Drugs / Lesinurad
last change Feb 2019 re-read 9 days ago

Lesinurad

Small molecule targets SLC22A12 via inhibition

Developed for
gout
Investigated by
Ardea Biosciences, Inc.

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Zurampic — 2016-02-18 europa.eu ↗
Approved US (FDA) ZURAMPIC — 2015-12-22 fda.gov ↗

Trials 17

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials
Phase 1 NCT02581553 Oct 2015 → Jul 2016 — Ardea Biosciences, Inc. Completed No outcome recorded
Phase 1 NCT02039700 Jan → Feb 2014 — Ardea Biosciences, Inc. Completed No outcome recorded
Phase 1 NCT01982201 Nov → Dec 2013 — Ardea Biosciences, Inc. Completed No outcome recorded
Phase 1 NCT01986556 Nov 2013 → Apr 2014 — Ardea Biosciences, Inc. Completed No outcome recorded
Phase 1 NCT02028689 Oct → Nov 2013 — Ardea Biosciences, Inc. Completed No outcome recorded
Phase 1 NCT01908257 Jul → Sep 2013 — Ardea Biosciences, Inc. Completed No outcome recorded
Phase 1 NCT01884272 Jun → Aug 2013 gout Ardea Biosciences, Inc. Completed No outcome recorded
Phase 1 NCT01744379 Dec 2012 → Mar 2013 gout Ardea Biosciences, Inc. Completed No outcome recorded
Phase 22 trials · 1 met primary
Phase 2 NCT01001338 Oct 2009 → Jan 2011 gout Ardea Biosciences, Inc. Completed Met primary
Phase 2 NCT00955981 Jul 2009 → Mar 2010 — Ardea Biosciences, Inc. Completed No outcome recorded
Phase 37 trials · 3 met primary
Phase 3 NCT01808144 Mar 2013 → Aug 2016 gout Ardea Biosciences, Inc. Completed No outcome recorded
Phase 3 NCT01808131 Feb 2013 → Aug 2016 gout Ardea Biosciences, Inc. Completed No outcome recorded
Phase 3 NCT01650246 Aug 2012 → Apr 2014 gout Ardea Biosciences, Inc. Completed No outcome recorded
Phase 3 NCT01508702 Jan 2012 → Oct 2013 gout Ardea Biosciences, Inc. Completed Met primary
Phase 3 NCT01510769 Jan 2012 → Jun 2014 gout Ardea Biosciences, Inc. Completed Mixed
Phase 3 NCT01510158 Jan 2012 → Jul 2014 gout Ardea Biosciences, Inc. Completed Met primary
Phase 3 NCT01493531 Dec 2011 → May 2014 gout Ardea Biosciences, Inc. Completed Met primary
Comparator or background therapy1 trial
Phase 4 NCT03226899 Comparator Jul 2017 → Feb 2019 chronic kidney disease, gout Ironwood Pharmaceuticals, Inc. Terminated No outcome recorded Stop: Business

Press releases naming this drug 12 releases

DateIssuerRelease
2017-08-21 Ironwood Pharmaceuticals, Inc. Ironwood Pharmaceuticals Announces FDA Approval of DUZALLO® (lesinurad and allopurinol) for the Treatment of Hyperuricemia in Patients with Uncontrolled Gout ironwoodpharma.com ↗
2017-01-04 Ironwood Pharmaceuticals, Inc. Ironwood Announces New Drug Application for DUZALLO™ (Fixed-Dose Combination of Lesinurad and Allopurinol) Has Been Accepted for FDA Review ironwoodpharma.com ↗
2016-11-13 Ironwood Pharmaceuticals, Inc. Ironwood Highlights ZURAMPIC® (lesinurad) Phase III Extension Study Data at the American College of Rheumatology 2016 Annual Meeting ironwoodpharma.com ↗
2016-10-03 Ironwood Pharmaceuticals, Inc. Ironwood Announces U.S. Availability of ZURAMPIC® (lesinurad) 200 mg Tablets for Patients with Uncontrolled Gout ironwoodpharma.com ↗
2016-06-03 AstraZeneca AstraZeneca completes US licensing agreement with Ironwood Pharmaceuticals for lesinurad astrazeneca.com ↗
2016-06-03 Ironwood Pharmaceuticals, Inc. Ironwood Pharmaceuticals Closes U.S. Transaction with AstraZeneca for Lesinurad ironwoodpharma.com ↗
2016-06-02 AstraZeneca AstraZeneca licenses Zurampic to Grünenthal GmbH in Europe and Latin America astrazeneca.com ↗
2016-04-26 AstraZeneca AstraZeneca enters into US licensing agreement with Ironwood Pharmaceuticals for lesinurad astrazeneca.com ↗
2016-04-26 Ironwood Pharmaceuticals, Inc. Ironwood Pharmaceuticals Enters into U.S. Licensing Agreement with AstraZeneca for Lesinurad ironwoodpharma.com ↗
2016-02-19 AstraZeneca Zurampic (lesinurad) approved in the European Union for patients with gout astrazeneca.com ↗
2015-12-22 AstraZeneca ZURAMPIC® (lesinurad) approved by US FDA for patients with gout astrazeneca.com ↗
2012-04-23 AstraZeneca AstraZeneca to acquire Ardea Biosciences for $1 billion (net of existing cash) including lead product lesinurad in Phase III development for gout astrazeneca.com ↗

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 19 sources stand behind the page.

FieldValueCited text
Known as lesinurad “Lesinurad in combination with allopurinol: results of a phase 2, randomised, double-blind study in patients with gout with an inadequate response to allopurinol.” PMID 26742777 ↗ Jan 2016
16

NCT02581553 ↗

NCT01650246 ↗

NCT02039700 ↗

NCT01982201 ↗

NCT02028689 ↗

NCT01808144 ↗

NCT01808131 ↗

NCT01493531 ↗

NCT01744379 ↗

NCT01508702 ↗

Show 6 more sources

Known as Lesinurad component of duzallo ChEMBL registry synonym — accepted as the source's own label CHEMBL2105720 ↗
Known as LESINURAD SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL2105720 ↗
Known as RDEA 594 SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL2105720 ↗
Known as RDEA594 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00955981 ↗
Known as Zurampic ChEMBL registry synonym — accepted as the source's own label CHEMBL2105720 ↗
Action Inhibit “oral selective uric acid reabsorption inhibitor” PMID 26742777 ↗ Jan 2016
1

“Solute carrier family 22 member 12 inhibitor” CHEMBL2105720 ↗

Modality Small molecule — CHEMBL2105720 ↗
Route Oral “lesinurad, an oral selective uric acid reabsorption inhibitor” PMID 26742777 ↗ Jan 2016
Target SLC22A12 “Solute carrier family 22 member 12 inhibitor” CHEMBL2105720 ↗