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probenecid 250 Milligrams (mg)
probenecid 250 Milligrams (mg) is a uricosuric Small molecule drug developed by University of Miami. It is currently in Phase 3 development for Gout, Hyperuricemia.
Probenecid works by inhibiting the reabsorption of uric acid in the kidneys, thereby increasing its excretion in the urine.
Probenecid works by inhibiting the reabsorption of uric acid in the kidneys, thereby increasing its excretion in the urine. Used for Gout, Hyperuricemia.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | probenecid 250 Milligrams (mg) |
|---|---|
| Sponsor | University of Miami |
| Drug class | uricosuric |
| Modality | Small molecule |
| Therapeutic area | Rheumatology |
| Phase | Phase 3 |
Mechanism of action
This results in a decrease in serum uric acid levels, making it a treatment for conditions such as gout. Probenecid also has a secondary effect of increasing the excretion of penicillin and other antibiotics, making it useful in combination therapy for bacterial infections.
Approved indications
- Gout
- Hyperuricemia
Common side effects
- Nausea
- Diarrhea
- Headache
- Rash
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- probenecid 250 Milligrams (mg) CI brief — competitive landscape report
- probenecid 250 Milligrams (mg) updates RSS · CI watch RSS
- University of Miami portfolio CI
Frequently asked questions about probenecid 250 Milligrams (mg)
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Related
- Drug class: All uricosuric drugs
- Manufacturer: University of Miami — full pipeline
- Therapeutic area: All drugs in Rheumatology
- Indication: Drugs for Gout
- Indication: Drugs for Hyperuricemia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing