Pravachol, Pravafenix(pravastatin)
Pravachol, Pravafenix, Pravigard (pravastatin) is a small molecule pharmaceutical. Pravastatin was first approved as Pravachol on 1991-10-31. It is used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia in the USA. It has been approved in Europe to treat dyslipidemias. The pharmaceutical is active against 3-hydroxy-3-methylglutaryl-Coenzyme A reductase. In addition, it is known to target solute carrier organic anion transporter family member 1B1.
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Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pravastatin sodium | ANDA | 2023-05-09 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| coronary artery disease | — | D003324 | I25.1 |
| hypercholesterolemia | HP_0003124 | D006937 | — |
| hyperlipoproteinemias | — | D006951 | — |
| hypertriglyceridemia | EFO_0004211 | D015228 | — |
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AA: Hmg coa reductase inhibitors, plain lipid modifying drugs
— C10AA03: Pravastatin
— C10B: Lipid modifying agents, combinations
— C10BA: Combinations of various lipid modifying agents
— C10BA03: Pravastatin and fenofibrate
— C10BA11: Pravastatin and ezetimibe
— C10BA12: Pravastatin, ezetimibe and fenofibrate
— C10BX: Lipid modifying agents in combination with other drugs
— C10BX02: Pravastatin and acetylsalicylic acid
HCPCS
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Clinical
Clinical Trials
146 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | HP_0003124 | — | 3 | 7 | 5 | 4 | 19 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 5 | 3 | 1 | 4 | 1 | 14 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | 4 | 2 | 3 | 10 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 1 | 1 | 2 | 4 | — | 8 |
| Dyslipidemias | D050171 | HP_0003119 | 1 | 1 | 1 | 3 | 2 | 8 | |
| Coronary disease | D003327 | — | 2 | 1 | 2 | — | 5 | ||
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | 2 | 1 | 1 | 4 |
| Coronary artery disease | D003324 | I25.1 | — | — | — | 1 | 3 | 4 | |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | — | 4 | — | 4 | |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | 2 | 1 | — | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 2 | — | 1 | 4 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 1 | 1 | — | — | 3 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | 2 | 1 | — | — | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | 1 | — | — | 2 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 1 | — | — | 1 | |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | — | 1 |
| Lung neoplasms | D008175 | C34.90 | — | — | 1 | — | — | 1 | |
| Hyperlipoproteinemia type iii | D006952 | — | — | 1 | — | — | 1 | ||
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 1 | — | — | 1 |
| Arterial occlusive diseases | D001157 | EFO_0009085 | — | — | 1 | — | — | 1 |
Show 6 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | 1 | 2 | — | — | 1 | 3 |
| Leukemia | D007938 | C95 | 2 | 1 | — | — | — | 3 | |
| Progeria | D011371 | E34.8 | — | 3 | — | — | — | 3 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | 1 | — | — | 1 | 2 | |
| Megakaryoblastic leukemia acute | D007947 | C94.2 | 1 | 1 | — | — | 1 | 2 | |
| Monocytic leukemia acute | D007948 | 1 | 1 | — | — | 1 | 2 | ||
| Myelomonocytic leukemia acute | D015479 | C92.5 | 1 | 1 | — | — | 1 | 2 | |
| Myeloid leukemia | D007951 | C92 | 1 | 1 | — | — | 1 | 2 | |
| Erythroblastic leukemia acute | D004915 | EFO_1001257 | C94.0 | 1 | 1 | — | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
Show 11 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 12 | — | — | — | — | 12 | ||
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 3 | — | — | — | — | 3 |
| Drug interactions | D004347 | 2 | — | — | — | — | 2 | ||
| Therapeutic equivalency | D013810 | 2 | — | — | — | — | 2 | ||
| Hiv seronegativity | D018023 | 1 | — | — | — | — | 1 | ||
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | 1 | — | — | — | — | 1 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | 1 | — | — | — | — | 1 |
| Peripheral arterial disease | D058729 | EFO_0004265 | 1 | — | — | — | — | 1 | |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | C61 | — | — | — | — | 1 | 1 | |
| Postpartum depression | D019052 | EFO_0007453 | F53.0 | — | — | — | — | 1 | 1 |
| Myelodysplastic syndromes | D009190 | D46 | — | — | — | — | 1 | 1 | |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | — | — | — | — | 1 | 1 | |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | — | — | 1 | 1 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | — | — | — | 1 | 1 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | — | — | 1 | 1 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | PRAVASTATIN |
| INN | pravastatin |
| Description | Pravastatin is a carboxylic ester resulting from the formal condensation of (S)-2-methylbutyric acid with the hydroxy group adjacent to the ring junction of (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6,8-dihydroxy-2-methyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid. Derived from microbial transformation of mevastatin, pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA). The sodium salt is used for lowering cholesterol and preventing cardiovascular disease. It is one of the lower potency statins, but has the advantage of fewer side effects compared with lovastatin and simvastatin. It has a role as a metabolite, an anticholesteremic drug, a xenobiotic and an environmental contaminant. It is a 3-hydroxy carboxylic acid, a hydroxy monocarboxylic acid, a carboxylic ester, a secondary alcohol, a carbobicyclic compound and a statin (semi-synthetic). It is functionally related to a (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6,8-dihydroxy-2-methyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid and a (S)-2-methylbutyric acid. It is a conjugate acid of a pravastatin(1-). |
| Classification | Small molecule |
| Drug class | enzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@H](C)C(=O)O[C@H]1C[C@H](O)C=C2C=C[C@H](C)[C@H](CC[C@@H](O)C[C@@H](O)CC(=O)O)[C@H]21 |
Identifiers
| PDB | — |
| CAS-ID | 81093-37-0 |
| RxCUI | 42463 |
| ChEMBL ID | CHEMBL1144 |
| ChEBI ID | 63618 |
| PubChem CID | 54687 |
| DrugBank | DB00175 |
| UNII ID | KXO2KT9N0G (ChemIDplus, GSRS) |
Target
Agency Approved
HMGCR
HMGCR
Organism
Homo sapiens
Gene name
HMGCR
Gene synonyms
NCBI Gene ID
Protein name
3-hydroxy-3-methylglutaryl-Coenzyme A reductase
Protein synonyms
3-hydroxy-3-methylglutaryl CoA reductase (NADPH), HMG-CoA reductase, hydroxymethylglutaryl-CoA reductase
Uniprot ID
Mouse ortholog
Hmgcr (15357)
3-hydroxy-3-methylglutaryl-coenzyme A reductase (Q5U4I2)
Alternate
SLCO1B1
SLCO1B1
Organism
Homo sapiens
Gene name
SLCO1B1
Gene synonyms
LST1, OATP1B1, OATP2, OATPC, SLC21A6
NCBI Gene ID
Protein name
solute carrier organic anion transporter family member 1B1
Protein synonyms
Liver-specific organic anion transporter 1, LST-1, OATP-2, OATP-C, Organic anion transporter SLC21A6, Sodium-independent organic anion-transporting polypeptide 2, solute carrier family 21 (organic anion transporter), member 6, Solute carrier family 21 member 6
Uniprot ID
Mouse ortholog
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Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000037346 | SLCO1B1, 521T>C, Val174Ala | drug response | 2022-02-15 | 1A |
| VCV001327417 | KIF6, 2155T>C, Trp719Arg | drug response | 2021-03-24 | 2B |
Financial
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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12,540 adverse events reported
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