CLINICAL TRIALS PROFILE FOR PROBENECID; SULOPENEM ETZADROXIL

All Clinical Trials for PROBENECID; SULOPENEM ETZADROXIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04700787 ↗	Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents	Not yet recruiting	Iterum Therapeutics, International Limited	Phase 1	2021-01-21	The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous sulopenem and oral sulopenem etzadroxil/probenecid in adolescent patients.
NCT03357614 ↗	Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults	Completed	Iterum Therapeutics, International Limited	Phase 3	2018-09-18	This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.
NCT03357614 ↗	Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults	Completed	Iterum Therapeutics, US Limited	Phase 3	2018-09-18	This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.
NCT03358576 ↗	Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)	Completed	Iterum Therapeutics, International Limited	Phase 3	2018-09-18	This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin-metronidazole for treatment of complicated intra-abdominal infections in adults.
NCT03358576 ↗	Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)	Completed	Iterum Therapeutics, US Limited	Phase 3	2018-09-18	This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin-metronidazole for treatment of complicated intra-abdominal infections in adults.
NCT03354598 ↗	Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women	Completed	Iterum Therapeutics, International Limited	Phase 3	2018-08-01	This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women
NCT03354598 ↗	Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women	Completed	Iterum Therapeutics, US Limited	Phase 3	2018-08-01	This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women

Clinical Trial Conditions for PROBENECID; SULOPENEM ETZADROXIL

Condition Name

Condition Name for PROBENECID; SULOPENEM ETZADROXIL
Intervention	Trials
Urinary Tract Infections	4
Antibiotic Resistant Infection	3
Complicated Infection	2
Complicated Urinary Tract Infections	1

Condition MeSH

Condition MeSH for PROBENECID; SULOPENEM ETZADROXIL
Intervention	Trials
Communicable Diseases	5
Urinary Tract Infections	4
Infections	4
Infection	4

Clinical Trial Locations for PROBENECID; SULOPENEM ETZADROXIL

Trials by Country

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−

Trials by Country for PROBENECID; SULOPENEM ETZADROXIL
Location	Trials
United States	49
Hungary	2
Georgia	2
Estonia	2
Latvia	2

Trials by US State

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−

Trials by US State for PROBENECID; SULOPENEM ETZADROXIL
Location	Trials
California	4
Ohio	3
Montana	3
Idaho	3
Texas	3

Clinical Trial Progress for PROBENECID; SULOPENEM ETZADROXIL

Clinical Trial Phase

Clinical Trial Phase for PROBENECID; SULOPENEM ETZADROXIL
Clinical Trial Phase	Trials
Phase 3	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for PROBENECID; SULOPENEM ETZADROXIL
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	2

Clinical Trial Sponsors for PROBENECID; SULOPENEM ETZADROXIL

Sponsor Name

Sponsor Name for PROBENECID; SULOPENEM ETZADROXIL
Sponsor	Trials
Iterum Therapeutics, International Limited	5
Iterum Therapeutics, US Limited	3

Sponsor Type

Sponsor Type for PROBENECID; SULOPENEM ETZADROXIL
Sponsor	Trials
Industry	8

Probenecid and Sulopenem Etzadroxil: Clinical Trials, Market Analysis, and Projections

Introduction to Probenecid and Sulopenem Etzadroxil

Probenecid, a drug traditionally used to treat gout, and sulopenem etzadroxil, a penem beta-lactam antibiotic, are being explored in various clinical trials for different indications. Here, we will delve into the current status of these drugs, their clinical trials, market analysis, and future projections.

Probenecid in Opioid Withdrawal

Clinical Trials

A groundbreaking clinical trial led by Dr. Lori Montgomery and Dr. Tuan Trang at the University of Calgary is investigating the use of probenecid to alleviate the symptoms of opioid withdrawal. This trial is based on research that showed probenecid effectively reduces opioid withdrawal in rodents by disrupting abnormal brain-spinal cord communication[1][4].

• Trial Design: The pilot 12-week randomized control trial is recruiting individuals aged 18 and over who aim to taper or stop their opioid use.
• Dosage and Side Effects: Probenecid is administered in doses lower than those used for gout, with common side effects including headache and nausea.
• Significance: Understanding the neurobiology behind opioid withdrawal is crucial for developing effective treatments, and probenecid shows promise in this area.

Sulopenem Etzadroxil in Urinary Tract Infections

Clinical Development

Sulopenem etzadroxil, combined with probenecid, is under clinical development by Iterum Therapeutics for the treatment of urinary tract infections (UTIs).

• Indications: The drug is indicated for uncomplicated UTIs caused by specific microorganisms such as Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options[2][3].
• Clinical Trials: The drug has completed a Phase III trial and is currently in a Phase I trial to evaluate its safety, tolerability, and pharmacokinetics in adolescent patients with bacterial infections, including UTIs[3].

Market Analysis

Market Potential

The combination of sulopenem etzadroxil and probenecid, known as Orlynvah, is expected to compete in the UTI market, which is anticipated to be impacted by the launch of late-stage emerging therapies.

• Competitive Landscape: The report by DelveInsight highlights that Orlynvah will face competition from other emerging products in the advanced stages of pipeline development for UTIs[3].
• Market Forecast: The market forecast analysis suggests that the launch of Orlynvah and other emerging therapies will significantly impact the UTI market, with detailed assessments available in market reports[3].

Regulatory Status

• FDA Response: In November 2020, Iterum Therapeutics filed a New Drug Application (NDA) with the FDA for oral sulopenem etzadroxil, but the FDA issued a Complete Response Letter (CRL) requiring additional data to support approval for the treatment of UTIs in adult women[3].

Likelihood of Approval and Phase Transition Success Rate

GlobalData's report provides insights into the likelihood of approval (LOA) and phase transition success rate (PTSR) for sulopenem etzadroxil and probenecid.

• PTSR Benchmark: Pre-Registration drugs for UTIs have an 87% phase transition success rate, indicating a high likelihood of progressing to the marketed stage[2][5].
• LOA Scores: The report assesses the drug-specific LOA scores compared to indication benchmarks, helping to predict the drug's success in clinical development[5].

Mechanism of Action and Drug Characteristics

Probenecid

• Traditional Use: Probenecid is traditionally used to treat gout by increasing the excretion of uric acid.
• New Application: In the context of opioid withdrawal, probenecid disrupts the abnormal brain-spinal cord communication that occurs during withdrawal, reducing severe pain and other symptoms[1][4].

Sulopenem Etzadroxil

• Mechanism of Action: Sulopenem etzadroxil acts as a penem beta-lactam antibiotic by targeting penicillin-binding proteins (PBPs), making it effective against a range of bacteria[2][3].
• Formulation: The drug is formulated as film-coated tablets or bilayer tablets for oral administration[2].

Future Projections

Probenecid in Opioid Withdrawal

• Potential Impact: If successful, probenecid could offer a new treatment option for opioid withdrawal, addressing a significant gap in current treatment strategies.
• Clinical Significance: Understanding the neurobiology behind opioid withdrawal and the role of probenecid could lead to more effective treatments and better patient outcomes[1][4].

Sulopenem Etzadroxil in UTIs

• Market Impact: The approval and launch of sulopenem etzadroxil and probenecid could significantly impact the UTI market, providing an alternative treatment option for patients with limited or no other oral antibacterial treatment choices[3].
• Competitive Advantage: The drug's unique mechanism of action and favorable safety profile could give it a competitive edge in the market[2][3].

Key Takeaways

• Probenecid: Shows promise in reducing opioid withdrawal symptoms by disrupting abnormal brain-spinal cord communication.
• Sulopenem Etzadroxil: Under development for UTIs, with a high likelihood of approval and significant market potential.
• Clinical Trials: Ongoing trials for both indications are crucial for understanding efficacy and safety.
• Market Analysis: The launch of these drugs could significantly impact their respective markets, offering new treatment options for patients.

FAQs

What is the current status of probenecid in treating opioid withdrawal?

Probenecid is currently in a 12-week randomized control trial to assess its efficacy in reducing opioid withdrawal symptoms. The trial is based on research showing its effectiveness in rodents.

What are the common side effects of probenecid in the context of opioid withdrawal?

The common side effects of probenecid in this context include headache and nausea.

What is sulopenem etzadroxil used for?

Sulopenem etzadroxil, combined with probenecid, is under development for the treatment of uncomplicated urinary tract infections (UTIs) caused by specific microorganisms.

What is the regulatory status of sulopenem etzadroxil and probenecid for UTIs?

The FDA has issued a Complete Response Letter (CRL) requiring additional data to support approval for the treatment of UTIs in adult women.

What is the market potential for sulopenem etzadroxil and probenecid in UTIs?

The drug has significant market potential, with a high likelihood of approval and the potential to compete effectively in the UTI market.

Sources

1. University of Calgary News: "New insights on brain-spinal communication in opioid withdrawal lead to clinical trial" - August 27, 2024.
2. Pharmaceutical Technology: "(Probenecid + sulopenem etzadroxil) by Iterum Therapeutics for Urinary Tract Infections" - August 28, 2024.
3. OpenPR: "Sulopenem Etzadroxil/Probenecid Drug Market Forecast and Analysis" - July 7, 2023.
4. News-Medical.Net: "Probenecid shows promise for easing opioid withdrawal symptoms in new study" - August 29, 2024.
5. GlobalData: "(Probenecid + Sulopenem Etzadroxil) in Urinary Tract Infections" - July 16, 2024.