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)

Therapeutic Areas

Hemic and Lymphatic DiseasesOther DiseasesImmune System Diseases+ [4]

Active Indication

Post-essential thrombocythemia myelofibrosisPost-polycythemia vera myelofibrosisPrimary Myelofibrosis+ [10]

Inactive Indication

Bone Marrow NeoplasmsInflammatory Bowel DiseasesMycosis Fungoides+ [2]

Originator Organization

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Active Organization

Suzhou Zelgen Biopharmaceuticals Co., Ltd.

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationOrphan Drug (US), Special Review Project (CN)

Structure

Molecular FormulaC23H25ClN6O3

InChIKeyPXDNVDFBKNFZEE-URSAUJDJSA-N

CAS Registry2056097-81-3

JAK inhibitors (JAKis), used in the treatment of myelofibrosis, have entered standard treatment, providing significant improvements in spleen size and symptom burden. Although splenomegaly provides a reduction and some improvement in cytopenia, there is still a way to go. Novel JAKis are being investigated to overcome barriers to treatment access, such as therapeutic challenges, intolerance, and unresponsiveness.

AREAS COVERED:

This review includes the current status of JAKi treatment for myelofibrosis, mainly focusing on investigational JAKis; jaktinib, lestaurtinib, itacitinib, gandotinib, BMS-911543, ilginatinib, TQ05105, and flonoltinib maleate. MEDLINE and clinicaltrials.gov were screened to identify all completed or active studies on this topic. The outcomes of the preclinical studies and clinical trials are presented and discussed for each drug.

EXPERT OPINION:

In patients with myelofibrosis, momelotinib was effective in treating anemia, whereas jaktinib was effective in both anemia and Total Symptom Score (TSS). More phase 3 studies are needed to provide more precise evidence. The increasing variety of JAKis will allow for more personalized treatment options for myelofibrosis in the future. The potential impact on disease progression, molecular responses, and the duration of this response will become important parameters for future evaluations of these drugs.

01 Oct 2023·American journal of hematology

Jaktinib and momelotinib for the treatment of myelofibrosis-Birds of a feather?

Author: Tefferi, Ayalew

01 Oct 2023·American journal of hematology

Safety and efficacy of jaktinib (a novel JAK inhibitor) in patients with myelofibrosis who are intolerant to ruxolitinib: A single-arm, open-label, phase 2, multicenter study.

Article

Author: Lu, Binhua ; He, Guangsheng ; Zhou, Hu ; Ma, Liangming ; Yin, Hewen ; Jing, Hongmei ; Li, Xin ; Chang, Chunkang ; Xiao, Zhijian ; Zhao, Qingwei ; Liu, Qingchi ; Zhu, Huanling ; Gao, Sujun ; Xu, Na ; Suo, Shanshan ; Du, Xin ; Li, Junmin ; Wu, Liqing ; Duan, Minghui ; Hong, Mei ; Jin, Jie ; Zhang, Yi ; Wang, Wei ; Yang, Haiping

Although ruxolitinib improves splenomegaly and constitutional symptoms in patients with myelofibrosis (MF), a substantial proportion of patients discontinue ruxolitinib because of intolerance. This phase 2 trial investigated the safety and efficacy of jaktinib, a novel JAK inhibitor in patients with ruxolitinib-intolerant MF. The primary endpoint was the proportion of patients with ≥35% reduction in spleen volume (SVR35) at week 24. The secondary endpoints included change of MF-related symptoms, anemic response, and safety profiles. Between December 18, 2019, and November 24, 2021, 51 patients were enrolled, 45 treated with jaktinib 100 mg bid (100 mg bid group) and six received non-100 mg bid doses (non-100 mg bid group). The SVR35 at week 24 in the 100 mg bid group was 43.2% (19/44, 95% CI 29.7%-57.8%). There were 41.9% (13/31) of transfusion-independent patients with hemoglobin (HGB) ≤100 g/L who had HGB elevation ≥20 g/L within 24 weeks. The proportion of patients with a ≥50% decrease in the total symptom score (TSS 50) at week 24 was 61.8% (21/34). The most commonly reported grade ≥3 treatment-emergent adverse events (TEAEs) in the 100 mg bid group were anemia 31.1%, thrombocytopenia 22.2%, and infectious pneumonia 17.8%. A total of 16 (35.6%) in the 100 mg bid group had serious adverse events, and 4 (8.9%) were considered possibly drug related. These results indicate jaktinib can provide a treatment option for patients with MF who are intolerant to ruxolitinib.

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
Dermatitis, Atopic	Phase 3	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	07 Jul 2022
Alopecia Areata	Phase 3	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	01 Sep 2021
Steroid Refractory Graft Versus Host Disease	Phase 2	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	01 Dec 2024
COVID-19	Phase 2	-	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	01 Sep 2022
Mycosis Fungoides	Phase 2	CN	Suzhou Zelgen Biopharmaceuticals Co., Ltd.	30 Sep 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05051761 (ZGJAK018, NEWS) Manual	Phase 3	Alopecia Areata	425	吉卡昔替尼 50mg	ayksnphtxe(cwaxmytvst) = 吉卡昔替尼治疗重症斑秃患者的安全性与耐受性良好 eyzwigokep (lqabrpogmk )	Positive	13 Jun 2024
				吉卡昔替尼 75mg
NCT04217993 (ZGJAK006, ASCO2024)	Phase 2	Myelofibrosis ferritin \| hemoglobin	39	jaktinib	maemrpbbao(tbagbvzaip) = yxonlzfwvr ycfcawjqhu (fbruakowxg ) View more	Positive	24 May 2024
				jaktinib	maemrpbbao(tbagbvzaip) = qhatpenlvu ycfcawjqhu (fbruakowxg ) View more
NCT04617028 (ZGJAK016, EHA2024)	Phase 3	Primary Myelofibrosis First line	105	Jaktinib 100 mg bid	wobwhdxead(qxdtgpiqee) = ylynxilfsf racvrjxicq (npquoaawhi ) View more	Positive	14 May 2024
				Hydroxyurea (HU) 500 mg bid	wobwhdxead(qxdtgpiqee) = gtvdhopxwg racvrjxicq (npquoaawhi ) View more
ZGJAK002, ZGJAK006, ZGJAK017 (EHA2024)	Phase 2	JAK2 V617F mutation	118	Jaktinib 100 mg bid	uvpzythuhi(oyavkympog) = uowwzxhypp bddsbvhztf (ukefsaqlfl ) View more	Positive	14 May 2024
ZGJAK002 (ASH2023)	Phase 2	Mycosis Fungoides	118	Jaktinib 100 mg BID	huhylqfyjy(dxbdxtjpzf) = tvfegmnysf husbhmyelh (kfgfdcwgkm, 55.9% - 81.2%)	Positive	09 Dec 2023
				Jaktinib 200 mg QD	huhylqfyjy(dxbdxtjpzf) = wrbxjgfwcc husbhmyelh (kfgfdcwgkm, 40.9% - 73.0%)
NCT04539639 (EADV2023)	Phase 2	Dermatitis, Atopic	166	Jaktinib 50mg Bid	rjtctluqrl(ttelvytros) = xogprhjhsb ukyboukkkb (jwlpvfmwdu ) View more	Positive	11 Oct 2023
				Jaktinib 75mg Bid	rjtctluqrl(ttelvytros) = oxiyndxyeq ukyboukkkb (jwlpvfmwdu ) View more
NCT04851535 (ZGJAK017, NEWS) Manual	Phase 2	Myelofibrosis	34	盐酸杰克替尼 100 mg Bid	sjguzoznsc(nnczsffuta) = cqtrvybcvp yjtrjibqwe (xssdvnkmta ) View more	Positive	12 Jul 2023
EHA2023	Phase 2	Myelofibrosis	44	Jaktinib 100 mg	mkjkdsxjhq(bqclbjuohw) = myfatvtuku susfmveagc (dlrkpbpndo ) View more	-	08 Jun 2023
EHA2023	Phase 3	Primary Myelofibrosis	253	Jaktinib 100 mg	qasegoxwcp(rptyjmuvuw) = yibmdzgkze iqouzzvkkr (zigbfpbkqp ) View more	-	08 Jun 2023
				Hydroxyurea 0.5 g	qasegoxwcp(rptyjmuvuw) = aqjppygnom iqouzzvkkr (zigbfpbkqp ) View more
EHA2023	Phase 2	Myelofibrosis	34	Jaktinib 100 mg bid	mrbutmgwyh(clxdaucyfh) = qkpscyhzjk twdhcahqcc (owvcjafzzs ) View more	-	08 Jun 2023