Panobinostat

Panobinostat
Clinical data
Trade names	Farydak
Other names	LBH-589
AHFS/Drugs.com	Monograph
License data	US DailyMed: Panobinostat;
Routes of; administration	By mouth
ATC code	L01XH03 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only); US: ℞-only; EU: Rx-only; In general: ℞ (Prescription only);
Pharmacokinetic data
Bioavailability	21%
Protein binding	90%
Metabolism	CYP3A (40%), CYP2D6, CYP2C19
Elimination half-life	37 hours
Excretion	Fecal (44–77%), renal (29–51%)
Identifiers
	IUPAC name (2E)-N-hydroxy-3-[4-({[2-(2-methyl-1H-indol-3-yl)ethyl]amino}methyl)phenyl]acrylamide;
CAS Number	404950-80-7 ;
PubChem CID	6918837;
IUPHAR/BPS	7489;
DrugBank	DB06603 ;
ChemSpider	5294028 ;
UNII	9647FM7Y3Z;
KEGG	D10319 ;
ChEBI	CHEBI:85990 ;
CompTox Dashboard (EPA)	DTXSID40193506 ;
ECHA InfoCard	100.230.582
Chemical and physical data
Formula	C21H23N3O2
Molar mass	349.434 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES O=C(NO)\C=C\c1ccc(cc1)CNCCc3c2ccccc2[nH]c3C;
	InChI InChI=1S/C21H23N3O2/c1-15-18(19-4-2-3-5-20(19)23-15)12-13-22-14-17-8-6-16(7-9-17)10-11-21(25)24-26/h2-11,22-23,26H,12-14H2,1H3,(H,24,25)/b11-10+ ; Key:FPOHNWQLNRZRFC-ZHACJKMWSA-N ;
	(what is this?) (verify)

Panobinostat, sold under the brand name Farydak, is a medication used for the treatment of multiple myeloma.^[2]^[3] It is a hydroxamic acid^[4] and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor).^[5]

Panobinostat was approved for medical use in the United States in February 2015,^[2]^[6]^[7] and in the European Union in August 2015.^[3]^[8] However, in March 2022, it was withdrawn in the United States.^[9]^[10]

^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
^ ^a ^b ^c ^d ^e ^f ^g ^h "Farydak- panobinostat capsule". DailyMed. 27 July 2021. Retrieved 22 October 2022.
^ ^a ^b ^c "Farydak EPAR". European Medicines Agency. 17 September 2018. Retrieved 22 October 2022.
^ Cite error: The named reference Revill2007 was invoked but never defined (see the help page).
^ Table 3: Select epigenetic inhibitors in various stages of development Archived 18 April 2016 at the Wayback Machine from Mack GS (December 2010). "To selectivity and beyond". Nature Biotechnology. 28 (12): 1259–66. doi:10.1038/nbt.1724. PMID 21139608. S2CID 11480326.
^ "Farydak Drug Approval Package". U.S. Food and Drug Administration (FDA). 17 March 2015. Retrieved 22 October 2022.
^ "Drug Trials Snapshot: Farydak (panobinostat)". U.S. Food and Drug Administration (FDA). 30 July 2020. Retrieved 22 October 2022.
^ "Farydak product details". European Medicines Agency. 17 September 2018. Archived from the original on 20 June 2018. Retrieved 1 February 2017.
^ "Withdrawn Oncology /Hematologic Malignancies Accelerated Approvals". U.S. Food and Drug Administration (FDA). 1 June 2022. Retrieved 22 October 2022.
^ "Secura Bio, Inc.; Withdrawal of Approval of New Drug Application for Farydak (panobinostat) Capsules, 10 Milligrams, 15 Milligrams, and 20 Milligrams". Federal Register. 24 March 2022. Retrieved 22 October 2022.

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

[Farydak_FDA_label-2] ^ ^a ^b ^c ^d ^e ^f ^g ^h "Farydak- panobinostat capsule". DailyMed. 27 July 2021. Retrieved 22 October 2022.

[Farydak_EPAR-3] "Farydak EPAR". European Medicines Agency. 17 September 2018. Retrieved 22 October 2022.

[Revill2007-4] Cite error: The named reference Revill2007 was invoked but never defined (see the help page).

[NBT2010-5] Table 3: Select epigenetic inhibitors in various stages of development Archived 18 April 2016 at the Wayback Machine from Mack GS (December 2010). "To selectivity and beyond". Nature Biotechnology. 28 (12): 1259–66. doi:10.1038/nbt.1724. PMID 21139608. S2CID 11480326.

[6] "Farydak Drug Approval Package". U.S. Food and Drug Administration (FDA). 17 March 2015. Retrieved 22 October 2022.

[7] "Drug Trials Snapshot: Farydak (panobinostat)". U.S. Food and Drug Administration (FDA). 30 July 2020. Retrieved 22 October 2022.

[8] "Farydak product details". European Medicines Agency. 17 September 2018. Archived from the original on 20 June 2018. Retrieved 1 February 2017.

[9] "Withdrawn Oncology /Hematologic Malignancies Accelerated Approvals". U.S. Food and Drug Administration (FDA). 1 June 2022. Retrieved 22 October 2022.

[10] "Secura Bio, Inc.; Withdrawal of Approval of New Drug Application for Farydak (panobinostat) Capsules, 10 Milligrams, 15 Milligrams, and 20 Milligrams". Federal Register. 24 March 2022. Retrieved 22 October 2022.

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