Drug

Marstacimab

Approved medicine

ClassTissue factor pathway inhibitor inhibitorResearchOngoing clinical research

Also known as Hympavzi, Immunoglobulin g1, anti-(human tissue factor pathway inhibitor) (human monoclonal pf-06741086 .gamma.1-chain), disulfide with human monoclonal pf-06741086 .lambda.-chain, dimer, Immunoglobulin g1-lambda, anti-(human tissue factor pathway inhibitor (tfpi, extrinsic pathway inhibitor, epi, lipoprotein-associated coagulation inhibitor, laci)).

RxNorm2697133 ChEMBLCHEMBL3990039 ATCB02BX11UNII0UB3OA67O7

Active clinical trials

Tissue factor pathway inhibitor

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A PHASE 1B OPEN-LABEL NON-RANDOMIZED STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MARSTACIMAB TREATMENT FOLLOWING THE DISCONTINUATION OF EMICIZUMAB THERAPY IN ADOLESCENT AND ADULT PARTICIPANTS WITH SEVERE HEMOPHILIA A WITHOUT INHIBITORS.

Clinical trial2026-06-03Results expected Q2 2027 · ClinicalTrials.gov

AN OPEN-LABEL STUDY IN PEDIATRIC (<18 YEARS OF AGE), SEVERE HEMOPHILIA A PARTICIPANTS (COAGULATION FACTOR ACTIVITY <1%) WITH OR WITHOUT INHIBITORS OR MODERATELY SEVERE TO SEVERE HEMOPHILIA B PARTICIPANTS (COAGULATION FACTOR ACTIVITY ≤2%) WITH OR WITHOUT INHIBITORS COMPARING 12 MONTHS OF HISTORICAL STANDARD TREATMENT TO MARSTACIMAB PROPHYLAXIS

Clinical trial2026-05-07Results expected Q3 2028 · ClinicalTrials.gov

Approval: Hympavzi (EMA)

Regulatory2024-11-18EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Marstacimab

Aliases & brands

HympavziImmunoglobulin g1, anti-(human tissue factor pathway inhibitor) (human monoclonal pf-06741086 .gamma.1-chain), disulfide with human monoclonal pf-06741086 .lambda.-chain, dimerImmunoglobulin g1-lambda, anti-(human tissue factor pathway inhibitor (tfpi, extrinsic pathway inhibitor, epi, lipoprotein-associated coagulation inhibitor, laci))

RxNorm CUI

2697133

ChEMBL ID

CHEMBL3990039

ATC codes

B02BX11

UNII

0UB3OA67O7

Primary mechanism

Tissue factor pathway inhibitor inhibitor

Regulatory jurisdictions

ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tissue factor pathway inhibitor

TFPI · P10646

INHIBITORTissue factor pathway inhibitor inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2024-11-18

Latest approval

2024-11-18

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2024-11-18Approval

Approval: Hympavzi (EMA)

Indication: Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with: severe haemophilia A (congenital factor… Show full indication

Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with: severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII inhibitors, or severe haemophilia B (congenital factor IX deficiency, FIX < 1%) without factor IX inhibitors.

Evidence ↗

Clinical trials

2 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

Active studies

Recruiting

Late-stage (III+)

PHASE DISTRIBUTIONn = 2

Phase 11Phase 31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

RecruitingPH IIIPfizern=1002028

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.