Summary
Fluvoxamine is tracked by OSMF as an investigational option for ME/CFS; no regulator has approved it for this indication, and most post-viral conditions have no approved disease-modifying therapy at all. ClinicalTrials.gov lists 1 registered trial linking Fluvoxamine to ME/CFS: 1 has completed. The most advanced is Phase 3 (NCT06128967, sponsored by Cardresearch). It plans or enrolled 399 participants. Registered activity dates to 2023. The literature layer holds 6 publications for this pair: 6 PubMed search records. Publication years run from 2025 to 2026. Items here are search-derived or curated references rather than classified trial reports; treat them as leads to read, not as graded evidence.
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome is tracked on the OSMF post-viral programme alongside ME/CFS, Long COVID, POTS and MCAS. Across the programme, 191 candidate agents are logged for ME/CFS, most of them preliminary; this page isolates the record for one of them.
Evidence table
| Evidence tier | B · Moderate |
|---|---|
| Evidence score | 20.5 (trials 4.5, literature 6.0, tier 10, approved bonus 0.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 6 (6 PubMed search records) |
| Agent type | Drug (Drug (Pharmaceutical)) |
| Development stage (any indication) | Investigational |
| Mechanism / class | Anti-inflammatory |
| Data sources | OSMF therapeutic agent database, ClinicalTrials.gov, PubMed |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 Cardresearch · 2023 | completed | Phase 3 | 399 |
Published literature
- PubMed record (biomarker-intervention search) The Effect of Fluvoxamine and Metformin for Fatigue in Patients With Long COVID : An Adaptive Randomized Trial.Annals of internal medicine · 2026 · PMID 41911553
- PubMed record (biomarker-intervention search) Current options for the treatment of anxiety in adults with autism spectrum disorder.Expert review of neurotherapeutics · 2026 · PMID 41731987
- PubMed record (biomarker-intervention search) Efficacy of the herbal product of Cuscuta campestris Yunck. and Polypodium vulgare L. in patients with obsessive-compulsive disorder: A triple-blind clinical trial.Journal of ethnopharmacology · 2026 · PMID 40848906
- PubMed record (biomarker-intervention search) Solutions to common issues in the use of LAIs.CNS spectrums · 2025 · PMID 41431308
- PubMed record (biomarker-intervention search) Therapeutic potential of Baicalin against experimental obsessive compulsive disorder: Evidence from CSF, blood plasma, and brain analysis.Journal of neuroimmunology · 2025 · PMID 40168745
- PubMed record (biomarker-intervention search) Combining in vitro, in vivo, and in silico approaches to evaluate the effect of serotonergic-based topical therapies on mild to moderate psoriasis.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2025 · PMID 39814240
Mechanism and notes
Recorded mechanism or class: Anti-inflammatory.
Clinical notes: Sigma-1 + SSRI; early COVID + some Long COVID data. 50-100mg. CYP interactions, GI/insomnia. Preliminary for select symptoms; not core fatigue/autonomic first choice.
Safety: Nausea, insomnia, somnolence; significant CYP1A2 and CYP2C19 interactions. Avoid in combination with thioridazine, pimozide. Monitor for serotonin syndrome if combined with other serotonergics.
Dosing in studies: 50–100 mg/day (often 100 mg); short courses (10–15 days) in early studies; some PASC protocols 4–8 weeks.
Frequently asked questions
Is Fluvoxamine approved for ME/CFS?
Fluvoxamine is tracked by OSMF as an investigational option for ME/CFS; no regulator has approved it for this indication, and most post-viral conditions have no approved disease-modifying therapy at all. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Fluvoxamine in clinical trials for ME/CFS?
ClinicalTrials.gov lists 1 registered trial linking Fluvoxamine to ME/CFS: 1 has completed. The most advanced is Phase 3 (NCT06128967, sponsored by Cardresearch). It plans or enrolled 399 participants. Registered activity dates to 2023.
What does the evidence show for Fluvoxamine in ME/CFS?
Fluvoxamine has 1 completed trial and 6 linked publications for ME/CFS. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is B (Moderate), taken from the OSMF therapeutic agent database, which grades agents by the volume and design of condition-specific evidence rather than by effect size.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-10-07. Page built 2026-10-07.