ABL inhibitors(Abl family tyrosine kinases inhibitors), EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), FLT3 inhibitors(Tyrosine-protein kinase receptor FLT3 inhibitors)

+ [1]

Therapeutic Areas

NeoplasmsHemic and Lymphatic Diseases

Active Indication

Acute Myeloid Leukemia with FLT3/ITD MutationFLT3 positive Acute Myeloid LeukemiaAdvanced Malignant Solid Neoplasm

Inactive Indication

Refractory acute myeloid leukemiaRelapsing acute myeloid leukemia

Originator Organization

Sichuan University

Active Organization

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

Sichuan University

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationSpecial Review Project (CN)

Structure

Molecular FormulaC24H29N9

InChIKeyWSOHOUHPUOAXIN-UHFFFAOYSA-N

CAS Registry1350544-93-2

Clinical Trials associated with Ruserontinib

NCT05072522 / Unknown statusPhase 1

An Open-label, Multicenter, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SKLB1028 in Patients With Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SKLB1028 in patients with advanced solid tumors.

Start Date01 Oct 2021

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

NCT05445154 / RecruitingPhase 1/2

A Single-Arm, Multicenter, Open-Label, Dose- Escalating and Expanding,Phase I/II Study of SKLB1028 Combined With "7+3" Standard Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

The purpose of this study is to describe the dose limiting toxicities (DLT) of SKLB1028 when combined with cytarabine/ daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of SKLB1028 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of SKLB1028 when given in combination with cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia .

Start Date31 Aug 2021

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

CTR20211937 / CompletedPhase 1

[14C]SKLB1028在中国成年男性健康受试者体内的物质平衡与生物转化I期临床试验

[Translation] Phase I clinical trial of [14C] mass balance and biotransformation of SKLB1028 in healthy adult male subjects in China

本试验旨在评价中国成年男性健康受试者单剂量口服150 mg/约120 μCi[14C] SKLB1028的物质平衡及生物转化途径，揭示SKLB1028在人体内的药代动力学整体特征，为药物的合理使用提供参考。

[Translation]

This study aims to evaluate the material balance and biotransformation pathway of a single oral dose of 150 mg/approximately 120 μCi [14C] SKLB1028 in healthy Chinese adult male subjects, reveal the overall pharmacokinetic characteristics of SKLB1028 in humans, and provide a reference for the rational use of the drug.

Start Date16 Aug 2021

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

[+1]

100 Clinical Results associated with Ruserontinib

100 Translational Medicine associated with Ruserontinib

100 Patents (Medical) associated with Ruserontinib

Literatures (Medical) associated with Ruserontinib

01 Nov 2024·Clinical and Translational Science

Evaluation of drug–drug interactions of a novel potent FLT3 inhibitor SKLB1028 in healthy subjects

Article

Author: Wu, Jingxuan ; Guo, Nini ; Song, Yuqin ; Wu, Le ; Wang, Bingyan ; Wu, Xiaofang ; Chen, Jingcheng ; Zhang, Meijuan ; Yin, Hang ; Li, Jiangshuo ; Li, Lijun ; Li, Ran ; Dong, Ruihua ; Kong, Yanhong ; Hou, Mengyu ; Gao, Qiannan

AbstractSKLB1028 is a novel multi‐target protein kinase inhibitor under investigation for the treatment of FLT3‐ITD mutated acute myeloid leukemia. Based on the preclinical characterization of SKLB1028 metabolism, three drug–drug interaction clinical studies were performed to investigate the effects of itraconazole, rifampin (CYP3A4 inhibitor and inducer, respectively), and gemfibrozil (CYP2C8 inhibitor) on the metabolism of SKLB1028. Fourteen healthy Chinese male subjects were enrolled in each study. In Study 1, subjects were administered a single dose of SKLB1028 (100 mg on days 1 and 11) and multiple doses of itraconazole (200 mg twice daily on day 8 and 200 mg once daily from days 9 to 18). Itraconazole was given with a loading dose on Day 8 and the total administration of itraconazole was 11 days. In Study 2, subjects were administered a single dose of SKLB1028 (100 mg on days 1 and 12) and multiple doses of gemfibrozil (600 mg twice daily from days 8 to 19). In Study 3, subjects were administered a single dose of SKLB1028 (150 mg on days 1 and 15) and multiple doses of rifampin (600 mg once daily from day 8 to 22). Itraconazole increased the AUC and Cmax of SKLB1028 by approximately 28% and 41%, respectively. Compared to the single drug, co‐administration with gemfibrozil increased the AUC of SKLB1028 by ~26% and the Cmax by ~21%. Co‐administration with rifampin reduced the AUC of SKLB1028 by ~30%, while the Cmax did not change significantly. All treatments were well tolerated in all three studies.

01 Aug 2012·LeukemiaQ1 · MEDICINE

SKLB1028, a novel oral multikinase inhibitor of EGFR, FLT3 and Abl, displays exceptional activity in models of FLT3-driven AML and considerable potency in models of CML harboring Abl mutants

Q1 · MEDICINE

Letter

Author: Xie Hz ; Yang J ; Wang Lj ; Zhong L ; Xu Y ; Liu Jj ; Ma S ; Zheng Rl ; Wang Bl ; Wang Zr ; Wei Yq ; Cao Zx ; Yang Sy ; Zhang Ch

SKLB1028 is a novel multikinase inhibitor that displays exceptional activity in models of FLT3-driven acute myeloid leukemia and considerable potency in chronic myeloid leukemia that harbors Abl mutations.SKLB1028 has the convenience of oral administration, favorable pharmacokinetic properties and low toxicity.Collectively, preclin. assessment of the pharmacodynamics, pharmacokinetics and initial toxicity of SKLB1028 supports the use of SKLB1028 as a promising candidate for clin. studies in patients with leukemia.SKLB1028 differs from other known FLT3 inhibitors in that it is also a typical EGFR inhibitor.

News (Medical) associated with Ruserontinib

30 Jan 2023

·www.prnewswire.com

Acute Myeloid Leukemia Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 200+ Companies Working in the Domain

The incidence of AML has gradually increased around the globe. Males and older people had a higher possibility to develop AML. Developed countries tended to have higher age-standardized incidence rates and death rates than developing regions. Novel therapies for AML, including refinements of conventional cytotoxic chemotherapies, genetic and epigenetic targeted drugs, as well as immunotherapies, have significantly improved patient outcomes in recent years. LAS VEGAS, Jan. 30, 2023 /PRNewswire/ -- DelveInsight's ' Acute Myeloid Leukemia Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline acute myeloid leukemia therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the acute myeloid leukemia pipeline domain. Key Takeaways from the Acute Myeloid Leukemia Pipeline Report DelveInsight's acute myeloid leukemia pipeline report depicts a robust space with 200+ active players working to develop 260+ pipeline therapies for acute myeloid leukemia treatment. Key acute myeloid leukemia companies such as GlycoMimetics, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Takeda Oncology, Orca Bio, Gilead Sciences, Actinium Pharmaceuticals, Kronos Bio, Bristol-Myers Squibb, ImmunityBio, Bellicum Pharmaceuticals, Syros Pharmaceuticals, Armaceutica, Teva Pharmaceutical Industries, New Epsilon Innovation Limited, MediGene, TC Biopharm, PersonGen BioTherapeutics, Oncoceutics, Janssen Research & Development, LLC, Immune-Onc Therapeutics, Novartis, Jasper Therapeutics, Agastiya Biotech, Poseida Therapeutics, Molecular Partners, Allogene Therapeutics, and others are evaluating new acute myeloid leukemia drugs to improve the treatment landscape. Promising acute myeloid leukemia pipeline therapies in various stages of development include Uproleselan, SKLB1028, Pevonedistat, Orca T, Magrolimab, Iomab-B, Entospletinib, Nivolumab, ALT 803, BPX-501, TCB008, Tamibarotene, Pyronaridine, Trisenox (Arsenic Trioxide), NEI-01, MDG1011, OmnImmune, anti-FLT3 CAR-T, JNJ 63709178, IO 202, IDH 305, JSP 191, AB001, P-ckit-ALLO1, MP-0533, ALLO-316, ALL0-819, and others. In January 2023, Innate Pharma SA announced the publication in Nature Biotechnology of preclinical data showing the control of acute myeloid leukemia (AML) cells by a trifunctional NKp46-CD16a-NK cell engager (NKCE) targeting CD123. In January 2023, the FDA granted JBI-802 orphan drug designation for patients diagnosed with small cell lung cancer (SCLC) and acute myeloid leukemia (AML), according to a press release from Jubilant Therapeutics. In January 2022, Astex Pharmaceuticals, Inc. announced that the European Commission (EC) had granted orphan-drug designation (ODD) to the oral fixed-dose combination of decitabine and cedazuridine (ASTX727) for the treatment of Acute Myeloid Leukemia (AML). Request a sample and discover the recent advances in acute myeloid leukemia drug treatment @ Acute Myeloid Leukemia Pipeline Report The acute myeloid leukemia pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage acute myeloid leukemia drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the acute myeloid leukemia clinical trial landscape. Acute Myeloid Leukemia Overview Acute myeloid leukemia (AML) is the most common type of leukemia in adults, accounting for roughly 80% of all cases. Clonal expansion of immature "blast cells" in the peripheral blood and bone marrow results in ineffective erythropoiesis and bone marrow failure. There are various types of AML. Each affects a different type of blood cell. The acute myeloid leukemia symptoms you experience are determined by the type of blood cell that is affected. The common acute myeloid leukemia symptoms include tiredness, weakness, pale skin, irregular heartbeat, dizziness, and others. Many tests are used for acute myeloid leukemia diagnosis. Doctors will also perform tests to determine the subtype of AML. Chemotherapy is the primary treatment for most AML types, sometimes in conjunction with a targeted therapy drug. A stem cell transplant could follow this. Other drugs (aside from standard chemotherapy drugs) may be used to treat people with acute promyelocytic leukemia (APL). Find out more about drugs for acute myeloid leukemia @ New Acute Myeloid Leukemia Drugs A snapshot of the Acute Myeloid Leukemia Pipeline Drugs mentioned in the report: Learn more about the emerging acute myeloid leukemia pipeline therapies @ Acute Myeloid Leukemia Clinical Trials Acute Myeloid Leukemia Therapeutics Assessment The acute myeloid leukemia pipeline report proffers an integral view of acute myeloid leukemia emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Acute Myeloid Leukemia Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous Therapeutics Assessment By Molecule Type: Small molecule, Cell therapy, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Cell replacements, E-selectin inhibitors, Interleukin-15 receptor agonists, Immunologic cytotoxicity, T lymphocyte replacements, Bcr-abl tyrosine kinase inhibitors, Epidermal growth factor receptor antagonists, Fms-like tyrosine kinase 3 inhibitors, Lyn protein-tyrosine kinase inhibitors, NEDD 8 activating enzyme inhibitors Key Acute Myeloid Leukemia Companies: GlycoMimetics, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Takeda Oncology, Orca Bio, Gilead Sciences, Actinium Pharmaceuticals, Kronos Bio, Bristol-Myers Squibb, ImmunityBio, Bellicum Pharmaceuticals, Syros Pharmaceuticals, Armaceutica, Teva Pharmaceutical Industries, New Epsilon Innovation Limited, MediGene, TC Biopharm, PersonGen BioTherapeutics, Oncoceutics, Janssen Research & Development, LLC, Immune-Onc Therapeutics, Novartis, Jasper Therapeutics, Agastiya Biotech, Poseida Therapeutics, Molecular Partners, Allogene Therapeutics, and others. Key Acute Myeloid Leukemia Pipeline Therapies: Uproleselan, SKLB1028, Pevonedistat, Orca T, Magrolimab, Iomab-B, Entospletinib, Nivolumab, ALT 803, BPX-501, TCB008, Tamibarotene, Pyronaridine, Trisenox (Arsenic Trioxide), NEI-01, MDG1011, OmnImmune, anti-FLT3 CAR-T, JNJ 63709178, IO 202, IDH 305, JSP 191, AB001, P-ckit-ALLO1, MP-0533, ALLO-316, ALL0-819, and others. Dive deep into rich insights for new drugs for acute myeloid leukemia treatment; visit @ Acute Myeloid Leukemia Medications Table of Contents For further information on the acute myeloid leukemia pipeline therapeutics, reach out @ Acute Myeloid Leukemia Drug Treatment Related Reports Acute Myeloid Leukemia Market Acute Myeloid Leukemia Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key acute myeloid leukemia companies, including Takeda Oncology, Immunity Bio, Teva Pharmaceuticals, among others. Relapsed/Refractory Acute Myeloid Leukemia Epidemiology Relapsed/Refractory Acute Myeloid Leukemia Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted relapsed/refractory acute myeloid leukemia epidemiology in the 7MM. Acute Lymphocytic Leukemia Pipeline Acute Lymphocytic Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute lymphocytic leukemia companies, including AbbVie, Novartis, Jazz Pharmaceutical, among others. Chronic Lymphocytic Leukemia Pipeline Chronic Lymphocytic Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic lymphocytic leukemia companies, including Celgene, Loxo Oncology, Octapharma, among others. Chronic Myeloid Leukemia Pipeline Chronic Myeloid Leukemia Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic myeloid leukemia companies, including Kartos Therapeutics, Novartis, Incyte Corporation, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Blogs Upcoming Oncology Drugs Oncology Market Outlook Future of Oncology Market Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

ImmunotherapyOrphan DrugASCO

100 Deals associated with Ruserontinib

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia with FLT3/ITD Mutation	Phase 3	CN	CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.	24 Mar 2021
FLT3 positive Acute Myeloid Leukemia	Phase 3	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	24 Mar 2021
FLT3 positive Acute Myeloid Leukemia	Phase 3	CN	Sichuan University	24 Mar 2021
Advanced Malignant Solid Neoplasm	Phase 1	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	29 Sep 2021
Advanced Malignant Solid Neoplasm	Phase 1	CN	Sichuan University	29 Sep 2021
Refractory acute myeloid leukemia	Preclinical	CN	CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.	01 Jul 2019
Relapsing acute myeloid leukemia	Preclinical	CN	CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.	01 May 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02859948 (ASH2019) Manual	Phase 1	FLT3 positive Acute Myeloid Leukemia FLT3 Mutation	28	SKLB-1028	(ysfntxmzrh) = pyrexia 67.9%, diarrhoea 64.3%, asthenia 53.6%, dizziness 50.0% fhuozaqdwz (pcybfgzsao ) View more	Positive	13 Nov 2019

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