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Marstacimab (marstacimab)
Marstacimab (generic name: marstacimab) is a For patients aged 12 years or older and weighing at least 35 kg, marstacimab is administered subcuta Monoclonal antibody drug developed by Pfizer Inc.. It is currently in preclinical development.
Marstacimab blocks a protein that normally prevents blood clotting, allowing patients with hemophilia to form clots more easily.
Marstacimab, also known as Hympavzi, is a monoclonal antibody medication used to treat hemophilia A and hemophilia B. It works by inhibiting tissue factor pathway inhibitor, a naturally occurring anticoagulant.
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Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Rare-disease pathway favourability
+5.0pp
Rare-disease drugs benefit from FDA Orphan Drug Act, smaller pivotal trials, and more flexible endpoints. Approval rates run ~5pp above baseline. -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | marstacimab |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | For patients aged 12 years or older and weighing at least 35 kg, marstacimab is administered subcuta |
| Modality | Monoclonal antibody |
| Therapeutic area | Rare Disease |
| Phase | preclinical |
Mechanism of action
Normally, your body has natural brakes on blood clotting to prevent dangerous clots from forming. One of these brakes is a protein called TFPI (tissue factor pathway inhibitor). In people with hemophilia, the blood already struggles to clot properly because they lack important clotting factors. Marstacimab works by disabling TFPI, essentially removing one of these natural brakes on clotting. By neutralizing TFPI, marstacimab allows the coagulation cascade—the body's clotting system—to function more efficiently. This enhances the ability to form blood clots through the extrinsic pathway, which is the initial trigger for clotting. For hemophilia patients, this boost in clotting activity helps compensate for their missing or deficient clotting factors, allowing their blood to clot more normally and reduce bleeding episodes. This represents a different approach from traditional hemophilia treatments. Rather than replacing the missing clotting factor (factor VIII or IX), marstacimab works by enhancing the clotting mechanisms that remain intact. This makes it particularly useful for hemophilia patients without inhibitors, as it provides an alternative or complementary way to restore clotting function and prevent life-threatening bleeds.
Approved indications
Pipeline indications
- Hemophilia A or B — preclinical
Common side effects
- months or longer and
- f venous thrombosis occurred in
Drug interactions
- 7 DRUG INTERACTIONS Partial Thromboplast
Key clinical trials
- PF-06741086 Multiple Dose Study in Severe Hemophilia (Phase 2)
- Dose Escalation Study of PF-06741086 In Healthy Subjects (Phase 1)
- A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibi (N/A)
- A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophil (Phase 3)
- Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors (Phase 3)
- A Study to Learn About How Changing Therapy From Emicizumab to Marstacimab Affects People With the S (Phase 1)
- Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophili (Phase 3)
- PF-06741086 Long-term Treatment in Severe Hemophilia (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Marstacimab CI brief — competitive landscape report
- Marstacimab updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Marstacimab
What is Marstacimab?
How does Marstacimab work?
Who makes Marstacimab?
What is the generic name of Marstacimab?
What drug class is Marstacimab in?
What development phase is Marstacimab in?
What are the side effects of Marstacimab?
Related
- Drug class: All For patients aged 12 years or older and weighing at least 35 kg, marstacimab is administered subcuta drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Rare Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing