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Factor VIII (Factor VIII, Ipsen / Hyate C / Hyate)

✓ Approved

Sanofi S.A · F8 · Cell-based Therapies

What is Factor VIII?

Factor VIII is a cell-based therapies developed by Sanofi S.A. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesFactor VIII, Ipsen, Hyate C, Hyate
CompanySanofi S.A
Drug ClassCell-based Therapies
Molecular TargetF8, VWF
RouteInjectable (Others), Intravenous (IV)
StatusApproved

Mechanism of Action

Molecular Targets

Factor VIII acts on 2 molecular targets:

F8coagulation factor VIII (AHF, FVIII)
VWFvon Willebrand factor (VWD, F8VWF)
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Therapeutic Indications

Factor VIII is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Congenital, familial and genetic disordersFactor VIII deficiency✓ Approved

Related Research Articles

PubMedHealthcare (Basel, Switzerland)2026-10-16

Association Between Meal Regularity and Obesity Among Korean Older Adults: A Population-Based Study Using KNHANES VIII.

Park Hyo-Eun HE, Jeong Kyoung-Eun KE, Song Hye-Young HY

Background: Obesity in older adults is a major public health concern associated with chronic disease and reduced healthy life expectancy. This study examined the associations between habitual meal regularity and general and abdominal obesity among Korean older adults using Andersen's Behavioral Model. Methods: Data from 3559 adults aged ≥65 years who participated in the eighth Korea National Health and Nutrition Examination Survey (2019-2021) were analyzed. Dietary behaviors included regular breakfast, lunch, and dinner consumption and the number of meal types regularly consumed. General obesity was defined as body mass index ≥ 25 kg/m2, and abdominal obesity as waist circumference ≥ 90 cm in men and ≥85 cm in women. Complex-sample hierarchical logistic regression analyses were conducted after adjusting for predisposing, enabling, and need factors. Results: Participants who regularly consumed all three meal types had lower body mass index and lower prevalence of general and abdominal obesity. In fully adjusted models, regular breakfast (adjusted odds ratio [aOR] = 0.64), dinner consumption (aOR = 0.51), and regular consumption of all three meal types (aOR = 0.61) were associated with lower odds of general obesity. Regular lunch consumption (aOR = 0.74) showed a nominally significant association with general obesity, but this association did not remain significant after the post hoc false discovery rate adjustment. Regular lunch consumption (aOR = 0.67) and regular consumption of all three meal types (aOR = 0.66) were also associated with lower odds of abdominal obesity. Conclusions: Regular meal consumption, particularly regular consumption of all three meal types, was associated with lower odds of general and abdominal obesity among Korean older adults. Meal regularity warrants further evaluation as a potential target in longitudinal and intervention studies, although causal relationships cannot be inferred from this cross-sectional study.

PubMedDiagnostics (Basel, Switzerland)2026-10-16

Thromboelastographic Assessment of the Differential Sensitivity of Three Contact Activators to Coagulation Factor Deficiencies in Hemocell Environments.

Liang Weiguo W, Xia Mao M, Li Junpo J, Li Fuyang F et al.

Background: Thromboelastography (TEG) assesses global coagulation, but its sensitivity for factor deficiencies is reportedly low and may depend on the contact activator. However, the differential TEG sensitivity of contact activators for individual factor deficiencies in whole blood containing platelets and red blood cells remains unclear. This study assessed the relative sensitivity of three contact activators for detecting single coagulation factor deficiencies in reconstituted whole-blood samples using TEG. Methods: Reconstituted whole-blood samples with graded activities of FII, FV, FVIII, FIX, FX, FXI, and FXII were prepared by mixing platelets, plasma, and red blood cells, and analyzed by TEG using kaolin-, ellagic acid-, and colloidal silica-based activators (KL, EA and CS). Relative sensitivity was assessed via: (1) the factor activity at which R time first showed a statistically significant prolongation; (2) a novel metric, Sensitivity for Detecting Factor Deficiencies (SDFD), defined as the normalized relative change in R time, enabling comparison without reference ranges. Results: KL showed the broadest and highest sensitivity, detecting significant prolongation at the mildest deficiency levels for most factors. EA showed intermediate-to-high sensitivity and the highest sensitivity for FXII. CS was the least sensitive except for FV. Notably, the activity threshold of KL for exceeding the reference range was substantially lower than that for statistical significance. Conclusions: The sensitivity of TEG to coagulation factor deficiencies is dependent on the contact activator. KL showed the highest overall sensitivity to factor deficiencies, while EA showed the highest sensitivity for FXII deficiency under the conditions of this study. R time of KL can be significantly prolonged yet still stay within the reference range. This mismatch calls for more sensitive TEG reagents and stricter ranges.

PubMedJournal of the American Heart Association2026-10-16

Temporal Dynamics of Complement Activation and Outcome in Patients With Acute Ischemic Stroke.

Wang Yan Y, Westendorp Willeke F WF, Bijlsma Merijn W MW, Tanck Michael W T MWT et al.

Immune-mediated inflammatory responses exacerbate brain injury and affect the prognosis in acute ischemic stroke. We characterized longitudinal complement activation after acute ischemic stroke using serial plasma samples from 10 patients and 8 controls. Initial markers of classical (C1q), lectin (mannose-binding lectin), and alternative (complement factor Bb) pathways, as well as regulatory (complement factor H) and downstream markers (C3a, C5a, and C5b-9) were measured by ELISA at 9 time points. Patients with stroke showed broad complement activation, with increased C1q, mannose-binding lectin, complement factor Bb, C3a, C5a, and C5b-9, and reduced complement factor H compared with controls. Complement components showed distinct temporal patterns during follow-up. Complement factor Bb levels were lower in patients with unfavorable functional outcome and in those with moderate-to-severe stroke. C1q and C3a trajectories differed according to functional outcome, whereas C3a trajectories also differed according to stroke severity. C1q trajectories differed according to age group and infarct volume. These findings suggest dynamic, pathway-specific complement activation after acute ischemic stroke and highlight the need for larger studies to clarify its prognostic and therapeutic relevance.

PubMedNutrients2026-10-16

Fit-Ideal Internalisation and Disordered Eating in Adolescent Girls: Psychometric Evaluation and Incremental Validity of the Fit Internalization Test.

Baceviciene Migle M, Balciuniene Vaiva V, Jankauskiene Rasa R

The present study aimed to validate the Lithuanian translation of the Fit Ideal Internalization Test (FIIT) in adolescent girls. A total of 1067 girls (mean age = 17.27, SD = 0.61; age range = 15-19 years) participated in the study. FIIT, muscular ideal internalization, body dissatisfaction (BD), disordered eating (DE), body appreciation (BA), and exercise motivation were assessed. Exploratory factor analysis (n = 534) replicated the original three-factor structure, explaining 74.43% of the total variance. Confirmatory factor analysis (n = 533) supported the three-factor model, with strong factor loadings. Composite reliability was excellent (McDonald's ω = 0.919-0.969). Measurement invariance was established across sport participation groups, and sport-involved girls reported higher Fit Drive, Fit Overvaluation, and FIIT total scores than non-sport-involved girls. All FIIT subscales were positively associated with muscular internalization, BD, and DE and negatively associated with BA, while Fit Idealisation and Fit Overvaluation showed weak negative associations with autonomous exercise motivation, consistent with the hypothesised pattern of associations. The FIIT explained significant additional variance in DE beyond body mass index, BD, and muscular ideal internalization, with Fit Idealisation showing the strongest unique association (β = 0.401, p < 0.001). The Lithuanian FIIT appears to be a psychometrically sound instrument for assessing fit ideal internalization among Lithuanian adolescent girls.

PubMedCells2026-10-16

Placental Insulin-like Growth Factor Signaling and Neurodevelopment: Emerging Evidence from the Placenta-Brain Axis.

Carver Annemarie J AJ, Williamson Eleanor G EG, Stevens Hanna E HE

The field of neuroplacentology is a growing area that focuses on the influence of placental function on brain development. This field has expanded our understanding of the placenta's crucial role in proper neurodevelopment as well as placental anomalies that increase the risk of adverse neurodevelopmental outcomes. Neuroplacentology studies have revealed distinct roles of placentally provided hormones and nutrients in neurodevelopment whose disruption by perinatal problems, including inflammation, can increase the risk of neurodevelopmental disorders such as autism spectrum disorder and ADHD. Placental insulin-like growth factor signaling significantly influences brain growth in animal model studies and is tightly linked with human neurodevelopmental outcomes. Insulin-like growth factor signaling is well-established as a regulator of placental function and is fundamental in fetal brain cell developmental processes and plays a role in inflammation. Placental insulin-like growth factor signaling underlies the placental production and delivery of hormones and nutrients that are necessary for fetal neural cell proliferation, differentiation, and growth. It is especially important to study this pathway in the placenta due to aberrant insulin-like growth factor signaling found in conditions such as preterm birth, fetal growth restriction, gestational diabetes, and obesity. All these conditions are linked to a greater risk for neurodevelopmental disorders, neuroinflammation, and other anomalies. This research subfield has also revealed sex differences in the insulin-like growth factor signaling pathway that will contribute to understanding the etiologies of these conditions. This area of study has and will continue to identify specific mechanisms, many currently in model systems, which could eventually be leveraged in preventative and interventive care to improve neurodevelopmental outcomes.

PubMedHealthcare (Basel, Switzerland)2026-10-16

Development and Psychometric Evaluation of the Peritoneal Dialysis Treatment Adherence Scale: A Multicenter Methodological Study.

Aydın Zehra Z, Sarıbudak Tuğba Pehlivan TP

Background/Objectives: Peritoneal dialysis (PD) requires patients to manage dialysis procedures, medications, fluid intake, and nutrition at home. Existing assessment approaches do not adequately distinguish patients' treatment-related knowledge and awareness from their self-reported adherence practices across these domains. This study aimed to develop and psychometrically evaluate the Peritoneal Dialysis Treatment Adherence Scale, a patient-reported instrument designed to assess treatment-related knowledge/awareness and self-reported adherence practices in peritoneal dialysis. Methods: This multicenter methodological study included 600 adults receiving PD at eight hospitals in Türkiye. An initial 64-item pool was evaluated by 12 experts and pilot-tested with 30 patients. The main sample was randomly divided into two independent subsamples of 300 participants for exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). EFA was conducted using principal axis factoring with direct oblimin rotation, and Horn's parallel analysis was used to determine factor retention. CFA was conducted in the independent confirmatory subsample. Internal consistency was evaluated using Cronbach's alpha and McDonald's omega, and three-week test-retest reliability was assessed in 30 participants using intraclass correlation coefficients. Results: The final instrument comprised a 32-item Knowledge Dimension, assessing self-reported treatment knowledge and awareness, and a 25-item Adherence Practices Dimension, assessing the frequency and consistency of self-reported adherence practices. Primary factor loadings ranged from 0.694 to 0.971 for Knowledge and from 0.508 to 0.951 for Adherence Practices, with no items meeting the prespecified criterion for problematic cross-loading. Separate four-factor CFA models demonstrated acceptable within-dimension fit; however, the additional integrated eight-factor CFA including all 57 items did not meet all conventional global-fit criteria, indicating that the overall measurement structure requires further independent validation. Internal consistency in the independent confirmatory subsample was high for both dimensions: Knowledge, α = 0.950 and ω = 0.984; Adherence Practices, α = 0.952 and ω = 0.986. Test-retest reliability was strong for Knowledge (ICC = 0.946) and Adherence Practices (ICC = 0.940). Conclusions: The Peritoneal Dialysis Treatment Adherence Scale demonstrated promising but provisional structural evidence, high internal consistency, and strong temporal stability. Its separately scored Knowledge and Adherence Practices dimensions may support domain-specific assessment in PD; however, the overall eight-factor measurement structure requires further independent validation before widespread clinical use.

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