Gepotidacin

Overview

Gepotidacin has been used in trials studying the treatment of Gonorrhea, Infections, Bacterial, and Infections, Respiratory Tract.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)	2024/09/19	NCT06597344	Phase 3	Completed	GlaxoSmithKline
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)	2022/11/30	NCT05630833	Phase 3	Completed	GlaxoSmithKline
A Study to Evaluate Pharmacokinetic, Safety, Tolerability and Relative Bioavailability of Gepotidacin in Healthy Adult Male and Female Participants	2022/03/09	NCT05271799	Phase 1	Completed	GlaxoSmithKline
Drug-drug Interaction Study of Gepotidacin	2020/07/30	NCT04493931	Phase 1	Completed	GlaxoSmithKline
Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue	2020/07/24	NCT04484740	Phase 1	Completed	Institut National de la Santé Et de la Recherche Médicale, France
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)	2019/12/05	NCT04187144	Phase 3	Completed	GlaxoSmithKline
Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects	2019/09/06	NCT04079790	Phase 1	Completed	GlaxoSmithKline
A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)	2019/07/16	NCT04020341	Phase 3	Completed	GlaxoSmithKline
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea	2019/07/08	NCT04010539	Phase 3	Completed	GlaxoSmithKline
Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)	2018/06/26	NCT03568942	Phase 2	Completed	GlaxoSmithKline

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

GSK's Tebipenem HBr Phase III Trial Stopped Early for Efficacy in Complicated UTI Treatment

2 months ago

GSK and Spero Therapeutics announced the pivotal Phase III PIVOT-PO trial for tebipenem HBr was stopped early for efficacy following a recommendation from an Independent Data Monitoring Committee based on data from 1,690 patients.

FDA Approves Blujepa: First Novel Oral Antibiotic for UTIs in Over Two Decades

4 months ago

• The FDA has approved gepotidacin (Blujepa), the first new class of oral antibiotics for urinary tract infections in nearly 30 years, addressing growing concerns about antimicrobial resistance. • Developed by GSK with partial funding from US government agencies, Blujepa works by interfering with bacterial enzymes needed for replication, potentially reducing the likelihood of resistance development. • Clinical trials involving over 3,000 females demonstrated Blujepa's efficacy comparable to or better than nitrofurantoin, with availability expected in the second half of 2025.

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