Lefamulin information

Lefamulin
Clinical data
Trade names	Xenleta
Other names	BC-3781
AHFS/Drugs.com	Monograph
License data	US DailyMed: Lefamulin;
Routes of; administration	Intravenous, by mouth
ATC code	J01XX12 (WHO) ;
Legal status
Legal status	CA: ℞-only; US: ℞-only; EU: Rx-only;
Identifiers
	IUPAC name (1S,2R,3S,4S,6R,7R,8R,14R)-3-Hydroxy-2,4,7,14-tetramethyl-9-oxo-4-vinyltricyclo[5.4.3.01,8]tetradec-6-yl {[(1R,2R,4R)-4-amino-2-hydroxycyclohexyl]sulfanyl}acetate;
CAS Number	1061337-51-6;
PubChem CID	25185057;
DrugBank	DB12825;
ChemSpider	32701544;
UNII	21904A5386;
KEGG	D11631;
ChEMBL	ChEMBL3291398;
Chemical and physical data
Formula	C28H45NO5S
Molar mass	507.73 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES C[C@@H]1CC[C@@]23CCC(=O)[C@H]2[C@@]1([C@@H](C[C@@]([C@H]([C@@H]3C)O)(C)C=C)OC(=O)CS[C@@H]4CC[C@H](C[C@H]4O)N)C;
	InChI InChI=1S/C28H45NO5S/c1-6-26(4)14-22(34-23(32)15-35-21-8-7-18(29)13-20(21)31)27(5)16(2)9-11-28(17(3)25(26)33)12-10-19(30)24(27)28/h6,16-18,20-22,24-25,31,33H,1,7-15,29H2,2-5H3/t16-,17+,18-,20-,21-,22-,24+,25+,26-,27+,28+/m1/s1; Key:KPVIXBKIJXZQJX-FCEONZPQSA-N;

Lefamulin, sold under the brand name Xenleta, is an antibiotic medication used it to treat adults with community-acquired bacterial pneumonia.^[5]^[6] It is taken by mouth or by injection into a vein.^[5]^[6]^[7]

Relatively common side effects include diarrhea, nausea, pain at the site of injection, and liver inflammation.^[5]^[8] It is a pleuromutilin antibiotic that inhibits the large subunit of bacterial ribosomes.^[9]^[10]

Lefamulin was approved for medical use in the United States in August 2019,^[5]^[11] and in the European Union in July 2020.^[3]

^ "Summary Basis of Decision (SBD) for Xenleta". Health Canada. 23 October 2014. Retrieved 29 May 2022.
^ "Xenleta- lefamulin acetate injection, solution citric buffered normal saline- anhydrous citric acid injection, solution Xenleta- lefamulin acetate tablet, coated". DailyMed. 12 February 2020. Retrieved 24 September 2020.
^ ^a ^b "Xenleta EPAR". European Medicines Agency. 26 May 2020. Retrieved 24 September 2020.
^ "Xenleta Product information". Union Register of medicinal products. Retrieved 3 March 2023.
^ ^a ^b ^c ^d "FDA approves new antibiotic to treat community-acquired bacterial pneumonia". U.S. Food and Drug Administration (FDA) (Press release). 19 August 2019. Archived from the original on 20 November 2019. Retrieved 19 November 2019. This article incorporates text from this source, which is in the public domain.
^ ^a ^b "Drug Trials Snapshots: Xenleta". U.S.Food and Drug Administration (FDA). 4 September 2019. Archived from the original on 20 November 2019. Retrieved 19 November 2019.
^ File TM, Goldberg L, Das A, Sweeney C, Saviski J, Gelone SP, et al. (November 2019). "Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial". Clinical Infectious Diseases. 69 (11): 1856–1867. doi:10.1093/cid/ciz090. PMC 6853694. PMID 30722059.
^ Alexander E, Goldberg L, Das AF, Moran GJ, Sandrock C, Gasink LB, et al. (November 2019). "Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia: The LEAP 2 Randomized Clinical Trial". JAMA. 322 (17): 1661–1671. doi:10.1001/jama.2019.15468. PMC 6865224. PMID 31560372.
^ Andrei S, Droc G, Stefan G (December 2019). "FDA approved antibacterial drugs: 2018-2019". Discoveries. 7 (4): e102. doi:10.15190/d.2019.15. PMC 7086080. PMID 32309620.
^ Eyal Z, Matzov D, Krupkin M, Paukner S, Riedl R, Rozenberg H, et al. (December 2016). "A novel pleuromutilin antibacterial compound, its binding mode and selectivity mechanism". Scientific Reports. 6: 39004. Bibcode:2016NatSR...639004E. doi:10.1038/srep39004. PMC 5154188. PMID 27958389.
^ Cite error: The named reference FDA approval package was invoked but never defined (see the help page).

[1] "Summary Basis of Decision (SBD) for Xenleta". Health Canada. 23 October 2014. Retrieved 29 May 2022.

[Xenleta_FDA_label-2] "Xenleta- lefamulin acetate injection, solution citric buffered normal saline- anhydrous citric acid injection, solution Xenleta- lefamulin acetate tablet, coated". DailyMed. 12 February 2020. Retrieved 24 September 2020.

[Xenleta_EPAR-3] "Xenleta EPAR". European Medicines Agency. 26 May 2020. Retrieved 24 September 2020.

[4] "Xenleta Product information". Union Register of medicinal products. Retrieved 3 March 2023.

[FDA2019-5] "FDA approves new antibiotic to treat community-acquired bacterial pneumonia". U.S. Food and Drug Administration (FDA) (Press release). 19 August 2019. Archived from the original on 20 November 2019. Retrieved 19 November 2019. This article incorporates text from this source, which is in the public domain.

[FDA2019Snap-6] "Drug Trials Snapshots: Xenleta". U.S.Food and Drug Administration (FDA). 4 September 2019. Archived from the original on 20 November 2019. Retrieved 19 November 2019.

[pmid30722059-7] File TM, Goldberg L, Das A, Sweeney C, Saviski J, Gelone SP, et al. (November 2019). "Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial". Clinical Infectious Diseases. 69 (11): 1856–1867. doi:10.1093/cid/ciz090. PMC 6853694. PMID 30722059.

[pmid31560372-8] Alexander E, Goldberg L, Das AF, Moran GJ, Sandrock C, Gasink LB, et al. (November 2019). "Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia: The LEAP 2 Randomized Clinical Trial". JAMA. 322 (17): 1661–1671. doi:10.1001/jama.2019.15468. PMC 6865224. PMID 31560372.

[pmid32309620-9] Andrei S, Droc G, Stefan G (December 2019). "FDA approved antibacterial drugs: 2018-2019". Discoveries. 7 (4): e102. doi:10.15190/d.2019.15. PMC 7086080. PMID 32309620.

[pmid27958389-10] Eyal Z, Matzov D, Krupkin M, Paukner S, Riedl R, Rozenberg H, et al. (December 2016). "A novel pleuromutilin antibacterial compound, its binding mode and selectivity mechanism". Scientific Reports. 6: 39004. Bibcode:2016NatSR...639004E. doi:10.1038/srep39004. PMC 5154188. PMID 27958389.

[FDA_approval_package-11] Cite error: The named reference FDA approval package was invoked but never defined (see the help page).

Lefamulin information

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ATC code J01

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