Micardis, Pritor(telmisartan)
/ Telmisartan, Actelsar, Kinzalkomb, Kinzalmono, Micardis, Pritor, PritorPlus, Telmisartan, Tolucombi, Tolura, Twynsta (telmisartan) is a small molecule pharmaceutical. Telmisartan was first approved as Micardis on 1998-11-10. It is used to treat diabetic nephropathies, heart failure, hypertension, and left ventricular dysfunction in the USA. It has been approved in Europe to treat essential hypertension and hypertension. The pharmaceutical is active against type-1 angiotensin II receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Micardis, Telmisartan (discontinued: Telmisartan)
CombinationsMicardis, Telmisartan amlodipine, Telmisartan hydrochlorothiazide (discontinued: Telmisartan amlodipine, Telmisartan hydrochlorothiazide, Twynsta)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrochlorothiazide
+
Telmisartan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MICARDIS HCT | Boehringer Ingelheim | N-021162 RX | 2000-11-17 | 3 products, RLD |
Telmisartan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MICARDIS | Boehringer Ingelheim | N-020850 RX | 1998-11-10 | 3 products, RLD, RS |
Amlodipine besylate
+
Telmisartan
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TWYNSTA | Boehringer Ingelheim | N-022401 DISCN | 2009-10-16 | 4 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| micardis | New Drug Application | 2023-05-30 |
| micardis hct | New Drug Application | 2023-06-29 |
| telmisartan | ANDA | 2024-10-29 |
| telmisartan and amlodipine | ANDA | 2023-12-15 |
| telmisartan and hydrochlorothiazide | ANDA | 2024-06-20 |
| truemed group llc | Export only | 2022-08-11 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
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ATC Codes
C: Cardiovascular system drugs
— C09: Agents acting on the renin-angiotensin system
— C09C: Angiotensin ii receptor blockers (arbs), plain
— C09CA: Angiotensin ii receptor blockers (arbs), plain
— C09CA07: Telmisartan
— C09D: Angiotensin ii receptor blockers (arbs), combinations
— C09DA: Angiotensin ii receptor blockers (arbs) and diuretics
— C09DA07: Telmisartan and diuretics
— C09DB: Angiotensin ii receptor blockers (arbs) and calcium channel blockers
— C09DB04: Telmisartan and amlodipine
HCPCS
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Clinical
Clinical Trials
338 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 19 | 7 | 64 | 57 | 71 | 218 |
| Healthy volunteers/patients | — | — | — | 41 | — | — | 1 | — | 42 |
| Essential hypertension | D000075222 | — | I10 | 3 | 2 | 8 | 8 | 6 | 27 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 4 | 8 | 2 | 14 |
| Covid-19 | D000086382 | — | — | — | 5 | 5 | 3 | 1 | 12 |
| Dyslipidemias | D050171 | HP_0003119 | — | 4 | — | 3 | 3 | 2 | 12 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | 5 | 4 | 2 | 12 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | 5 | 5 | 2 | 12 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | 3 | 4 | 2 | 9 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | 1 | 5 | 1 | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 9 | — | 4 | — | — | 13 |
| Infections | D007239 | EFO_0000544 | — | 1 | 3 | 2 | — | — | 5 |
| Communicable diseases | D003141 | — | — | 1 | 3 | 2 | — | — | 5 |
| Hyperlipoproteinemias | D006951 | HP_0010980 | — | — | — | 4 | — | — | 4 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | 3 | — | — | 3 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | 2 | 3 | — | — | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 2 | — | 1 | 3 |
| Cerebral hemorrhage | D002543 | — | — | — | — | 2 | — | 1 | 3 |
| Sars-cov-2 | D000086402 | — | — | — | 2 | 2 | — | — | 2 |
| Cerebral small vessel diseases | D059345 | — | — | — | — | 1 | — | 1 | 2 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 3 | — | — | — | 4 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 2 | — | — | — | 3 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | 2 | — | — | — | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | — | — | — | 1 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | 1 | — | — | — | 1 |
| Acute lung injury | D055371 | EFO_0004610 | — | — | 1 | — | — | — | 1 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | — | 1 | — | — | — | 1 |
| Psychotic affective disorders | D000341 | — | F39 | — | 1 | — | — | — | 1 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | 1 | — | — | — | 1 |
| Treatment-resistant schizophrenia | D000090663 | — | — | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 1 | — | — | — | — | 1 |
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | 1 | — | — | — | — | 1 |
| Apnea | D001049 | HP_0002104 | R06.81 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cough | D003371 | HP_0012735 | R05 | — | — | — | — | 2 | 2 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | — | — | 1 | 1 |
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 1 | 1 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | — | 1 | 1 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 1 | 1 |
| Angina pectoris | D000787 | EFO_0003913 | I20 | — | — | — | — | 1 | 1 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | — | — | 1 | 1 |
| Abdominal obesity | D056128 | HP_0001956 | — | — | — | — | — | 1 | 1 |
| Vascular stiffness | D059289 | — | — | — | — | — | — | 1 | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Telmisartan |
| INN | telmisartan |
| Description | Telmisartan is a member of the class of benzimidazoles used widely in the treatment of hypertension. It has a role as an antihypertensive agent, an angiotensin receptor antagonist, an EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor, a xenobiotic and an environmental contaminant. It is a member of biphenyls, a member of benzimidazoles and a carboxybiphenyl. |
| Classification | Small molecule |
| Drug class | angiotensin II receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCc1nc2c(C)cc(-c3nc4ccccc4n3C)cc2n1Cc1ccc(-c2ccccc2C(=O)O)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 144701-48-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1017 |
| ChEBI ID | 9434 |
| PubChem CID | 65999 |
| DrugBank | DB00966 |
| UNII ID | U5SYW473RQ (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
PPARG
PPARG
Organism
Homo sapiens
Gene name
PPARG
Gene synonyms
NR1C3
NCBI Gene ID
Protein name
peroxisome proliferator-activated receptor gamma
Protein synonyms
Nuclear receptor subfamily 1 group C member 3, peroxisome proliferator-activated receptor-gamma 5, peroxisome proliferator-activated receptor-gamma splicing, PPAR-gamma
Uniprot ID
Mouse ortholog
Pparg (19016)
peroxisome proliferator-activated receptor gamma (P37238)
Variants
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Financial
Revenue by drug
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Estimated US medical usage
Telmisartan
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Amlodipine
Total medical expenditures per year (USD, in millions)
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Telmisartan
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Hydrochlorothiazide
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Telmisartan
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Micardis, Micardis hct, Telmisartan, Telmisartan and amlodipine, Telmisartan and hydrochlorothiazide
Adverse Events
Top Adverse Reactions
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15,036 adverse events reported
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