Perindopril
Perindopril Erbumine, Prestalia (perindopril) is a small molecule pharmaceutical. Perindopril was first approved as Aceon on 1993-12-30. It is used to treat diabetic nephropathies, heart failure, hypertension, and left ventricular dysfunction in the USA. The pharmaceutical is active against angiotensin-converting enzyme.
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Prestalia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amlodipine besylate
+
Perindopril arginine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PRESTALIA | Adhera Therapeutics | N-205003 RX | 2015-01-21 | 3 products, RLD, RS |
Perindopril erbumine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACEON | Symplmed Pharmaceuticals | N-020184 DISCN | 1993-12-30 | 3 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| prestalia | New Drug Application | 2019-10-25 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Amlodipine Besylate / Perindopril Arginine, Prestalia, Adhera | |||
| 7846961 | 2029-10-05 | DS, DP | U-3 |
ATC Codes
C: Cardiovascular system drugs
— C09: Agents acting on the renin-angiotensin system
— C09A: Ace inhibitors, plain
— C09AA: Ace inhibitors, plain
— C09AA04: Perindopril
— C09B: Ace inhibitors, combinations
— C09BA: Ace inhibitors and diuretics
— C09BA04: Perindopril and diuretics
— C09BB: Ace inhibitors and calcium channel blockers
— C09BB04: Perindopril and amlodipine
— C09BX: Ace inhibitors, other combinations in atc
— C09BX01: Perindopril, amlodipine and indapamide
— C09BX02: Perindopril and bisoprolol
— C09BX04: Perindopril, bisoprolol and amlodipine
— C10: Lipid modifying agents
— C10B: Lipid modifying agents, combinations
— C10BX: Lipid modifying agents in combination with other drugs
— C10BX11: Atorvastatin, amlodipine and perindopril
— C10BX12: Atorvastatin, acetylsalicylic acid and perindopril
— C10BX13: Rosuvastatin, perindopril and indapamide
— C10BX14: Rosuvastatin, amlodipine and perindopril
— C10BX15: Atorvastatin and perindopril
HCPCS
No data
Clinical
Clinical Trials
93 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 | 3 | 15 | 6 | 27 |
| Essential hypertension | D000075222 | — | I10 | — | — | 4 | 1 | 3 | 8 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | 4 | — | 5 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 3 | 1 | 4 |
| Covid-19 | D000086382 | — | U07.1 | — | — | 1 | 1 | 1 | 3 |
| Heart failure | D006333 | HP_0001635 | I50 | 1 | 1 | — | 1 | 1 | 3 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | 2 | 1 | 3 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 1 | 1 | 1 | 3 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | — | 1 | 1 | 2 |
| Dyslipidemias | D050171 | HP_0003119 | — | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 1 | — | 2 | 3 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | 1 | — | — | 1 |
| Dilated cardiomyopathy | D002311 | HP_0001644 | I42.0 | — | — | 1 | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aging | D000375 | GO_0007568 | R41.81 | — | 1 | — | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | — | — | — | 2 |
| Ischemic stroke | D000083242 | — | — | — | 1 | — | — | 1 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | — | — | 1 | 2 |
| Sedentary behavior | D057185 | — | — | — | 1 | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | — | 1 | — | — | — | 1 |
| Abdominal aortic aneurysm | D017544 | EFO_0004214 | — | — | 1 | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | 1 | 5 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 2 | 2 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | — | — | — | — | 1 | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | — | 1 | 1 |
| Patient participation | D010358 | — | — | — | — | — | — | 1 | 1 |
| Coronary disease | D003327 | — | — | — | — | — | — | 1 | 1 |
| Subdural hematoma chronic | D020200 | — | — | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 1 | 1 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 1 | 1 |
| Cardio-renal syndrome | D059347 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Perindopril |
| INN | perindopril |
| Description | Perindopril is an alpha-amino acid ester that is the ethyl ester of N-{(2S)-1-[(2S,3aS,7aS)-2-carboxyoctahydro-1H-indol-1-yl]-1-oxopropan-2-yl}-L-norvaline It has a role as an EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor and an antihypertensive agent. It is an alpha-amino acid ester, a dicarboxylic acid monoester, an organic heterobicyclic compound and an ethyl ester. It is a conjugate acid of a perindopril(1-). |
| Classification | Small molecule |
| Drug class | antihypertensives (ACE inhibitors) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC[C@H](N[C@@H](C)C(=O)N1[C@H](C(=O)O)C[C@@H]2CCCC[C@@H]21)C(=O)OCC |
Identifiers
| PDB | — |
| CAS-ID | 82834-16-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1581 |
| ChEBI ID | 8024 |
| PubChem CID | 107807 |
| DrugBank | DB00790 |
| UNII ID | Y5GMK36KGY (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
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Prestalia – Adhera Therapeutics
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Estimated US medical usage
Perindopril
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Safety
Black-box Warning
Black-box warning for: Prestalia
Adverse Events
Top Adverse Reactions
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10,970 adverse events reported
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