Gout

Metabolic Diseases
24
Pipeline Programs
13
Companies
35
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
1
7
2
6
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
2100%
+ 27 programs with unclassified modality

On Market (2)

Approved therapies currently available

Takeda
ULORICApproved
febuxostat
Takeda
Xanthine Oxidase Inhibitor [EPC]oral2009
Ironwood Pharmaceuticals
ZURAMPICApproved
lesinurad
Ironwood Pharmaceuticals
oral2015

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Takeda
TakedaTOKYO, Japan
6 programs
1
1
2
1
ULORIC(Febuxostat)Phase 3Small Molecule5 trials
High Dose ColchicinePhase 31 trial
Febuxostat IRPhase 22 trials
Febuxostat XRPhase 11 trial
CLinical Prediction Rule Score in VeteransN/A1 trial
+1 more programs
Active Trials
NCT01418781Withdrawn0Est. Mar 2010
NCT00175006Completed13Est. Jan 2003
NCT02374164Completed36Est. Apr 2015
+8 more trials
Ironwood Pharmaceuticals
1 program
1
LesinuradPhase 41 trial
Active Trials
NCT03226899TerminatedEst. Feb 2019
Regeneron
RegeneronTARRYTOWN, NY
4 programs
1
2
RilonaceptPhase 32 trials
RilonaceptPhase 31 trial
RilonaceptPhase 21 trial
CLinical Prediction Rule Score in VeteransN/A
Active Trials
NCT00610363Completed83Est. Oct 2008
NCT00609544Withdrawn0
NCT00856206Completed1,315Est. Jan 2011
+1 more trials
E
EisaiChina - Liaoning
1 program
1
DotinuradPhase 31 trial
Active Trials
NCT05007392Completed451Est. Jun 2023
Astellas
AstellasChina - Shenyang
1 program
1
febuxostatPhase 3Small Molecule1 trial
Active Trials
NCT01736514Completed109Est. Feb 2012
Atom Therapeutics
Atom TherapeuticsChina - Suzhou
6 programs
3
1
2
ABP-671Phase 2/31 trial
ABP-671Phase 2/31 trial
ABP-671Phase 21 trial
ABP-671Phase 11 trial
ABP-671Phase 11 trial
+1 more programs
Active Trials
NCT04303039CompletedEst. Jun 2020
NCT03906006CompletedEst. Jun 2019
NCT06258213CompletedEst. Jul 2024
+3 more trials
GS
Gilead SciencesFOSTER CITY, CA
3 programs
3
ArhalofenatePhase 21 trial
ArhalofenatePhase 21 trial
Arhalofenate 600 mgPhase 21 trial
Active Trials
NCT01399008Completed100Est. Feb 2012
NCT02252835Completed32Est. Dec 2014
NCT02063997Completed248Est. Jan 2015
BioCryst Pharmaceuticals
1 program
1
ulodesinePhase 21 trial
Active Trials
NCT01265264Completed279Est. Feb 2013
Alnylam Pharmaceuticals
1 program
1
ALN-XDHPhase 1/21 trial
Active Trials
NCT05256810Terminated44Est. Jan 2023
Evopoint Biosciences
Evopoint BiosciencesChina - Beijing
1 program
1
XNW3009Phase 11 trial
Active Trials
NCT04040907Completed40Est. May 2021
Variant Bio
Variant BioWA - Seattle
3 programs
Epidemiological studyN/A1 trial
Epidemiological studyN/A1 trial
Epidemiological studyN/A1 trial
Active Trials
NCT04812886Completed1,088Est. Aug 2021
NCT05607797Completed1,858Est. Apr 2024
NCT04900090Completed33Est. Aug 2021
Novartis
NovartisBASEL, Switzerland
1 program
CLinical Prediction Rule Score in VeteransN/A

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Ironwood PharmaceuticalsLesinurad
TakedaFebuxostat
EisaiDotinurad
TakedaFebuxostat IR
RegeneronRilonacept
Astellasfebuxostat
TakedaFebuxostat
RegeneronRilonacept
TakedaHigh Dose Colchicine
TakedaFebuxostat
TakedaFebuxostat
TakedaFebuxostat
Atom TherapeuticsABP-671
Atom TherapeuticsABP-671
Atom TherapeuticsABP-671

Showing 15 of 34 trials with date data

Clinical Trials (35)

Total enrollment: 42,662 patients across 35 trials

NCT03226899Ironwood PharmaceuticalsLesinurad

A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment

Start: Jul 2017Est. completion: Feb 2019
Phase 4Terminated
NCT01112982TakedaFebuxostat

An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.

Start: May 2010Est. completion: Dec 201474 patients
Phase 4Completed
NCT05007392EisaiDotinurad

A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout

Start: Dec 2021Est. completion: Jun 2023451 patients
Phase 3Completed
NCT02139046TakedaFebuxostat IR

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout

Start: Apr 2014Est. completion: Nov 20151,790 patients
Phase 3Completed
NCT01459796RegeneronRilonacept

Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

Start: Nov 2011Est. completion: Jun 2013220 patients
Phase 3Terminated
NCT01736514Astellasfebuxostat

A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout

Start: Mar 2011Est. completion: Feb 2012109 patients
Phase 3Completed
NCT01101035TakedaFebuxostat

Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)

Start: Apr 2010Est. completion: Jul 20176,198 patients
Phase 3Completed
NCT00856206RegeneronRilonacept

Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)

Start: Mar 2009Est. completion: Jan 20111,315 patients
Phase 3Completed
NCT00506883TakedaHigh Dose Colchicine

MPC-004 for the Treatment of an Acute Gout Flare

Start: Apr 2007Est. completion: Oct 2007185 patients
Phase 3Completed
NCT00430248TakedaFebuxostat

Efficacy and Safety of Oral Febuxostat in Participants With Gout

Start: Feb 2007Est. completion: Mar 20082,269 patients
Phase 3Completed
NCT00175019TakedaFebuxostat

Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010

Start: Jul 2003Est. completion: Feb 20071,086 patients
Phase 3Completed
NCT00102440TakedaFebuxostat

Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

Start: Jul 2002Est. completion: Feb 2004760 patients
Phase 3Completed
NCT06276556Atom TherapeuticsABP-671

Extension Study of ABP-671 in Participants With Gout

Start: Apr 2024Est. completion: Sep 2024
Phase 2/3Terminated
NCT05818085Atom TherapeuticsABP-671

Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout

Start: Aug 2023Est. completion: Mar 2025
Phase 2/3Completed
NCT00609544RegeneronRilonacept

Study of the Safety and Effectiveness of Rilonacept (IL-1 Trap) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia

0
Phase 2Withdrawn
NCT04638543Atom TherapeuticsABP-671

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia

Start: Nov 2020Est. completion: Oct 2021
Phase 2Completed
NCT02252835Gilead SciencesArhalofenate

Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout

Start: Aug 2014Est. completion: Dec 201432 patients
Phase 2Completed
NCT02128490TakedaFebuxostat IR

Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment

Start: May 2014Est. completion: Oct 2015189 patients
Phase 2Completed
NCT02063997Gilead SciencesArhalofenate 600 mg

Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients

Start: Mar 2014Est. completion: Jan 2015248 patients
Phase 2Completed
NCT01399008Gilead SciencesArhalofenate

Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients

Start: Jun 2011Est. completion: Feb 2012100 patients
Phase 2Completed
NCT01265264BioCryst Pharmaceuticalsulodesine

Study to Evaluate sUA Lowering Activity, Safety and Efficacy of Oral Ulodesine Added to Allopurinol

Start: Dec 2010Est. completion: Feb 2013279 patients
Phase 2Completed
NCT00610363RegeneronRilonacept

Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares

Start: Nov 2007Est. completion: Oct 200883 patients
Phase 2Completed
NCT00174941TakedaFebuxostat

Long-Term Safety of Febuxostat in Subjects With Gout.

Start: Mar 2001Est. completion: Dec 2006116 patients
Phase 2Completed
NCT05256810Alnylam PharmaceuticalsALN-XDH

A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout

Start: Feb 2022Est. completion: Jan 202344 patients
Phase 1/2Terminated
NCT06258213Atom TherapeuticsABP-745

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy Volunteers

Start: Jan 2024Est. completion: Jul 2024
Phase 1Completed
NCT04303039Atom TherapeuticsABP-671

Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects

Start: May 2020Est. completion: Jun 2020
Phase 1Completed
NCT04040907Evopoint BiosciencesXNW3009

The the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XNW3009 in Health Subject

Start: Nov 2019Est. completion: May 202140 patients
Phase 1Completed
NCT03906006Atom TherapeuticsABP-671

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects

Start: Oct 2018Est. completion: Jun 2019
Phase 1Completed
NCT02374164TakedaFebuxostat XR

Food Effect Study of Febuxostat XR in Healthy Participants

Start: Feb 2015Est. completion: Apr 201536 patients
Phase 1Completed
NCT05607797Variant BioEpidemiological study

Genetic of Chronic Kidney Disease and Gout in New Caledonia

Start: Mar 2023Est. completion: Apr 20241,858 patients
N/ACompleted
NCT04900090Variant BioEpidemiological study

Tahiti-families: Polynesian Families of Gout Patients

Start: May 2021Est. completion: Aug 202133 patients
N/ACompleted
NCT04812886Variant BioEpidemiological study

Epidemiology of Gout in French Polynesia

Start: Apr 2021Est. completion: Aug 20211,088 patients
N/ACompleted
NCT04853160TakedaFebuxostat

Drug Use Study of Febuxostat After Recent Changes in the Prescribing Information

Start: Aug 2020Est. completion: Jan 202124,046 patients
N/ACompleted
NCT01418781TakedaCLinical Prediction Rule Score in Veterans

CLinical Prediction Rule Score in Veterans

Start: Jan 2008Est. completion: Mar 20100
N/AWithdrawn
NCT00175006TakedaMeasurement of Tophi to validate procedure

Validation Study of Physical Measurement of Tophi

Start: Nov 2002Est. completion: Jan 200313 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

6 late-stage (Phase 3) programs — potential near-term approvals
13 companies competing in this space

Related Indications

Diabetes(737)Diabetes Mellitus, Type 2(485)Obesity(246)Type 2 Diabetes(207)Type 2 Diabetes Mellitus(190)Diabetes Mellitus(127)Diabetes Mellitus, Type 1(95)Type 1 Diabetes Mellitus(51)Type 1 Diabetes(50)Dyslipidemia(45)