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probenecid 250 Milligrams (mg)

University of Miami · Phase 3 active Small molecule

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.

Likelihood of approval
59.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameprobenecid 250 Milligrams (mg)
SponsorUniversity of Miami
Drug classuricosuric
ModalitySmall molecule
Therapeutic areaRheumatology
PhasePhase 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

Common side effects

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about probenecid 250 Milligrams (mg)

What is probenecid 250 Milligrams (mg)?

probenecid 250 Milligrams (mg) is a uricosuric drug developed by University of Miami, indicated for Gout, Hyperuricemia.

How does probenecid 250 Milligrams (mg) work?

Probenecid works by inhibiting the reabsorption of uric acid in the kidneys, thereby increasing its excretion in the urine.

What is probenecid 250 Milligrams (mg) used for?

probenecid 250 Milligrams (mg) is indicated for Gout, Hyperuricemia.

Who makes probenecid 250 Milligrams (mg)?

probenecid 250 Milligrams (mg) is developed by University of Miami (see full University of Miami pipeline at /company/university-of-miami).

What drug class is probenecid 250 Milligrams (mg) in?

probenecid 250 Milligrams (mg) belongs to the uricosuric class. See all uricosuric drugs at /class/uricosuric.

What development phase is probenecid 250 Milligrams (mg) in?

probenecid 250 Milligrams (mg) is in Phase 3.

What are the side effects of probenecid 250 Milligrams (mg)?

Common side effects of probenecid 250 Milligrams (mg) include Nausea, Diarrhea, Headache, Rash.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing