ArticleClinical pharmacokinetics2026
Clinical Pharmacokinetics and Pharmacodynamics of Marstacimab, an Anti-tissue Factor Pathway Inhibitor Monoclonal Antibody, in Adolescent and Adult Participants with Hemophilia.
Article in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Intravenous Or Subcutaneous Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-06741086 In Healthy Subjects And An Open-label Evaluation In Healthy Japanese Subjects
A multicenter, open-label, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of subcutaneous or intravenous pf-06741086 in subjects with severe hemophilia
A multicenter, open-label study to evaluate the long-term safety, tolerability and efficacy of subcutaneous pf-06741086 in subjects with severe hemophilia
An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A Participants With or Without Inhibitors or Moderately Severe to Severe Hemophilia B Participants (Coagulation Factor Activity ≤2%) With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis
A phase 1, open-label, randomized, 4-period, 2-sequence, crossover study to evaluate the bioequivalence of marstacimab (pf-06741086) prefilled syringe device and prefilled pen device following subcutaneous administration in healthy adult male participants
A phase 1, single-arm, open-label, non-randomized, non-controlled multicenter study to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single subcutaneous dose of pf-06741086 in chinese adult participants with severe hemophilia
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4 authors.
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Abstract
BACKGROUND AND
objectivesMarstacimab, a monoclonal antibody that targets tissue factor pathway inhibitor (TFPI), was developed for prophylactic treatment of hemophilia, with or without inhibitors. A nonlinear mixed-effects modeling approach was used to characterize plasma marstacimab and TFPI concentrations and identify covariates impacting marstacimab concentration.
methodsPopulation modeling using nonlinear mixed-effects modeling (NONMEM) 7.5.0 software was performed with marstacimab and total TFPI concentration data pooled from 213 participants across 6 clinical trials including healthy volunteers (n = 63) and participants with hemophilia (n = 150). Participants received subcutaneous marstacimab at doses ranging from 30 mg to 450 mg. Plasma samples to determine marstacimab and total TFPI were analyzed using validated assays. An E
resultsMarstacimab and total TFPI concentrations were adequately described with a target mediated drug disposition (TMDD) model with nonlinear clearance. Body weight was the key structural covariate. After adjusting for body weight, no clinically relevant effect of age (adolescent vs adult), race (Asian vs non-Asian), participant status (healthy vs hemophilia) or mild hepatic impairment was seen. There was good agreement between observed and model-predicted peak thrombin levels in adults and adolescents, with no clinically relevant differences between the populations.
conclusionsA TMDD model with first-order absorption and quasi-steady-state approximation adequately characterized marstacimab PK and total TFPI concentrations. An E CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov: NCT02531815, NCT02974855, NCT03363321, NCT03938792, NCT04832139, NCT04878731.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.