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.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Lynparza (discontinued: 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 | 2025-07-10 |
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, U-3631 | |
| 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, U-3631 | |
| 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, U-3631 | |
| 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, U-3631 | |
| 9566276 | 2024-03-12 | U-2716 | |
HCPCS
No data
Clinical
Clinical Trials
484 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 | 10 | 23 | 11 | 2 | 12 | 54 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 13 | 20 | 6 | 1 | 3 | 38 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | 14 | 7 | 3 | 9 | 34 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 14 | 1 | 1 | 3 | 21 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 7 | 3 | 1 | 2 | 13 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 7 | 1 | — | 2 | 12 |
| Triple negative breast neoplasms | D064726 | — | — | 4 | 8 | 1 | — | — | 12 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 2 | 5 | 4 | — | 2 | 11 |
| Adenocarcinoma | D000230 | — | — | 1 | 5 | 1 | — | — | 7 |
| Hereditary breast and ovarian cancer syndrome | D061325 | — | — | — | 3 | 2 | — | 1 | 6 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | 4 | 1 | — | — | 5 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 1 | 3 | — | 1 | 5 |
| Colorectal neoplasms | D015179 | — | — | 1 | 2 | 1 | — | — | 4 |
| Fallopian tube neoplasms | D005185 | — | — | 2 | 1 | 1 | — | — | 4 |
| Endometrioid carcinoma | D018269 | — | — | 1 | — | 1 | — | — | 2 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 22 | 9 | — | — | — | 30 |
| Carcinoma | D002277 | — | C80.0 | 6 | 6 | — | — | 1 | 13 |
| Lung neoplasms | D008175 | — | C34.90 | 4 | 7 | — | — | — | 9 |
| Small cell lung carcinoma | D055752 | — | — | 5 | 7 | — | — | — | 9 |
| Recurrence | D012008 | — | — | 3 | 5 | — | — | 1 | 8 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 5 | — | — | — | 6 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 1 | — | — | — | 4 |
| Squamous cell carcinoma | D002294 | — | — | 3 | 1 | — | — | — | 4 |
| Sarcoma | D012509 | — | — | 1 | 3 | — | — | — | 4 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | 3 | — | — | — | 3 |
Show 30 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Head and neck neoplasms | D006258 | — | — | 2 | — | — | — | — | 2 |
| Squamous cell neoplasms | D018307 | — | — | 2 | — | — | — | — | 2 |
| Laryngeal neoplasms | D007822 | EFO_0003817 | C32 | 1 | — | — | — | — | 1 |
| Hyperthermia | D000084462 | — | — | 1 | — | — | — | — | 1 |
| Clear cell adenocarcinoma | D018262 | — | — | 1 | — | — | — | — | 1 |
| Mullerian mixed tumor | D018200 | — | — | 1 | — | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | 1 | — | — | — | — | 1 |
| Brca1 genes | D019398 | — | — | 1 | — | — | — | — | 1 |
| Telomeric repeat binding protein 2 | D035341 | — | — | 1 | — | — | — | — | 1 |
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 | — |
| CAS-ID | 763113-22-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL521686 |
| ChEBI ID | 83766 |
| PubChem CID | 23725625 |
| DrugBank | DB09074 |
| UNII ID | WOH1JD9AR8 (ChemIDplus, GSRS) |
Target
Agency Approved
PARP2
PARP2
Organism
Homo sapiens
Gene name
PARP2
Gene synonyms
ADPRT2, ADPRTL2
NCBI Gene ID
Protein name
poly [ADP-ribose] polymerase 2
Protein synonyms
ADP-ribosyltransferase (NAD+; poly(ADP-ribose) polymerase)-like 2, ADP-ribosyltransferase diphtheria toxin-like 2, ADPRT-2, ARTD2, DNA ADP-ribosyltransferase PARP2, hPARP-2, NAD(+) ADP-ribosyltransferase 2, pADPRT-2, poly (ADP-ribose) polymerase family, member 2, poly (ADP-ribosyl) transferase-like 2, Poly[ADP-ribose] synthase 2, poly[ADP-ribose] synthetase 2, Protein poly-ADP-ribosyltransferase PARP2
Uniprot ID
Mouse ortholog
Parp2 (11546)
poly [ADP-ribose] polymerase 2 (Q99N29)
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
No data
Financial
Revenue by drug
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Lynparza – AstraZeneca
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Lynparza – Merck & Co
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Estimated US medical usage
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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17,944 adverse events reported
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