TheraRadar
Data updated: May 26, 2026

PROBENECID

Metabolic Approved 1976-01-13

PROBENECID is indicated for the treatment of Hyperuricemia; Gout; Gouty Arthritis.

Source: FDA Label • LEDERLE
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
5
Indications
--
Phase 3 Trials
50
Years on Market

Details

Status
Discontinued
First Approved
1976-01-13
Routes
ORAL
Dosage Forms
TABLET

Companies

LEDERLE Aurobindo Pharma WATSON LABS TEVA IVAX SUB TEVA PHARMS WATSON LABS RISING
Active Ingredient: PROBENECID

PROBENECID Approval History

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Original
New Indication
New Form
Label Update
60 FDA actions from 1976 to 2023
Nov 2023 SUPPL
Update
Nov 2002 SUPPL
Mfg · Manufacturing (CMC)
Jul 2002 SUPPL
Mfg · Manufacturing (CMC)

What PROBENECID Treats

3 indications

PROBENECID is approved for 3 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hyperuricemia
  • Gout
  • Gouty Arthritis
Source: FDA Label

PROBENECID Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

GLOPERBA
SCILEX PHARMS
2019 1 indic.
COLCHICINE
PH HEALTH
2016 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to PROBENECID

3 of 15

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

KRYSTEXXA
PEGLOTICASE
2 shared
HORIZON PHARMA
Shared indications:
GoutHyperuricemia
ULORIC
FEBUXOSTAT
2 shared
Takeda
Shared indications:
HyperuricemiaGout
COLCHICINE
COLCHICINE
1 shared
PH HEALTH
Shared indications:
Gout
View all 15 similar drugs Pro
📋

Clinical Trial Registry

22 trials
Trial Sponsor ID Phase Status Title
NCT04939623 Probenacid 1.0 Ph 2 recruiting Novel Use of Probenecid to Alleviate Symptoms of Opioid Withdrawal
NCT07160738 C4391011 Ph 1 completed A Study to Learn About How the Study Medicines Called Itraconazole and Probenecid Change How the Body Processes PF-07220060
NCT04551222 Re-Prosper HF CARA-006-19F I01CX001968 Ph 2, Ph 3 completed The Re-Prosper HF Study
NCT07318870 PROBCLUSTER GHD_2024_12 Ph 2 not yet recruiting Efficacy of Probenecid on Cluster Seizures During Anti Seizure Medication Withdrawal in Presurgical Focal Epilepsy Video-EEG Monitoring
NCT06416800 INCB54707-110 Ph 1 completed A Study to Assess the Effect of Povorcitinib on Digoxin, Rosuvastatin, and Metformin Pharmacokinetics and the Effect of Probenecid on Povorcitinib Pharmacokinetics When Administered Orally to Healthy Adult Participants
NCT05082909 ADDPROPEN results posted 21HH6936 Ph 1, Ph 2 completed Addition of Probenecid to Penicillin-V Therapy
NCT06647810 1378-0025 2024-513590-45-00, U1111-1307-2145 Ph 1 completed A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood
NCT05954624 ZSP1273-23-13 Ph 1 completed Drug-durg Interaction of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid
NCT03307252 results posted 0352-2100 2017-001549-29 Ph 1 completed This Study Tests the Effect of Certain Medicines on the Transport of Other Medicines in the Body of Healthy Men
NCT05497674 DJT1116PG-DM-108 Ph 1 completed Effects of Rifampicin and Probenecid On The Pharmacokinetic Profile Of Rongliflozin In Healthy Subjects
NCT03965351 results posted 2017-0541 Ph 4 completed TRPV2 Agonists in the Fontan Circulation
NCT03296800 results posted THR-1442-C-454 Ph 1 completed Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
NCT03937258 B7451043 Ph 1 completed A Study to Assess Pharmacokinetics of PF-04965842 and Its Metabolites and Effect of Probenecid in Healthy Participants
NCT03466567 NN9924-4394 U1111-1197-9088, 2017-002498-21 Ph 1 completed A Trial Investigating the Effect of Probenecid and Ciclosporin on the Concentrations of SNAC in Healthy Subjects
NCT03801746 AKB-6548-CI-0029 Ph 1 completed Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin
NCT03105986 CR108300 64041575RSV1002, 2016-003923-49 Ph 1 completed A Phase 1 Study to Evaluate the Effect of the Organic Anion Transporter Inhibitor Probenecid on the Pharmacokinetics of JNJ-64041575 in Healthy Adults
NCT00288158 DK71223 (completed) R21DK071223 Ph 2 completed Primary Prevention of Hypertension in Obese Adolescents
NCT01320722 MODERATE results posted 2010-P-002049 1R01HL105440 Ph 3 completed Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function
NCT01937026 results posted 14604 I4V-MC-JAGG Ph 1 completed A Study of Baricitinib and Probenecid in Healthy Participants
NCT03138759 PL3397-A-U122 Ph 1 completed Effect of Probenecid on Pexidartinib Pharmacokinetics
NCT01816646 2012-0903 NCI-2013-02184 Ph 1 completed Intravesical Cidofovir for Hemorrhagic Cystitis
NCT01634100 results posted 1245.83 2012-000971-17 Ph 1 completed Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PROBENECID FDA Label Details

Indications & Usage

PROBENECID is indicated for the treatment of Hyperuricemia; Gout; Gouty Arthritis.

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Full clinical data, patents, trials, and competitive landscape for probenecid.

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Data Sources

FDA Approval: ANDA086917 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.