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Factor VIII (ReFacto AF / Xyntha)

✓ Approved

Sobi · F8 · Recombinant Proteins

What is Factor VIII?

Factor VIII is a recombinant proteins developed by Sobi. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesReFacto AF, Xyntha
CompanySobi
Drug ClassRecombinant Proteins, Cell-based Therapies
Molecular TargetF8
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Sobi

Mechanism of Action

Molecular Targets

Factor VIII acts on 1 molecular target:

F8coagulation factor VIII (AHF, FVIII)
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

PubMedThe American surgeon2026-07-25

Blunt Splenic Injury in Hemophilia A: Embolic Agent Selection When Hemostasis Cannot be Assumed.

Akalın Çağrı Ç, Akkaya Hüseyin H

Blunt splenic injury in a patient with hemophilia A presents a dilemma that has traditionally been settled by splenectomy. Removing the spleen leaves a patient already prone to bleeding without its immune function, and the factor VIII (FVIII) exposure that open surgery requires is itself a recognized trigger for inhibitor formation. In the general trauma population, nonoperative management is now the standard for hemodynamically stable patients: observation suffices in most, and splenic artery embolization is reserved for higher-risk injuries. Patients with inherited coagulopathy, however, sit outside the trials and guidelines that built this paradigm. We present a 66-year-old man with mild hemophilia A (FVIII activity 13%), cardiac comorbidity, and a plasma allergy who sustained a blunt splenic laceration graded as American Association for the Surgery of Trauma (AAST) Grade II. No interim computed tomography was obtained; by hospital day 3, selective angiography showed an arteriovenous fistula that had been absent at presentation, a delayed vascular complication of the original injury. Coils and particulate agents failed to achieve occlusion, whereas a 1:3 N-butyl cyanoacrylate (NBCA)-lipiodol mixture produced immediate and complete vessel sealing via coagulation-independent polymerization. Using this case as an anchor, we review nonoperative management of splenic injury across inherited and acquired coagulopathy, compare coagulation-dependent and coagulation-independent embolic agents, and propose a multidisciplinary approach spanning factor replacement, agent selection, and immunoprophylaxis for this underserved population.

PMID 42498673
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PubMedRadiology case reports2026-07-25

An unusual case of neglected CSOM presenting with perineural spread along seventh/eighth cranial nerves to form cerebellar peduncle abscess: A case report.

Sonker Shailly S, Raj Gaurav G

Chronic suppurative otitis media (CSOM) is a common otologic disorder that may occasionally result in intracranial complications. However, extension of infection into the posterior cranial fossa through the facial (VII) and vestibulocochlear (VIII) nerve complex is exceedingly rare. We report the case of an 18-year-old male with a 7-year history of neglected bilateral ear discharge, hearing impairment, and left-sided lower motor neuron facial nerve palsy who presented with severe headache, vomiting, and seizures. Contrast-enhanced magnetic resonance imaging (MRI) demonstrated findings consistent with labyrinthitis, with contiguous enhancement involving the labyrinth, the VII/VIII cranial nerve complex, and the left middle cerebellar peduncle, where an abscess had developed. High-resolution computed tomography (HRCT) of the temporal bone revealed features of advanced CSOM, extensive osseous destruction, labyrinthine fistula formation, and labyrinthitis ossificans. Notably, no defect was identified in Trautmann's triangle. In the absence of alternative pathways of intracranial extension, perineural spread along the facial and vestibulocochlear nerves was considered the most plausible mechanism of infection dissemination. This case highlights a rare route of intracranial spread of otogenic infection through the VII/VIII cranial nerve complex, culminating in cerebellar peduncle abscess formation. Awareness of this uncommon pathway is important for early diagnosis and management of atypical intracranial complications of CSOM.

PMID 42500495
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PubMedJournal of neurotrauma2026-07-25

Inhibition of Soluble TNF Mitigates Traumatic Brain Injury as a Risk Factor for the Development of Amyloidogenic Proteins and Functional Deficits in 3xTg-AD Mice.

Poffenberger Chelsie N CN, Taylor Michelle M MM, Larson Katelyn K, Mufson Elliott J EJ et al.

Traumatic brain injury (TBI) is a well-known risk factor for dementia with Alzheimer's disease (AD), and there are no known therapies that can mitigate this risk. Pre-clinical studies demonstrate a temporary upregulation of amyloid beta (Aβ) and corresponding neurological dysfunction following TBI with little-to-no studies developing interventions to prevent this pathophysiology. The pro-inflammatory cytokine tumor necrosis factor (TNF) has been shown to promote the development of AD, and here we investigate whether a clinically relevant biologic known as XPro1595 that neutralizes soluble TNF (solTNF) can mitigate TBI as a risk factor for the development of amyloidogenic proteins and corresponding neurological dysfunction. Following a single controlled cortical impact model of TBI or sham-injury, adult male 3xTg-AD mice were treated acutely with either XPro1595, a dominant-negative protein that neutralizes soluble TNF (10 mg/kg, S.C.), or vehicle solution. Between 6 h and 1 month post-injury (MPI), levels of cytokines, inflammatory markers, and AD-related proteins were evaluated in the ipsilateral hippocampus. Additionally, animals were behaviorally tested for deficits in cognition (learning and memory), as well as hindpaw mechanical hypersensitivity. TBI induced a significant increase in TNF (ELISA, 6 h) and TNFR1 (Western blot, 3 days post-injury [DPI]) expression, which correlated with an increase in BACE1, Aβ42, and caspase-3 at 3 and 7 DPI. Significant deficits in cognition and mechanical hypersensitivity were found at 7 DPI with similar trends at 1 MPI. In comparison, injured mice treated with XPro1595 had improvements in cognition and mechanical hypersensitivity (cf. vehicle-treated injured mice) and did not have these same increases in BACE1, Aβ42, and caspase-3 (levels were similar to sham-injured mice), likely by increasing NF-κB deactivation (pNF-κB [p65; Ser468]), indicative of a reduced inflammatory response. Overall, treatment with XPro1595 following TBI prevented the development of amyloidogenic proteins and corresponding neurological dysfunction. Clinically, these data support the use of XPro1595 as a clinically relevant therapeutic for patients with TBI to mitigate the risk of increased Aβ levels and neurological decline subacutely post-injury.

PMID 42498936
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PubMedTurkish journal of medical sciences2026-07-25

Impact of transforaminal epidural steroid injection on pain, disability, and kinesiophobia in lumbar disc herniation with radicular pain.

Öz Hande Ece HE, Çetinkaya Bulutoğlu Rumeysa R, Çetin Furkan F, Can Ezgi E et al.

The aim was to evaluate the effect of single-level transforaminal epidural steroid injection (TFESI) on kinesiophobia (KP) in patients with lumbar radicular pain (RP) caused by single-root, single-level lumbar disc herniation (LDH). A total of 63 patients diagnosed with unilateral single-level radicular pain due to LDH and treated with single-level TFESI were included. The Numeric Rating Scale (NRS), modified Oswestry Disability Index (MODI), Tampa Scale of Kinesiophobia (TSK), and Neuropathic pain (NP)-Douleur Neuropathique 4 Questionnaire (DN4) were used before the procedure and at 3 weeks and 3 months postoperatively. At baseline, 76.19% (n = 48) of the patients exhibited KP. Significant improvements were observed in the NRS, TSK, MODI, and DN4 scores at both 3 weeks and 3 months (p < 0.001). Clinical outcomes were similar between the patients with and without KP, except for DN4 scores, which remained significantly higher in the KP group. A ≥50% reduction in the TSK score at the 3-month follow-up was positively correlated with ≥50% improvements in the NRS, MODI, and DN4 scores. Additionally, a longer symptom duration was negatively associated with the degree of improvement in the TSK. Our findings suggest that TFESI is an effective and safe method for alleviating pain and kinesiophobia in patients with chronic radicular pain due to LDH. Clinicians should be aware that a prolonged duration of symptoms is a risk factor that negatively influences the effectiveness of TFESI in cases of KP.

PMID 42499450
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PubMedMedicine2026-07-25

Psychometric validation of the Japanese version of the lymphedema functioning, disability, and health questionnaire for upper limb lymphedema: A multicenter cross-sectional study.

Sakamoto Daigo D, Hamaguchi Toyohiro T, Kato Rumiko R, Miyake Kazumasa K et al.

Upper limb lymphedema that develops after breast cancer treatment affects not only patients' physical function and daily activities but also their psychosocial well-being, thereby reducing their health-related quality of life (HRQOL). The Lymphedema Functioning, Disability, and Health Questionnaire for Upper Limb Lymphedema (Lymph-ICF-UL) is a scale that comprehensively evaluates these effects. However, a Japanese version is not yet available. This study aimed to translate and develop a Japanese version of the Lymph-ICF-UL and to verify its psychometric properties in patients with breast cancer-related upper limb lymphedema. The scale was translated in accordance with international guidelines. A total of 208 women from 3 facilities in Japan completed the questionnaire. For test-retest reliability, 142 participants were randomly selected, among whom 131 completed the retest. Content validity was evaluated by 21 experts, and internal consistency and test-retest reliability were verified. For construct validity, exploratory and confirmatory factor analyses were conducted, and convergent and discriminant validities were evaluated using subscales of the 36-Item Short-Form Health Survey Questionnaire. The Japanese version of the Lymph-ICF-UL demonstrated acceptable content validity, high internal consistency, and good test-retest reliability. Exploratory and confirmatory factor analyses provided partial support for the original five-factor structure; however, some model fit indices did not meet conventional thresholds. The forced five-factor model with low-loading items removed showed the lowest Bayesian information criterion. Convergent validity was supported for all predefined hypotheses, whereas discriminant validity was supported for 4 of 9 hypotheses, resulting in confirmation of 64% of all hypotheses. The Japanese version of the Lymph-ICF-UL has been demonstrated to have sufficient reliability and validity. This scale is a practical assessment tool for evaluating the HRQOL in patients with upper limb lymphedema.

PMID 42499074
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PubMedPharmacological research2026-07-25

Targeting KLF4 Degradation by Doxycycline Restores Peroxisome Lipid Metabolism and Mitochondrial Energy Production in Acute Kidney Injury.

Feng Ji J, Yao Zhi-Sheng ZS, Li Yu-Hong YH, Bai Yan Y et al.

Acute kidney injury (AKI) is a life‑threatening condition with limited preventive medications. While the transcription factor Krüppel-like factor 4 (KLF4) is critical to AKI pathophysiology, its underlying molecular mechanisms remain incompletely understood. This study investigates KLF4 from a metabolic perspective and explores the renoprotective potential of doxycycline, an FDA-approved antibiotic. In murine models of ischemia‑reperfusion (IR)‑ and cisplatin (CDDP)‑induced AKI, doxycycline administered significantly attenuated kidney injury and protected renal tubular cells from glucose deprivation- and oxygen‑glucose deprivation-induced stress in vitro. Integrative transcriptomic and metabolomic profiling revealed that AKI progression involves profound metabolic dysfunction, characterized by the downregulation of peroxisomal Acyl-CoA oxidase 3 (ACOX3) and mitochondrial Isocitrate dehydrogenase 2 (IDH2). We identified KLF4 as a dual transcriptional repressor of ACOX3 and IDH2. Mechanistically, molecular docking, surface plasmon resonance, and co-immunoprecipitation assays demonstrated that doxycycline directly binds KLF4 and promotes its ubiquitin-mediated degradation via the E3 ligase FBXO32, which restores ACOX3/IDH2-mediated fatty acid oxidation and the TCA cycle, enhancing cellular resilience against ischemic crisis. These findings define a novel KLF4‑ACOX3/IDH2 metabolic axis and highlight doxycycline as a promising repositioning candidate for AKI prevention.

PMID 42498145
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