20 completed, 1 terminated, 1 withdrawn. 11 Phase 1, 7 Phase 3, 2 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 11 |
| Phase 3 | 7 | Completed 7 |
| Phase 2 | 2 | Completed 2 |
| Phase 4 | 1 | Terminated 1 |
Follow lesinurad: new trials by email Literature Review of lesinurad trials Research Report on lesinurad
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Post-Authorisation Safety Study of Lesinurad Zurampic®, Control group: xanthine oxidase inhibitor monotherapy - Gout, Hyperuricemia | Withdrawn | AstraZeneca | 2021-01-29 | 2021-04-19 | ||
| Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence. lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, allopurinol 300 mg - Gout | Phase 1 | Completed | Ardea Biosciences, Inc. | 32 | 2017-08-14 | 2018-11-07 |
| A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment Lesinurad, XOI, Placebo - Gout, Chronic Kidney Disease (CKD) | Phase 4 | Terminated | Ironwood Pharmaceuticals, Inc. | 242 | 2017-07-19 | 2021-11-04 |
| Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence lesinurad/allopurinol 200/300 FDC tablet, lesinurad 200 mg, allopurinol 300 mg - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 28 | 2016-08-30 | 2017-06-16 |
| Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, allopurinol 300 mg - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 116 | 2015-10-01 | 2016-12-19 |
| Lesinurad Tablet Bioequivalence Lesinurad 400 mg (manufactured at Site 1), Lesinurad 400 mg (manufactured at Site 2) - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 54 | 2014-04-01 | 2014-09-22 |
| Bioavailability of Lesinurad and Intravenous [14C]Lesinurad Lesinurad 400 mg, [14C]lesinurad (100 μg per 10 mL) - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 10 | 2014-01-01 | 2014-05-20 |
| Lesinurad Tablet Relative Bioavailability Lesinurad 400 mg (Site 1), Lesinurad 400 mg (Site 2, Lot A), Lesinurad 400 mg (Site 2, Lot B) - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 36 | 2013-11-01 | 2014-09-22 |
| Antacid Interaction Study Lesinurad 400 mg, Tums 500 mg and 750 mg, MINTOX 10 mL - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 24 | 2013-11-01 | 2014-05-20 |
| Metformin and Furosemide Drug-Drug Interaction Study Lesinurad 400 mg, Metformin 850 mg, Furosemide 40 mg - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 23 | 2013-10-01 | 2014-02-14 |
| Lesinurad Interaction Study With Ranitidine lesinurad 400 mg, ranitidine 150 mg, lesinurad 400 mg + ranitidine 150 mg - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 16 | 2013-07-01 | 2014-01-09 |
| NSAID Drug Interaction Study lesinurad 400 mg, naproxen 250 mg, indomethacin 25 mg - Gout | Phase 1 | Completed | Ardea Biosciences, Inc. | 24 | 2013-06-01 | 2013-11-08 |
| Lesinurad and Febuxostat Combination Extension Study in Gout lesinurad, febuxostat - Gout | Phase 3 | Completed | Ardea Biosciences, Inc. | 196 | 2013-03-01 | 2018-01-30 |
| Lesinurad and Allopurinol Combination Extension Study in Gout Lesinurad - Gout | Phase 3 | Completed | Ardea Biosciences, Inc. | 717 | 2013-02-01 | 2017-01-24 |
| Single and Multiple Dose Study in Japanese Lesinurad, Placebo - Gout | Phase 1 | Completed | Ardea Biosciences, Inc. | 40 | 2012-12-01 | 2013-06-19 |
| Open-Label Lesinurad Monotherapy Extension Study in Gout lesinurad - Gout | Phase 3 | Completed | Ardea Biosciences, Inc. | 143 | 2012-08-01 | 2016-05-26 |
| Combining Lesinurad With Allopurinol in Inadequate Responders Lesinurad, Placebo, Allopurinol - Gout | Phase 3 | Completed | Ardea Biosciences, Inc. | 607 | 2012-01-01 | 2016-08-18 |
| Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat Lesinurad, Placebo, Febuxostat - Tophaceous Gout | Phase 3 | Completed | Ardea Biosciences, Inc. | 330 | 2012-01-01 | 2016-05-26 |
| Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors lesinurad, Placebo - Gout | Phase 3 | Completed | Ardea Biosciences, Inc. | 214 | 2012-01-01 | 2016-02-12 |
| Combining Lesinurad With Allopurinol in Inadequate Responders Lesinurad, Placebo, Allopurinol - Gout | Phase 3 | Completed | Ardea Biosciences, Inc. | 610 | 2011-12-01 | 2016-05-26 |
Showing 20 of 22. Sign in to see all of them.
Gout (12) · Hyperuricemia (2) · Renal Insufficiency, Chronic (1)
Ardea Biosciences, Inc. (20) · AstraZeneca (1) · Ironwood Pharmaceuticals, Inc. (1)
United States (20) · Canada (8) · Poland (7) · Australia (6) · New Zealand (6) · Germany (5) · Belgium (4) · South Africa (4) · Switzerland (4) · Spain (3) · Ukraine (3) · Czechia (2) · Brazil (1) · Bulgaria (1) · Georgia (1)
Chris Storgard, MD (5) · J. Hall (3) · N. Bhakta (3) · Nihar Bhakta, MD (3) · S Bradley, MD (2) · J. Hall, MD (1) · S. Bradley (1) · S. Bradley, MD (1) · Vijay Hingorani, MD, PhD, MBA (1)
PMID 35835008, PMID 26742777, PMID 27564409, PMID 27821644, PMID 28597604, PMID 29029210, PMID 30616614