Lesinurad clinical trials
Also written RDEA594.
How each study uses lesinurad is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Approvals
The first approval found in each region, with its record
- United States
- 22 Dec 2015 · ZURAMPIC · NDA 207988 (FDA, Drugs@FDA)
- European Union
- 18 Feb 2016 · Zurampic · EMEA/H/C/003932 (EMA; now withdrawn)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
21 studies that test it; most in 2013 (7)
| Year | Studies |
|---|---|
| 2009 | 2 |
| 2011 | 1 |
| 2012 | 5 |
| 2013 | 7 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 21 · Other 0
Ardea Biosciences, Inc. (20) · Ironwood Pharmaceuticals, Inc. (1)
Often tested with
Tested in the same studies.
Allopurinol (4) · Furosemide (1) · Naproxen (1) · Indomethacin (1)
Studies
Open first, then newest update. How each study uses lesinurad is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 21
- A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal ImpairmentTerminatedPhase 4Ironwood Pharmaceuticals, Inc.NCT03226899Written as Lesinurad
- Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.CompletedPhase 1Ardea Biosciences, Inc.NCT03272425Written as lesinurad 200 mg
- Lesinurad and Febuxostat Combination Extension Study in GoutCompletedPhase 3Ardea Biosciences, Inc.NCT01808144Written as lesinurad
- Lesinurad/Allopurinol 200/300 FDC Tablets BioequivalenceCompletedPhase 1Ardea Biosciences, Inc.NCT02888054Written as lesinurad 200 mg
- Lesinurad and Allopurinol Combination Extension Study in GoutCompletedPhase 3Ardea Biosciences, Inc.NCT01808131Written as Lesinurad
- Allopurinol Combination StudyCompletedPhase 2Ardea Biosciences, Inc.NCT01001338Written as RDEA594
- Lesinurad/Allopurinol 200/300 FDC Tablets BioavailabilityCompletedPhase 1Ardea Biosciences, Inc.NCT02581553Written as lesinurad 200 mg
- Combining Lesinurad With Allopurinol in Inadequate RespondersCompletedPhase 3Ardea Biosciences, Inc.NCT01510158Written as Lesinurad
- Combining Lesinurad With Allopurinol in Inadequate RespondersCompletedPhase 3Ardea Biosciences, Inc.NCT01493531Written as Lesinurad
- Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and FebuxostatCompletedPhase 3Ardea Biosciences, Inc.NCT01510769Written as Lesinurad
- Open-Label Lesinurad Monotherapy Extension Study in GoutCompletedPhase 3Ardea Biosciences, Inc.NCT01650246Written as lesinurad
- Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase InhibitorsCompletedPhase 3Ardea Biosciences, Inc.NCT01508702Written as lesinurad
- Lesinurad Tablet BioequivalenceCompletedPhase 1Ardea Biosciences, Inc.NCT02127775Written as Lesinurad 400 mg (manufactured at Site 1)
- Lesinurad Tablet Relative BioavailabilityCompletedPhase 1Ardea Biosciences, Inc.NCT01986556Written as Lesinurad 400 mg (Site 1)
- Antacid Interaction StudyCompletedPhase 1Ardea Biosciences, Inc.NCT01982201Written as Lesinurad 400 mg
- Bioavailability of Lesinurad and Intravenous [14C]LesinuradCompletedPhase 1Ardea Biosciences, Inc.NCT02039700Written as Lesinurad 400 mg
- Gout Dose Response StudyCompletedPhase 2Ardea Biosciences, Inc.NCT00955981Written as RDEA594
- Metformin and Furosemide Drug-Drug Interaction StudyCompletedPhase 1Ardea Biosciences, Inc.NCT02028689Written as Lesinurad 400 mg
- Lesinurad Interaction Study With RanitidineCompletedPhase 1Ardea Biosciences, Inc.NCT01908257Written as lesinurad 400 mg
- NSAID Drug Interaction StudyCompletedPhase 1Ardea Biosciences, Inc.NCT01884272Written as lesinurad 400 mg
Codes
What other systems call lesinurad · ClinicalTrials.gg INT000128
- MeSH (NLM) C000593471lesinuradConfirmed ClinicalTrials.gov, NLM, Wikidata
- UNII (FDA) 09ERP08I3WLESINURADConfirmed FDA, NLM, Wikidata
- RxNorm 1731031Confirmed FDA, Wikidata
- Wikidata Q21820633lesinuradConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C175109LesinuradOne source FDA
- DrugBank DB11560One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000593471 | lesinurad | Confirmed ClinicalTrials.gov, NLM, Wikidata |
| UNII (FDA) | 09ERP08I3W | LESINURAD | Confirmed FDA, NLM, Wikidata |
| RxNorm | 1731031 | — | Confirmed FDA, Wikidata |
| Wikidata | Q21820633 | lesinurad | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C175109 | Lesinurad | One source FDA |
| DrugBank | DB11560 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.