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CSF-G

✓ Approved

Dong-A ST · CSF3R · Recombinant Proteins

What is CSF-G?

CSF-G is a recombinant proteins developed by Dong-A ST. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

CompanyDong-A ST
Drug ClassRecombinant Proteins
Molecular TargetCSF3R
RouteInjectable (Others), Subcutaneous Injection
StatusApproved

Mechanism of Action

Molecular Targets

CSF-G acts on 1 molecular target:

CSF3Rcolony stimulating factor 3 receptor (CD114, GCSFR)
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Therapeutic Indications

CSF-G is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Blood and lymphatic system disordersNeutropenia✓ Approved

Related Research Articles

PubMedAnnals of clinical and laboratory science2026-06-09

Correlation of CSF Biomarkers with Cognitive Screening Tests and PET Scan: A Tandem Approach.

Nelson Melody B MB, Crecelius Corey C, Jones Andrew P AP, Coffey Candice C et al.

Testing for amyloid beta protein (Aβ42), total tau (t-Tau), and phosphorylated tau (p-Tau at position 181: p-Tau 181) in CSF using Roche Elecsys assays has been approved by the FDA as biomarkers for Alzheimer's disease. We studied correlation between pTau181/Aβ42 ratios (>0.023 positive cutoff), screening for cognitive functions (commonly used for screening patients suspected of dementia and AD) with actual AD diagnosis based on PET scans in 143 patients. All Roche Elecsys (electrochemiluminescence) assays for biomarkers were run on Cobas e 801 analyzer. Imaging studies were performed using fluorodeoxyglucose PET scans. Screening patients for cognitive functions (SCFs) included either MOCA, SLUMS, STMS, or MMSE. Out of 143 patients with CSF AD biomarker ratios studied, 80 patients showed positive values (mean: 0.0555), while 63 patients showed negative ratios (mean: 0.0138). We also compared biomarker results with PET imaging in 40 patients (PET scan results were not available for all patients). Chi-square analysis showed a statistically significant association between positive CSF biomarker tests and PET scans {X2(1, N=40)=14.593; p<0.01}. In contrast, we observed poor correlation between SCFs and PET scan results using chi-square analysis {X2(1, N=40)=3.558, p=0.059}. However, binary logistic regression demonstrated a combination of abnormal SCF and a positive CSF screen significantly predicted a positive imaging result {X2(2, N=40)=15.940, p<.001}. CSF pTau181/Aβ42 ratios correlated significantly better with PET scan findings compared to various SCFs. Furthermore, a combination approach that included SCF and CSF biomarkers provided better correlation with positive PET imaging.

PubMedThe journal of prevention of Alzheimer's disease2026-06-09

Multimodal biomarker characterization of amnestic objective subtle cognitive decline in aging and preclinical Alzheimer's disease.

López-Martos David D, Cacciaglia Raffaele R, Suárez-Calvet Marc M, Salvadó Gemma G et al.

The objective of this study was to provide a multimodal biomarker characterization of amnestic objective subtle cognitive decline (obj-SCD) in aging and preclinical Alzheimer's disease (AD). Prospective observational study; data from the Alzheimer's and Families+ (ALFAs+) cohort, including cognitively unimpaired (CU) individuals with available baseline CSF biomarkers (normal or AD continuum profiles) and longitudinal neuropsychological assessment (2 time points, 3-year follow-up). Amnestic obj-SCD was defined using robust longitudinal neuropsychological references with multivariate base rate thresholds of significant decline (Free and Cued Selective Reminding Test, Memory Binding Test, Wechsler Memory Scale IV: Logical Memory). Study outcomes included plasma p-tau217, NfL, and GFAP; CSF p-tau181/Aβ42, NfL, and GFAP; Aβ and tau PET; and MRI Grey Matter volume (GMv). The associations of amnestic obj-SCD with fluid (plasma and CSF) and neuroimaging biomarkers (PET and GMv) were evaluated using mixed-effects and voxel-wise linear regression models, respectively. 350 CU individuals were included (mean age 61 years; 60% female; mean education 14 years; 35% CSF Aβ-positive). Amnestic obj-SCD was identified in 10% of the sample, associated with greater AD pathology (higher plasma p-tau217, CSF p-tau181/Aβ42, global Aβ PET, medial temporal tau PET), neurodegeneration (higher plasma and CSF NfL, reduced GMv in cingulate cortex, longitudinal GMv reductions in hippocampus) and inflammation (higher plasma and CSF GFAP, longitudinal GMv increases in neocortical brain regions). These findings highlight the need for standardized clinical staging criteria to enhance early detection and risk stratification in aging and preclinical AD.

PubMedAcademic radiology2026-06-09

Radiopharmaceutical Transit Timing in Pediatric and Young Adult Nuclear Medicine CSF Shunt Imaging: A 5-Year Retrospective Review.

Hoo Kim Mishka G MG, Morin Cara E CE, Sharp Susan E SE, Trout Andrew T AT

To retrospectively characterize the movement of radiopharmaceutical through cerebrospinal fluid (CSF) shunt catheters on nuclear medicine (NM) examinations with an aim of optimizing duration of image acquisition for children and young adults. An institutional reivew board approved retrospective review was conducted of all NM CSF shunt imaging examinations performed at our hospital between June 2020 and June 2025. Variables collected included: shunt type (ventriculoperitoneal (VP), ventriculoatrial (VA), ventriculopleural (VPL), lumboperitoneal (LP)); radiopharmaceutical dose; and time of first visualization of radiopharmaceutical activity in the shunt catheter and drainage compartment. Visualization of activity in the drainage compartment was considered indicative of patency of the distal shunt limb. Continuous data were summarized using medians and ranges. Categorial variables were summarized using counts and percentages. Among 197 CSF shunts, VP shunts were the most common (n = 174; 88.3%), followed by VPL shunts (n = 15; 7.6%), VA shunts (n = 7; 3.6%) and LP shunt (n = 1; 0.5%). Forty-six (23%) shunts never showed drainage compartment activity. Among the 151 shunts that demonstrated drainage compartment activity, VP shunts displayed peritoneal activity at a median of 17 min (range:1- 81) with peritoneal activity visible only after 60 min for 6 shunts. VPL shunts displayed pleural activity at a median of 5 min (range: 1- 33) and VA shunts displayed systemic activity at a median of 7.5 min (range: 5- 33). The single LP shunt showed radiopharmaceutical activity in the peritoneum at 30 min. In this sample of children and young adults with CSF shunts, drainage compartment activity was demonstrated within 60 min in the majority of NM CSF shunt exams. Imaging beyond this interval, infrequently provides additional information for clinical-decision making.

PubMedAJNR. American journal of neuroradiology2026-06-09

Patient-Reported Barriers to Care in Spinal Cerebrospinal Fluid Leak: A Cross-Sectional Survey.

Ettenberg Jodi J, Montes Daniel D, Spawn Kyle K, Bolan Aubrey A et al.

Spinal cerebrospinal fluid (CSF) leak is a disabling condition associated with prolonged diagnostic delays and fragmented care pathways. We sought to characterize patient-reported barriers to spinal CSF leak care and to identify factors associated with adverse financial, employment, and emotional outcomes. We performed a cross-sectional, anonymous online survey of adults with confirmed or suspected spinal CSF leak. Survey domains included diagnostic timelines, clinician encounters, referral pathways, structural barriers, and socioeconomic and emotional outcomes. Primary analyses were performed in respondents who completed all survey sections. Multivariable logistic and ordinal regression models identified predictors of financial worsening, employment disruption, and emotional wellbeing. Among 691 responses, 93.8% reported clinician-confirmed diagnosis and 60.9% remained symptomatic. Timelines were prolonged; 31.1% reported spinal CSF leak suspicion within 3 months, while 17.4% of respondents reported delays of over 4 years. Misdiagnosis occurred in 78%, and respondents saw a median of 6.5 clinicians. Financial worsening occurred in 74.2% and employment disruption in 67.6%. Multivariable analysis showed positive imaging was protective against financial worsening (aOR 0.55 [95% CI 0.35-0.87], p = .01), while each additional clinician increased odds of financial worsening (aOR 1.05 [95% CI 1.02-1.08], p = .003) and of employment disruption (aOR 1.03 [95% CI 1.01-1.06], p = .01). Post-lumbar puncture leak carried >2-fold higher odds of employment disruption (aOR 2.34 [95% CI 1.23-4.45], p = .01). CSF-venous fistula had the longest timelines, with 21.9% waiting >4 years for a first procedure. Delays of >4 years independently increased odds of financial worsening (OR 1.80 [95% CI 1.05-3.08], p= .03). Wait-related access barriers (63.6%) were independently associated with self-harm ideation. Poorly managed emotional states were reported by 42.0%; caregiver support (OR 0.41 [95% CI 0.26-0.65], p < .001) and physician acknowledgment (OR 0.78 [95% CI 0.66-0.91], p = .002) were independently associated with improved emotional outcomes. Patients with spinal CSF leak experience substantial diagnostic delay and fragmented care, with measurable downstream financial, occupational, and emotional consequences. Diagnostic burden and access barriers, rather than disease characteristics alone, are key drivers of adverse outcomes, while objective imaging confirmation and supportive clinical and caregiver interactions appear protective.

PubMedZhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences2026-06-09

[Clinical value of cerebrospinal fluid metagenomic next genera-tion sequencing in diagnosing neonatal intracranial infections].

Li Lingchen L, DU Lizhong L

To evaluate the diagnostic performance of cerebrospinal fluid (CSF) metagenomic next generation sequencing (mNGS) for neonatal intracranial infections and its impact on clinical decision making. A retrospective observational study was conducted. Neonates admitted to the Children's Hospital, Zhejiang University School of Medicine from 2020 to 2025 with suspected intracranial infection who underwent CSF mNGS were enrolled. The sensitivity of mNGS and its concordance with CSF culture and PCR were calculated. Clinical impact was assessed using predefined criteria, and samples were categorized into positive impact and no impact groups to identify independent factors influencing the clinical utility of mNGS. Among 61 neonates with suspected intracranial infection, 48 were confirmed. Pathogens were identified in 18 cases, of which 9 were detected exclusively by mNGS, accounting for 50% of etiological diagnoses. The sensitivity of mNGS was 31.3% (95% CI: 18.7%-46.3%), higher than that of culture PCR (18.8%, 95% CI: 8.9%-32.6%), but the difference was not statistically significant (P=0.15). The positive and negative concordance rates between mNGS and culture PCR were 66.7% (95% CI: 29.9%-92.5%) and 76.9% (95% CI: 60.7%-88.9%), respectively. mNGS positively influenced clinical decisions in 37.7% (23/61) of patients: 12 cases with positive results guided etiological diagnosis and treatment adjustment, and 11 cases with negative results led to antibiotic de escalation or discontinuation. Multivariate analysis identified a positive mNGS result as an independent factor associated with positive clinical impact (OR = 22.127, P<0.01). CSF mNGS provides valuable support in etiological diagnosis and clinical decision making for neonatal intracranial infections.

PubMedNeurocritical care2026-06-09

Safety and Additive Efficacy of Dual CSF Drainage (Ventricular + Lumbar) in Severe Aneurysmal Subarachnoid Hemorrhage: A Secondary Analysis of the EARLYDRAIN Trial.

Trevisi Gianluca G, Palermo Matteo M, D'Arrigo Sonia S, Doglietto Francesco F et al.

The EARLYDRAIN trial demonstrated the efficacy of lumbar drainage (LD) in aneurysmal subarachnoid hemorrhage (aSAH) but did not differentiate between patients requiring dual drainage [LD plus external ventricular drainage (EVD)] versus single-catheter management. The purpose of this study was to investigate the safety and additive efficacy of simultaneous double drainage (EVD + LD) compared with isolated EVD in patients with high-grade aSAH, stratifying by actual device usage. This secondary analysis stratified 254 EARLYDRAIN trial participants on the basis of daily intensive care unit (ICU) device records. To minimize selection bias, the isolated LD cohort (n = 43), characterized by significantly milder admission severity (mean Glasgow Coma Scale (GCS) 13.3, p < 0.001), was excluded from efficacy models. The primary analysis compared simultaneous double drainage (n = 92) vs. isolated EVD (n = 119). Multivariable logistic regression models were adjusted for age, Hunt-Hess grade, modified Fisher grade, and total cerebrospinal fluid (CSF) drainage volume. Double drainage and isolated EVD groups were well balanced for admission GCS (p = 0.672) and intraventricular hemorrhage prevalence (p = 0.355). Suspected infection rates were similar (47.8% vs. 44.5%, p = 0.631). In multivariable analysis, the drainage strategy (double vs. EVD) was not an independent predictor of clinical vasospasm (OR 1.02, p = 0.950), permanent shunt dependency (OR 0.75, p = 0.382), or unfavorable functional outcome (mRS 3-6) at 6 months (OR 0.75, p = 0.336). Instead, shunt dependency was independently predicted by higher total CSF drainage volume (p < 0.001) and age. Conversely, unfavorable functional outcome was driven exclusively by admission Hunt-Hess grade (p < 0.001) and age (p < 0.001), with total CSF volume showing no significance (p = 0.704). In patients with high-grade aSAH, the addition of a lumbar drain to an EVD is safe but does not independently mitigate vasospasm or improve functional outcomes when adjusted for injury severity. High-volume CSF drainage predicts shunt dependency but is not a marker of functional recovery, suggesting a "volume paradox" in severe hydrocephalus. Yet, because this was not a prespecified analysis, it is not possible to definitively establish the superiority of a dual-drainage strategy over ventricular drainage alone. Therefore, these results should be interpreted as exploratory.

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