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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

PubMedCochlear implants international2026-08-30

Translation and validation of the extended version of the effort assessment scale for adults with cochlear implant in Turkish language.

Kartal Özcan Ahsen A, Çiprut Ayça A, Aktaş Selman S

Although assessing listening effort is clinically essential, no validated Turkish self-report measure currently exists. This study aimed to translate and culturally adapt the Extended version of the Effort Assessment Scale (EEAS) into Turkish and to evaluate the validity and reliability of the Turkish EEAS (T-EEAS) in adults with typical hearing (TH) and cochlear implant (CI) users. A standardized cross-cultural adaptation protocol was followed. Psychometric properties were evaluated in 567 adults (463 TH and 104 CI users). Construct validity was examined using confirmatory factor analysis. Reliability was assessed using Cronbach's alpha, test-retest correlation, intraclass correlation coefficient (ICC), and Bland-Altman agreement analysis. Discriminant validity was evaluated by comparing T-EEAS scores between groups. Confirmatory factor analysis supported a two-factor structure with good model fit. The T-EEAS showed high internal consistency (Cronbach's alpha = 0.938) and excellent test-retest reliability (Spearman's r = 0.867; ICC = 0.877). CI users reported higher listening effort than the TH group (P < 0.001), with a large effect size (Cliff's δ = 0.838). The T-EEAS captures subjective listening effort in Turkish-speaking populations. The two-factor structure distinguishes effort in quiet versus noise, which may support outcome monitoring in audiological rehabilitation. The higher scores observed in CI users support the discriminant validity of the scale. The T-EEAS is a valid and reliable measure of subjective listening effort in Turkish-speaking adults and can distinguish between TH adults and CI users, supporting its use in clinical and research settings.

PMID 42668441
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PubMediScience2026-08-30

A transcriptomics-based computational drug repurposing pipeline identifies simvastatin and primaquine as therapeutics for endometriosis.

Oskotsky Tomiko T TT, Tang Xinyu X, Arthurs Erin E, Govil Arpita A et al.

Endometriosis has limited treatment options, prompting the search for data-driven therapeutics. We previously used a transcriptomics-based computational drug repositioning pipeline and identified several drug candidates. Fenoprofen, our top in silico candidate, was validated in a rat model of endometriosis-associated pain. Building on this, we evaluated two additional candidates, simvastatin and primaquine. Using the rat model, we conducted behavioral testing, bulk RNA sequencing, and differential expression analysis to assess their therapeutic potential. We also assessed endometriosis diagnosis among patients prescribed simvastatin in electronic medical records across six University of California (UC) healthcare institutions. Overall, simvastatin and primaquine attenuated pain-associated behaviors and reversed endometriosis-related gene expression changes in our animal model. Moreover, simvastatin prescription was associated with a lower observed relative risk of endometriosis in our retrospective multi-center cohort study. These findings highlight their potential as repurposed therapeutics for endometriosis and support the effectiveness of computational drug repositioning in identifying treatment strategies.

PMID 42668641
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PubMedJournal of healthcare leadership2026-08-30

A Cross-Sectional Methodological Study to Validate Authentic Leadership Questionnaire (ALQ) Among Selected Latin American Nursing Staff.

Periañez Carlos Alberto Henao CAH, Trejos Serrato Jhovana J, Castillo-Díaz Marcio Alexander MA

Authentic leadership has been associated with work-related well-being, job satisfaction, and quality of nursing care. However, psychometric evidence supporting instruments used to assess this construct remains limited across Latin American nursing contexts, highlighting the need for further validation studies. To evaluate evidence of validity for the Authentic Leadership Questionnaire (ALQ) among nursing staff in a Latin American context. This cross-sectional methodological study included 418 nursing staff members-registered nurses and nursing assistants-selected through proportional stratified sampling from a public high-complexity hospital in Cali, Colombia, between May and October 2025. SELF and RATER versions of the ALQ were evaluated using confirmatory factor analysis. Four measurement models were compared for each version: unidimensional, correlated four-factor, second-order, and bifactor models. The final model was assessed through standardized loadings, internal consistency (McDonald's omega, ordinal alpha, composite reliability), measurement invariance (configural, metric, scalar) between nursing staff members, and correlations with job satisfaction. The revised correlated four-factor model (excluding item 9) showed the best fit (ALQ-RATER: CFI= 0.998, TLI= 0.997, SRMR= 0.045, RMSEA= 0.079; ALQ-SELF: CFI= 0.996, TLI= 0.995, SRMR= 0.047, RMSEA= 0.050). Factor loadings were significant (RATER λ = 0.661-0.945; SELF λ = 0.671-0.897). Reliability was adequate (ALQ-RATER: ω = 0.883-0.938, ordinal α = 0.887-0.952, CR = 0.899-0.957; ALQ-SELF: ω = 0.801-0.847, ordinal α = 0.846-0.880, CR = 0.850-0.880). Configural, metric, and scalar invariance were supported. Registered nurses demonstrated significantly higher latent means across all authentic leadership dimensions than nursing assistants. All ALQ dimensions were positively associated with intrinsic job satisfaction (r = 0.287-0.550) and satisfaction with supervision (r = 0.336-0.633). The ALQ demonstrated evidence of structural validity, reliability, measurement invariance, and external validity among Colombian nursing staff. The instrument can be used to assess authentic leadership in healthcare settings, support leadership development initiatives, and facilitate research examining its relationship with job satisfaction.

PMID 42668982
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PubMedKidney medicine2026-08-30

Metabolomic Signatures of Inflammation in Chronic Kidney Disease.

Chen Teresa K TK, Surapaneni Aditya L AL, Estrella Michelle M MM, Appel Lawrence J LJ et al.

Inflammation is associated with adverse kidney, cardiovascular, and mortality outcomes. Investigation of the metabolic milieu as it relates to inflammation may provide important insights into these disease processes. Prospective cohort. African American Study of Kidney Disease and Hypertension (AASK), Atherosclerosis Risk in Communities (ARIC) study, and Boston Kidney Biopsy Cohort (BKBC) participants with available metabolomics and inflammatory protein data. Baseline blood levels of 718 metabolites. Baseline and longitudinal changes in blood levels of tumor necrosis factor receptors 1 and 2 (TNFR1, TNFR2), tumor necrosis factor-alpha (TNF-α), interferon-gamma (IFN-γ), interleukins 6, 8, and 10 (IL-6, IL-8, IL-10), uromodulin (UMOD), and epidermal growth factor (EGF). Multivariable linear regression and linear mixed-effects models. Among 491 AASK participants (mean age 54 years; 37% women; mean glomerular filtration rate, 45 mL/min/1.73 m2), 367 cross-sectional associations between metabolites and inflammatory proteins were significant after correction for multiple comparisons. The direction of association was mostly positive for TNFR1 (97%), TNFR2 (97%), IL-8 (77%), and IL-10 (100%); negative for UMOD (80%) and EGF (97%); and variable for TNF-⍺, IFN-γ, and IL-6. Pathways were distinct for several inflammatory proteins (eg, tryptophan metabolism for TNFR2). Forty-five associations between metabolites and longitudinal change in inflammatory proteins were identified. Notable metabolites included tigylcarnitine and N 2,N 5-diacetylornithine, which were associated with 2-year increases in TNFR1 and/or TNFR2, and 1,5-anhydroglucitol, where lower levels were associated with decreases in UMOD. In ARIC (n = 3,773) and BKBC (n = 413), replication of cross-sectional associations was excellent for TNFR1 (ARIC 83%; BKBC 85%) and TNFR2 (ARIC 64%; BKBC 79%) but poor for IL-8 (ARIC 3%; BKBC 3%). Metabolite data limited to baseline visit; potential for residual confounding. Using an untargeted approach, multiple metabolites were cross-sectionally and longitudinally associated with inflammatory proteins in persons with chronic kidney disease.

PMID 42668601
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PubMedNeuromolecular medicine2026-08-30

AMBMP Hydrochloride Reverses STZ-Induced Alzheimer-Type Dementia Associated with Wnt/β-catenin/TLR4 Signaling.

Kalra Palak P, Chaturvedi Deepak D, Kumar Amit A, Grewal Amarjot Kaur AK et al.

Alzheimer's disease (AD) is a debilitating neurodegenerative disorder with progressive cognitive decline and neuronal loss. This study investigated the neuroprotective effects of AMBMP Hydrochloride, a Wnt/β-catenin agonist, in a streptozotocin (STZ)-induced mice model of AD, elucidating the interplay between dysregulated Wnt/β-catenin signaling and Toll-Like Receptor 4 (TLR4)-mediated inflammation, with Palmitic acid used as a TLR4 pathway modulator. Mice received bilateral intracerebroventricular (i.c.v.) injections of STZ (3 mg/kg) on Day 1 and Day 3, followed by administration of Donepezil (3 mg/kg)/ AMBMP Hydrochloride (5 mg/kg and 10 mg/kg)/Palmitic acid (TLR4 agonist, 20 mg/kg) via the intraperitoneal (i.p.) route from Day 4 to Day 22. STZ-treated mice exhibited significant cognitive dysfunction, characterized by impaired performance in the Morris Water Maze (MWM) task along with increase in acetylcholinesterase (AChE) activity, oxidative stress (thiobarbituric acid reactive substances; TBARS), neuroinflammation [tumor necrosis factor alpha (TNF-α)/Interleukin-6 (IL-6)/Interleukin-1 beta (IL-1β) and nuclear factor kappa B (NF-κB)] and decreased reduced glutathione (GSH) levels. However, AMBMP Hydrochloride significantly improved behavioral and biochemical alterations possibly through modulation of Wnt/β-catenin signaling and attenuation of TLR4-mediated inflammation. Interestingly, Palmitic acid co-treatment was found to counteract these protective effects, further pointing to a role of TLR4 in the pharmacological effect of AMBMP Hydrochloride. In summary, we confirmed that AMBMP Hydrochloride exhibits potent neuroprotective effects associated with modulating Wnt/β-catenin/TLR4 signaling, offering a promising therapeutic approach against Alzheimer-Type Dementia. Future studies should delve deeper into the molecular mechanisms and translational promise of AMBMP hydrochloride, paving the way for its development as a potential candidate for AD management.

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PubMedJournal of extracellular biology2026-08-30

Engineering Piezo1-Mediated Calcium Signalling for Enhanced Extracellular Vesicle Biogenesis and Cargo Loading.

Saleh Najla A NA, Shafiq Rozita R, Cicerone Amanda P AP, Kilangodi Sadhana S et al.

Cell-derived extracellular vesicles (EVs) are promising nanocarriers for therapeutic delivery platforms owing to their biocompatibility and capacity to protect and efficiently transport bioactive molecules. However, EV-based therapeutics remain constrained by inefficient cargo loading and low production yields, which limit scalable biomanufacturing. To overcome these limitations, we exploited the use of the mechanosensitive ion channel Piezo1 as a robust regulator of EV biogenesis using HEK293FT cells co-transfected with Piezo1 and the bioluminescent EV reporter PalmReNL. Activation of Piezo1 with Yoda1 (30 µM) increased PalmReNL-EV release by 3-fold, while GsMTx4 inhibited EV release by 80.7%. This effect was unaffected by removal of extracellular Ca2+ but was suppressed by intracellular Ca2+ chelation with BAPTA-AM, indicating a reliance on intracellular Ca2+ mobilisation. Small EVs (sEVs) from Piezo1-activated cells were purified by anion exchange chromatography and analysed by proteomics, identifying 48 proteins exclusively in Piezo1-induced sEVs preparations among 148 total detected, including cytoskeletal and stress-related factors, while preserving enrichment of extracellular matrix (ECM) structural components prominent in both conditions. Yoda1 treatment increased the release of both large EVs (lEVs) and sEVs, with a particularly pronounced increase in sEV production. As a proof of concept for therapeutic cargo delivery, Yoda1 stimulation increased the incorporation of exogenously expressed interleukin-10 (IL-10) into sEVs by up to 4-fold, and the bioactivity of sEV-associated IL-10 was validated using IL-10-CyCLoPs reporter cells. However, exposing Piezo1-overexpressing cells to 30 µM Yoda1 markedly delayed cell adhesion and spreading, indicating that excessive Piezo1 activation may constrain sustained production of therapeutic sEVs. Collectively, these results identify mechanotransduction as a key regulator of sEV biogenesis and underscore the need for precise temporal control, potentially achievable through ultrasound-based modulation, for the rational engineering of next-generation sEV therapeutics.

PMID 42669009
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