Delving into the Latest Updates on Sivelestat Sodium Hydrate with Synapse

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.

Start Date01 Apr 2026

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

ChiCTR2400086632 / SuspendedPhase 2IIT

The feaSibility and safety of sIvelestat soDIum hydrate adjunct to fentaNyl for analGesia in patients under mechanical ventilation : a multi-center, randomized, controlled trial (The SIDING trial)

Start Date15 Jul 2024

Sponsor / Collaborator

Huai'an First People's Hospital

NCT06387823 / RecruitingNot ApplicableIIT

Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS: a Pilot Study of a Prospective, Multicenter, Double-blind, Double-mock Randomized Controlled Clinical Study

The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are:
Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo?
Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo.

Start Date15 Apr 2024

Sponsor / Collaborator

Peking Union Medical College Hospital

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100 Clinical Results associated with Sivelestat Sodium Hydrate

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100 Translational Medicine associated with Sivelestat Sodium Hydrate

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100 Patents (Medical) associated with Sivelestat Sodium Hydrate

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468

Literatures (Medical) associated with Sivelestat Sodium Hydrate

01 Nov 2024·JOURNAL OF CONTROLLED RELEASE

Elastase-targeting biomimic nanoplatform for neurovascular remodeling by inhibiting NETosis mediated AlM2 inflammasome activation in ischemic stroke

Article

Author: Li, Jinyu ; Jia, Feng ; Chen, Xufeng ; Wang, Yanling ; Lu, Xiaowei ; Chen, Weilin ; Tang, Chunming ; Ding, Yan ; Han, Feng ; Xu, Huae ; Wu, Min

Neutrophil elastase (NE) is a protease released by activated neutrophils in the brain parenchyma after cerebral ischemia, which plays a pivotal role in the regulation of neutrophil extracellular traps (NETs) formation. The excess NETs could lead to blood-brain barrier (BBB) breakdown, overwhelming neuroinflammation, and neuronal injury. While the potential of targeting neutrophils and inhibiting NE activity to mitigate ischemic stroke (IS) pathology has been recognized, effective strategies that inhibit NETs formation remain under-explored. Herein, a biomimic multifunctional nanoplatform (HM@ST/TeTeLipos) was developed for active NE targeting and IS treatment. The core of the HM@ST/TeTeLipos consisted of sivelestat-loaded ditelluride-containing liposomes with ROS-responsive and NE-inhibiting properties. The outer shell was composed of platelet-neutrophil hybrid membrane vesicles (HMVs), which acted to hijack neutrophils and neutralize proinflammatory cytokines. Our studies revealed that HM@ST/TeTeLipos could effectively inhibit NE activity, thereby suppressing the release of NETs, impeding the activation of the AIM2 inflammasome, and consequently redirecting the immune response away from a pro-inflammatory M1 microglia phenotype. This resulted in enhanced neurovascular remodeling, reduced BBB disruption, and diminished neuroinflammation, ultimately promoting neuron survival. We believe that this innovative approach holds significant potential for improving the treatment of IS and various NE-mediated inflammatory diseases.

01 Oct 2024·International journal of cosmetic science

Cosmetic application of the stem‐bark extract of Bertholletia excelsa H.B.K

Article

Author: Carneiro, Simone B. ; Acho, Leonard D. R. ; Lima, Emerson S. ; Guimarães, Anderson C. ; Silva, Márcia J. A.

Abstract:

Objective:

The Amazon has a rich biodiversity where many different plant species can be found. This diversity is an important source of bioactive substances, mainly due to the different structural components of their phytometabolites. Research for natural products is a strategy for the development of new agents in therapeutic applications, especially cosmetic applications, that have better pharmacological potential. Within this perspective, the objective of the study was to investigate the cosmetic application (anti‐aging potential) of the stem‐bark extract of Bertholletia excelsa H.B.K – (SBEBE), popularly known as the Brazil nut tree, here called SBEBE, a noble plant species of the Amazon that is rich in selenium.

Methods:

Enzymatic, glycation, proliferation, cell‐healing, collagen quantification, toxicity and genotoxicity assays were used.

Results:

Among the enzymes involved in the extracellular matrix of the skin, SBEBE was able to inhibit only elastase (62.67 ± 3.75) when compared to the standard sivelestat (89.04 ± 0.53), and the extract was also able to inhibit both the oxidative and the non‐oxidative pathway. When cell toxicity in fibroblasts (MRC‐5) and keratinocytes (HACAT) was evaluated, SBEBE did not present toxicity in 24 h of incubation. After this period, the extract showed average cytotoxicity in 48 and 72 h, but not enough to reach the concentration of 50% of MRC‐5 fibroblasts. In the trypan blue assay, the extract promoted fibroblast proliferation in 24, 48 and 72 h of incubation, which was evaluated through exponential cell growth, with emphasis mainly on the lowest concentration with results higher than the standard. When the cell healing capacity was evaluated, in 48 h of exposure to fibroblast, SBEBE was able to induce a cell carpet (cell film) in the cell monolayer scratch assay.

Conclusions:

SBEBE stimulated collagen production at all concentrations tested. In the alkaline comet assay, at the lowest concentration, the extract did not induce DNA damage when compared to the reference drug doxorubicin. This study proved that SBEBE extract can be considered an ally in the treatment of skin anti‐ageing as a possible biotechnological, phytocosmetic product.

01 Sep 2024·Heliyon

Clinical utility of the neutrophil elastase inhibitor sivelestat for the treatment of ALI/ARDS patients with COVID-19

Article

Author: Cheng, Mengyu ; Yin, Junping ; Wang, Ruiying ; Chen, Yuan ; Liu, Hu ; Liu, Xiansheng ; Li, Jian ; Bai, Xueli ; Wang, Lei ; Wei, Shuang

Background:

Sivelestat, a neutrophil elastase inhibitor, is postulated to mitigate acute lung injury in patients following emergency surgery. However, its efficacy in patients with acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) induced by coronavirus disease 2019 (COVID-19) remains uncertain. This study aims to evaluate the pulmonary protective effects of sivelestat in COVID-19 patients with ALI/ARDS.

Methods:

A retrospective study was conducted involving 2454 COVID-19 patients between October 5, 2022, and February 1, 2023. Of these, 102 patients received sivelestat (0.2 mg/kg/h), while 2352 age- and sex-matched controls were identified. Propensity score matching (PSM) analysis was used to match sivelestat and non-sivelestat subgroups in ratios of 1:1 and 1:3 for sensitivity analysis. The primary outcome was a composite of effective outcomes, including 30-day mortality. Secondary outcomes included changes in partial pressure of arterial oxygen (PaO₂), the ratio of PaO₂ to the fraction of inspired oxygen (PaO₂/FiO₂), and various cytokine levels. Safety evaluations included assessments of liver function, kidney function, and leukopenia.

Results:

In the propensity score-matched analysis, the sivelestat group had a higher proportion of severe/critical patients (87.26 % vs. 51.02 %, P < 0.001), more ARDS patients (4.9 % vs. 0.43 %, P < 0.001), and more patients with interstitial lung disease (4.9 % vs. 1.49 %, P = 0.023), but fewer patients with stroke (17.65 % vs. 19.86 %, P < 0.001). Oxygen therapy rates were similar between the groups (79.41 % vs. 80.95 %, P = 0.9). The relative risk reduction in 30-day mortality was 88.45 % (95 % confidence interval [CI] 81.23%-93.21 %) for severe/critical COVID-19 patients treated with sivelestat. Sivelestat significantly decreased cytokine levels of interferon alpha (IFNα), interleukin-1 beta (IL-1β), and interleukin-2 (IL-2).In the sivelestat group, the mortality rate was significantly reduced with standard oxygenation and HFNC therapy(P < 0.05). The treatment with sivelestat did not increase side effects.

Conclusion:

The administration of the neutrophil elastase inhibitor sivelestat may improve clinical outcomes in COVID-19 patients with ALI/ARDS. These findings suggest that sivelestat could be considered an effective treatment option to alleviate pulmonary inflammatory injury caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

100 Deals associated with Sivelestat Sodium Hydrate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Sivelestat Sodium Hydrate	R03	DB12863

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Lung Injury	JP	Maruishi Pharmaceutical Co., Ltd.	11 Apr 2002
Acute Lung Injury	JP	Ono Pharmaceutical Co., Ltd.	11 Apr 2002
Systemic Inflammatory Response Syndrome	JP	Ono Pharmaceutical Co., Ltd.	11 Apr 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Distress Syndrome, Adult	Phase 2	US	Eli Lilly & Co.	01 Aug 2001
Respiratory Distress Syndrome, Adult	Phase 2	AU	Eli Lilly & Co.	01 Aug 2001
Respiratory Distress Syndrome, Adult	Phase 2	BE	Eli Lilly & Co.	01 Aug 2001
Respiratory Distress Syndrome, Adult	Phase 2	CA	Eli Lilly & Co.	01 Aug 2001
Respiratory Distress Syndrome, Adult	Phase 2	NZ	Eli Lilly & Co.	01 Aug 2001
Respiratory Distress Syndrome, Adult	Phase 2	ES	Eli Lilly & Co.	01 Aug 2001