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Disease

Gout

Late-stage therapeutic developmentEmerging researchRising momentum
MeSHGout
4
Publications
19
Clinical trials
1
Related conditions
2024
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

Elucidating the role of gut microbiota dysbiosis in hyperuricemia and gout: Insights and therapeutic strategies.

Research2024-10-01World journal of gastroenterology

The dysregulation of immune cells induced by uric acid: mechanisms of inflammation associated with hyperuricemia and its complications.

Research2023-11-20Frontiers in immunology

Metabolomics and Machine Learning Identify Metabolic Differences and Potential Biomarkers for Frequent Versus Infrequent Gout Flares.

Research2023-11-09Arthritis & rheumatology (Hoboken, N.J.)

Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.

Research2020-02-13Lancet (London, England)

Approval: Febuxostat Krka (EMA)

Regulatory2019-03-28EMA

Approval: Febuxostat Viatris (previously Febuxostat Mylan) (EMA)

Regulatory2017-06-15EMA

Approval: Adenuric (EMA)

Regulatory2008-04-21EMA

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 6 clinical trials expected to report results, the earliest in Q4 2026.
  • 2 industry developments reported.
Upcoming Milestones
Major developments
Major trial resultsHigh impact
A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants With Uncontrolled Refractory Gout (FORWARD II)
Results posted2026-07-01
Major trial resultsHigh impact
A Phase 4, Open-Label, Multicenter, Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Trial of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks With Co-Administration of Weekly Doses of Methotrexate in Patients With Uncontrolled Refractory Gout (FORWARD Open-Label [OL] Trial)
Results posted2026-05-19
Clinical Milestones12View all 12
Results posted 3
Results expected 5
Recently completed 2
Other updates 1
+4 more in the activity timeline below
Industry & Market2View
Activity timeline14

Clinical trials

14 sponsors · 2 new · 3 completed in the last 12 months (net +1)

The current development programme across all trial phases.

Clinical programme
19
All trials
6
Active
16
Late-stage
6
Completed
Late-stage studies

Effect of Dotinurad in Hyperuricemia With Hypertension: a Randomized Study With Febuxostat (DIANA-NEXT)

Phase 4 · Recruiting · Saga University

Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial

Phase 4 · Recruiting · Massachusetts General Hospital

A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout

Phase 3 · Recruiting · Amgen

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Tophaceous Gout

Phase 3 · Recruiting · Crystalys Therapeutics

SAVE-Care (SGLT2i As Novel Gout Care) Trial

Phase 4 · Recruiting · Massachusetts General Hospital

A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Phase 2/3 · Recruiting · Olatec Therapeutics, Inc.
Recruiting

Effect of Dotinurad in Hyperuricemia With Hypertension: a Randomized Study With Febuxostat (DIANA-NEXT)

Phase 4 · Recruiting · Saga University

Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial

Phase 4 · Recruiting · Massachusetts General Hospital

A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout

Phase 3 · Recruiting · Amgen

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Tophaceous Gout

Phase 3 · Recruiting · Crystalys Therapeutics

SAVE-Care (SGLT2i As Novel Gout Care) Trial

Phase 4 · Recruiting · Massachusetts General Hospital

A Multi-Center Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare

Phase 2/3 · Recruiting · Olatec Therapeutics, Inc.
Recently completed

A Phase 3 Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of AR882 in Participants With Gout

Phase 3 · Completed · Arthrosi Therapeutics

A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants With Uncontrolled Refractory Gout (FORWARD II)

Phase 4 · Completed · Amgen

Safety & Efficacy of Genakumab in Patients With Frequent Flares

Phase 3 · Completed · Changchun GeneScience Pharmaceutical Co., Ltd.

A Multi-center, Randomized, Double-blind, Active-controlled, Therapeutic Confirmatory, Phase III Study to Compare and Evaluate the Efficacy and Safety of Epaminurad With Febuxostat in Gout Patients

Phase 3 · Completed · JW Pharmaceutical

A Phase 4, Multicenter, Open-Label, Infusion Duration Study To Assess Safety, Tolerability and Efficacy of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate

Phase 4 · Completed · Amgen

A Phase 4, Open-Label, Multicenter, Efficacy, Safety, Pharmacokinetics and Pharmacodynamics Trial of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks With Co-Administration of Weekly Doses of Methotrexate in Patients With Uncontrolled Refractory Gout (FORWARD Open-Label [OL] Trial)

Phase 4 · Completed · Amgen

Research activity

4 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20202024
Major themes8
  • Gout3
  • Hyperuricemia2
  • Arthritis, Gouty1
  • Dysbiosis1
  • Gastrointestinal Microbiome1
  • Global Burden of Disease1
  • Prebiotics1
  • Probiotics1
Leading journals4
  • Arthritis & rheumatology (Hoboken, N.J.)1
  • Frontiers in immunology1
  • Lancet (London, England)1
  • World journal of gastroenterology1
Leading researchers8
  • Li C2
  • Chen X1
  • Cui L1
  • Dalbeth N1
  • Deng Y1
  • Durairajan SSK1
  • Fu X1
  • Hu S1
Affiliations (unnormalised)6
  • California and University of California San Diego1
  • CAS Key Laboratory of Nutrition1
  • Center for Excellence in Post-Harvest Technologies1
  • Guizhou Provincial People's Hospital1
  • Karpagam Academy of Higher Education1
  • Ministry of Education Key Laboratory of Pharmacology of Traditional Chinese Medical Formulae1

Related conditions

1 match

Diseases frequently studied alongside this one. Number shows shared papers.

Hyperuricemia2

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Metabolic disorder characterized by recurrent acute arthritis, hyperuricemia and deposition of sodium urate in and around the joints, sometimes with formation of URIC ACID calculi.

Identifiers
MeSHGout
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.