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Mifamurtide

Generic Name
Mifamurtide
Brand Names
Mepact
Drug Type
Small Molecule
Chemical Formula
C59H110N6NaO20P
CAS Number
83461-56-7
Unique Ingredient Identifier
1LM890Q4FY

Overview

Mifamurtide is an immunomodulator with antitumor activity via activation of macrophages and monocytes. Also called L-MTP-PE, mifamurtide may be a liposomal form of of the active ingredient MTP-PE, which is a synthetic, less pyrogenic, and longer-acting derivative of muramyl dipeptide (MDP). MDP is a motif present in all gram-positive and gram-negative bacterial walls that is recognized by different signalling molecules and activators such as nucleotide-binding and oligomerization domain (NOD)-like receptors (NLRs) and toll-like receptors present in macrophages and monocytes. The overall result of MDP recognition leads to the production of proinflammatory cytokines and promotion of bactericidal and tumoricidal effects . As a liposomal formulation, mifamurtide demonstrates an enhanced tumoricidal effect and improved safety profile . Mifamurtide is marketed in Europe as Mepact for intravenous infusion. It is administered as an adjuvant therapy to postoperative combination chemotherapy in pediatric, adolescent or adult patients with high-grade, resectable, non-metastatic osteosarcoma after macroscopically complete surgical resection. In the US, it is currently under investigation that holds orphan drug status for the treatment of osteosarcoma . Osteosarcoma is the most common primary malignant bone tumor that usually arises in the metaphyses of long bone in children and adolescents . The standard therapy for osteosarcoma is comprised of macroscopic surgical resection and multi-agent chemotherapy consisting of doxorubicin, cisplatin, high-dose methotrexate with leucovorin rescue, and ifosfamide . While about 90% of patients with newly diagnosed osteosarcoma may achieve complete remission from first-line therapies, the prognosis is still poor for patients with non-metastatic osteosarcoma with lower 5-year event-free survival. In a large, randomized, open-label, multicenter, phase III trial, the treatment of mifamurtide in conjunction with three- or four-drug combination chemotherapy (doxorubicin, cisplatin, and high-dose methotrexate with, or without, ifosfamide) was associated with significant improvement in survival rates and good tolerance . The adverse events (AEs) associated with mifamurtide were generally mild to moderate in severity .

Indication

Indicated in children, adolescents and young adults for the treatment of high-grade, resectable, non-metastatic osteosarcoma after macroscopically complete surgical resection, typically in combination with post-operative multi-agent chemotherapy .

Associated Conditions

  • High-grade, nonmetastatic Osteosarcoma
  • Resectable, nonmetastatic Osteosarcoma

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
3/6/2009
Takeda France,16 place de l'Iris,92400 Courbevoie,France
Authorised
3/6/2009

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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No TGA approvals found for this drug.

Health Canada Drug Approvals

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Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
MEPACT 4 mg POLVO PARA SUSPENSION PARA PERFUSION
Takeda France S.A.S.
08502001
POLVO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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Authorization Date
No UK EMC drug information found for this drug.

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