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. The pharmaceutical is active against angiotensin-converting enzyme.
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Commercial
Trade Name
FDA
EMA
Epaned, Vasotec (generic drugs available since 2000-08-22)
CombinationsVaseretic (generic drugs available since 2000-08-22, discontinued: Lexxel, Teczem)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Diltiazem malate
+
Enalapril maleate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TECZEM | Bausch Health Companies | N-020507 DISCN | 1996-10-04 | 1 products |
Hide discontinued
Enalapril maleate
Enalapril maleate
+
Felodipine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LEXXEL | AstraZeneca | N-020668 DISCN | 1996-12-27 | 2 products |
Hide discontinued
Enalapril maleate
+
Hydrochlorothiazide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VASERETIC | Bausch Health Companies | N-019221 RX | 1986-10-31 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| enalapril maleate | ANDA | 2023-06-15 |
| epaned | New Drug Application | 2020-03-31 |
| vaseretic | New Drug Application | 2020-08-31 |
| vasotec | New Drug Application | 2020-12-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bartter syndrome | Orphanet_112 | D001477 | E26.81 |
| diabetic nephropathies | EFO_0000401 | D003928 | — |
| edema | — | D004487 | R60.9 |
| heart failure | EFO_0003144 | D006333 | I50 |
| left ventricular dysfunction | — | D018487 | — |
| malignant hypertension | EFO_1001031 | D006974 | — |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
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
No data
Clinical
Clinical Trials
113 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 4 | 15 | 10 | 1 | 28 |
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | 5 | 11 | 8 | 3 | 27 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 2 | 2 | 2 | — | 6 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | 1 | 1 | 3 |
| Essential hypertension | D000075222 | I10 | 1 | 2 | — | 1 | — | 3 | |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 1 | 1 | 2 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | — | 1 | 1 | 2 | |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | 1 | — | 1 | — | 2 |
| Healthy volunteers/patients | — | 1 | — | — | 1 | — | 2 | ||
| Cardiotoxicity | D066126 | EFO_1001482 | — | — | 1 | 1 | — | 2 |
Show 17 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | 2 | 4 | — | — | 4 |
| Coronary disease | D003327 | — | 1 | 2 | — | 1 | 3 | ||
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 2 | — | — | 3 |
| Dilated cardiomyopathy | D002311 | EFO_0000407 | I42.0 | — | 2 | 3 | — | — | 3 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | 1 | — | 1 | 2 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | — | 1 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | 1 | 2 |
| Neoplasms | D009369 | C80 | — | — | 2 | — | — | 2 | |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | 1 | — | 1 | 2 | |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | 1 | 2 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral hemorrhage | D002543 | — | 2 | — | — | 1 | 3 | ||
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | 1 | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | 2 | — | — | — | 2 | |
| Chronic renal insufficiency | D051436 | N18 | 1 | 1 | — | — | 1 | 2 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | — | — | — | 1 |
| Melanoma | D008545 | — | 1 | — | — | — | 1 | ||
| Glomerulonephritis | D005921 | N05 | — | 1 | — | — | — | 1 | |
| Membranoproliferative glomerulonephritis | D015432 | — | 1 | — | — | — | 1 | ||
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | 1 | — | — | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | — | — | 1 |
Show 3 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 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lupus nephritis | D008181 | EFO_0005761 | — | — | — | — | 1 | 1 | |
| Fabry disease | D000795 | E75.21 | — | — | — | — | 1 | 1 | |
| Prehypertension | D058246 | — | — | — | — | 1 | 1 | ||
| Exercise | D015444 | EFO_0000483 | — | — | — | — | 1 | 1 | |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | — | 1 | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | 1 | |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | — | — | 1 | 1 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | — | — | 1 | 1 | |
| Orthostatic hypotension | D007024 | I95.1 | — | — | — | — | 1 | 1 | |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | — | — | — | 1 | 1 |
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 | 3827 |
| 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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Enalapril maleate, Epaned, Vaseretic, Vasotec
Adverse Events
Top Adverse Reactions
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1,654 adverse events reported
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