PROBALAN (probenecid)
PROBALAN is indicated for the treatment of Uncomplicated Urinary Tract Infection.
How PROBALAN Works
ORLYNVAH consists of sulopenem etzadroxil (a penem antibacterial) and probenecid. Probenecid acts as a renal tubular transport inhibitor that blocks the OAT3-mediated renal clearance of sulopenem. By inhibiting this excretion pathway, probenecid increases the plasma concentrations and extends the half-life of sulopenem, thereby enhancing its therapeutic efficacy against target pathogens.
Details
- Status
- Prescription
- First Approved
- 1976-07-29
- Routes
- ORAL
- Dosage Forms
- TABLET
PROBALAN Approval History
What PROBALAN Treats
1 indicationsPROBALAN is approved for 1 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Uncomplicated Urinary Tract Infection
PROBALAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
PROBALAN FDA Label Details
Indications & Usage
PROBALAN is indicated for the treatment of Uncomplicated Urinary Tract Infection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.