Vasotec, Aqumeldi(enalapril)
Aqumeldi, Enalapril, Epaned, Lexxel, Teczem, Vaseretic, Vasotec (enalapril) is a small molecule pharmaceutical. Enalapril was first approved as Vasotec on 1985-12-24. It is used to treat bartter syndrome, diabetic nephropathies, edema, heart failure, and left ventricular dysfunction amongst others in the USA. It has been approved in Europe to treat heart failure. The pharmaceutical is active against angiotensin-converting enzyme.
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Commercial
Trade Name
FDA
EMA
Enalapril, Epaned, Vasotec (discontinued: Enalapril, Epaned)
CombinationsEnalapril hydrochlorothiazide, Vaseretic (discontinued: Enalapril hydrochlorothiazide, Lexxel, Teczem)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Enalapril maleate
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Felodipine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LEXXEL | AstraZeneca | N-020668 DISCN | 1996-12-27 | 2 products |
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Enalapril maleate
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Hydrochlorothiazide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VASERETIC | Bausch Health Companies | N-019221 RX | 1986-10-31 | 2 products, RLD, RS |
Enalapril maleate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| EPANED | Azurity | N-208686 RX | 2016-09-20 | 1 products, RLD, RS |
| VASOTEC | Bausch Health Companies | N-018998 RX | 1985-12-24 | 4 products, RLD, RS |
Show 1 discontinued
Diltiazem malate
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Enalapril maleate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TECZEM | Bausch Health Companies | N-020507 DISCN | 1996-10-04 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| enalapril maleate | ANDA | 2025-09-30 |
| enalapril maleate and hydrochlorothiazide | ANDA | 2024-02-12 |
| enalapril maleate oral solution | ANDA | 2024-07-09 |
| enalaprilat | ANDA | 2024-06-07 |
| epaned | New Drug Application | 2020-07-27 |
| vaseretic | New Drug Application | 2020-08-31 |
| vasotec | New Drug Application | 2020-12-01 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Enalapril Maleate, Epaned, Azurity | |||
| 9669008 | 2036-03-25 | DP | |
| 9808442 | 2036-03-25 | U-3, U-71, U-185, U-1723, U-1892 | |
| 10039745 | 2036-03-25 | DP | |
| 10154987 | 2036-03-25 | U-3, U-71, U-185, U-1723, U-1892 | |
| 10772868 | 2036-03-25 | DP | |
| 10786482 | 2036-03-25 | DP | |
| 11040023 | 2036-03-25 | DP | |
| 11141405 | 2036-03-25 | DP | |
| 11173141 | 2036-03-25 | DP | |
| Enalapril Maleate, Epaned Kit, Silvergate Pharms | |||
| 8568747 | 2032-11-06 | DP | |
| 8778366 | 2032-11-06 | U-3, U-71, U-185, U-1723, U-1892 | |
| 9855214 | 2032-11-06 | DP | |
| 9968553 | 2032-11-06 | U-3, U-71, U-185, U-1723, U-1892 | |
ATC Codes
C: Cardiovascular system drugs
— C09: Agents acting on the renin-angiotensin system
— C09A: Ace inhibitors, plain
— C09AA: Ace inhibitors, plain
— C09AA02: Enalapril
— C09B: Ace inhibitors, combinations
— C09BA: Ace inhibitors and diuretics
— C09BA02: Enalapril and diuretics
— C09BB: Ace inhibitors and calcium channel blockers
— C09BB02: Enalapril and lercanidipine
— C09BB06: Enalapril and nitrendipine
HCPCS
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Clinical
Clinical Trials
171 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 | 3 | 10 | 14 | 18 | 12 | 54 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 5 | 16 | 15 | 3 | 37 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 3 | 5 | 4 | 2 | 14 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 4 | 1 | 2 | 7 | 13 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 4 | 4 | 1 | 3 | 10 |
| Essential hypertension | D000075222 | — | I10 | 1 | 3 | 2 | 3 | 1 | 9 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | 3 | 3 | 8 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 2 | 1 | 2 | 3 | 7 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | 2 | 4 | 7 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | 3 | 4 | 1 | 1 | 7 |
Show 40 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 2 | — | 4 | 6 |
| Congenital heart defects | D006330 | — | Q24.9 | — | 2 | 4 | — | — | 4 |
| Coronary disease | D003327 | — | — | — | 1 | 2 | — | 1 | 3 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | — | 1 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | 1 | 2 |
| Ischemic stroke | D000083242 | — | — | — | — | 1 | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | — | — | 2 | — | — | 2 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 1 | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | 1 | — | — | 1 |
| Balloon angioplasty coronary | D015906 | EFO_0003951 | — | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral hemorrhage | D002543 | — | — | — | 2 | — | — | 2 | 4 |
| Glomerulonephritis | D005921 | — | N05 | — | 2 | — | — | 1 | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 2 | — | — | 1 | 3 |
| Systolic murmurs | D054160 | — | R01.1 | — | 1 | — | — | 1 | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | — | 2 | — | — | — | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | — | — | — | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | 1 | — | — | — | 1 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | 1 | — | — | — | 1 |
| Melanoma | D008545 | — | — | — | 1 | — | — | — | 1 |
| Membranoproliferative glomerulonephritis | D015432 | — | — | — | 1 | — | — | — | 1 |
Show 15 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | 1 | — | — | — | — | 1 |
| Kidney transplantation | D016030 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | — | 3 | 3 |
| Hypertrophic cardiomyopathy | D002312 | EFO_0000538 | I42.1 | — | — | — | — | 2 | 2 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | — | 2 | 2 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 1 | 1 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | — | — | — | 1 | 1 |
| Fabry disease | D000795 | Orphanet_324 | E75.21 | — | — | — | — | 1 | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | — | 1 | 1 |
| Unstable angina | D000789 | EFO_1000985 | I20.0 | — | — | — | — | 1 | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | — | 1 | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | — | — | 1 | 1 |
Show 22 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Enalapril |
| INN | enalapril |
| Description | Enalapril is a dicarboxylic acid monoester that is ethyl 4-phenylbutanoate in which a hydrogen alpha to the carboxy group is substituted by the amino group of L-alanyl-L-proline (S-configuration). It has a role as a prodrug, an EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor, an antihypertensive agent and a geroprotector. It is a dicarboxylic acid monoester and a dipeptide. It is functionally related to an enalaprilat (anhydrous). |
| Classification | Small molecule |
| Drug class | narcotic agonists/antagonists (normorphine type); antihypertensives (ACE inhibitors) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCOC(=O)[C@H](CCc1ccccc1)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 75847-73-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL578 |
| ChEBI ID | 4784 |
| PubChem CID | 5388962 |
| DrugBank | DB00584 |
| UNII ID | 69PN84IO1A (ChemIDplus, GSRS) |
Target
Agency Approved
ACE
ACE
Organism
Homo sapiens
Gene name
ACE
Gene synonyms
DCP, DCP1
NCBI Gene ID
Protein name
angiotensin-converting enzyme
Protein synonyms
angiotensin I converting enzyme (peptidyl-dipeptidase A) 1, carboxycathepsin, CD143, CD143 antigen, dipeptidyl carboxypeptidase 1, Dipeptidyl carboxypeptidase I, Kininase II, peptidase P
Uniprot ID
Mouse ortholog
Ace (11421)
angiotensin-converting enzyme (P09470)
Alternate
No data
Variants
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Financial
Revenue by drug
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Estimated US medical usage
Enalapril
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Diltiazem
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Enalapril
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Enalapril
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Felodipine
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Enalapril
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Hydrochlorothiazide
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 22,192 documents
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Safety
Black-box Warning
Black-box warning for: Enalapril maleate, Enalapril maleate and hydrochlorothiazide, Enalapril maleate oral solution, Enalaprilat, Epaned, Vaseretic, Vasotec
Adverse Events
Top Adverse Reactions
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15,587 adverse events reported
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