Lisinopril
Lisinopril, Qbrelis, Zestoretic, Zestril (lisinopril) is a small molecule pharmaceutical. Lisinopril was first approved as Prinivil on 1987-12-29. It is used to treat diabetic nephropathies, heart failure, hypertension, left ventricular dysfunction, and myocardial infarction in the USA. The pharmaceutical is active against angiotensin-converting enzyme.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Qbrelis, Zestril (generic drugs available since 2002-07-01, discontinued: Prinivil)
CombinationsZestoretic (generic drugs available since 2002-07-01, discontinued: Prinzide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydrochlorothiazide
+
Lisinopril
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZESTORETIC | Almatica Pharma | N-019888 RX | 1989-07-20 | 3 products, RLD |
Show 1 discontinued
Lisinopril
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| QBRELIS | Azurity | N-208401 RX | 2016-07-29 | 1 products, RLD, RS |
| ZESTRIL | TWi Pharmaceuticals | N-019777 RX | 1988-05-19 | 6 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lisinopril | ANDA | 2009-09-02 |
| lisinopril and hctz | ANDA | 2014-07-23 |
| lisinopril and hydrochlorothiazide | ANDA | 2024-01-15 |
| lisinopril with hydrochlorothiazide | ANDA | 2016-06-27 |
| lisinopril-hydrochlorothiazide | ANDA | 2013-03-07 |
| zestoretic | New Drug Application | 2021-07-01 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Lisinopril, Qbrelis, Azurity | |||
| 9463183 | 2035-11-06 | DP | |
| 9616096 | 2035-11-06 | U-3, U-8, U-71, U-185, U-1723, U-1864, U-1991 | |
| 9814751 | 2035-11-06 | DP | |
| 10039800 | 2035-11-06 | U-3, U-8, U-71, U-185, U-1723, U-1864, U-1991 | |
| 10265370 | 2035-11-06 | DP | |
| 10406199 | 2035-11-06 | U-3, U-8, U-71, U-185, U-1723, U-1864, U-1991 | |
| 10940177 | 2035-11-06 | DP | |
| 11179434 | 2035-11-06 | DP | |
| 11771733 | 2035-11-06 | DP | |
ATC Codes
C: Cardiovascular system drugs
— C09: Agents acting on the renin-angiotensin system
— C09A: Ace inhibitors, plain
— C09AA: Ace inhibitors, plain
— C09AA03: Lisinopril
— C09B: Ace inhibitors, combinations
— C09BA: Ace inhibitors and diuretics
— C09BA03: Lisinopril and diuretics
— C09BB: Ace inhibitors and calcium channel blockers
— C09BB03: Lisinopril and amlodipine
— C10: Lipid modifying agents
— C10B: Lipid modifying agents, combinations
— C10BX: Lipid modifying agents in combination with other drugs
— C10BX07: Rosuvastatin, amlodipine and lisinopril
HCPCS
No data
Clinical
Clinical Trials
147 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 | 11 | 5 | 11 | 17 | 12 | 55 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 2 | 5 | 3 | 3 | 13 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 2 | — | 2 | 4 | 1 | 9 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | 3 | 4 | 1 | 8 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 1 | 1 | 3 | 1 | 6 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | 1 | 4 | 1 | 6 |
| Coronary disease | D003327 | — | — | — | — | 2 | 1 | 2 | 5 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | 2 | 1 | 4 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | — | — | 1 | 1 | 3 |
| Essential hypertension | D000075222 | — | I10 | — | 1 | — | 1 | 1 | 3 |
Show 17 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | — | 1 | 1 | — | 1 | 2 |
| Polycystic kidney diseases | D007690 | HP_0000113 | Q61.3 | — | — | 2 | — | — | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | 1 | — | — | 2 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | 2 | — | — | 2 |
| Left ventricular hypertrophy | D017379 | EFO_0003896 | — | — | — | 2 | — | — | 2 |
| Hyperoxaluria | D006959 | — | E72.53 | — | — | 1 | — | — | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | — | 1 |
| Abdominal obesity | D056128 | HP_0001956 | — | — | — | 1 | — | — | 1 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | 1 | — | — | 1 |
| Limb-girdle muscular dystrophies | D049288 | EFO_0000758 | G71.03 | — | 1 | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | 2 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Focal segmental glomerulosclerosis | D005923 | EFO_0004236 | — | — | 1 | — | — | — | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | 1 | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
| Cardiotoxicity | D066126 | EFO_1001482 | — | — | 1 | — | — | — | 1 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | — | — | — | 1 |
| Oligospermia | D009845 | — | N46.1 | — | 1 | — | — | — | 1 |
| Prehypertension | D058246 | — | — | 1 | 1 | — | — | — | 1 |
Show 12 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | 1 | 6 |
| Therapeutic equivalency | D013810 | — | — | 3 | — | — | — | — | 3 |
| Fasting | D005215 | EFO_0002756 | — | 2 | — | — | — | — | 2 |
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 2 | 2 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | — | — | 1 | 1 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | — | 1 | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | — | — | 1 | 1 |
| Chest pain | D002637 | HP_0100749 | R07.9 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | — | — | — | — | 1 | 1 |
| Diastolic heart failure | D054144 | EFO_1000899 | I50.30 | — | — | — | — | 1 | 1 |
| Diabetes complications | D048909 | — | — | — | — | — | — | 1 | 1 |
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lisinopril |
| INN | lisinopril |
| Description | Lisinopril is a dipeptide. It has a role as an EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor. It contains a L-prolino group and a L-lysine residue. |
| Classification | Small molecule |
| Drug class | antihypertensives (ACE inhibitors) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O.O.O |
Identifiers
| PDB | — |
| CAS-ID | 83915-83-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL419213 |
| ChEBI ID | 6503 |
| PubChem CID | 5362119 |
| DrugBank | DB00722 |
| UNII ID | 7Q3P4BS2FD (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
No data
Financial
Revenue by drug
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Estimated US medical usage
Lisinopril
+
Hydrochlorothiazide
Total medical expenditures per year (USD, in millions)
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Refill frequency
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Price per prescription (USD)
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Lisinopril
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,320 documents
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Safety
Black-box Warning
Black-box warning for: Lisinopril, Lisinopril and hctz, Lisinopril and hydrochlorothiazide, Lisinopril with hydrochlorothiazide, Lisinopril-hydrochlorothiazide, Zestoretic
Adverse Events
Top Adverse Reactions
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47,818 adverse events reported
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