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- | danirixin (GSK1325756) / GSK
Journal: Inhibition of chemokine receptor CXCR2 attenuates postoperative peritoneal adhesion formation. (Pubmed Central) - Mar 18, 2024
Inflammation plays an important role in the early stages of postoperative peritoneal adhesion formation, whereas collagen fibers and angiogenesis play important roles in the late stages. The CXCL2-CXCL3-CXCR2 signaling axis is an important link in the mechanism of postoperative peritoneal adhesion formation, and the application of CXCR2 inhibitors can alleviate the formation of postoperative peritoneal adhesions.
- | PLX5622 / Daiichi Sankyo
Preclinical, Journal: CXCR2-Blocking Has Context-Sensitive Effects on Rat Glioblastoma Cell Line Outgrowth (S635) in an Organotypic Rat Brain Slice Culture Depending on Microglia-Depletion (PLX5622) and Dexamethasone Treatment. (Pubmed Central) - Dec 9, 2023
Our method allowed us to study the influence of three different factors-dexamethasone, PLX5622, and CXCL2-in a well-controlled, simplified, and straight-forward mechanistic manner, and at the same time in a more realistic ex vivo scenario compared to in vitro studies. In our model, we showed a GBM outgrowth enhancing synergism between CXCR2-blocking and Dex-treatment in the native condition, which was levelled by PLX5622-pretreatment.
- | danirixin (GSK1325756) / GSK
Journal, Heterogeneity: High-Throughput Cellular Heterogeneity Analysis in Cell Migration at the Single-Cell Level. (Pubmed Central) - Dec 1, 2022
To explain the observed cell behaviors, single-cell morphological and molecular analysis were performed. These studies establish a novel technology to identify promising migration inhibitors for cancer treatment and relevant applications.
- | Journal: New Insight into Drugs to Alleviate Atopic March via Network Pharmacology-Based Analysis. (Pubmed Central) - Jun 10, 2022
The network analysis unveiled key targets against AM, and the MDT confirmed the affinity between significant compounds and targets. In this study, we described the significance of the eight uppermost targets (CCL2, CTLA4, CXCL8, ICAM1, IL10, IL17A, IL1B, and IL2) and eight ligands (Bindarit, CTLA-4 inhibitor, Danirixin, A-205804, AX-24 HCl, Y-320, T-5224, and Apilimod) against AM, providing a scientific basis for further experiments.
- || danirixin (GSK1325756) / GSK
Clinical, P2 data, Journal: Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial. (Pubmed Central) - Jan 11, 2022
Patients received either oral danirixin 75 mg twice daily (n = 45) or placebo (n = 48) on top of standard of care over 52 weeks...The IRM showed a higher probability of a positive predictive value (34%) than MMRM (22%). An item model-based analysis data gave more precise estimates of drug effect than MMRM analysis for the same endpoint in this one case study.
- | danirixin (GSK1325756) / GSK, reparixin (DF 1681Y) / Dompe
Journal: CXCL8 Associated Dendritic Cell Activation Marker Expression and Recruitment as Indicators of Favorable Outcomes in Colorectal Cancer. (Pubmed Central) - Oct 27, 2021
Furthermore, CXCL8 induced DC migration in transwell migration assays. Taken together, our data suggested that targeting the CXCL8-CXCR2 axis might impede DC activation or recruitment, and this axis could be considered a favorable factor rather than a target for critical antitumor effects on CRC.
- || danirixin (GSK1325756) / GSK
Clinical, Journal: Exhaled volatile organic compounds and lung microbiome in COPD: a pilot randomised controlled trial. (Pubmed Central) - Oct 8, 2021
In a pilot RCT, our exploratory objectives were feasibility of measuring VOCs via multiple techniques, assessing relationships between VOCs and Haemophilus colonisation and whether CXCR2 antagonism with danirixin altered lung microbiome composition in individuals with COPD...VOC measurement in clinical trials to identify subsets of COPD is feasible, but assessment of new VOC technologies must include concurrent GC-MS validation. Further work to standardise collection of VOCs and measuring a background or "housekeeper" VOC is required to understand and normalise individual VOC quantities.
- || danirixin (GSK1325756) / GSK
Clinical, Journal: Negative Food Effect of Danirixin: Use of PBPK Modelling to Explore the Effect of Formulation and Meal Type on Clinical PK. (Pubmed Central) - Aug 8, 2021
Further work to standardise collection of VOCs and measuring a background or "housekeeper" VOC is required to understand and normalise individual VOC quantities. Interactions between DNX and food components are the likely the source of the negative food effect via micellar entrapment, ion pairing and/or meal induced viscosity changes.
- | danirixin (GSK1325756) / GSK
Journal: Tumor-associated macrophages-mediated CXCL8 infiltration enhances breast cancer metastasis: Suppression by Danirixin. (Pubmed Central) - Jun 11, 2021
Collectively, TAMs/CXCL8 could enhance BCSCs self-renewal and breast cancer metastasis, and these effects could be markedly abolished by Danirixin treatment, suppressing breast cancer progression consequently. Therefore, Danirixin could be considered as a novel and effective therapeutic strategy for breast cancer treatment without obvious toxicity to major organs.
- || danirixin (GSK1325756) / GSK
Clinical, P2b data, Journal: CXCR2 antagonist for patients with chronic obstructive pulmonary disease with chronic mucus hypersecretion: a phase 2b trial. (Pubmed Central) - May 7, 2021
P2
The robust placebo and study effects prohibited any conclusions on the efficacy of danirixin. However, the absence of a clear efficacy benefit and the observed increase in exacerbations in danirixin-treated groups suggests an unfavorable benefit-risk profile in patients with COPD.
- || danirixin (GSK1325756) / GSK
Clinical, Journal: CXCL-8-dependent and -independent neutrophil activation in COPD: experiences from a pilot study of the CXCR2 antagonist danirixin. (Pubmed Central) - Dec 3, 2020
However, the absence of a clear efficacy benefit and the observed increase in exacerbations in danirixin-treated groups suggests an unfavorable benefit-risk profile in patients with COPD. The implications of these findings are significant for development of CXCR2 antagonists and other mechanisms targeting neutrophil activation or NETosis, suggesting that IL-8-dependent mechanisms will only work in a subset of COPD patients https://bit.ly/32SeisO.
- || danirixin (GSK1325756) / GSK
Clinical, PK/PD data, Journal: Evaluation of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Danirixin Hydrobromide Tablets in Japanese Healthy Elderly Participants. (Pubmed Central) - Aug 19, 2020
The exposure to danirixin was lower in the fed state (low-fat meal) than in the fasted state (a 56% and 35% decrease in C and AUC , respectively). This first study of danirixin in Japanese healthy elderly participants showed a favorable safety profile with no drug-related adverse events and no clinically significant concerns in clinical laboratory values, vital signs, ocular examination, or electrocardiograms.
- danirixin (GSK1325756) / GSK
[VIRTUAL] Neutrophil Extracellular Traps and CXCR2 Antagonism in Chronic Obstructive Pulmonary Disease: A Pilot Randomized Control Study (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_4878;
P2
Study results were inconclusive in determining whether blocking CXCR2 antagonism via danirixin reduced NET formation or changed lung microbiome composition COPD patients due to the small number of study participants following early termination of the study. Funding: This study (GSK study 207551) was funded by GSK (NCT03250689).
- danirixin (GSK1325756) / GSK
Neutrophil Extracellular Traps and CXCR2 Antagonism in Chronic Obstructive Pulmonary Disease: A Pilot Randomized Control Study (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area C) - Mar 15, 2020 - Abstract #ATS2020ATS_7398;
P2
Conclusion Measurement of NETs is feasible in a clinical trial. Study results were inconclusive in determining whether blocking CXCR2 antagonism via danirixin reduced NET formation or changed lung microbiome composition COPD patients due to the small number of study participants following early termination of the study.Funding: This study (GSK study 207551) was funded by GSK (NCT03250689).
- | AZD5069 / AstraZeneca, danirixin (GSK1325756) / GSK
Review, Journal: NETopathic Inflammation in Chronic Obstructive Pulmonary Disease and Severe Asthma. (Pubmed Central) - Dec 23, 2019
Clinical validation of this type could lead to novel therapeutics for multiple CXCR2-related NETopathologies. In this Review, we discuss the emerging role of NETs in the clinicopathobiology of COPD and severe asthma and provide an outlook on how novel NET-stabilizing therapies via CXCR2 blockade could be leveraged to disrupt NETopathic inflammation in disease-specific phenotypes.
- | danirixin (GSK1325756) / GSK
Journal: Effect of the CXCR2 antagonist danirixin on symptoms and health status in COPD. (Pubmed Central) - Aug 21, 2019
In this Review, we discuss the emerging role of NETs in the clinicopathobiology of COPD and severe asthma and provide an outlook on how novel NET-stabilizing therapies via CXCR2 blockade could be leveraged to disrupt NETopathic inflammation in disease-specific phenotypes. No abstract available
- | danirixin (GSK1325756) / GSK
Clinical, P2b data, Journal: Efficacy and Safety of Danirixin (GSK1325756) Co-administered With Standard-of-Care Antiviral (Oseltamivir): A Phase 2b, Global, Randomized Study of Adults Hospitalized With Influenza. (Pubmed Central) - May 2, 2019
P2
The registration data for the trial are in the ClinicalTrials.gov database, number NCT02927431, and in the EU Clinical Trials Register (https://www.clinicaltrialsregister.eu/) as GSK study 201023, EudraCT 2016-002512-40. Anonymized individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com.
- | danirixin (GSK1325756) / GSK
Clinical, Journal: Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Clinical Effect of Danirixin in Adults With Acute, Uncomplicated Influenza. (Pubmed Central) - Apr 27, 2019
No differences in viral load assessments were observed among treatment groups. Danirixin treatment was well tolerated and did not impede viral clearance.
- | danirixin (GSK1325756) / GSK
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, HEOR: A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Feb 6, 2019
P2, N=54, Terminated, Sponsor: GlaxoSmithKline
Danirixin treatment was well tolerated and did not impede viral clearance. N=100 --> 54 | Trial completion date: Mar 2020 --> Nov 2018 | Recruiting --> Terminated | Trial primary completion date: Mar 2020 --> Nov 2018; Terminated based on lack of efficacy seen in participants taking danirixin in dose ranging study and Sponsor decision to stop development of danirixin for COPD
- ||| danirixin (GSK1325756) / GSK
Trial termination: Randomized Study Evaluating the Effect of Danirixin on Neutrophil Extracellular Traps (NETs) in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Jan 24, 2019
P2, N=19, Terminated, Sponsor: GlaxoSmithKline
N=100 --> 54 | Trial completion date: Mar 2020 --> Nov 2018 | Recruiting --> Terminated | Trial primary completion date: Mar 2020 --> Nov 2018; Terminated based on lack of efficacy seen in participants taking danirixin in dose ranging study and Sponsor decision to stop development of danirixin for COPD Active, not recruiting --> Terminated; Study terminated due to a change in the benefit-risk profile for danirixin in COPD.
- | danirixin (GSK1325756) / GSK
Enrollment closed: Randomized Study Evaluating the Effect of Danirixin on Neutrophil Extracellular Traps (NETs) in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Oct 12, 2018
P2, N=19, Active, not recruiting, Sponsor: GlaxoSmithKline
Active, not recruiting --> Terminated; Study terminated due to a change in the benefit-risk profile for danirixin in COPD. Recruiting --> Active, not recruiting
- | danirixin (GSK1325756) / GSK
Trial completion: Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Oct 10, 2018
P2, N=626, Completed, Sponsor: GlaxoSmithKline
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | danirixin (GSK1325756) / GSK
Enrollment change: GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects (clinicaltrials.gov) - Sep 10, 2018
P1, N=40, Completed, Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed N=16 --> 40
- | danirixin (GSK1325756) / GSK
Trial completion date, Trial primary completion date, HEOR: A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Sep 5, 2018
P2, N=100, Recruiting, Sponsor: GlaxoSmithKline
N=16 --> 40 Trial completion date: Oct 2019 --> Mar 2020 | Trial primary completion date: Oct 2019 --> Mar 2020
- | danirixin (GSK1325756) / GSK
New P1 trial: GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects (clinicaltrials.gov) - Aug 3, 2018
P1, N=16, Completed, Sponsor: GlaxoSmithKline
- | danirixin (GSK1325756) / GSK
Trial completion, Enrollment change: GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects (clinicaltrials.gov) - Aug 3, 2018
P1, N=16, Completed, Sponsor: GlaxoSmithKline
Trial completion date: Oct 2019 --> Mar 2020 | Trial primary completion date: Oct 2019 --> Mar 2020 Active, not recruiting --> Completed | N=40 --> 16
- || danirixin (GSK1325756) / GSK
Enrollment closed: GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects (clinicaltrials.gov) - Jul 2, 2018
P1, N=40, Active, not recruiting, Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed | N=40 --> 16 Recruiting --> Active, not recruiting
- ||| danirixin (GSK1325756) / GSK
Enrollment closed: Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Jun 15, 2018
P2, N=600, Active, not recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- || danirixin (GSK1325756) / GSK
Trial completion date, Trial primary completion date, HEOR: A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Apr 20, 2018
P2, N=100, Recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Active, not recruiting Trial completion date: Jun 2019 --> Oct 2019 | Trial primary completion date: Jun 2019 --> Oct 2019
- danirixin (GSK1325756) / GSK
Enrollment open: GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects (clinicaltrials.gov) - Mar 20, 2018
P1, N=40, Recruiting, Sponsor: GlaxoSmithKline
Trial completion date: Jun 2019 --> Oct 2019 | Trial primary completion date: Jun 2019 --> Oct 2019 Not yet recruiting --> Recruiting
- | danirixin (GSK1325756) / GSK
New P1 trial: GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects (clinicaltrials.gov) - Mar 7, 2018
P1, N=40, Not yet recruiting, Sponsor: GlaxoSmithKline
- ||| danirixin (GSK1325756) / GSK
Trial initiation date: Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Mar 3, 2018
P2, N=600, Recruiting, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Initiation date: Apr 2017 --> Apr 2017
- || danirixin (GSK1325756) / GSK
Trial completion date, Trial primary completion date: Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Mar 3, 2018
P2, N=600, Recruiting, Sponsor: GlaxoSmithKline
Initiation date: Apr 2017 --> Apr 2017 Trial completion date: Nov 2018 --> Oct 2018 | Trial primary completion date: Nov 2018 --> Oct 2018
- || danirixin (GSK1325756) / GSK
Trial completion date, Trial primary completion date, HEOR: A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Feb 9, 2018
P2, N=100, Recruiting, Sponsor: GlaxoSmithKline
Trial completion date: Nov 2018 --> Oct 2018 | Trial primary completion date: Nov 2018 --> Oct 2018 Trial primary completion date: Mar 2019 --> Jun 2019 | Trial completion date: Mar 2019 --> Jun 2019
- | danirixin (GSK1325756) / GSK
Enrollment open: Randomized Study Evaluating the Effect of Danirixin on Neutrophil Extracellular Traps (NETs) in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Nov 22, 2017
P2, N=24, Recruiting, Sponsor: GlaxoSmithKline
Trial primary completion date: Mar 2019 --> Jun 2019 | Trial completion date: Mar 2019 --> Jun 2019 Not yet recruiting --> Recruiting
- |||| danirixin (GSK1325756) / GSK
Enrollment open, HEOR: A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Oct 24, 2017
P2, N=100, Recruiting, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | danirixin (GSK1325756) / GSK
New P2 trial: Randomized Study Evaluating the Effect of Danirixin on Neutrophil Extracellular Traps (NETs) in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Aug 16, 2017
P2, N=24, Not yet recruiting, Sponsor: GlaxoSmithKline
- | danirixin (GSK1325756) / GSK
Trial completion: Study of Danirixin in Japanese Healthy Elderly Male Subjects (clinicaltrials.gov) - Aug 15, 2017
P1, N=34, Completed, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Recruiting --> Completed
- danirixin (GSK1325756) / GSK
Enrollment change, Trial termination, Trial primary completion date: Study to Evaluate the Efficacy and Safety of Danirixin Co-administered With Oseltamivir in the Treatment of Adults Hospitalized With Influenza (clinicaltrials.gov) - Aug 9, 2017
P2, N=11, Terminated, Sponsor: GlaxoSmithKline
Recruiting --> Completed N=300 --> 11 | Recruiting --> Terminated | Trial primary completion date: Jun 2019 --> May 2017; The study was stopped early due to lack of enrollment.
- danirixin (GSK1325756) / GSK
Enrollment open: Study of Danirixin in Japanese Healthy Elderly Male Subjects (clinicaltrials.gov) - May 31, 2017
P1, N=34, Recruiting, Sponsor: GlaxoSmithKline
N=300 --> 11 | Recruiting --> Terminated | Trial primary completion date: Jun 2019 --> May 2017; The study was stopped early due to lack of enrollment. Not yet recruiting --> Recruiting
- ||||| danirixin (GSK1325756) / GSK
New P2 trial, HEOR: A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - May 30, 2017
P2, N=100, Not yet recruiting, Sponsor: GlaxoSmithKline
- |||| danirixin (GSK1325756) / GSK
Enrollment open: Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - May 3, 2017
P2, N=600, Recruiting, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | danirixin (GSK1325756) / GSK
New P1 trial: Study of Danirixin in Japanese Healthy Elderly Male Subjects (clinicaltrials.gov) - May 1, 2017
P1, N=34, Not yet recruiting, Sponsor: GlaxoSmithKline
- |||| danirixin (GSK1325756) / GSK
Enrollment open: Study to Evaluate the Efficacy and Safety of Danirixin Co-administered With Oseltamivir in the Treatment of Adults Hospitalized With Influenza (clinicaltrials.gov) - Feb 6, 2017
P2, N=300, Recruiting, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||||| danirixin (GSK1325756) / GSK
New P2 trial: Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - Jan 30, 2017
P2, N=600, Not yet recruiting, Sponsor: GlaxoSmithKline
- |||| danirixin (GSK1325756) / GSK
Trial completion: Investigation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of Oral Danirixin in Symptomatic COPD Subjects With Mild to Moderate Airflow Limitation at Risk for Exacerbations (clinicaltrials.gov) - Nov 25, 2016
P2a, N=102, Completed, Sponsor: GlaxoSmithKline
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||||| danirixin (GSK1325756) / GSK
New P2 trial: Study to Evaluate the Efficacy and Safety of Danirixin Co-administered With Oseltamivir in the Treatment of Adults Hospitalized With Influenza (clinicaltrials.gov) - Oct 7, 2016
P2, N=300, Not yet recruiting, Sponsor: GlaxoSmithKline
- | danirixin (GSK1325756) / GSK
Trial completion, Enrollment change: Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza (clinicaltrials.gov) - Jun 29, 2016
P2, N=45, Completed, Sponsor: GlaxoSmithKline
Active, not recruiting --> Completed Recruiting --> Completed | N=120 --> 45
- || danirixin (GSK1325756) / GSK
Trial primary completion date: Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza (clinicaltrials.gov) - Apr 4, 2016
P2, N=120, Recruiting, Sponsor: GlaxoSmithKline
Recruiting --> Completed | N=120 --> 45 Trial primary completion date: Oct 2015 --> Apr 2016
- ||| danirixin (GSK1325756) / GSK
Enrollment closed, Trial primary completion date: Investigation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of Oral Danirixin in Symptomatic COPD Subjects With Mild to Moderate Airflow Limitation at Risk for Exacerbations (clinicaltrials.gov) - Sep 14, 2015
P2a, N=110, Active, not recruiting, Sponsor: GlaxoSmithKline
Trial primary completion date: Oct 2015 --> Apr 2016 Recruiting --> Active, not recruiting | Trial primary completion date: May 2016 --> Aug 2016