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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)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

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

PubMedTransfusion clinique et biologique : journal de la Societe francaise de transfusion sanguine2026-07-16

The Influence of Freezing Methodology on Coagulation Factor Preservation in Fresh Frozen Plasma: A Pilot Study.

Pawar Amit Ajay AA, Tomar Akshaya A, Sharma Anoop A, Sadana Ushasree U et al.

Rapid freezing is thought to better preserve labile coagulation factors in Fresh Frozen Plasma (FFP). This pilot study compared Contact Shock Freezing (CSF) with Conventional Freezing (CF) to assess their effectiveness in maintaining post-thaw coagulation factor levels. Although the ABO blood group may influence plasma characteristics, its role was not a primary objective and was only noted for preliminary observation during the comparison of the two freezing methods. In a prospective pilot study, plasma from 75 donors (balanced by ABO group) was divided into matched aliquots and subjected to either CSF (30 min at -30°C) or CF (7-8 hours at -30°C). Post-thaw analyses of PT, aPTT, fibrinogen, factor V, factor VIII, and factor IX were performed. Non-parametric statistics (Wilcoxon Signed-Rank tests and Aligned Ranks Transform ANOVA) were used for analysis. Study data suggested a trend towards superior preservation with CSF, yielding lower median PT and aPTT and higher median activities of Fibrinogen, Factor V, and Factor VIII. Notably, statistically significant interaction effects between the freezing method and ABO group were observed for fibrinogen (p=0.033), Factor VIII (p=0.012), and Factor IX (p=0.003). Post-hoc analysis indicated that the potential benefit of CSF for Fibrinogen may be most pronounced in group AB, and for Factor VIII in group B, while CF might better preserve Factor IX in group A. This in vitro pilot study demonstrates that Contact Shock Freezing is superior to Conventional Freezing in preserving the coagulation integrity of Fresh Frozen Plasma across all major parameters. The observed ABO-related differences emerged as incidental exploratory findings and should be interpreted with caution. The clinical significance of these biochemical improvements requires further investigation in well-designed clinical outcome studies.

PubMedHamostaseologie2026-07-16

Subcutaneous Treatment Hope: Non-Factor Care in Children with Hemophilia.

Thom Katharina K

Hemophilia A or B is an inherited bleeding disorder due to a deficiency of factor VIII or IX. Depending on the severity, bleeding may already occur after birth and in very young patients, e.g., intracranial hemorrhage or bleeding in muscle, soft tissue, and joints during surgery or after little accidents. Despite great improvements in factor therapy concerning half-life and less frequent injections, remaining issues are the intravenous administration and inhibitor development. Additionally, a primary regular factor prophylaxis maybe more effective to prevent joint bleeds and damages in adolescence and adults. Non-factor therapies have been a so-called "game changer" in hemophilia care, most of all due to the subcutaneous application and improved quality of life. Existing data demonstrate a more stable coagulation activation and effective bleeding prevention, also in patients with inhibitors. These novel therapies work either as factor mimetics, providing similarity to the missing factor, or they have a rebalancing effect by targeting natural coagulation inhibitors, such as tissue factor pathway inhibitor, or protein C. Depending on data and the approval situation, these therapies may allow an easier and earlier start of prophylaxis and potentially prevent early bleeding. However, concerns about these new treatments include, e.g., risk of coagulation imbalances and insufficient monitoring. This review will comprise an overview of non-factor treatment, such as FVIII mimetics and re-balancing therapies, including working profile, pediatric data, and approval situation in Europe, Switzerland, and the United States.

PubMedClinical medicine (London, England)2026-07-16

First Report of Bilateral Avascular Necrosis (AVN) of the Femoral Heads in a Patient with Dual Factor V Deficiency and Factor V Leiden Mutation: A Unique Coagulopathy Intersection with Therapeutic Insights.

Li Wei W, Li Huibo H, Dou Xixi X, Zheng Deqiang D et al.

We present what appears to be the first documented case worldwide of bilateral avascular necrosis (AVN) of the femoral heads in a young adult with the rare co-occurrence of congenital factor V (FV) deficiency and heterozygous FV Leiden mutation.

PubMedPhytomedicine : international journal of phytotherapy and phytopharmacology2026-07-16

Corrigendum to "Xanthoxylin alleviates dextran sulfate sodium (DSS)-induced colitis by targeting macrophage infiltration via the tumor necrosis factor (TNF)/nuclear factor-kappa B (NF-κB) signaling pathway" [Phytomedicine 153:157971 (2026) PMID: 41720014].

Chen Yuxin Y, Chen Ziyan Z, Li Jiacheng J, Zhao Rui R et al.

PubMedPsychology and psychotherapy2026-07-16

The Counselling Session Benefits Scale: Reliability, validity and psychometric properties.

Li Yonghui Y, Yang Jiaping J, Zhang Xin X, Sun Xiyuan X et al.

To develop and validate the Counselling Session Benefits Scale (CSBS), a self-report measure for assessing counselling benefits. In Study 1, expert evaluation and exploratory factor analysis (EFA) were conducted among university clients in China to establish content validity and factor structure. Besides, confirmatory factor analysis (CFA) and internal consistency were assessed. In Study 2, the scale's factor structure, internal consistency, validity and measurement invariance were examined among clients in general hospitals in China. The 23-item CSBS identified five factors: emotional release, cognitive changes, increase in coping skills, increase in confidence and self-acceptance. Both samples showed acceptable Cronbach's α coefficients, and EFA/CFA confirmed the scale's factor structure. Further, the CSBS correlated positively with working alliance and demonstrated measurement invariance across gender, medication use, psychotherapy experience and time. The CSBS is a reliable and valid tool for evaluating client gains after a single counselling session in university and clinical settings. Research is needed to validate the CSBS in western countries using a representative sample.

PubMedDusunen adam : Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi yayin organi2026-07-16

Turkish validity and reliability study of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) Scale.

Bilici Rabia R, Unubol Basak B, Cinka Elif E, Akulker Gizem G et al.

The use of alcohol, cigarettes, and substances contributes to the global burden of disease and causes acute harms, including high-dose use, as well as chronic problems such as addiction and infectious diseases. Among preventable diseases, smoking, alcohol, and substance use have been among the top ten causes of illness-related mortality. This study aimed to examine the Turkish validity and reliability of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) Scale. Two different sample groups (n=339) were interviewed by experienced clinicians. The Fagerstrom Nicotine Dependence Test (FNDT), Alcohol Use Disorder Identification Test (AUDIT), and Drug Use Disorder Identification Test (DUDIT) were also administered to examine correlations with ASSIST. To analyze the internal consistency of ASSIST, Cronbach's alpha coefficients were calculated for each group, ranging from 0.70 to 0.98. To examine the factor structure of the scale, exploratory factor analysis was conducted, and the Kaiser-Meyer-Olkin (KMO) measure of sampling adequacy was higher than 0.60, while Bartlett's Test of Sphericity was significant (KMO>0.60, p<0.05). Based on factor loadings, all items loaded onto a single factor except the "sedatives and hallucinogens" item, in which items 2-4 were grouped in factor 1 and items 6 and 7 were grouped in factor 2. ASSIST Tobacco scores were significantly correlated with FNDT scores (0.70 for Group 1 and 0.74 for Group 2). ASSIST Alcohol scores and total scores were significantly correlated with AUDIT and DUDIT scores, respectively (0.92 for Group 1 and 0.94 for Group 2; 0.91 for Group 1 and 0.90 for Group 2, respectively). It was concluded that ASSIST v3.1 can be applied to screen for cigarette, alcohol, and substance use/abuse in general psychiatry and psychiatric counseling centers in our country. Future studies conducted in different populations would provide new data regarding the effectiveness of ASSIST and contribute to both the literature and daily practice.

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