OnCo
drugsProductNot mapped hereapproved

Mifamurtide

An immune-activating drug approved in Europe for osteosarcoma after a trial suggested it improved survival; the FDA never approved it, and it remains one of oncology's transatlantic disagreements.

INT-0133 (Meyers, JCO 2008): 6-year OS 78% vs 70% when added to MAP chemotherapy, but a factorial design confounded by ifosfamide made interpretation contentious. EMA approved 2009; FDA issued a not-approvable letter (2007). Chills, fever, fatigue.

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Mifamurtide (sodium salt record) · 2D coordinates (no PubChem conformer)
PubChem
Modality
Liposomal muramyl tripeptide (macrophage activator)
Mechanism
Synthetic NOD2 ligand delivered in liposomes to monocytes and macrophages, activating them to a tumoricidal state.
Brand / code
Mepact
Medicare
Not covered (not FDA-approved)

Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request. Approved in the EU for osteosarcoma; the FDA declined approval in 2007.

Commercial insurance
unknown

Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.

Sources: CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA235 · 2011SMC: accepted
Appraised for
High-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection (age 2-30)
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA235 · SMC advice: mifamurtide. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
EU2009High-grade resectable non-metastatic osteosarcoma after complete resection, with chemotherapy, ages 2-30

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
4 studies1 recruiting4 Phase 2
Search “Mifamurtide” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Mifamurtide
intervention: Mifamurtide
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Mifamurtide" OR ABSTRACT:"Mifamurtide" OR TITLE:"Mepact" OR ABSTRACT:"Mepact") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Mifamurtide, not a curated reading list.

Connected

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