Summary
Metformin Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome) would be drug repurposing rather than first-in-human development. This does not mean it is approved for ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome). ClinicalTrials.gov lists 2 registered trials linking Metformin Hydrochloride to ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome): 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT06128967). It plans or enrolled 399 participants. Registration activity spans 2023 to 2024. No published literature item is linked to Metformin Hydrochloride and ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome) in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Myalgic Encephalomyelitis / Chronic Fatigue Syndrome ranks 126 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: Full recovery without intervention: <5% of adult ME/CFS patients; partial improvement in ~40% over 5 years; post-COVID ME/CFS appears to have similarly low spontaneous recovery rate.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 27.5 (trials 7.5, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 1 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor |
| Data sources | DGIdb |
| Linked via biomarker / target | COXFA4L2 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT06128967 | A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial 2023 | completed | Phase 3 | 399 |
| NCT06147050 | Effect of Metformin in Reducing Fatigue in Long COVID in Adolescents 2024 | status unknown | Phase 3 | 16 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
Recorded mechanism or class: inhibitor.
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 COXFA4L2. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Metformin Hydrochloride approved for ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome)?
Metformin Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome) would be drug repurposing rather than first-in-human development. This does not mean it is approved for ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Metformin Hydrochloride in clinical trials for ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome)?
ClinicalTrials.gov lists 2 registered trials linking Metformin Hydrochloride to ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome): 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT06128967). It plans or enrolled 399 participants. Registration activity spans 2023 to 2024.
What does the evidence show for Metformin Hydrochloride in ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome)?
Metformin Hydrochloride has 1 completed registered trial for ME/CFS (Myalgic Encephalomyelitis / Chronic Fatigue Syndrome) but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. 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 COXFA4L2. 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.