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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

PubMedMolecular neurodegeneration advances2026-09-19

CSF proteomic quantitative trait loci mapping reveals genetic insights into Alzheimer's disease.

Reus Lianne M LM, Jiang Chenyang C, Vilor-Tejedor Natalia N, Boltz Toni T et al.

Despite the identification of numerous genetic risk variants for Alzheimer's disease (AD), mechanisms through which these variants act remain unclear. Identifying specific proteins levels affected by genetic variation can provide valuable insights into the underlying biological pathways implicated in AD. To gain more insight into effects of genetic variation on AD-related processes, we conducted a genome-wide protein pQTL study using untargeted TMT mass spectrometry in cerebrospinal fluid (CSF) of 2,215 proteins across 487 individuals. Replication was assessed in the independent EMIF-AD MBD cohort of 242 individuals. We identified 399 independent CSF pQTL signals (P Bonferroni < 2.26 × 10⁻11) associated with 222 proteins, 69% of which were novel. Findings included gene-protein links such as RPS23P10/HSPA6 with CSF FCGR2A, BIN2 with CSF GALNT6, APOE with CSF HS3ST1, and the HLA-region with CSF HLA-DPB1 and PLXDC2. We replicated 230 of 270 gene-protein associations. A proteome-wide association study identified genetically predicted CSF protein levels to be associated with AD, including SIRPA, PLXDC2, and GALNT6. Many AD pQTLs in CSF were enriched in neuroimmune activation, suggesting a genetic basis for neuroimmune dysregulation in AD. This study highlights how genetic variation shapes protein expression in the central nervous system, offering mechanistic insight into AD. The online version contains supplementary material available at https://doi.org/10.1186/s44477-026-00048-7.

PubMedFrontiers in oncology2026-09-19

Comparative evidence on the independent contribution of granulocyte-macrophage colony-stimulating factor to anti-GD2 immunotherapy in neuroblastoma: a systematic review and gap analysis.

Wieczorek Aleksandra A, Mielecka-Jarmocik Gabriela G, Synakiewicz Anna A, Śladowska Katarzyna K et al.

To assess comparative evidence on the independent contribution of GM-CSF to the efficacy and safety of anti-GD2 immunotherapy in neuroblastoma and to identify evidence gaps. This systematic review was conducted in accordance with the PRISMA guidelines in February 2026. MEDLINE (via PubMed), EMBASE, and the Cochrane Library were searched to identify comparative studies evaluating anti-GD2 immunotherapy with and without GM-CSF in patients with neuroblastoma. In addition, the websites of key oncology societies were searched. No study directly compared otherwise equivalent anti-GD2 regimens that differed only in the inclusion of GM-CSF. Two studies met the broader comparative eligibility criterion and provided only indirect regimen-level information. Both evaluated older, non-licensed murine anti-GD2 antibodies (m3F8 and 14.G2a), and neither evaluated GM-CSF with currently licensed anti-GD2 antibodies. In the retrospective study by Cheung et al., survival outcomes differed across treatment eras; however, GM-CSF was co-administered with 13-cis-retinoic acid and treatment groups also differed with respect to prior stem cell transplantation, induction therapy, baseline characteristics, follow-up duration and supportive care. Therefore, the observed survival differences cannot be attributed to GM-CSF. Toxicity comparisons in this study were also limited by differences in toxicity ascertainment across treatment eras. The prospective phase I/Ib study by Frost et al. was primarily designed to evaluate dose finding and toxicity, included very small and heterogeneous treatment groups, and did not isolate GM-CSF as an independent treatment variable. No eligible comparative study was identified for dinutuximab, dinutuximab beta or naxitamab. Available comparative evidence is insufficient to determine the independent contribution of GM-CSF to the efficacy or safety of anti-GD2 immunotherapy in neuroblastoma. These findings should not be used to justify modification of licensed product-specific anti-GD2 regimens. A randomized trial holding the anti-GD2 backbone and relevant co-interventions constant is needed to isolate the effect of GM-CSF. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD420251116911.

PubMedEuropean journal of neurology2026-09-19

Chitinases in Tear Fluid of Patients With Amyotrophic Lateral Sclerosis.

Wenz Lara L, Scholl Lena-Sophie LS, Reinhardt Nya N, Heynitz Ricarda von RV et al.

Chitinases, including chitotriosidase (CHIT1) and chitinase-3-like protein 1 (CHI3L1), are markers of neuroinflammation, a key process in amyotrophic lateral sclerosis (ALS). Tear fluid (TF) can be collected non-invasively and may represent a promising alternative to CSF or blood to study chitinases. TF was collected from 50 ALS patients and 50 control subjects using Schirmer strips. CHIT1 and CHI3L1 levels in TF, serum, and CSF were quantified using ELISA. Serum NfL was measured using SIMOA. The frequency of a 24 bp-duplication polymorphism in the CHIT1 gene influencing CHIT1 expression was assessed by PCR. No group differences in the distribution of the CHIT1 polymorphism were detected. Carriers of the polymorphism in both ALS and controls showed lower CHIT1 levels in serum and TF. CHI3L1 levels in TF were higher in ALS patients compared to controls (p = 0.007), consistent with changes in CSF but not serum. In ALS, males showed higher TF CHIT1 values compared to females (p = 0.009). Combining TF chitinase values with serum NfL values improved discrimination between ALS and controls. Chitinases are detectable in TF, and CHI3L1 levels recapitulate changes observed in CSF, highlighting its potential for non-invasive longitudinal assessment. Furthermore, chitinase values in TF, together with serum NfL, may act complementarily by capturing distinct aspects of the disease, neuroinflammation and axonal damage. These results suggest TF chitinases and serum NfL could complementarily contribute to the diagnosis and monitoring of the disease, and call for further evaluation of TF as a biomarker source in ALS.

PubMedMedicine2026-09-19

Middle ear malformations combined with cerebrospinal fluid otorrhea: A case report.

Liu Ya Y, Xu Yaping Y

Middle ear malformations (MEMs) encompass a diverse spectrum of congenital anomalies that significantly impair auditory function. They account for approximately 0.5% to 3% of conductive hearing loss cases, with etiologies involving both genetic and environmental factors. Clinically, MEMs complicated by cerebrospinal fluid (CSF) otorrhea are extremely rare. A 17-year-old male presented with right-sided hearing loss of over 7 years' duration. Otoscopic examination revealed a perforation in pars flaccid of the tympanic membrane. Pure-tone audiometry confirmed moderate conductive hearing loss in the right ear, while mastoid high-resolution computed tomography showed no obvious abnormalities. Intraoperative observations revealed partial dehiscence of the vertical segment of the facial nerve canal, agenesis of the long process of the incus, and Hyrtl fissure with suspected CSF leakage from the bony defect. The patient underwent tympanic cavity exploration surgery, during which the fissure was repaired, a partial ossicular replacement prosthesis was implanted, and the ossicular chain was reconstructed. At the 45-day postoperative follow-up, the tympanic membrane perforation was closed, conductive hearing loss improved, and the air-bone gap was markedly reduced. To our knowledge, this represents the 1st reported case of MEMs complicated by presumed CSF otorrhea. The surgical intervention involving defect repair and artificial ossicle implantation significantly improved the patient's quality of life.

PubMedEuropean journal of neurology2026-09-19

Intrathecal Plasma Cell Activity as Measured by the Kappa Free Light Chain Index Is Associated With Retinal Layer Atrophy in Early Multiple Sclerosis.

Berek Klaus K, Schmidauer Martin M, Föttinger Fabian F, Auer Michael M et al.

The relationship between intrathecal kappa free light chain (κ-FLC) synthesis and retinal layer atrophy in multiple sclerosis (MS) is unknown. To investigate whether the κ-FLC index is associated with peripapillary retinal nerve fiber layer (pRNFL) and ganglion cell plus inner plexiform layer (GCIPL) thickness. Patients with newly diagnosed clinically isolated syndrome or relapsing MS and available cerebrospinal fluid (CSF) analysis and optical coherence tomography (OCT) were included. Clinical and magnetic resonance imaging (MRI) data were also assessed. κ-FLC concentrations were measured by nephelometry, and the κ-FLC index was calculated as (CSF κ-FLC/serum κ-FLC)/albumin quotient. A total of 100 patients at a median age of 33 (25th-75th percentile: 25-39) years and a female predominance (58%) were included. In multivariable linear regression analysis adjusted for age, sex, disease duration, number of T2-hyperintense and number of contrast-enhancing MRI lesions, the κ-FLC index was associated with pRNFL (log-transformed κ-FLC index: β: -2.51; 95% confidence interval [CI]: -4.01, -1.01; p = 0.001) and GCIPL thinning (log-transformed κ-FLC index: β: -1.24, 95% CI: -2.32, -0.17; p = 0.024). Intrathecal plasma cell activity, as measured by the κ-FLC index, is associated with neuroaxonal damage, as reflected by pRNFL and GCIPL atrophy.

PubMedBJOG : an international journal of obstetrics and gynaecology2026-09-19

Association Between Proteinuria and Pregnancy Outcomes in Women With Preterm Pre-Eclampsia Undergoing Expectant Management: Secondary Analysis of Two Randomised Trials.

Rooyen Amy van AV, Bergman Lina L, Imberg Henrik H, Sproul Denise D et al.

Evaluate whether proteinuria levels, in women undergoing expectant management for pre-eclampsia, are associated with pregnancy latency and adverse outcomes. Secondary analysis of data from two randomised trials. Tygerberg Hospital, Cape Town, South Africa. Women undergoing expectant management for pre-eclampsia diagnosed between 26 and 32 weeks. Latency was analysed using parametric time-to-event methods to estimate increases. Composite outcomes were assessed using Poisson regression. Pregnancy latency Composite adverse maternal or perinatal outcomes. Two hundred and ninety-one women were included. Women with < 3 g/24 h had a median prolongation of 15.3 days (interquartile range (IQR) 4.3 to 25.6), compared to 10.0 days (IQR 5.0 to 19.6) with proteinuria between 3 to 5 g/24 h; and 4.9 days (IQR 3.8 to 11.7) for those with ≥ 5 g/24 h. Increasing levels were also associated with increases in subsequent adverse composite maternal outcomes: 8.8% of women with < 3 g/24 h experienced maternal complications, compared to 16.1% with 3 to 5 g/24 h, and 27.9% with ≥ 5 g/24 h. There was no association with composite perinatal adverse outcomes. The sFlt-1/PIGF ratio performed slightly better in predicting latency (area under the receiver operating characteristic curve (AUC) 0.78 vs. 0.67) but similarly in predicting adverse composite maternal outcomes (AUC 0.67 vs. 0.64). Both had poor performance for predicting composite adverse perinatal outcomes (AUC 0.61 vs. 0.56). Levels of proteinuria strongly correlate with pregnancy latency and adverse maternal outcomes, but not perinatal outcomes, in women with pre-eclampsia undergoing expectant management. They perform similarly to angiogenic markers. Proteinuria levels may confer useful prognostic information to assist clinical decision-making.

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