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Gepotidacin

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Gepotidacin
Clinical data
Trade namesBlujepa
Other namesGSK2140944
AHFS/Drugs.comBlujepa
License data
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
  • (2R)-2-({4-[(3,4-Dihydro-2H-pyrano[2,3-c]pyridin-6-ylmethyl)amino]-1-piperidinyl}methyl)-1,2-dihydro-3H,8H-2a,5,8a-triazaacenaphthylene-3,8-dione
CAS Number
DrugBank
ChemSpider
UNII
KEGG
ECHA InfoCard100.249.088 Edit this at Wikidata
Chemical and physical data
FormulaC24H28N6O3
Molar mass448.527 g·mol−1
3D model (JSmol)
  • c1cc(=O)n2c3c1ncc(=O)n3[C@@H](C2)CN4CCC(CC4)NCc5cc6c(cn5)OCCC6
  • InChI=1S/C24H28N6O3/c31-22-4-3-20-24-29(22)15-19(30(24)23(32)13-27-20)14-28-7-5-17(6-8-28)25-11-18-10-16-2-1-9-33-21(16)12-26-18/h3-4,10,12-13,17,19,25H,1-2,5-9,11,14-15H2/t19-/m1/s1
  • Key:PZFAZQUREQIODZ-LJQANCHMSA-N

Gepotidacin, sold under the brand name Blujepa, is an antibiotic medication used for the treatment of urinary tract infection.[1] Gepotidacin is a triazaacenaphthylene bacterial type II topoisomerase inhibitor.[1][2] It is used as the salt gepotidacin mesylate, and is taken by mouth.[1]

Gepotidacin was approved for medical use in the United States in March 2025.[1][3]

Medical uses

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Gepotidacin is indicated for the treatment of females aged twelve years of age and older weighing at least 40 kilograms (88 lb) with uncomplicated urinary tract infections (uUTI) caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis

Society and culture

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In October 2024, gepotidacin was granted priority review by the US Food and Drug Administration (FDA) for the treatment of uncomplicated urinary tract infections.[4]

Gepotidacin was approved for medical use in the United States in March 2025.[1][5]

Names

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Gepotidacin is the international nonproprietary name.[6]

Gepotidacin is sold under the brand name Blujepa.[1][5]

Research

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Gepotidacin is being studied for the treatment of Neisseria gonorrhoeae (gonorrhea) infection, including multidrug resistant strains.[7][8]

References

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  1. ^ a b c d e f g https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218230s000lbl.pdf
  2. ^ Biedenbach DJ, Bouchillon SK, Hackel M, Miller LA, Scangarella-Oman NE, Jakielaszek C, et al. (January 2016). "In Vitro Activity of Gepotidacin, a Novel Triazaacenaphthylene Bacterial Topoisomerase Inhibitor, against a Broad Spectrum of Bacterial Pathogens". Antimicrobial Agents and Chemotherapy. 60 (3): 1918–1923. doi:10.1128/aac.02820-15. PMC 4776004. PMID 26729499.
  3. ^ Maggie Fick, Sneha S K and Mariam E Sunny (2025). "FDA approval". Reuters.
  4. ^ "GSK's investigational antibiotic granted FDA priority review for urinary tract infections". PMLiVE. 18 October 2024. Retrieved 21 October 2024.
  5. ^ a b "Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients 12 years of age and older". GSK (Press release). 25 March 2025. Retrieved 28 March 2025.
  6. ^ World Health Organization (2015). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 74". WHO Drug Information. 29 (3). hdl:10665/331070.
  7. ^ Scangarella-Oman NE, Hossain M, Dixon PB, Ingraham K, Min S, Tiffany CA, et al. (December 2018). "Microbiological Analysis from a Phase 2 Randomized Study in Adults Evaluating Single Oral Doses of Gepotidacin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria gonorrhoeae". Antimicrobial Agents and Chemotherapy. 62 (12). doi:10.1128/AAC.01221-18. PMC 6256812. PMID 30249694.
  8. ^ Jacobsson S, Golparian D, Scangarella-Oman N, Unemo M (August 2018). "In vitro activity of the novel triazaacenaphthylene gepotidacin (GSK2140944) against MDR Neisseria gonorrhoeae". The Journal of Antimicrobial Chemotherapy. 73 (8): 2072–2077. doi:10.1093/jac/dky162. PMC 6927889. PMID 29796611.

Further reading

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  • Wagenlehner F, Perry CR, Hooton TM, Scangarella-Oman NE, Millns H, Powell M, et al. (February 2024). "Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials". Lancet. 403 (10428): 741–755. doi:10.1016/S0140-6736(23)02196-7. PMID 38342126. S2CID 267548740.
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  • Clinical trial number NCT04020341 for "A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)" at ClinicalTrials.gov
  • Clinical trial number NCT04187144 for "Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)" at ClinicalTrials.gov


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