TheraRadar
Landscape / Musculoskeletal
Data updated: Jun 28, 2026

Gout Clinical Trial Landscape

Gout is being studied across 228 clinical trials registered since 2008, with 42 programs currently active. The competitive pipeline includes 10 active Phase 3 trials, 15 active Phase 2 trials, and 8 active Phase 1 trials.

Trial activity

42 active / 228 total since 2008
Active by phase 10 Ph3 / 52 15 Ph2 / 81 8 Ph1 / 57 9 Ph4 / 38

Sponsor activity

Who is running trials now — green active, blue completed, red failed/terminated.

Sorted by active Active Done Failed
Crystalys Therapeutics 3 0 0
Jiangsu HengRui Medicine Co., Ltd. 2 10 0
Atom Therapeutics Co., Ltd 2 6 1
Arthrosi Therapeutics 2 4 0
Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. 2 0 0
Shanton Pharma Pte. Ltd. 2 0 0
Amgen 1 7 0
InventisBio Co., Ltd 1 3 0
Innovent Biologics (Suzhou) Co. Ltd. 1 2 0
Protalix 1 1 0
Shanghai Institute Of Biological Products 1 1 0
TJ Biopharma Co., Ltd. 1 0 0
BioRay Pharmaceutical Co., Ltd. 1 0 0
Innovent Biologics Technology Limited (Shanghai R&D Center) 1 0 0
Olatec Therapeutics LLC 1 0 0

All 15 active Gout sponsors

Unlock the remaining 7 sponsors with active / completed / failed counts — sortable and exportable.

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How the field has grown

New-trial starts peaked in 2023 (20 registered); 2025 saw 16. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (28 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.

New trials started by year

2016
8
2017
11
2018
9
2019
15
2020
11
2021
11
2022
11
2023
20
2024
17
2025
16
2026
12

TheraRadar.com

Median Phase 3 enrollment by start year

2016 (2)
176
2017 (1)
201
2018 (1)
203
2019 (1)
594
2020 (2)
133
2021 (2)
615
2022 (1)
354
2023 (8)
393
2024 (4)
535
2025 (4)
375
2026 (2)
435

TheraRadar.com

Full trial pipeline

Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.

NCT07089875 RECRUITING
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Crystalys Therapeutics n=500
NCT07089888 RECRUITING
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Crystalys Therapeutics n=250
NCT06846515 ACTIVE NOT RECRUITING
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)
Arthrosi Therapeutics n=750
NCT07388498 RECRUITING
A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
Amgen n=270
NCT07414394 RECRUITING
Tigulixostat (IBI128) vs Febuxostat in Gout
Innovent Biologics Technology Limited (Shanghai R&D Center) n=600
NCT05658575 RECRUITING
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Olatec Therapeutics LLC n=300
NCT05109936 RECRUITING
Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration
University Hospital, Rouen n=128
NCT06863701 RECRUITING
Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis
Laboratorios Silanes S.A. de C.V. n=72
NCT06603142 ACTIVE NOT RECRUITING
Phase II/III Study of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd n=636
NCT06414837 NOT YET RECRUITING
Clinical Trial of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
Jiangsu HengRui Medicine Co., Ltd. n=434
NCT06439602 COMPLETED
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)
Arthrosi Therapeutics n=818
NCT05815901 COMPLETED
A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients
JW Pharmaceutical n=612
NCT06068478 COMPLETED
A Study to Evaluate Efficacy and Safety of Qingzhu Granules in the Treatment of Acute Gouty Arthritis
Tasly Pharmaceutical Group Co., Ltd n=472
NCT05818085 COMPLETED
Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout
Atom Therapeutics Co., Ltd n=300
NCT04596540 COMPLETED
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II
Swedish Orphan Biovitrum n=153
NCT05586958 COMPLETED
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
LG Chem n=354
NCT06139393 COMPLETED
Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
Jiangsu HengRui Medicine Co., Ltd. n=765
NCT04513366 COMPLETED
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
Swedish Orphan Biovitrum n=112
NCT05007392 COMPLETED
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
Eisai Co., Ltd. n=451
NCT05586971 COMPLETED
Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
LG Chem n=2,202
NCT06276556 TERMINATED
Extension Study of ABP-671 in Participants With Gout
Atom Therapeutics Co., Ltd n=43
NCT04956432 COMPLETED
A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout
Jiangsu HengRui Medicine Co., Ltd. n=779
NCT05983445 COMPLETED
Safety & Efffficacy of Genakumab in Patients With Frequent Flares
Changchun GeneScience Pharmaceutical Co., Ltd. n=313
NCT04052932 COMPLETED
A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout
Jiangsu HengRui Medicine Co., Ltd. n=594
NCT02578394 COMPLETED
Anakinra vs. Steroids for the Treatment of Gout Attacks in Patients With Renal Disease (ASGARD): A Feasibility Study
Mid and South Essex NHS Foundation Trust n=21
NCT01431638 COMPLETED
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Novartis Pharmaceuticals n=397
NCT01470989 COMPLETED
β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
Novartis Pharmaceuticals n=136
NCT03006445 COMPLETED
Study of FYU-981 in Hyperuricemia With or Without Gout
Fuji Yakuhin Co., Ltd. n=330
NCT03100318 COMPLETED
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
Fuji Yakuhin Co., Ltd. n=201
NCT03372200 COMPLETED
Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
Mochida Pharmaceutical Company, Ltd. n=203
NCT01808144 COMPLETED
Lesinurad and Febuxostat Combination Extension Study in Gout
Ardea Biosciences, Inc. n=196
NCT01459796 TERMINATED
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
Regeneron Pharmaceuticals n=220
NCT01362608 TERMINATED
Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
Novartis Pharmaceuticals n=136
NCT00856206 COMPLETED
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
Regeneron Pharmaceuticals n=1,315
NCT00958438 COMPLETED
PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
Regeneron Pharmaceuticals n=248
NCT00855920 COMPLETED
Study Utilizing Rilonacept in Gout Exacerbations
Regeneron Pharmaceuticals n=225
NCT00829829 COMPLETED
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
Regeneron Pharmaceuticals n=241
NCT01593527 WITHDRAWN
Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
Novartis Pharmaceuticals
NCT01808131 COMPLETED
Lesinurad and Allopurinol Combination Extension Study in Gout
Ardea Biosciences, Inc. n=717
NCT02139046 COMPLETED
Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout
Takeda n=1,790
NCT01510158 COMPLETED
Combining Lesinurad With Allopurinol in Inadequate Responders
Ardea Biosciences, Inc. n=607
NCT01510769 COMPLETED
Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat
Ardea Biosciences, Inc. n=330
NCT01650246 COMPLETED
Open-Label Lesinurad Monotherapy Extension Study in Gout
Ardea Biosciences, Inc. n=143
NCT01493531 COMPLETED
Combining Lesinurad With Allopurinol in Inadequate Responders
Ardea Biosciences, Inc. n=610
NCT01508702 COMPLETED
Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
Ardea Biosciences, Inc. n=214
NCT02082769 COMPLETED
Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Xijing Hospital n=504
NCT00921375 COMPLETED
Safety and Efficacy of TULY (Rasburicase) in Prevention and Treatment of Malignancy-associated Hyperuricemia
Virchow Group n=100
NCT01736514 COMPLETED
A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout
Astellas Pharma Taiwan, Inc. n=109
NCT01029652 COMPLETED
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study
Novartis Pharmaceuticals n=230
NCT01080131 COMPLETED
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
Novartis Pharmaceuticals n=226
NCT01356602 COMPLETED
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Novartis Pharmaceuticals n=397
NCT00675103 COMPLETED
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
Savient Pharmaceuticals n=7

Full Gout Pipeline

Every trial across Phase 1–4, plus enrollment analytics. Sortable, filterable, exportable.

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Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only