CLINICAL TRIALS PROFILE FOR FURADANTIN

All Clinical Trials for FURADANTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02021006 ↗	Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract	Active, not recruiting	IL Sogno di Stefano	Phase 3	2013-12-01	The exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage. Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.
NCT02021006 ↗	Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract	Active, not recruiting	Ministero della Salute, Italy	Phase 3	2013-12-01	The exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage. Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.
NCT02021006 ↗	Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract	Active, not recruiting	Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi	Phase 3	2013-12-01	The exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage. Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.

Clinical Trial Conditions for FURADANTIN

Condition Name

Condition Name for FURADANTIN
Intervention	Trials
Chronic Kidney Disease	1
Complication of Surgical Procedure	1
Renal Hypodysplasia, Nonsyndromic, 1	1

Condition MeSH

Condition MeSH for FURADANTIN
Intervention	Trials
Urinary Tract Infections	1
Infections	1
Infection	1

Clinical Trial Locations for FURADANTIN

Trials by Country

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Trials by Country for FURADANTIN
Location	Trials
China	1
Italy	1

Clinical Trial Progress for FURADANTIN

Clinical Trial Phase

Clinical Trial Phase for FURADANTIN
Clinical Trial Phase	Trials
Phase 3	1
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for FURADANTIN
Clinical Trial Phase	Trials
Active, not recruiting	1
Unknown status	1

Clinical Trial Sponsors for FURADANTIN

Sponsor Name

Sponsor Name for FURADANTIN
Sponsor	Trials
Ministero della Salute, Italy	1
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi	1
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	1

Sponsor Type

Sponsor Type for FURADANTIN
Sponsor	Trials
Other	5

Gepotidacin and the Future of Uncomplicated Urinary Tract Infections (uUTIs) Treatment: A Clinical Trials Update, Market Analysis, and Projections

Introduction

Uncomplicated urinary tract infections (uUTIs) are a common health issue, particularly affecting women. The current standard of care often involves antibiotics like nitrofurantoin, but the rise of antibiotic resistance necessitates the development of new treatments. Gepotidacin, a novel antibiotic, has shown promising results in recent clinical trials and is poised to potentially revolutionize the treatment of uUTIs.

Clinical Trials Update: Gepotidacin vs. Nitrofurantoin

Gepotidacin has undergone extensive clinical testing through the EAGLE-2 and EAGLE-3 phase III trials. These trials compared the efficacy and safety of gepotidacin to nitrofurantoin, the current first-line treatment for uUTIs.

Efficacy Results

In both trials, gepotidacin demonstrated non-inferiority to nitrofurantoin in treating uUTIs. The EAGLE-2 trial showed therapeutic success in 50.6% of patients treated with gepotidacin, compared to 47% for those treated with nitrofurantoin[1][3][5].

The EAGLE-3 trial was even more promising, with gepotidacin achieving statistically significant superiority over nitrofurantoin. Here, therapeutic success was observed in 58.5% of patients treated with gepotidacin, compared to 43.6% for those treated with nitrofurantoin[1][3][5].

Safety and Tolerability

The safety and tolerability profile of gepotidacin was consistent with previous trials. The most common adverse events were gastrointestinal, with diarrhea and nausea being the most frequently reported. However, the majority of these events were mild or moderate, and severe events were rare[1][3].

Market Analysis: The Current State of Nitrofurantoin

Nitrofurantoin, marketed under the brand name Furadantin among others, has been a staple in the treatment of uUTIs for decades.

Market Size and Trends

The global nitrofurantoin market has seen steady growth, driven by the high prevalence of uUTIs. However, the market is also facing challenges due to increasing antibiotic resistance and the need for new therapeutic options. The market analysis indicates a significant demand for alternative treatments, which gepotidacin could potentially fulfill[2].

Market Competition

The nitrofurantoin market is competitive, with several manufacturers vying for market share. The introduction of gepotidacin could disrupt this market dynamics, especially if it gains regulatory approval and demonstrates superior efficacy and safety profiles[2].

Market Projections: The Impact of Gepotidacin

Regulatory Approval

Gepotidacin has been accepted for priority review by the US FDA, with a decision expected by March 26, 2025. If approved, gepotidacin could be the first new class of oral antibiotics for uUTIs in over 20 years, significantly impacting the market[3][5].

Market Share and Adoption

Given its superior efficacy in the EAGLE-3 trial and its novel mechanism of action, gepotidacin is likely to capture a significant share of the uUTI treatment market. This could lead to a decline in the market share of nitrofurantoin and other existing treatments.

Economic Impact

The introduction of gepotidacin could have broader economic implications, including reduced healthcare costs associated with treatment failures and recurrent infections. Additionally, it could alleviate the economic burden on patients by reducing the need for additional antibiotic treatments and hospitalizations[3].

Industry Chain and Supply Dynamics

Upstream Raw Materials

The production of gepotidacin will depend on the availability of its raw materials. Ensuring a stable supply chain will be crucial for meeting the anticipated demand if the drug is approved.

Downstream Industry

The approval of gepotidacin will likely influence the downstream industry, including pharmacies, hospitals, and healthcare providers. These entities will need to adapt to the new treatment option and integrate it into their treatment protocols[2].

Challenges and Opportunities

Antibiotic Resistance

One of the significant challenges in the treatment of uUTIs is the increasing rate of antibiotic resistance. Gepotidacin, with its novel mechanism of action, offers a promising solution to this problem. However, continuous monitoring and stewardship will be necessary to prevent the development of resistance to this new antibiotic as well[3].

Patient Burden

uUTIs cause significant discomfort and restrict daily activities for many patients. Gepotidacin’s potential to offer a more effective treatment could greatly reduce this burden, improving the quality of life for affected individuals.

Key Takeaways

• Clinical Efficacy: Gepotidacin has demonstrated non-inferiority and, in one trial, superiority to nitrofurantoin in treating uUTIs.
• Safety Profile: Gepotidacin has a consistent safety and tolerability profile, with gastrointestinal adverse events being the most common.
• Market Impact: If approved, gepotidacin could significantly disrupt the uUTI treatment market, potentially reducing the market share of nitrofurantoin.
• Economic Benefits: The introduction of gepotidacin could reduce healthcare costs and alleviate the economic burden on patients.
• Challenges and Opportunities: Managing antibiotic resistance and integrating gepotidacin into treatment protocols will be key challenges and opportunities.

FAQs

What is gepotidacin, and how does it differ from existing treatments for uUTIs?

Gepotidacin is a novel, first-in-class oral antibiotic with a new mechanism of action. It has shown superior efficacy in some trials compared to nitrofurantoin, the current standard of care for uUTIs.

What were the key findings of the EAGLE-2 and EAGLE-3 trials?

The EAGLE-2 and EAGLE-3 trials demonstrated that gepotidacin was non-inferior to nitrofurantoin in treating uUTIs. The EAGLE-3 trial also showed that gepotidacin was statistically superior to nitrofurantoin in achieving therapeutic success.

What is the current status of gepotidacin’s regulatory approval?

Gepotidacin has been accepted for priority review by the US FDA, with a decision expected by March 26, 2025.

How might the introduction of gepotidacin affect the market for nitrofurantoin?

The approval of gepotidacin could significantly reduce the market share of nitrofurantoin, as it offers a potentially more effective treatment option for uUTIs.

What are the potential economic benefits of gepotidacin?

Gepotidacin could reduce healthcare costs associated with treatment failures and recurrent infections, and alleviate the economic burden on patients by reducing the need for additional treatments and hospitalizations.

Sources

1. GSK Press Release: "Gepotidacin's positive phase III data shows potential to be the first in a new class of oral antibiotics for uncomplicated urinary tract infections in over 20 years."
2. Prof Research: "Nitrofurantoin Market Size, Share, Trend and Forecast to 2025."
3. GSK Stock-exchange announcement: "Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents."
4. JAMA Network: "Effect of 5-Day Nitrofurantoin vs Single-Dose Fosfomycin on Clinical and Microbiologic Resolution of Uncomplicated Urinary Tract Infection."
5. GSK Press Release: "Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents."