Overview
The prototypical uricosuric agent. It inhibits the renal excretion of organic anions and reduces tubular reabsorption of urate. Probenecid has also been used to treat patients with renal impairment, and, because it reduces the renal tubular excretion of other drugs, has been used as an adjunct to antibacterial therapy.
Indication
For the reduction of serum uric acid concentrations in chronic gouty arthritis and tophaceous gout in patients with frequent disabling gout attacks. Has also been effectively used to promote uric acid excretion in hyperuricemia secondary to the administration of thiazide and related diuretics.
Associated Conditions
- Bacterial Infections
- Chronic Gouty Arthritis
- Elevated Serum Uric Acid
- Gout Chronic
- Hyperuricemia
- Infection
Research Report
A Comprehensive Monograph on Probenecid (DB01032): Pharmacology, Clinical Utility, and Safety Profile
Executive Summary
Probenecid is a small molecule drug classified as a prototypical uricosuric and renal tubular blocking agent. A sulfonamide derivative, its development was initially driven by the need to extend the therapeutic efficacy of limited penicillin supplies during World War II by inhibiting the antibiotic's renal excretion.[1] This dual-action profile defines its modern clinical utility. Probenecid is primarily indicated for the long-term management of hyperuricemia associated with chronic gout and gouty arthritis, where it promotes the excretion of uric acid.[3] Concurrently, it serves as an adjuvant to therapy with certain β-lactam antibiotics and other medications, elevating their plasma concentrations to enhance therapeutic effects.[5] The pharmacological basis for these actions is its competitive inhibition of organic anion transporters (OATs) in the renal tubules, which simultaneously blocks the reabsorption of urate and the secretion of various acidic drugs.[7] While effective, its use is complicated by a significant potential for drug-drug interactions stemming from this mechanism and a notable risk of promoting uric acid nephrolithiasis, which necessitates specific patient management strategies.[2] This report provides a comprehensive examination of Probenecid's chemical properties, pharmacological profile, clinical applications, and safety considerations.
Chemical Identity and Physicochemical Properties
The precise identification and characterization of Probenecid's chemical and physical properties are fundamental to understanding its formulation, biological activity, and disposition within the body.
Nomenclature and Identifiers
Probenecid is recognized across scientific and regulatory domains by a variety of names and unique identifiers.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/12 | Not Applicable | Not yet recruiting | |||
2024/10/18 | Phase 1 | Completed | |||
2024/05/16 | Phase 1 | Completed | |||
2023/09/06 | Phase 1 | Completed | |||
2023/07/20 | Phase 1 | Completed | Guangdong Raynovent Biotech Co., Ltd | ||
2023/06/15 | Phase 3 | Recruiting | |||
2022/11/10 | N/A | Recruiting | |||
2022/08/11 | Phase 1 | Completed | |||
2022/05/09 | Early Phase 1 | Completed | |||
2022/03/15 | Phase 1 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 72162-2237 | ORAL | 500 mg in 1 1 | 8/14/2021 | |
| Rising Pharma Holdings, Inc. | 16571-832 | ORAL | 500 mg in 1 1 | 11/6/2023 | |
| Bryant Ranch Prepack | 71335-1697 | ORAL | 500 mg in 1 1 | 12/4/2019 | |
| HHS/Program Support Center/Supply Service Center | 11819-282 | ORAL | 500 mg in 1 1 | 2/29/2012 | |
| Ingenus Pharmaceuticals, LLC | 50742-263 | ORAL | 500 mg in 1 1 | 5/21/2019 | |
| Physicians Total Care, Inc. | 54868-0159 | ORAL | 500 mg in 1 1 | 10/23/2012 | |
| Actavis Pharma, Inc. | 0591-5347 | ORAL | 500 mg in 1 1 | 12/1/2016 | |
| Marlex Pharmaceuticals Inc | 10135-541 | ORAL | 500 mg in 1 1 | 11/15/2023 | |
| Carilion Materials Management | 68151-1993 | ORAL | 500 mg in 1 1 | 3/9/2006 | |
| Lannett Company, Inc. | 0527-1367 | ORAL | 500 mg in 1 1 | 8/14/2021 |
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 |
|---|---|---|---|---|---|
| PROBENECID TABLET 500 mg | SIN07685P | TABLET | 500 mg | 4/15/1994 |
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 |
|---|---|---|---|---|---|
| PRO-CID probenecid 500mg tablet bottle | 74598 | Medicine | A | 6/5/2000 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PRO BIOSAN KIT | icn canada ltd. | 00284009 | Tablet
,
Capsule - Oral | 500 MG / PCK | 12/31/1979 |
| BENURYL | valeant canada lp / valeant canada s.e.c. | 00294926 | Tablet - Oral | 500 MG | 12/31/1974 |
| BENEMID TAB 500MG | merck frosst canada & cie, merck frosst canada & co. | 00016616 | Tablet - Oral | 500 MG / TAB | 12/31/1952 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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