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Drug ReportsOlaparib
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
neoplasmsD009369
urogenital diseasesD000091642
endocrine system diseasesD004700
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
LYNPARZAAstraZenecaN-208558 RX2017-08-17
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
lynparzaNew Drug Application2023-11-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ovarian neoplasmsEFO_0003893D010051C56
Agency Specific
FDA
EMA
Expiration
Code
OLAPARIB, LYNPARZA, ASTRAZENECA
2027-05-08ODE-306
2026-12-27ODE-283
2025-12-19ODE-226
2025-03-11I-885
2024-08-17ODE-180, ODE-181
2023-05-19I-832
2023-05-08I-831
Patent Expiration
Patent
Expires
Flag
FDA Information
Olaparib, Lynparza, Astrazeneca
88595622031-08-04U-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
84758422029-12-31DP
116333962029-10-07DP
82474162028-09-24DP
80715792027-08-12U-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
81432412027-08-12U-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
74494642024-10-11DS, DP
79818892024-10-11DS, DP
89121872024-03-12U-1634, U-2101, U-2480, U-2482, U-2483, U-2819, U-2820, U-2821, U-2822, U-2823, U-2824, U-3333
91692352024-03-12U-2832, U-2833, U-3631
95662762024-03-12U-2716
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XK: Poly (adp-ribose) polymerase (parp) inhibitors
— L01XK01: Olaparib
HCPCS
No data
Clinical
Clinical Trials
466 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 neoplasmsD010051EFO_0003893C5610231121254
Ovarian epithelial carcinomaD000077216——21893940
Breast neoplasmsD001943EFO_0003869C50122061338
Prostatic neoplasmsD011471—C6121531526
Castration-resistant prostatic neoplasmsD064129———731213
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.0691—117
Pancreatic neoplasmsD010190EFO_0003860C25271—212
Endometrial neoplasmsD016889EFO_0004230—254—211
AdenocarcinomaD000230——172——10
RecurrenceD012008——242—19
Hereditary breast and ovarian cancer syndromeD061325——142—17
Stomach neoplasmsD013274EFO_0003897C16141——5
HypersensitivityD006967EFO_0003785T78.40—13—15
Colorectal neoplasmsD015179——121——4
Fallopian tube neoplasmsD005185——211——4
Show 6 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80239———31
Triple negative breast neoplasmsD064726——47———11
Lung neoplasmsD008175—C34.9037———9
Small cell lung carcinomaD055752——35———7
Non-small-cell lung carcinomaD002289——15———6
Neoplasm metastasisD009362EFO_0009708—32———4
Squamous cell carcinomaD002294——31———4
SarcomaD012509——13———4
Renal cell carcinomaD002292EFO_0000376——3———3
Urinary bladder neoplasmsD001749—C6712———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 neoplasmsD006258——2————2
Squamous cell neoplasmsD018307——2————2
Laryngeal neoplasmsD007822EFO_0003817C321————1
HyperthermiaD000084462——1————1
LymphomaD008223—C85.91————1
Thyroid neoplasmsD013964EFO_0003841—1————1
Male genital neoplasmsD005834——1————1
Bone neoplasmsD001859EFO_0003820D161————1
Brca1 genesD019398——1————1
Telomeric repeat binding protein 2D035341——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOlaparib
INNolaparib
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 classpoly-ADP-ribose polymerase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C(c1cc(Cc2n[nH]c(=O)c3ccccc23)ccc1F)N1CCN(C(=O)C2CC2)CC1
Identifiers
PDB—
CAS-ID763113-22-0
RxCUI—
ChEMBL IDCHEMBL521686
ChEBI ID83766
PubChem CID23725625
DrugBankDB09074
UNII IDWOH1JD9AR8 (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
$
€
£
â‚£
Lynparza – AstraZeneca
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Lynparza – Merck & Co
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15,737 adverse events reported
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