Summary
Folic Acid has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Gout would be drug repurposing rather than first-in-human development. This does not mean it is approved for Gout. ClinicalTrials.gov lists 2 registered trials linking Folic Acid to Gout: 2 have completed. The most advanced is Phase 4 (NCT03994731). It plans or enrolled 152 participants. Registration activity spans 2018 to 2019. The literature layer holds 2 publications for this pair: 1 systematic review and 1 clinical trial publication. Publication years run from 2021 to 2024. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Gout ranks 186 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Acute flares self-resolve in 7-14 days without treatment; but urate crystal deposition continues; only 10-15% achieve serum urate <360 µmol/L spontaneously without ULT; progressive tophus formation and joint damage in untreated patients.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 34.0 (trials 9.0, literature 5.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 0 recruiting, 0 active / not yet recruiting, 2 completed, 0 other |
| Linked publications | 2 (1 systematic review, 1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ABCG2 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT03635957 | Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout 2018 | completed | Phase 4 | 14 |
| NCT03994731 | Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout 2019 | completed | Phase 4 | 152 |
Published literature
- Systematic review Dutch pharmacogenetics working group guideline for the gene-drug interaction of ABCG2, HLA-B and Allopurinol, and MTHFR, folic acid and methotrexatevan der Pol KH, Nijenhuis M, Soree B et al. · European journal of human genetics : EJHG · 2024 · PMID 36056234
- Clinical trial publication Pegloticase in Combination With Methotrexate in Patients With Uncontrolled Gout: A Multicenter, Open-label Study (MIRROR)Botson JK, Tesser JRP, Bennett R et al. · The Journal of rheumatology · 2021 · PMID 32934137
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ABCG2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Folic Acid approved for Gout?
Folic Acid has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Gout would be drug repurposing rather than first-in-human development. This does not mean it is approved for Gout. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Folic Acid in clinical trials for Gout?
ClinicalTrials.gov lists 2 registered trials linking Folic Acid to Gout: 2 have completed. The most advanced is Phase 4 (NCT03994731). It plans or enrolled 152 participants. Registration activity spans 2018 to 2019.
What does the evidence show for Folic Acid in Gout?
Folic Acid has both completed registered trials and synthesis-level publications linked to Gout. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ABCG2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.