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Factor IX (AlphaNine SD / AlphaNine)

✓ Approved

Mitsubishi Tanabe Pharma Corporation · F9 · Cell-based Therapies

What is Factor IX?

Factor IX is a cell-based therapies developed by Mitsubishi Tanabe Pharma Corporation. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesAlphaNine SD, AlphaNine
CompanyMitsubishi Tanabe Pharma Corporation
Drug ClassCell-based Therapies
Molecular TargetF9
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Mitsubishi Tanabe Pharma Corporation

Mechanism of Action

Molecular Targets

Factor IX acts on 1 molecular target:

F9coagulation factor IX (P19, F9 p22)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

Factor IX is developed for 3 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Vascular disordersExtravasation blood✓ Approved
Congenital, familial and genetic disordersFactor IX deficiency✓ Approved
Vascular disordersHaemorrhage✓ Approved

Related Research Articles

PubMedThe Egyptian journal of immunology2026-10-15

Assessment of serum levels of vitamin D and tumor necrosis factor alpha in ulcerative colitis patients at Egyptian Military Hospitals: Cross-sectional observational study.

Eldahan Wedad W, Hassan Mohamed Z H MZH, Asaad Ahmed M AM, Salaheldin Mohamed M et al.

Ulcerative colitis (UC) is a chronic inflammatory disorder confined to the colonic and rectal mucosa. The disease is marked by infiltration of immune cells, leading to excessive production of inflammatory mediators. A key pro-inflammatory cytokine that plays a vital role in the pathophysiology of ulcerative colitis is tumor necrosis factor alpha (TNF-alpha). Low levels of vitamin D have been associated with several autoimmune disorders. This study aimed to assess vitamin D serum levels in UC patients as regard TNF-alpha serum levels and the Severity of UC (UCDAI). This cross-sectional observational research was carried out at Military healthcare facilities in Cairo, Egypt, over six months, from 1 July 2025 to 31 December 2025. Utilizing a convenience sample of 50 adults aged 15 to 70 years with a confirmed diagnosis of ulcerative colitis, newly diagnosed. They were divided into two groups according to disease severity (UCDAI or Mayo score): 26 patients in the mild group & 24 patients in the moderate/severe group. Demographic data were collected from patients' interviews. Colonoscopy for ulcerative colitis disease activity index (UCDAI) score, CBC, ESR, CRP, and Fecal calprotectin (FC) were investigated at Egyptian Military hospitals. Serum levels of 25-hydroxyvitamin D (using CLIA) and TNF-alpha (using ELISA) were measured at central laboratories of the armed forces and blood bank. Correlation analysis showed Serum Vitamin D had a moderate negative correlation with UCDAI (r = -0.466, p-value= 0.001), and a strong negative correlation with serum TNF-alpha (r = -0.669, p-value <0.001). Serum TNF-alpha showed a moderate positive correlation with UCDAI (r = 0.472, p-value= 0.001). Fecal calprotectin had a strong positive correlation with UCDAI (r = 0.704, p-value <0.001) and a weak positive correlation with serum TNF-alpha (r = 0.388, p-value= 0.005). In conclusion, this study demonstrates that patients with moderate to severe ulcerative colitis had pronounced mucosal and systemic inflammation, reflected by markedly elevated fecal calprotectin and TNF-alpha levels, concomitant with significantly lower vitamin D concentrations compared with those in mild disease.

PMID 42875905
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PubMedInternational journal of emergency medicine2026-10-15

Psychometric evaluation of the Persian version of the shared decision‑making questionnaire in patients undergoing emergency surgery.

Hanifi Nasrin N, Sharif-Nia Hamid H, Gheiasi Seyede Fatemeh SF, Maleki Maryam M et al.

Accurate assessment of shared decision-making (SDM) is essential in emergency surgery, yet no culturally adapted and validated instrument is available in Iran. This study aimed to translate, culturally adapt, and assess the psychometric properties of the Persian SDM-Q-9 among patients undergoing emergency surgery. This methodological cross-sectional study followed a forward-backward translation procedure to adapt the SDM-Q-9 into Persian. Face and content validity were established prior to construct validation. Data were collected from 575 patients undergoing emergency surgery and randomly split into two independent subsamples for exploratory factor analysis (EFA; n = 287) and confirmatory factor analysis (CFA; n = 288). Internal consistency was assessed using Cronbach's alpha, McDonald's omega, and composite reliability (CR). Convergent validity was examined using average variance extracted (AVE). The data were suitable for factor analysis (Kaiser-Meyer-Olkin [KMO] = 0.923; Bartlett's test of sphericity: χ² = 3433.445, df = 36, p < 0.001). EFA using Maximum Likelihood (ML) extraction with Promax rotation supported a single-factor structure explaining 58.60% of the total variance, with all factor loadings exceeding 0.70. CFA of the independent validation subsample initially showed inadequate fit for the one-factor model. After reviewing modification indices and item content, three theoretically justified residual correlations were retained. The resulting model showed good fit (χ²/df = 2.78, Comparative Fit Index [CFI] = 0.962, Tucker-Lewis Index [TLI] = 0.944, Root Mean Square Error of Approximation [RMSEA] = 0.059, and Standardized Root Mean Square Residual [SRMR] = 0.052). Factor loadings ranged from 0.67 to 0.84, supporting a predominantly unidimensional structure. The scale demonstrated strong internal consistency (Cronbach's alpha = 0.921, McDonald's omega = 0.926, and CR = 0.924). Convergent validity was supported by an AVE of 0.576. The Persian SDM-Q-9 demonstrated satisfactory validity and strong reliability for assessing patient-perceived shared decision-making in emergency surgical settings in Iran. Its predominantly unidimensional structure supports its use, although the localized residual associations identified in CFA warrant replication in independent, multicenter samples.

PMID 42875738
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PubMedBritish journal of cancer2026-10-15

Paediatric therapeutic development workshop on desmoplastic small round cell tumours.

Baxter Joseph S JS, Molenaar Jan J JJ, Agrawal Arushi A, Amaral Ana Teresa AT et al.

The sixth Paediatric Therapeutic Development Workshop focused on desmoplastic small round cell tumours (DSRCT). Less than 20% of patients with DSRCT survive beyond 5 years and there is no targeted therapy for this disease, which represents an urgent unmet need for new therapeutics. High priority targets include the EWSR1::WT1 fusion protein, the oncogenic driver, and targeting a junction-derived neopeptide presented by HLA-A*03 and HLA-A*11 using a T-cell receptor (TCR) is a novel approach. Other targets (LRRC15, SSTR3 and SSTR5, NECTIN4, STEAP1 and mesothelin) require further validation. Targeting ERBB2/HER2 or claudin-6 by antibody-drug conjugates (ADCs) and NTRK3 by a small molecule inhibitor are promising approaches and are currently being evaluated. Existing clinical assets targeting (in order of importance) B7-H3, the DNA damage response, androgen signalling, FGFR4 and STEAP1 are also high priorities for evaluation in DSRCT, but obtaining therapeutics for clinical trials is a barrier. In view of the rarity of DSRCT, a global initiative in preclinical and clinical research to establish international trials and collect data from patients treated in a harmonised form would benefit patients. Progress can be made by a combined approach of developing new agents whilst evaluating existing therapeutics in well-designed trials.

PMID 42875477
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PubMedJournal of human nutrition and dietetics : the official journal of the British Dietetic Association2026-10-15

Cross-Cultural Adaptation and Psychometric Evaluation of the Turkish DESTEK (D-SCOPE) Questionnaire: A Multidimensional Assessment of Dietitians' Knowledge, Attitudes and Preparedness Regarding Dietary Supplements in Türkiye.

Bilen Ayşe Betül AB, Çalık Ayşenur A, Demiray Pınar Ece PE, Kandemir Kardelen K et al.

The increasing use of dietary supplements in Türkiye underscores the need for validated instruments to assess dietitians' knowledge, attitudes and self-efficacy regarding supplements. However, no validated Turkish tool is currently available. This study aimed to culturally adapt the Dietitians' Survey of Comfort, Opinions and Preparedness in Education in Supplements (-SCOPE) Questionnaire into Turkish (Diyetisyenlerin Eğitim, Supleman Tercihleri ve Konforu Anketi; DESTEK) and evaluate its psychometric properties. This methodological study included 223 dietitians. Exploratory factor analysis (Principal Axis Factoring with Direct Oblimin rotation) was conducted to identify the underlying structure, followed by confirmatory factor analysis to test model fit. Internal consistency was assessed using Cronbach's alpha. Convergent validity was examined through composite reliability and average variance extracted, and discriminant validity was evaluated using the Fornell-Larcker criterion. A four-factor structure explaining 38.3% of total variance was identified. Sampling adequacy was acceptable (KMO = 0.78; Bartlett's test: χ2(153) = 1023.27, p < 0.001). Confirmatory factor analysis demonstrated acceptable model fit (CFI = 0.915; TLI = 0.893; RMSEA = 0.062; SRMR = 0.057). The total scale showed acceptable internal consistency (α = 0.795), with subscale α values ranging from 0.531 to 0.824. Composite reliability values ranged from 0.60 to 0.83. Test-retest analysis demonstrated acceptable temporal stability (overall ICC = 0.772). Discriminant validity was supported. The findings provide preliminary evidence supporting the validity and reliability of the DESTEK scale for assessing Turkish dietitians' knowledge, attitudes and perceived preparedness regarding dietary supplements. Given its multidimensional structure, DESTEK may be useful for evaluating specific domains of supplement-related competence; however, further validation in larger and more diverse samples is recommended.

PMID 42875989
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PubMedFrontiers in aging neuroscience2026-10-15

Resting-state cortical alpha frequency in Parkinson's disease and multiple system atrophy: associations with diagnosis, age, and symptom burden.

Chen Daichao D, Tang Huada H, Pan Yanfei Y, Sang Hui H et al.

Parkinson's disease (PD) and multiple system atrophy (MSA) are clinically overlapping neurodegenerative disorders that present with a complex, heterogeneous burden of motor and non-motor symptoms. Resting-state EEG reveals that cortical alpha slowing is a hallmark of pathological aging, yet its specific presence and clinical significance in these distinct synucleinopathies remain incompletely understood. Therefore, precisely quantifying the individual alpha frequency serves as a critical, non-invasive approach to characterize cortical network dysfunction across synucleinopathies and evaluate how aging moderates its association with clinical symptom burden. We analyzed source-reconstructed resting-state EEG data from 104 participants, comprising patients with PD, patients with the parkinsonian (MSA-P) and cerebellar subtypes (MSA-C) of MSA, and healthy controls. To accurately capture oscillatory dynamics, a data-driven masking empirical mode decomposition approach was applied to extract the individual alpha frequency across canonical cortical networks. General linear models tested diagnostic group differences, age-related effects, and age-dependent associations between individual alpha frequency and clinical symptom scores. Relative to healthy controls, both PD and MSA-C exhibited significant lower cortical IAF, whereas MSA-P showed no significant global IAF difference. At the network level, significant reduction of IAF was detected in the visual and dorsal attention networks in both PD and MSA-C. Advancing age independently contributed to alpha slowing across all participants without accelerating the disease-related trajectories. Notably, chronological age significantly moderated the relationship between alpha slowing and non-motor symptoms. In older patients, reduced individual alpha frequency was strongly associated with a higher burden of overall non-motor, autonomic, and psychiatric/cognitive symptoms, a relationship not observed in younger patients or with motor symptom severity. Cortical alpha slowing was detected in PD and MSA-C, but not in MSA-P. Age independently contributes to alpha slowing and strengthens its association with non-motor symptom burden, supporting age-aware interpretation of resting-state electroencephalography biomarkers in synucleinopathies.

PMID 42876674
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PubMediScience2026-10-15

NDUFAF2 promotes abdominal aortic aneurysm formation through mitochondrial dysfunction-induced apoptosis.

He Haipeng H, Peng Jiaxin J, Chen Huining H, Zhang Yibo Y et al.

Abdominal aortic aneurysm (AAA) is a life-threatening vascular disease closely associated with mitochondrial dysfunction and apoptosis. Here, we found that NDUFAF2 (NADH dehydrogenase (ubiquinone) 1 alpha subcomplex assembly factor 2) was significantly upregulated in cultured cells and murine AAA tissues. Knockdown of NDUFAF2 in vitro attenuated Ang II-induced mitochondrial fragmentation, reactive oxygen species (ROS) production, and apoptosis in vascular smooth muscle cells (VSMCs), while improving mitochondrial membrane potential and oxygen consumption rate. In addition, NDUFAF2 knockdown reduced the expression of DRP1 (dynamin-related protein 1) while restoring the mitochondrial fusion protein OPA1 (optic atrophy 1), and OPA1 overexpression further enhanced mitochondrial integrity and function. In vivo, NDUFAF2 knockdown suppressed CaCl2-induced AAA formation, preserved aortic structure, reduced apoptosis, and restored mitochondrial complex subunits and smooth muscle cell markers. These results indicate that NDUFAF2 contributes to AAA progression by triggering mitochondrial damage and apoptosis, representing a promising therapeutic target for AAA.

PMID 42876502
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