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NCT05586971: EURELIA2
Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
Phase 3 trial testing Tigulixostat in Gout in 2,202 participants. Completed in 6 May 2025.
6 May 2025
Quick facts
| Lead sponsor | LG Chem |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 2,202 |
| Start date | 30 March 2023 |
| Primary completion | 6 May 2025 |
| Estimated completion | 6 May 2025 |
| Sites | 279 locations across Italy, Colombia, Malaysia, Taiwan, Poland, South Korea, Philippines, New Zealand |
Drugs / interventions tested
- Tigulixostat — full drug profile →
- Allopurinol (ALLOPURINOL) — full drug profile →
- Placebo
Conditions studied
- Gout — all drugs for Gout →
- Hyperuricemia — all drugs for Hyperuricemia →
- Gout Flare — all drugs for Gout Flare →
- Tophi — all drugs for Tophi →
Sponsor
LG Chem — full company profile →
Who can join
Adults 18 to 85, any sex, with Gout or Hyperuricemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Past, present and future of xanthine oxidase inhibitors: design strategies, structural and pharmacological insights, patents and clinical trials.
Singh A, Singh K, Sharma A, Kaur K, et al · · 2023 · cited 10× · PMID 37974965 · DOI 10.1039/d3md00316g -
Heterocyclic compounds as xanthine oxidase inhibitors for the management of hyperuricemia: synthetic strategies, structure-activity relationship and molecular docking studies (2018-2024).
Singh A, Debnath R, Chawla V, Chawla PA. · · 2024 · cited 6× · PMID 38911168 · DOI 10.1039/d4md00072b -
Evaluation of the efficacy and safety of a novel xanthine oxidase inhibitor, tigulixostat, in gout patients with hyperuricemia: Design of the EURELIA 1 and EURELIA 2 studies.
Saag KG, Dalbeth N, Hsu CY, Kuo CF, et al · · 2025 · cited 1× · PMID 39929260 · DOI 10.1016/j.cct.2025.107843
Verify or expand the search:
- PubMed search for NCT05586971
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tigulixostat
Trials testing the same drug.
- NCT07414394 — Tigulixostat (IBI128) vs Febuxostat in Gout · Phase 3 · recruiting
- NCT06189404 — Effect of Tigulixostat on the Pharmacokinetics of Theophylline · Phase 1 · completed
- NCT05586958 — Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients · Phase 3 · completed
Other recruiting trials for Gout
Currently open trials in the same condition.
- NCT07414394 — Tigulixostat (IBI128) vs Febuxostat in Gout · Phase 3 · recruiting
- NCT07367971 — Drug-Drug Interaction Study of ABP-671 in Gout Patients · Phase 1 · recruiting
- NCT07346079 — Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares · Phase 4 · recruiting
- NCT07089875 — A Study of Dotinurad Versus Allopurinol in Participants With Gout · Phase 3 · recruiting
- NCT05507723 — Tight Control of Gouty Arthritis Compared to Usual Care · NA · recruiting
Other LG Chem trials
Trials by the same sponsor.
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- NCT07399470 — A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagl · Phase 1 · active not recruiting
- NCT07333742 — A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metfor · Phase 1 · completed
- NCT06921395 — Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulat · Phase 4 · recruiting
- NCT06743997 — A Study to Compare Eutropin Formulations in Healthy Volunteers for Bioavailability, Safety, and Tolerability · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05586971 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LG Chem
- Last refreshed: 22 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05586971.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing