial2026-07-22Results expected Q2 2027 · ClinicalTrials.gov

A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

Clinical trial2026-05-08Results expected Q1 2029 · ClinicalTrials.gov

Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes: A Hybrid Design in a Real-World Setting

Clinical trial2026-05-06Results expected Q2 2028 · ClinicalTrials.gov

Market withdrawal: Pritor (EMA)

Regulatory2026-05-04EMA

Market withdrawal: Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) (EMA)

Regulatory2026-04-30EMA

Study of Antihypertensive Treatment and Cardiovascular Risk in Chinese Prehypertensive Population

Clinical trial2026-04-30Completed · ClinicalTrials.gov

Efficacy of Telmisartan in Preventing Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients

Clinical trial2026-01-29Results expected Q1 2027 · ClinicalTrials.gov

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

Clinical trial2026-01-28Results expected Q2 2027 · ClinicalTrials.gov

A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared With Losartan in Patients With Diabetic Nephropathy and Hypertension

Clinical trial2025-10-31Primary completion · ClinicalTrials.gov

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Lowers systolic blood pressure in hypertension
47%Low confidence
Uncertainty ±23%Evidence coverage: HighUpdated 8 October 2026

High point estimate, but substantial uncertainty remains.

Evidence is mixed — 4 supporting evidence families · contradictory evidence

Confidence has a low point estimate but a wide uncertainty band — the evidence base is still thin.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Telmisartan
Aliases & brands
4'-((4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl)methyl)-2-biphenylcarboxylic acidMicardisMicardis HCTMicardis-HCTSemintraTwynstaWidaplikHydrochlorothiazide-Telmisartan4'-((1,4'-dimethyl-2'-propyl(2,6'-bi-1H-benzimidazol)-1'-yl)methyl)-(1,1'-biphenyl)-2-carboxylic acid
RxNorm CUI
73494
ChEMBL ID
CHEMBL1017
ATC codes
C09CA07
UNII
U5SYW473RQ
Primary mechanism
Type-1 angiotensin II receptor antagonist
Regulatory jurisdictions
fdaema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Type-1 angiotensin II receptor
AGTR1 · P30556
ANTAGONISTType-1 angiotensin II receptor antagonist

Regulatory timeline

15 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1998-12-11
Latest approval
2026-09-22
Authorities
FDA · EMA
Total events
15
fdaU.S. Food and Drug Administration· 8 events
2026-10-08Label change
Label change: TELMISARTAN (ANDA203171)
Evidence ↗
2026-10-08Label change
Label change: TELMISARTAN (ANDA203171)
Evidence ↗
2026-09-22Supplemental approval
Supplemental approval: TELMISARTAN AND AMLODIPINE (ANDA205234)
Evidence ↗
emaEuropean Medicines Agency· 7 events
2026-05-04Market withdrawalMarket
Market withdrawal: Pritor (EMA)
Indication: Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic… Show full indication

Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage.

Evidence ↗
2026-04-30Market withdrawalMarket
Market withdrawal: Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) (EMA)
Indication: Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic… Show full indication

Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type-2 diabetes mellitus with documented target-organ damage.

Evidence ↗
2010-09-29Generic approvalMarket
Generic medicine authorisation: Telmisartan Actavis (EMA)
Indication: Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic… Show full indication

Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or; type 2 diabetes mellitus with documented target organ damage.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

140 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
140
registered trials across all phases
LATEST COMPLETION 2026
6
Active studies
6
Recruiting
92
Late-stage (III+)
109
Completed
25
Discontinued
PHASE DISTRIBUTIONn = 140
Early Phase 11Phase 132Phase 1 / 22Phase 213Phase 2 / 33Phase 334Phase 444Phase N / A11

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

Not yet recruitingPH IVBaylor Research Instituten=642029

A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial To Evaluate the Efficacy and Safety of Telmisartan Compared With Losartan in Patients With Diabetic Nephropathy and Hypertension

Unknown statusPH IVChong Kun Dang Pharmaceuticaln=982025

A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome

Unknown statusPH IVChong Kun Dang Pharmaceuticaln=1162023

Randomized, Open, Multicenter Study to Evaluate the Renal Function of HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria

Unknown statusPH IVYuhan Corporationn=3742021

A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Evaluate the Central Aortic Pressure Effect Between Fixed Dose Combination (Duowell® Tab) and Monotherapy of Telmisartan in Mild Dyslipidemia Patients With Hypertension

CompletedPH IVYuhan Corporationn=802020

Recent completions

Trials that read out recently, adding to the completed evidence base.

Study of Antihypertensive Treatment and Cardiovascular Risk in Chinese Prehypertensive Population

CompletedN/AQilu Hospital of Shandong Universityn=6902026

Prevention of Paclitaxel-induced Neuropathic Pain by Telmisartan in Patients With Planned Paclitaxel Chemotherapy Due to Ovarian or Breast Cancer (PrevTel)

CompletedPH IIDr. Frank Behrensn=352023

Telmisartan Versus Enalapril in Heart Failure With Reduced Ejection Fraction Patients With Moderately Impaired Kidney Functions. "TRIUMF Trial"

CompletedN/ACairo Universityn=1072022

Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease

CompletedN/ANorthwestern Universityn=1142022

Health Evaluation in African Americans Using RAS Therapy

CompletedPH I/IIEmory Universityn=612022

Combination Therapies to Reduce the Nasopharyngeal Carriage of SARS-CoV-2 and Improve the Outcome of COVID-19 Infection in Ivory Coast (INTENSE-COV): a Phase IIb Randomized Clinical Trial

CompletedPH II/IIIANRS, Emerging Infectious Diseasesn=2942021
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.