Olaparib

Olaparib
Clinical data
Trade names	Lynparza, others
Other names	AZD-2281, MK-7339, KU0059436
AHFS/Drugs.com	Monograph
MedlinePlus	a614060
License data	US DailyMed: Olaparib;
Pregnancy; category	AU: D; ;
Routes of; administration	By mouth
ATC code	L01XK01 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only); CA: ℞-only; UK: POM (Prescription only); US: ℞-only; EU: Rx-only; In general: ℞ (Prescription only);
Identifiers
	IUPAC name 4-[(3-[(4-cyclopropylcarbonyl)piperazin-1-yl]carbonyl) -4-fluorophenyl]methyl(2H)phthalazin-1-one;
CAS Number	763113-22-0 ;
PubChem CID	23725625;
IUPHAR/BPS	7519;
DrugBank	DB09074 ;
ChemSpider	23343272 ;
UNII	WOH1JD9AR8;
KEGG	D09730;
ChEBI	CHEBI:83766 ;
ChEMBL	ChEMBL521686 ;
PDB ligand	09L (PDBe, RCSB PDB);
CompTox Dashboard (EPA)	DTXSID60917988 ;
ECHA InfoCard	100.170.811
Chemical and physical data
Formula	C24H23FN4O3
Molar mass	434.471 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES c4cccc2c4c(n[nH]c2=O)Cc(ccc1F)cc1C(=O)N3CCN(CC3)C(=O)C5CC5;
	InChI InChI=1S/C24H23FN4O3/c25-20-8-5-15(14-21-17-3-1-2-4-18(17)22(30)27-26-21)13-19(20)24(32)29-11-9-28(10-12-29)23(31)16-6-7-16/h1-5,8,13,16H,6-7,9-12,14H2,(H,27,30) ; Key:FDLYAMZZIXQODN-UHFFFAOYSA-N ;
	(what is this?) (verify)

Olaparib, sold under the brand name Lynparza, is a medication for the maintenance treatment of BRCA-mutated advanced ovarian cancer in adults. It is a PARP inhibitor, inhibiting poly ADP ribose polymerase (PARP), an enzyme involved in DNA repair. It acts against cancers in people with hereditary BRCA1 or BRCA2 mutations, which include some ovarian, breast, and prostate cancers.^[10]

In December 2014, olaparib was approved for use as a single agent by the European Medicines Agency (EMA) in the European Union and by the Food and Drug Administration (FDA) in the United States.^[11]^[12]^[13]^[14]

^ https://www.tga.gov.au/resources/auspar/auspar-olaparib-1
^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
^ "Product monograph brand safety updates". Health Canada. February 2024. Retrieved 24 March 2024.
^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
^ "Lynparza 50 mg hard capsules - Summary of Product Characteristics (SmPC)". (emc). 7 October 2019. Archived from the original on 23 September 2020. Retrieved 13 April 2020.
^ "Lynparza 100mg Film-Coated Tablets - Summary of Product Characteristics (SmPC)". (emc). 7 October 2019. Retrieved 13 April 2020.
^ Cite error: The named reference Lynparza capsule PI was invoked but never defined (see the help page).
^ Cite error: The named reference Lynparza FDA label was invoked but never defined (see the help page).
^ "Lynparza EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 6 October 2020.
^ Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, et al. (July 2009). "Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers". The New England Journal of Medicine. 361 (2): 123–134. doi:10.1056/NEJMoa0900212. PMID 19553641.
^ "Lynparza (olaparib): An overview of Lynparza and why it is authorised in the EU" (PDF). European Medicines Agency (EMA). Archived from the original (PDF) on 16 March 2018. Retrieved 13 April 2020.
^ "Lynparza EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 April 2020.
^ "Drug Approval Package: Lynparza (olaparib) Capsules NDA #206162". U.S. Food and Drug Administration (FDA). 22 January 2015. Retrieved 13 April 2020.
^ "FDA approves Lynparza to treat advanced ovarian cancer". U.S. Food and Drug Administration (FDA) (Press release). 19 December 2014. Archived from the original on 19 December 2014. Retrieved 30 December 2019. This article incorporates text from this source, which is in the public domain.

[1] ttps://www.tga.gov.au/resources/auspar/auspar-olaparib-1

[2] "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.

[3] "Product monograph brand safety updates". Health Canada. February 2024. Retrieved 24 March 2024.

[4] "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.

[5] "Lynparza 50 mg hard capsules - Summary of Product Characteristics (SmPC)". (emc). 7 October 2019. Archived from the original on 23 September 2020. Retrieved 13 April 2020.

[6] "Lynparza 100mg Film-Coated Tablets - Summary of Product Characteristics (SmPC)". (emc). 7 October 2019. Retrieved 13 April 2020.

[Lynparza_capsule_PI-7] Cite error: The named reference Lynparza capsule PI was invoked but never defined (see the help page).

[Lynparza_FDA_label-8] Cite error: The named reference Lynparza FDA label was invoked but never defined (see the help page).

[9] "Lynparza EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 6 October 2020.

[Fong2009-10] Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, et al. (July 2009). "Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers". The New England Journal of Medicine. 361 (2): 123–134. doi:10.1056/NEJMoa0900212. PMID 19553641.

[EMA-11] "Lynparza (olaparib): An overview of Lynparza and why it is authorised in the EU" (PDF). European Medicines Agency (EMA). Archived from the original (PDF) on 16 March 2018. Retrieved 13 April 2020.

[Lynparza_EPAR-12] "Lynparza EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 April 2020.

[FDA_approval-13] "Drug Approval Package: Lynparza (olaparib) Capsules NDA #206162". U.S. Food and Drug Administration (FDA). 22 January 2015. Retrieved 13 April 2020.

[FDAapp-14] "FDA approves Lynparza to treat advanced ovarian cancer". U.S. Food and Drug Administration (FDA) (Press release). 19 December 2014. Archived from the original on 19 December 2014. Retrieved 30 December 2019. This article incorporates text from this source, which is in the public domain.

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