Marstacimab is a recombinant human monoclonal antibody that targets tissue factor pathway inhibitor (TFPI). It is an IgG1 antibody designed to neutralize TFPI activity and enhance thrombin generation through the extrinsic coagulation pathway.
Marstacimab-hncq is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells and has a molecular mass of approximately 146 kDa.
Marstacimab is a specialized biologic pharmaceutical API / drug substance used in the development and manufacture of therapies for hemophilia.
As a monoclonal antibody, its quality assessment requires characterization of identity, purity, aggregation, charge variants, glycosylation, protein concentration and biological potency.
CAS Number: 1985638-39-8
UNII: 0UB3OA67O7
Molecular Type: Recombinant Human Monoclonal Antibody
Antibody Class: IgG1
Target: Tissue Factor Pathway Inhibitor (TFPI)
Development Code: PF-06741086
Drug Class: TFPI Antagonist
Therapeutic Class: Hemostatic Agent
Therapeutic Area: Hematology
Molecular Mass: Approximately 146 kDa
Marstacimab binds to Kunitz domain 2 (K2) of TFPI, neutralizing TFPI activity. TFPI normally inhibits components of the extrinsic coagulation pathway, including factor Xa and the TF–FVIIa complex.
By antagonizing TFPI, marstacimab increases downstream thrombin generation, helping restore coagulation capacity in people with hemophilia.
Marstacimab is used for:
The U.S. FDA approved HYMPAVZI (marstacimab-hncq) in 2024, with subsequent labeling expansion in 2026. Current U.S. labeling covers routine prophylaxis in patients aged 6 years and older with hemophilia A or B, with or without factor inhibitors.
The approved drug product is supplied as a sterile solution for subcutaneous administration, including prefilled syringes and prefilled pens. Current presentations include 150 mg/mL and 75 mg/0.5 mL strengths.
Marstacimab is a recombinant protein therapeutic rather than a conventional small-molecule API. The drug substance therefore requires control of structural and biological characteristics such as:
A controlled Marstacimab manufacturing process may involve:
Typical Marstacimab biologic API testing may include:
Marstacimab drug substance should be stored according to validated biologic stability conditions, with protection from freezing, excessive heat and unnecessary light exposure. Exact drug-substance storage conditions should follow the approved manufacturer's specification.
Marstacimab is relevant to research involving:
Marstacimab is a human IgG1 monoclonal antibody targeting TFPI. It is produced using recombinant DNA technology in CHO cells and has an approximate molecular mass of 146 kDa. By neutralizing TFPI, it enhances thrombin generation and is used as a prophylactic therapy for hemophilia A and B.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |