Gepotidacin

Generic Name: Gepotidacin

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₈N_₆O_₃

CAS Number: 1075236-89-3

Unique Ingredient Identifier: DVF0PR037D

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

Associated Conditions: -

Associated Therapies: -

Clinical Trials

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)

Phase 3

Recruiting

Conditions: Urinary Tract Infections

Interventions: Drug: Gepotidacin

First Posted Date: 2024-09-19

Last Posted Date: 2024-11-05

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 90

Registration Number: NCT06597344

Locations: 🇺🇸
GSK Investigational Site, Bountiful, Utah, United States

A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)

Phase 3

Completed

Conditions: Urinary Tract Infections

Interventions: Drug: Gepotidacin
Drug: Nitrofurantoin
Drug: Placebo

First Posted Date: 2022-11-30

Last Posted Date: 2024-08-28

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 382

Registration Number: NCT05630833

Locations: 🇯🇵
GSK Investigational Site, Tokyo, Japan

A Study to Evaluate Pharmacokinetic, Safety, Tolerability and Relative Bioavailability of Gepotidacin in Healthy Adult Male and Female Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Gepotidacin

First Posted Date: 2022-03-09

Last Posted Date: 2023-01-30

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 24

Registration Number: NCT05271799

Locations: 🇺🇸
GSK Investigational Site, Las Vegas, Nevada, United States

Drug-drug Interaction Study of Gepotidacin

Phase 1

Completed

Conditions: Infections, Bacterial

Interventions: Drug: Gepotidacin
Other: Placebo matching to gepotidacin
Drug: Midazolam
Drug: Cimetidine
Drug: Rifampicin
Drug: Digoxin

First Posted Date: 2020-07-30

Last Posted Date: 2022-03-04

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 64

Registration Number: NCT04493931

Locations: 🇺🇸
GSK Investigational Site, Las Vegas, Nevada, United States

Penetration of the Innovative Antibiotic Gepotidacin Into Prostate and Tonsillar Tissue

Phase 1

Completed

Conditions: Infection, Bacterial
Gonorrhea

Interventions: Drug: Gepotidacin

First Posted Date: 2020-07-24

Last Posted Date: 2023-10-25

Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Target Recruit Count: 53

Registration Number: NCT04484740

Locations: 🇫🇷
CHU POITIERS Département Urologie, Poitiers, France
🇫🇷
CHU POITIERS Département ORL, Poitiers, France
🇦🇹
MUVienna, Vienne, Austria

and more 1 locations

Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)

Phase 3

Completed

Conditions: Urinary Tract Infections

Interventions: Drug: Nitrofurantoin
Drug: Gepotidacin
Drug: Placebo matching nitrofurantoin
Drug: Placebo matching gepotidacin

First Posted Date: 2019-12-05

Last Posted Date: 2023-07-18

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 1606

Registration Number: NCT04187144

Locations: 🇵🇱
GSK Investigational Site, Warszawa, Poland

Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects

Phase 1

Completed

Conditions: Infections, Bacterial

Interventions: Drug: Placebo
Drug: Gepotidacin

First Posted Date: 2019-09-06

Last Posted Date: 2020-09-04

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 34

Registration Number: NCT04079790

Locations: 🇺🇸
GSK Investigational Site, Las Vegas, Nevada, United States

A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)

Phase 3

Completed

Conditions: Urinary Tract Infections

Interventions: Drug: Gepotidacin
Drug: Nitrofurantoin
Drug: Placebo matching gepotidacin
Drug: Placebo matching nitrofurantoin

First Posted Date: 2019-07-16

Last Posted Date: 2023-06-22

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 1531

Registration Number: NCT04020341

Locations: 🇬🇧
GSK Investigational Site, Peterborough, United Kingdom

A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

Phase 3

Completed

Conditions: Gonorrhea

Interventions: Drug: Ceftriaxone
Drug: Gepotidacin
Drug: Azithromycin

First Posted Date: 2019-07-08

Last Posted Date: 2024-05-30

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 628

Registration Number: NCT04010539

Locations: 🇬🇧
GSK Investigational Site, St Helens, United Kingdom

Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)

Phase 2

Completed

Conditions: Infections, Bacterial

Interventions: Drug: Gepotidacin

First Posted Date: 2018-06-26

Last Posted Date: 2020-06-29

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 22

Registration Number: NCT03568942

Locations: 🇺🇸
GSK Investigational Site, La Mesa, California, United States

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