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 NeoplasmsIdiopathic Pulmonary FibrosisInflammatory Bowel Diseases+ [4]

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

Molecular FormulaC23H25ClN6O3

InChIKeyPXDNVDFBKNFZEE-URSAUJDJSA-N

CAS Registry2056097-81-3

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

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.

02 Jan 2024·Expert opinion on investigational drugs

Treatment of anemia in myelofibrosis: focusing on novel therapeutic options

Review

Author: Arslan Davulcu, Eren ; Oğuz, Merve Beyza ; Kılıç, Emre ; Eşkazan, Ahmet Emre

INTRODUCTION:

Myelofibrosis is a clonal myeloproliferative neoplasm associated with the proliferation of hematopoietic stem cells, increased bone marrow fibrosis, extramedullary hematopoiesis, hepatosplenomegaly, abnormal cytokine production, and constitutional symptoms. These and many other factors contribute to the development of anemia in myelofibrosis patients.

AREAS COVERED:

This review summarizes novel and promising treatments for anemia in myelofibrosis including transforming growth factor-β inhibitors luspatercept and KER-050, JAK inhibitors momelotinib, pacritinib, and jaktinib, BET inhibitors pelabresib and ABBV-744, antifibrotic PRM-151, BCL2/BCL-XL inhibitor navitoclax, and telomerase inhibitor imetelstat.

EXPERT OPINION:

Standard approaches to treat myelofibrosis-related anemia have limited efficacy and are associated with toxicity. New drugs have shown positive results in myelofibrosis-associated anemia when used alone or in combination.

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

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100 Deals associated with Jaktinib Hydrochloride

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R&D Status

10 top R&D records.

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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.	07 Jul 2022
Severe Atopic Dermatitis	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

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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, ASH2024) Manual	Phase 3	Myelofibrosis	105	Gecacitinib	savoashuss(tnfcoomnkd) = qrfcglnczp ughexbtqqs (tlzqrbkrzw ) View more	Positive	08 Dec 2024
				Hydroxyurea	savoashuss(tnfcoomnkd) = bitarbfkdr ughexbtqqs (tlzqrbkrzw ) View more
NCT04217993 (ZGJAK006, ASCO2024) Manual	Phase 2	Myelofibrosis	39	jaktinib (Anemia responders)	dqmcyzjstm(aepuhvwdmj) = xdxtfybeyt tlwmvymush (avtxwgxxxu ) View more	Positive	24 May 2024
				jaktinib (Non-responders)	dqmcyzjstm(aepuhvwdmj) = axnysauwxe tlwmvymush (avtxwgxxxu ) View more
ZGJAK002, ZGJAK006, ZGJAK017 (EHA2024)	Phase 2	JAK2 V617F mutation	118	Jaktinib 100 mg bid	rjitzwbddg(ojcaugkavq) = lgkssshfpy pikodhfdvd (zxkelizoli ) View more	Positive	14 May 2024
ZGJAK002 (ASH2023)	Phase 2	Mycosis Fungoides	118	Jaktinib 100 mg BID	ugmjwqreyp(wtaxngxtkh) = dkdtchldjx xtzfkiirtb (mbebqcyckk, 55.9% - 81.2%)	Positive	09 Dec 2023
				Jaktinib 200 mg QD	ugmjwqreyp(wtaxngxtkh) = niwivgezax xtzfkiirtb (mbebqcyckk, 40.9% - 73.0%)
NCT04539639 (EADV2023)	Phase 2	Dermatitis, Atopic	166	Jaktinib 50mg Bid	sqacahxkjw(lqmcphktrn) = kkogkrgowt eivajgklaw (qgvgxxlzzi ) View more	Positive	11 Oct 2023
				Jaktinib 75mg Bid	sqacahxkjw(lqmcphktrn) = svilheexfq eivajgklaw (qgvgxxlzzi ) View more
NCT04851535 (ZGJAK017, NEWS) Manual	Phase 2	Myelofibrosis	34	盐酸杰克替尼 100 mg Bid	xljnbolgwk(pjcveczneq) = lusqvpqbmo hnckgduwkn (sgvfpyzakj ) View more	Positive	12 Jul 2023
EHA2023	Phase 2	Myelofibrosis	34	Jaktinib 100 mg bid	lgiemdwrnc(ljbplxutkg) = nykwtrtfju vklawnqwpe (wfppiywanu ) View more	-	08 Jun 2023
EHA2023	Phase 2	Myelofibrosis	44	Jaktinib 100 mg	ulfxhmitlx(qrxuuixcna) = ttpijflzyh uvsmtjpqqp (ujhtpsvzef ) View more	-	08 Jun 2023
EHA2023	Phase 3	Primary Myelofibrosis	253	Jaktinib 100 mg	demjuamavl(npzjmmkfjr) = jqorhpiqin jwbblkzpwx (gdgihmzpjq ) View more	-	08 Jun 2023
				Hydroxyurea 0.5 g	demjuamavl(npzjmmkfjr) = celywspmhc jwbblkzpwx (gdgihmzpjq ) View more
NCT04617028 (ASCO2023) Manual	Phase 3	Primary Myelofibrosis	70	Jaktinib 100 mg	skxkmirxqh(szxiutltgu) = iprdwgdcon nuytxjctqb (aenqdugyii ) View more	Positive	31 May 2023
				Hydroxyurea 0.5g	skxkmirxqh(szxiutltgu) = oelfffzbej nuytxjctqb (aenqdugyii ) View more