Summary
Lumbrokinase 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 Lumbrokinase to ME/CFS: 1 is currently recruiting. The most advanced is Phase 1 (NCT06511050, sponsored by Icahn School of Medicine at Mount Sinai). It plans or enrolled 120 participants. Registered activity dates to 2024. The literature layer holds 1 publication for this pair: 1 curated reference. 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 | 10.0 (trials 3.5, literature 1.5, tier 5, approved bonus 0.0) |
| Registered trials | 1 total: 1 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 1 (1 curated reference) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT06511050 | Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Icahn School of Medicine at Mount Sinai · 2024 | recruiting | Phase 1 | 120 |
Published literature
- Curated reference (PACVS Evidence Map) Fibrinolytic enzyme trial for microclot dissolution; no results yet; most rigorous fibrinolytic trial in long COVID to date; PolyBio Research FoundatiPACVS Evidence Map
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
Clinical notes: Mount Sinai RCT recruiting (NCT06511050) for microclots in Long COVID/ME-CFS. Fibrinolytic. 20-40mg 2-3x/day protocols. Low bleeding risk but caution with anticoagulants. Rigorous trial underway; currently research-only.
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 Lumbrokinase approved for ME/CFS?
Lumbrokinase 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 Lumbrokinase in clinical trials for ME/CFS?
ClinicalTrials.gov lists 1 registered trial linking Lumbrokinase to ME/CFS: 1 is currently recruiting. The most advanced is Phase 1 (NCT06511050, sponsored by Icahn School of Medicine at Mount Sinai). It plans or enrolled 120 participants. Registered activity dates to 2024.
What does the evidence show for Lumbrokinase in ME/CFS?
Trials of Lumbrokinase in ME/CFS are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. 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.