Lynparza(olaparib)
Lynparza (olaparib) is a small molecule pharmaceutical. Olaparib was first approved as Lynparza on 2014-12-16. It is used to treat ovarian neoplasms in the USA. It has been approved in Europe to treat ovarian neoplasms. The pharmaceutical is active against poly [ADP-ribose] polymerase 1 and poly [ADP-ribose] polymerase 2. In addition, it is known to target poly [ADP-ribose] polymerase tankyrase-1.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
neoplasms | D009369 |
urogenital diseases | D000091642 |
endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Lynparza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Olaparib
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
LYNPARZA | AstraZeneca | N-208558 RX | 2017-08-17 | 2 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
lynparza | New Drug Application | 2021-03-11 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
ovarian neoplasms | EFO_0003893 | D010051 | C56 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
OLAPARIB, LYNPARZA, ASTRAZENECA | |||
2027-05-08 | ODE-306 | ||
2026-12-27 | ODE-283 | ||
2025-12-19 | ODE-226 | ||
2025-03-11 | I-885 | ||
2024-08-17 | ODE-180, ODE-181 | ||
2023-05-19 | I-832 | ||
2023-05-08 | I-831 |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Olaparib, Lynparza, Astrazeneca | |||
8859562 | 2031-08-04 | U-1634, U-2101, U-2103, U-2480, U-2482, U-2483, U-2716, U-2819, U-2820, U-2821, U-2822, U-2823, U-2824, U-2832, U-2833, U-3333 | |
8475842 | 2029-12-31 | DP | |
11633396 | 2029-10-07 | DP | |
8247416 | 2028-09-24 | DP | |
8071579 | 2027-08-12 | U-2101, U-2103, U-2480, U-2482, U-2483, U-2716, U-2819, U-2820, U-2821, U-2822, U-2823, U-2824, U-2832, U-2833, U-3333 | |
8143241 | 2027-08-12 | U-1634, U-2101, U-2103, U-2480, U-2482, U-2483, U-2716, U-2819, U-2820, U-2821, U-2822, U-2823, U-2824, U-2832, U-2833, U-3333 | |
7449464 | 2024-10-11 | DS, DP | |
7981889 | 2024-10-11 | DS, DP | |
8912187 | 2024-03-12 | U-1634, U-2101, U-2480, U-2482, U-2483, U-2819, U-2820, U-2821, U-2822, U-2823, U-2824, U-3333 | |
9169235 | 2024-03-12 | U-2832, U-2833 | |
9566276 | 2024-03-12 | U-2716 |
HCPCS
No data
Clinical
Clinical Trials
368 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 24 | 38 | 15 | 1 | 8 | 77 |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 27 | 37 | 6 | 1 | 1 | 62 |
Neoplasms | D009369 | C80 | 18 | 14 | — | 1 | 2 | 32 | |
Castration-resistant prostatic neoplasms | D064129 | 7 | 16 | 3 | 1 | — | 21 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Prostatic neoplasms | D011471 | C61 | 7 | 18 | 1 | — | — | 23 | |
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 8 | 14 | 1 | — | — | 21 |
Fallopian tube neoplasms | D005185 | 8 | 10 | 3 | — | — | 17 | ||
Non-small-cell lung carcinoma | D002289 | 5 | 9 | 2 | — | — | 14 | ||
Endometrial neoplasms | D016889 | EFO_0004230 | 5 | 7 | 2 | — | 1 | 12 | |
Stomach neoplasms | D013274 | EFO_0003897 | C16 | 4 | 9 | 1 | — | — | 10 |
Small cell lung carcinoma | D055752 | 5 | 6 | 1 | — | — | 10 | ||
Endometrioid carcinoma | D018269 | 3 | 7 | 2 | — | — | 9 | ||
Colorectal neoplasms | D015179 | 2 | 5 | 1 | — | — | 7 | ||
Ovarian epithelial carcinoma | D000077216 | 1 | 6 | 1 | — | — | 7 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Triple negative breast neoplasms | D064726 | 10 | 17 | — | — | — | 24 | ||
Squamous cell carcinoma of head and neck | D000077195 | 4 | 4 | — | — | — | 7 | ||
Adenocarcinoma | D000230 | 1 | 7 | — | — | — | 7 | ||
Non-hodgkin lymphoma | D008228 | C85.9 | 2 | 4 | — | — | — | 6 | |
Glioma | D005910 | EFO_0000520 | 1 | 6 | — | — | — | 6 | |
Glioblastoma | D005909 | EFO_0000515 | 2 | 3 | — | — | — | 5 | |
Urinary bladder neoplasms | D001749 | C67 | 1 | 4 | — | — | — | 5 | |
Renal cell carcinoma | D002292 | 1 | 3 | — | — | — | 4 | ||
Pancreatic ductal carcinoma | D021441 | 1 | 3 | — | — | — | 4 | ||
Cholangiocarcinoma | D018281 | C22.1 | — | 4 | — | — | — | 4 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hodgkin disease | D006689 | C81 | 2 | — | — | — | — | 2 | |
Neoplasm metastasis | D009362 | EFO_0009708 | 2 | — | — | — | — | 2 | |
Head and neck neoplasms | D006258 | 2 | — | — | — | — | 2 | ||
Squamous cell neoplasms | D018307 | 2 | — | — | — | — | 2 | ||
Lymphoma | D008223 | C85.9 | 2 | — | — | — | — | 2 | |
Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | — | — | — | — | 1 | |
Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | OLAPARIB |
INN | olaparib |
Description | Olaparib is a member of the class of N-acylpiperazines obtained by formal condensation of the carboxy group of 2-fluoro-5-[(4-oxo-3,4-dihydrophthalazin-1-yl)methyl]benzoic acid with the free amino group of N-(cyclpropylcarbonyl)piperazine; used to treat advanced ovarian cancer. It has a role as an antineoplastic agent, an EC 2.4.2.30 (NAD(+) ADP-ribosyltransferase) inhibitor and an apoptosis inducer. It is a N-acylpiperazine, a member of cyclopropanes, a member of monofluorobenzenes and a member of phthalazines. |
Classification | Small molecule |
Drug class | poly-ADP-ribose polymerase inhibitors |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | O=C(c1cc(Cc2n[nH]c(=O)c3ccccc23)ccc1F)N1CCN(C(=O)C2CC2)CC1 |
Identifiers
PDB | 7KKO |
CAS-ID | 763113-22-0 |
RxCUI | 1597582 |
ChEMBL ID | CHEMBL521686 |
ChEBI ID | 83766 |
PubChem CID | 23725625 |
DrugBank | DB09074 |
UNII ID | WOH1JD9AR8 (ChemIDplus, GSRS) |
Target
Agency Approved
PARP1
PARP1
PARP2
PARP2
Organism
Homo sapiens
Gene name
PARP1
Gene synonyms
ADPRT, PPOL
NCBI Gene ID
Protein name
poly [ADP-ribose] polymerase 1
Protein synonyms
ADP-ribosyltransferase (NAD+; poly (ADP-ribose) polymerase), ADP-ribosyltransferase diphtheria toxin-like 1, ADP-ribosyltransferase NAD(+), ADPRT 1, ARTD1, DNA ADP-ribosyltransferase PARP1, NAD(+) ADP-ribosyltransferase 1, poly (ADP-ribose) polymerase family, member 1, poly(ADP-ribose) synthetase, poly(ADP-ribosyl)transferase, Poly[ADP-ribose] synthase 1, Protein poly-ADP-ribosyltransferase PARP1
Uniprot ID
Mouse ortholog
Parp1 (11545)
poly [ADP-ribose] polymerase 1 (P11103)
Alternate
TNKS
TNKS
Organism
Homo sapiens
Gene name
TNKS
Gene synonyms
PARP5A, PARPL, TIN1, TINF1, TNKS1
NCBI Gene ID
Protein name
poly [ADP-ribose] polymerase tankyrase-1
Protein synonyms
ADP-ribosyltransferase diphtheria toxin-like 5, ARTD5, Poly [ADP-ribose] polymerase 5A, Protein poly-ADP-ribosyltransferase tankyrase-1, TANK1, Tankyrase I, tankyrase, TRF1-interacting ankyrin-related ADP-ribose polymerase, Tankyrase-1, TNKS-1, TRF1-interacting ankyrin-related ADP-ribose polymerase, TRF1-interacting ankyrin-related ADP-ribose polymerase 1
Uniprot ID
Mouse ortholog
Tnks (21951)
poly [ADP-ribose] polymerase tankyrase-1 (Q8BX62)
Variants
Clinical Variant
No data
Financial
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Lynparza - Merck Sharp & Dohme
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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