Delving into the Latest Updates on Jaktinib Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Gecacitinib Hydrochloride, Jakotinib hydrochloride, Jaktinib

+ [3]

Target

ALK2 x JAK1 x JAK2 x JAK3 x TYK2

Mechanism

ALK2 inhibitors(Activin receptor type-1 inhibitors), JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors), JAK2 inhibitors(Tyrosine-protein kinase JAK2 inhibitors)

+ [2]

Therapeutic Areas

Hemic and Lymphatic DiseasesOther DiseasesImmune System Diseases+ [5]

Active Indication

Post-essential thrombocythemia myelofibrosisPost-polycythemia vera myelofibrosisPrimary Myelofibrosis+ [13]

Inactive Indication

Bone Marrow NeoplasmsIdiopathic Pulmonary FibrosisInflammatory Bowel Diseases+ [3]

Originator Organization

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Active Organization

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationSpecial Review Project (CN), Orphan Drug (US)

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Structure/Sequence

Molecular FormulaC23H25ClN6O3

InChIKeyPXDNVDFBKNFZEE-URSAUJDJSA-N

CAS Registry2056097-81-3

ObjectiveThe objective of this study is to evaluate the efficacy and safety of jaktinib hydrochloride tablets (jaktinib), a Janus kinase inhibitor, in patients with active radiographic axial spondyloarthritis (r-axSpA).MethodsAdults with active r-axSpA who met modified New York criteria and had an inadequate response to non-steroidal anti-inflammatory drugs were randomised 1:1:1 to receive jaktinib 75 mg two times per day, 100 mg two times per day, or placebo. The primary and key secondary endpoints were Assessment of SpondyloArthritis international Society 20 (ASAS 20) and ASAS 40 responses, respectively, at week 16. Safety was evaluated by analysing adverse events.ResultsA total of 107 patients with active r-axSpA were randomised (jaktinib 75 mg two times per day, n=35; jaktinib 100 mg two times per day, n=36; placebo, n=36). In the ASAS20 response rates, the 100 mg two times per day group had the highest response at 61.1%, followed by the 75 mg two times per day group at 57.1%, and the placebo group had the lowest at 33.3% for the 16 weeks of treatment. The ASAS40 response rates were significantly higher with jaktinib (100 mg two times per day group: 47.2%, 75 mg two times per day group: 37.1%) compared with placebo (13.9%). The incidence of treatment-emergent adverse events in the 75 mg two times per day, 100 mg two times per day and placebo groups was 88.6% versus 94.4% versus 86.1%, respectively, with no statistically significant difference among the three groups. No major adverse cardiovascular events, malignancy, thromboembolism or deaths were reported.ConclusionsJaktinib showed good efficacy and tolerability in the treatment of active r-axSpA, with the 100 mg two times per day showing a trend towards better efficacy.Trial registration numberNCT04507659.

01 Dec 2024·Drug Metabolism and Pharmacokinetics

Clinical pharmacokinetic characteristics of Jaktinib in subjects with hepatic impairment in a phase I trial

Article

Author: Ma, Sheng ; Zhao, Manna ; Zhao, Weifeng ; Wei, Cheng ; Miao, Liyan ; Gong, Shuqing ; Zhang, Hua

Jaktinib is a novel Janus kinase (JAK) inhibitor, and a phase I clinical trial of single-dose Jaktinib was conducted in a population of subjects with hepatic impairment to assess the safety, tolerability, and pharmacokinetic characteristics of Jaktinib. The patients were administered orally with 100 mg Jaktinib on day 1 in all the mild hepatic impairment group (mild group, n = 8), moderate hepatic impairment group (moderate group, n = 8) and normal hepatic function group (normal group, n = 8), and the blood samples were collected for later analysis. The mild to moderate hepatic impairment affected the metabolism of Jaktinib, which may lead to accumulation of original Jaktinib. The pharmacokinetic characteristics of the metabolites (ZG0244 and ZG0245) of Jaktinib were also analyzed. The exposure of Jaktinib is approximately 2-fold in patients with mild and moderate hepatic impairment than normal hepatic function. No serious adverse events occurred. In summary, a dosage reduction is recommended for patients with mild or moderate hepatic impairment. Further investigations for the dose adjustment in mild/moderate hepatic impairment will be considered. Trial registration number: NCT04993404.

01 Apr 2024·American Journal of Hematology

Efficacy, safety, and survival findings after long‐term follow‐up of ZGJAK002: A phase 2 study comparing jaktinib at 100 mg twice daily (BID) and 200 mg once daily (QD) in patients with myelofibrosis

Letter

Author: Suo, Shanshan ; Zhu, Huanling ; Wu, Dengshu ; Zhou, Hu ; Xia, Ruixiang ; Jin, Jie ; Hu, Yu ; Jiang, Zhongxing ; Yu, Wenjuan ; Yin, Hewen ; Wang, Xiuli ; Jin, Chenghao ; Wu, Liqing ; Zhou, Zeping ; Zhang, Feng ; Liu, Jing ; Li, Wei ; Sun, Kai ; Zhuang, Junling ; Zhang, Yi ; Yang, Linhua ; Li, Fei ; Huang, Jinwen ; Hu, Jianda ; Jiang, Qian ; Li, Yan ; Du, Xin

Jaktinib, a novel JAK and ACVR1 inhibitor, has exhibited promising results in treating patients with myelofibrosis (MF). ZGJAK002 is a Phase 2 trial aimed to assess the efficacy and safety of jaktinib 100 mg BID (N = 66) and 200 mg QD (N = 52) in JAK inhibitor-naive patients with intermediate- or high-risk MF. We herein present the long-term data with a median follow-up of 30.7 months. At data cutoff, 30.3% of patients in 100 mg BID and 28.8% in 200 mg QD were still continuing their treatment. The 100 mg BID group displayed a numerically higher best spleen response compared with the 200 mg QD group (69.7% vs. 46.2%), with 50.4% from the BID and 51.2% from the QD group maintaining spleen responses over 120 weeks. The 36-month survival rates were 78.2% in BID and 73.6% in QD group. The tolerability of jaktinib remained well, and common grade ≥3 adverse drug reactions included anemia (15.2% vs. 21.2%), thrombocytopenia (15.2% vs. 11.5%), and infectious pneumonia (10.6% vs. 1.9%) in BID and QD groups, respectively. By comparing the two groups, the incidence of adverse events (AEs) were similar, except for drug-related serious AEs (24.2% vs. 9.6%) and AEs leading to treatment discontinuation (15.2% vs. 7.7%), which were higher in BID group. The percentages of AEs resulting in death were comparable, with 6.1% in BID and 5.8% in QD group. These analyses further support the long-term durable efficacy and acceptable safety of jaktinib at 100 mg BID and 200 mg QD doses for treating MF.

1

News (Medical) associated with Jaktinib Hydrochloride

18 Jun 2021

·www.globenewswire.com

Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight

Los Angeles, June 17, 2021 (GLOBE NEWSWIRE) -- Axial Spondyloarthritis Pipeline: Drug Pipeline, Regulatory Events and Clinical Trials in the Spotlight| Insights by DelveInsight The report offers the most up-to-date information on Axial Spondyloarthritis pipeline products being developed by notable companies such as Pfizer, Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, FunPep Co Ltd., Kinevant Sciences, Izana Bioscience, Mycenax Biotech, and UCB Biopharma, among others. DelveInsight’s ‘Axial Spondyloarthritis (axSpA) Pipeline Insights’ report offers exhaustive coverage of the emerging therapies in different stages of development from pre-clinical till late-stage, along with dormant, inactive, and abandoned therapeutic agents. Some of the important takeaways from the Axial Spondyloarthritis Pipeline report: Request for Sample to know more about the therapies expected to make grab the maximum patient pool @ Axial Spondyloarthritis Emerging Therapies and Forecast The Axial Spondyloarthritis Pipeline reports lay down a thorough coverage of the ongoing clinical trials, collaborations taking place in the domain, recent happenings in the Axial Spondyloarthritis pipeline space, and growth prospects across the Axial Spondyloarthritis domain. Axial Spondyloarthritis: Overview Axial Spondyloarthritis is a chronic, inflammatory rheumatic disease that affects primarily the axial joints leading to severe pain, stiffness, and fatigue. It starts with an early inflammatory phase in which there is no structural damage in the sacroiliac joints (non-radiographic disease) progressing to later stages in which structural damage is visible on X‑ray scans of the sacroiliac joints as erosions, sclerosis, or bony bridges (radiographic disease; also known as Ankylosing Spondylitis). Discover more about the disease, treatments, and pipeline therapies @ axSpA Pipeline Assessment Axial Spondyloarthritis Pipeline Drugs Request for Sample to know more @ Axial Spondyloarthritis Pipeline Analysis, Key Companies, and Futuristic Trends Axial Spondyloarthritis Therapeutics Assessment The Axial Spondyloarthritis Pipeline report presents a kaleidoscopic view of the axSpA emerging novel therapies segmented by Stage, Product Type, Route of Administration (RoA), Molecule Type, Target, and Mechanism of Action. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets For rich insights into merging therapies and assessment, visit Axial Spondyloarthritis Pipeline: Emerging Novel Therapies Scope of the Axial Spondyloarthritis Pipeline Report Coverage: GlobalKey Players: Izana Bioscience, UCB, Sun Pharma Global, Akeso Biopharma, Kinevant Sciences, Jiangsu Hengrui Medicine Co., Suzhou Zelgen Biopharmaceuticals, Clover Biopharmaceuticals, Mycenax Biotech, Boehringer Ingelheim, and Qyuns Therapeutics among others.Key Axial Spondyloarthritis Pipeline Therapies: Namilumab , Bimekizumab, Tofacitinib, Tildrakizumab, AK-111, NDI 031232, Gimsilumab, QX002N, SHR-0302, Jaktinib, SCB-808, FPP003, KIN-1901, ENIA11, BI 730357, and QX002N among others. Discover more about the report offerings @ axSpA Emerging Therapies, Treatments, and Ongoing Clinical Trials Table of Contents Get in touch with our Business executive for Regulatory Analysis, Licensing Services, and Consulting Solutions Related Reports Axial Spondyloarthritis MarketDelveInsight's "Axial Spondyloarthritis Market Insights, Epidemiology, and Market Forecast-2030" report. Non-Radiographic Axial Spondyloarthritis MarketDelveInsight's "Non-Radiographic Axial Spondyloarthritis (nr-AxSpA) Market Insights, Epidemiology, and Market Forecast-2030" report. Spondylolisthesis Market InsightsDelveInsight's “Spondylolisthesis Market Insights, Epidemiology, and Market Forecast-2030" report. Ankylosing Spondylitis MarketDelveInsight’s ‘Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast–2030’ report. Global Kinase Inhibitor In Autoimmune Diseases MarketDelveInsight’s ‘Global Kinase Inhibitor in Autoimmune Diseases Market Insights and Market Forecast – 2030’ report. Adenosine Deaminase Severe Combined Immunodeficiency MarketDelveInsight's "Adenosine Deaminase-Severe Combined Immunodeficiency Market Insights, Epidemiology, and Market Forecast-2030" report. Adult-Onset Still Disease MarketDelveInsight’s “Adult-onset Still’s Disease Market Insights, Epidemiology, and Market Forecast – 2030” report. Browse through our posts ABSSSI Pipeline Analysis Parkinson's Disease Risk FactorsWearable Healthcare Devices Market 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. For more insights, visit Pharma, Healthcare, and Biotech News

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100 Deals associated with Jaktinib Hydrochloride

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Post-essential thrombocythemia myelofibrosis	NDA/BLA	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	17 Oct 2022
Post-polycythemia vera myelofibrosis	NDA/BLA	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	17 Oct 2022
Primary Myelofibrosis	NDA/BLA	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	17 Oct 2022
Ankylosing Spondylitis	Phase 3	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	19 Jun 2023
Acute Graft Versus Host Disease	Phase 3	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	14 Jul 2022
Moderate Atopic Dermatitis	Phase 3	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	14 Jul 2022
Severe Atopic Dermatitis	Phase 3	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	14 Jul 2022
Alopecia Areata	Phase 3	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	01 Sep 2021
Mild Atopic Dermatitis	Phase 2	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	12 Oct 2020
Idiopathic Pulmonary Fibrosis	Phase 2	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	13 Aug 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04617028 (ZGJAK016, Pubmed \| Blood Cancer J)	Phase 3	JAK inhibitor naïve	-	Gecacitinib 100 mg BID	(sdgzcmrxxc) = sjnaokjjfh zrczgvhwwt (zbbvkfbtgs ) View more	Positive	18 Dec 2024
				Hydroxyurea 500 mg BID	(sdgzcmrxxc) = xhqpnyndsx zrczgvhwwt (zbbvkfbtgs ) View more
NCT04617028 (ZGJAK016, ASH2024) Manual	Phase 3	Myelofibrosis	105	Gecacitinib	(gnurawjoui) = vkqxulbfmf kajwincisa (jvlwgqiput ) View more	Positive	08 Dec 2024
				Hydroxyurea	(gnurawjoui) = rehuqyzesx kajwincisa (jvlwgqiput ) View more
NCT05051761 (ZGJAK018, NEWS) Manual	Phase 3	Alopecia Areata	425	吉卡昔替尼 50mg	(sfmxhyxcug) = 吉卡昔替尼治疗重症斑秃患者的安全性与耐受性良好 cbfohwqaxl (qufvxdeceh )	Positive	13 Jun 2024
				吉卡昔替尼 75mg
NCT04217993 (ZGJAK006, ASCO2024) Manual	Phase 2	Myelofibrosis	39	jaktinib (Anemia responders)	(stezfpqelf) = egadburwwc fmkzbhzzii (qwgbqoaseo ) View more	Positive	24 May 2024
				jaktinib (Non-responders)	(stezfpqelf) = tzoaarrqoi fmkzbhzzii (qwgbqoaseo ) View more
NCT04617028 (ZGJAK016, EHA2024) Manual	Phase 3	Myelofibrosis First line	105	Jaktinib 100 mg bid	(apytsktuup) = ihlrdbubie jdyjpcbjef (vcjoctmdoc ) View more	Positive	14 May 2024
				Hydroxyurea (HU) 500 mg bid	(apytsktuup) = hcurjqmynt jdyjpcbjef (vcjoctmdoc ) View more
ZGJAK002 \| ZGJAK006 \| ZGJAK017 (EHA2024)	Phase 2	JAK2 V617F mutation	118	Jaktinib 100 mg bid	pncaxesurs(aasbsrdmar) = pfykiqnync rlylfggfmp (xmdxcohcni ) View more	Positive	14 May 2024
NCT03886415 (ZGJAK002, ASH2023)	Phase 2	Myelofibrosis	118	Jaktinib 100 mg BID	(bcpbgnnsjg) = cgfswgrkdb fdxllcljfm (zwpvtudkef, 55.9% - 81.2%)	Positive	09 Dec 2023
				Jaktinib 200 mg QD	(bcpbgnnsjg) = ikeiycjtxh fdxllcljfm (zwpvtudkef, 40.9% - 73.0%)
NCT04539639 (EADV2023)	Phase 2	Severe Atopic Dermatitis	166	Jaktinib 50mg Bid	sdjiqsprtw(vjlxptsgbs) = nptjehhsia cbruhgcowa (spkzuiennv ) View more	Positive	11 Oct 2023
				Jaktinib 75mg Bid	sdjiqsprtw(vjlxptsgbs) = xgvdihwrrn cbruhgcowa (spkzuiennv ) View more
NCT04851535 (ZGJAK017, NEWS) Manual	Phase 2	Myelofibrosis	34	盐酸杰克替尼 100 mg Bid	(dwrcbyzuga) = ouydgdsgec oqihvrmbkq (tbczsqydfq ) View more	Positive	12 Jul 2023
EHA2023	Phase 2	Myelofibrosis	44	Jaktinib 100 mg	(zetluorpuu) = sduoufskiq qjrrxrzqyk (dtnrovmarn ) View more	-	08 Jun 2023