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Last Updated: March 24, 2025

CLINICAL TRIALS PROFILE FOR PROBENECID


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All Clinical Trials for Probenecid

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000670 ↗ Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To evaluate the interaction of probenecid with zidovudine (AZT). Because AZT is eliminated quickly from the body, it must be taken frequently. A previous study showed that probenecid slowed the elimination of AZT without side effects, but that study lasted only 5 days. This study is to see whether this effect continues for 1 month and whether the continuation of probenecid and AZT is free of side effects over 1 month.
NCT00000706 ↗ Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 Part I studies the effect of quinine on how zidovudine (AZT) is used by the body and eliminated through the kidneys in HIV infected patients. Part II studies the effect of probenecid and quinine on the same aspects. Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.
NCT00000799 ↗ HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol Completed Gilead Sciences N/A 1969-12-31 To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Probenecid

Condition Name

Condition Name for Probenecid
Intervention Trials
HIV Infections 10
Cytomegalovirus Retinitis 7
Healthy 6
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Condition MeSH

Condition MeSH for Probenecid
Intervention Trials
HIV Infections 11
Communicable Diseases 8
Retinitis 7
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Clinical Trial Locations for Probenecid

Trials by Country

Trials by Country for Probenecid
Location Trials
United States 195
Canada 10
Germany 6
South Africa 6
Poland 5
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Trials by US State

Trials by US State for Probenecid
Location Trials
California 16
Texas 13
Ohio 10
New York 10
Florida 8
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Clinical Trial Progress for Probenecid

Clinical Trial Phase

Clinical Trial Phase for Probenecid
Clinical Trial Phase Trials
Phase 4 6
Phase 3 10
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Probenecid
Clinical Trial Phase Trials
Completed 45
Not yet recruiting 11
Recruiting 6
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Clinical Trial Sponsors for Probenecid

Sponsor Name

Sponsor Name for Probenecid
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 8
Iterum Therapeutics, International Limited 5
National Institutes of Health (NIH) 5
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Sponsor Type

Sponsor Type for Probenecid
Sponsor Trials
Industry 41
Other 34
NIH 21
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Probenecid: Clinical Trials, Market Analysis, and Projections

Introduction to Probenecid

Probenecid is a medication primarily used to treat gout and hyperuricemia by reducing the renal excretion of uric acid. It is also utilized to enhance the efficacy of certain antibiotics, such as penicillin, by inhibiting their renal excretion. Here, we will delve into the current clinical trials, market analysis, and future projections for probenecid.

Clinical Trials and Recent Developments

Sulopenem Etzadroxil/Probenecid Combination

One of the significant recent developments involving probenecid is its combination with sulopenem etzadroxil for the treatment of uncomplicated urinary tract infections (uUTIs). Iterum Therapeutics has resubmitted this combination to the FDA after receiving a Complete Response Letter (CRL) in 2021, which requested additional clinical data. This combination has been granted Fast Track and Qualified Infectious Disease Product (QIDP) designations, highlighting its potential in addressing antibiotic-resistant infections[1][3].

Ongoing and Completed Trials

  • Sulopenem Etzadroxil/Probenecid: Currently, sulopenem is undergoing Phase I clinical investigation in adolescent patients with bacterial infections, including uUTIs. This multi-center, open-label study aims to evaluate the safety, tolerability, and pharmacokinetics of sulopenem and the combination with probenecid[3].

Market Analysis

Global Probenecid Market

The global probenecid market is driven by several key factors:

  • Increasing Prevalence of Gout: The rising incidence of gout and related disorders is a significant driver for the probenecid market. As the population ages and lifestyle factors contribute to higher uric acid levels, the demand for probenecid is expected to increase[5].

  • Cost-Effective Healthcare Solutions: The growing demand for cost-effective healthcare solutions, particularly in emerging economies, is another driver. Generic versions of probenecid offer affordable alternatives to branded medications, making them more accessible to a broader population[5].

  • Enhancement of Antibiotic Efficacy: Probenecid's role in enhancing the efficacy of antibiotics by reducing their renal excretion continues to be a critical application, especially in the context of increasing antibiotic resistance[5].

Market Size and Growth

  • The global probenecid market is expected to grow significantly over the next few years, driven by the increasing prevalence of gout and the need for cost-effective healthcare solutions. The market size analysis from 2013 to 2025 indicates a steady growth trend, with forecasts suggesting continued expansion through 2030[2][5].

  • Regional Outlook: The market is segmented by regions, including the United States, Europe, China, Japan, Southeast Asia, India, and Brazil. Each region presents unique growth opportunities and challenges, with emerging economies offering significant potential for market expansion[2].

Competitive Landscape

  • The probenecid market is competitive, with several key players involved in the production and distribution of generic probenecid. Companies are focusing on developing new formulations, enhancing drug delivery systems, and improving patient compliance to gain a competitive edge[5].

  • Strategic Collaborations: Strategic collaborations for drug advancement and integration with telehealth platforms are also significant strategies employed by pharmaceutical firms to expand their market share[5].

Market Projections

Future Growth Opportunities

  • Expanding Generics Market: The generics market in emerging economies is expected to grow due to increasing healthcare accessibility and a burgeoning population. This presents a significant opportunity for probenecid generics[5].

  • Innovations in Formulations: Innovations focusing on developing probenecid formulations with reduced side effects and enhanced drug delivery systems are expected to drive market growth. Exploring untapped uses of probenecid beyond existing applications could also contribute to market expansion[5].

Market Restraints

  • Regulatory Requirements: Stringent regulatory requirements and the need for continuous compliance can pose challenges to market growth. Potential side effects and the presence of alternative treatments may also deter prescription rates[5].

  • Awareness and Education: Lack of widespread awareness about the benefits of probenecid may hinder market growth. Therefore, companies must invest in education campaigns targeting healthcare professionals and potential end-users to expand the market base[5].

Key Takeaways

  • Clinical Trials: The combination of sulopenem etzadroxil and probenecid is a significant development, with ongoing clinical trials aimed at treating uUTIs.
  • Market Drivers: The global probenecid market is driven by the increasing prevalence of gout, the need for cost-effective healthcare solutions, and the enhancement of antibiotic efficacy.
  • Market Growth: The market is expected to grow significantly, particularly in emerging economies, driven by increasing healthcare accessibility and innovations in drug formulations.
  • Challenges: Regulatory requirements, potential side effects, and lack of awareness are key challenges that need to be addressed to ensure sustained market growth.

FAQs

What is the primary use of probenecid?

Probenecid is primarily used to treat gout and hyperuricemia by reducing the renal excretion of uric acid. It is also used to enhance the efficacy of certain antibiotics.

What is the current status of the sulopenem etzadroxil/probenecid combination?

The sulopenem etzadroxil/probenecid combination is currently undergoing clinical trials and has been resubmitted to the FDA after receiving a Complete Response Letter in 2021.

What drives the growth of the global probenecid market?

The growth of the global probenecid market is driven by the increasing prevalence of gout, the need for cost-effective healthcare solutions, and the enhancement of antibiotic efficacy.

What are the challenges facing the probenecid market?

Challenges include stringent regulatory requirements, potential side effects, the presence of alternative treatments, and a lack of widespread awareness about the benefits of probenecid.

How is the probenecid market expected to grow in the future?

The probenecid market is expected to grow significantly, particularly in emerging economies, driven by increasing healthcare accessibility and innovations in drug formulations.

Sources

  1. Prime Therapeutics: FDA Decisions Expected: October 2024 - Prime Therapeutics - Portal
  2. Maiaresearch: Global Probenecid Consumption Market Research Report 2013-2025
  3. Openpr: Sulopenem Etzadroxil/Probenecid Drug Market Forecast and Analysis
  4. JACC: Cardiovascular Risks of Probenecid Versus Allopurinol in Older Adults
  5. 360iResearch: Probenecid Generics Market Size & Share 2025-2030

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