Last reviewed 2026-04-23 · How we verify

Probenecid 500 Milligrams (mg)

University of Miami · Phase 3 active Small molecule

Probenecid 500 Milligrams (mg) is a Uricosuric agent Small molecule drug developed by University of Miami. It is currently in Phase 3 development for Chronic gout management and prevention of gout attacks, Hyperuricemia.

Probenecid inhibits the renal tubular reabsorption of uric acid, increasing urinary excretion and lowering serum uric acid levels.

Probenecid inhibits the renal tubular reabsorption of uric acid, increasing urinary excretion and lowering serum uric acid levels. Used for Chronic gout management and prevention of gout attacks, 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 name	Probenecid 500 Milligrams (mg)
Sponsor	University of Miami
Drug class	Uricosuric agent
Target	URAT1 (urate transporter 1)
Modality	Small molecule
Therapeutic area	Rheumatology
Phase	Phase 3

Mechanism of action

Probenecid is a uricosuric agent that blocks the URAT1 transporter in the proximal convoluted tubule of the kidney, preventing the reabsorption of filtered uric acid back into the bloodstream. By promoting urinary uric acid excretion, it reduces serum uric acid concentrations, thereby preventing gout attacks and uric acid crystal deposition in tissues. It also has secondary effects on the renal secretion of other organic anions.

Approved indications

Chronic gout management and prevention of gout attacks
Hyperuricemia

Common side effects

Gout flare (acute attack)
Headache
Nausea
Rash
Nephrolithiasis (kidney stones)

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 500 Milligrams (mg) CI brief — competitive landscape report
Probenecid 500 Milligrams (mg) updates RSS · CI watch RSS
University of Miami portfolio CI

Frequently asked questions about Probenecid 500 Milligrams (mg)

What is Probenecid 500 Milligrams (mg)?

Probenecid 500 Milligrams (mg) is a Uricosuric agent drug developed by University of Miami, indicated for Chronic gout management and prevention of gout attacks, Hyperuricemia.

How does Probenecid 500 Milligrams (mg) work?

Probenecid inhibits the renal tubular reabsorption of uric acid, increasing urinary excretion and lowering serum uric acid levels.

What is Probenecid 500 Milligrams (mg) used for?

Probenecid 500 Milligrams (mg) is indicated for Chronic gout management and prevention of gout attacks, Hyperuricemia.

Who makes Probenecid 500 Milligrams (mg)?

Probenecid 500 Milligrams (mg) is developed by University of Miami (see full University of Miami pipeline at /company/university-of-miami).

What drug class is Probenecid 500 Milligrams (mg) in?

Probenecid 500 Milligrams (mg) belongs to the Uricosuric agent class. See all Uricosuric agent drugs at /class/uricosuric-agent.

What development phase is Probenecid 500 Milligrams (mg) in?

Probenecid 500 Milligrams (mg) is in Phase 3.

What are the side effects of Probenecid 500 Milligrams (mg)?

Common side effects of Probenecid 500 Milligrams (mg) include Gout flare (acute attack), Headache, Nausea, Rash, Nephrolithiasis (kidney stones).

What does Probenecid 500 Milligrams (mg) target?

Probenecid 500 Milligrams (mg) targets URAT1 (urate transporter 1) and is a Uricosuric agent.

Drug class: All Uricosuric agent drugs
Target: All drugs targeting URAT1 (urate transporter 1)
Manufacturer: University of Miami — full pipeline
Therapeutic area: All drugs in Rheumatology
Indication: Drugs for Chronic gout management and prevention of gout attacks
Indication: Drugs for Hyperuricemia

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