Summary
Anakinra 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 Anakinra to ME/CFS: 1 has completed. The most advanced is Phase 2 (NCT02108210, sponsored by Radboud University Medical Center). It plans or enrolled 50 participants. Registered activity dates to 2014. The literature layer holds 6 publications for this pair: 6 PubMed search records. Publication years run from 2015 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 | C · Preliminary |
|---|---|
| Evidence score | 14.5 (trials 3.5, literature 6.0, tier 5, 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 | Other (Other / Unclassified) |
| Development stage (any indication) | Investigational |
| Mechanism / class | Not recorded |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02108210 | Cytokine Inhibition in Chronic Fatigue Syndrome Patients Radboud University Medical Center · 2014 | completed | Phase 2 | 50 |
Published literature
- PubMed record (biomarker-intervention search) Evaluation of the Effect of IL-1 Antagonists on Pituitary Function.International journal of endocrinology · 2026 · PMID 41531813
- PubMed record (biomarker-intervention search) Effects of interleukin-1 antagonism on cortisol levels in individuals with obesity: a randomized clinical trial.Endocrine connections · 2019 · PMID 31042669
- PubMed record (biomarker-intervention search) Hair and salivary cortisol in a cohort of women with chronic fatigue syndrome.Hormones and behavior · 2018 · PMID 29807037
- PubMed record (biomarker-intervention search) Interleukin-1 Antagonism Decreases Cortisol Levels in Obese Individuals.The Journal of clinical endocrinology and metabolism · 2017 · PMID 28324042
- PubMed record (biomarker-intervention search) Muscle-Derived IL-6 Is Not Regulated by IL-1 during Exercise. A Double Blind, Placebo-Controlled, Randomized Crossover Study.PloS one · 2015 · PMID 26448147
- PubMed record (biomarker-intervention search) Cytokine inhibition in chronic fatigue syndrome patients: study protocol for a randomized controlled trial.Trials · 2015 · PMID 26438161
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
Clinical notes: Investigational for listed conditions. 1 associated trial(s) and 0 study reference(s) in current data. Review primary sources and consult specialists before use.
Safety: Limited specific safety data in these populations. Review full prescribing information and consult specialist. Many agents used off-label or investigational.
Dosing in studies: See linked studies/trials for reported doses and durations; typical protocols vary widely.
Frequently asked questions
Is Anakinra approved for ME/CFS?
Anakinra 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 Anakinra in clinical trials for ME/CFS?
ClinicalTrials.gov lists 1 registered trial linking Anakinra to ME/CFS: 1 has completed. The most advanced is Phase 2 (NCT02108210, sponsored by Radboud University Medical Center). It plans or enrolled 50 participants. Registered activity dates to 2014.
What does the evidence show for Anakinra in ME/CFS?
Anakinra 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 C (Preliminary), 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.