Pitavastatin
Livalo, Nikita, Pitavastatin, Zypitamag (pitavastatin) is a small molecule pharmaceutical. Pitavastatin was first approved as Livalo on 2009-08-03. It is used to treat hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia in the USA. It is known to target 3-hydroxy-3-methylglutaryl-Coenzyme A reductase.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Livalo, Pitavastatin, Zypitamag (discontinued: Nikita, Zypitamag)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pitavastatin sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NIKITA | Lupin Research | N-209875 DISCN | 2017-08-04 | 3 products, RLD |
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Pitavastatin calcium
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| livalo | New Drug Application | 2024-09-03 |
| nikita | New Drug Application | 2023-06-30 |
| pitavastatin | ANDA | 2024-09-03 |
| pitavastatin calcium | ANDA | 2024-08-15 |
| zypitamag | New Drug Application | 2024-08-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hypercholesterolemia | HP_0003124 | D006937 | — |
| hypertriglyceridemia | EFO_0004211 | D015228 | — |
| hyperlipoproteinemias | HP_0010980 | D006951 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM, AUROBINDO PHARMA | |||
| 2024-02-19 | PC | ||
HCPCS
No data
Clinical
Clinical Trials
102 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyslipidemias | D050171 | HP_0003119 | — | — | — | 15 | 10 | 6 | 31 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | 1 | 1 | 13 | 9 | 4 | 28 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 4 | — | 3 | 3 | 1 | 11 |
| Healthy volunteers/patients | — | — | — | 3 | — | — | 5 | 1 | 9 |
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | — | 1 | 4 | 1 | 8 |
| Hyperlipoproteinemias | D006951 | HP_0010980 | — | 1 | — | 3 | 3 | — | 7 |
| Coronary disease | D003327 | — | — | — | — | 1 | 4 | 1 | 6 |
| Syndrome | D013577 | — | — | 1 | — | — | 3 | 2 | 6 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 2 | 3 | 1 | 6 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 1 | 1 | 4 | 6 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | 1 | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | 1 | — | 1 | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 2 | — | — | 2 |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | — | 1 | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 1 | — | — | 1 |
| Weight gain | D015430 | HP_0004324 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 1 |
| Ototoxicity | D000081015 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | — | — | — | — | 1 |
| Human influenza | D007251 | EFO_0007328 | J11.1 | 1 | — | — | — | — | 1 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | HP_0000855 | — | — | — | — | — | 1 | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | — | 1 | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | — | 1 | 1 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | — | 1 | 1 |
| Hypothyroidism | D007037 | EFO_0004705 | E03.9 | — | — | — | — | 1 | 1 |
| Atherosclerotic plaque | D058226 | HP_0031678 | I70 | — | — | — | — | 1 | 1 |
| Carotid artery diseases | D002340 | EFO_0003781 | — | — | — | — | — | 1 | 1 |
| Vertigo | D014717 | — | H81.39 | — | — | — | — | 1 | 1 |
| Benign paroxysmal positional vertigo | D065635 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pitavastatin |
| INN | pitavastatin |
| Description | Pitavastatin is a dihydroxy monocarboxylic acid that is (6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]hept-6-enoic acid in which the two hydroxy groups are located at positions 3 and 5 (the 3R,5S-stereoisomer). Used as its calcium salt for treatment of hypercholesterolemia (elevated levels of cholesterol in the blood) on patients unable to sufficiently lower their cholesterol levels by diet and exercise. It has a role as an antioxidant. It is a member of quinolines, a dihydroxy monocarboxylic acid, a member of cyclopropanes, a statin (synthetic) and a member of monofluorobenzenes. It is a conjugate acid of a pitavastatin(1-). |
| Classification | Small molecule |
| Drug class | enzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)C[C@H](O)C[C@H](O)/C=C/c1c(C2CC2)nc2ccccc2c1-c1ccc(F)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 147511-69-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201753 |
| ChEBI ID | 32020 |
| PubChem CID | 5282452 |
| DrugBank | — |
| UNII ID | M5681Q5F9P (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
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)
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Pitavastatin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,791 adverse events reported
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