Last update 12 Dec 2024

Golidocitinib

Last update 12 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(R)-N-(3-(2-((3-methoxy-1-methyl-1H-pyrazol-4-yl)amino)pyrimidin-4-yl)-1H-indol-7-yl)-2-(4-methylpiperazin-1-yl)propenamide hemi ethyl acetate solvate, Golidocitnib, AZD-4205

+ [5]

Target

JAK1

Mechanism

JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [3]

Active Indication

Peripheral T-Cell LymphomaPD-L1 positive Non-Small Cell Lung CancerT-cell lymphoma recurrent+ [2]

Inactive Indication

EGFR-mutated non-small Cell Lung Cancer

Originator Organization

Dizal (Jiangsu) Pharmaceutical Co., Ltd.

AstraZeneca PLC

Active Organization

Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Inactive Organization

AstraZeneca PLC

Drug Highest PhaseApproved

First Approval Date

CN (18 Jun 2024),

Peripheral T-Cell Lymphoma

RegulationFast Track (US), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (US)

Structure

Molecular FormulaC25H31N9O2

InChIKeyCVCVOSPZEVINRM-MRXNPFEDSA-N

CAS Registry2091134-68-6

Clinical Trials associated with Golidocitinib

NCT06630091 / Not yet recruitingPhase 2IIT

A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study

To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL.

Start Date28 Mar 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT06690671 / Not yet recruitingPhase 1/2IIT

An Open-Label, Single-Arm, Phase Ib Exploratory Study to Evaluate the Safety and Efficacy of Golidocitinib in Combination With Anti-PD-1 in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated With First-Line Anti-PD-1 Containing Regimens

This study is a phase Ib, single-center, single-arm exploratory clinical study designed to evaluate the safety and efficacy of Golidocitinib in combination with anti-PD-1 monoclonal antibody in locally advanced or metastatic NSCLC treated with anti-PD-1 in combination with or without platinum-containing chemotherapy regimens.

Start Date15 Dec 2024

Sponsor / Collaborator

Shanghai Chest Hospital

NCT06716658 / RecruitingPhase 2IIT

Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial

Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Golidocitnib, with an expected overall response rate of 60% for JAK1 inhibitor Golidocitnib treatment.

Start Date15 Dec 2024

Sponsor / Collaborator

Hematology Hospital of Chinese Academy of Medical Sciences

[+6]

100 Clinical Results associated with Golidocitinib

100 Translational Medicine associated with Golidocitinib

100 Patents (Medical) associated with Golidocitinib

Literatures (Medical) associated with Golidocitinib

01 Oct 2024·DRUGS

Golidocitinib: First Approval

Review

Author: Keam, Susan J

Golidocitinib (^®) is an oral, potent, selective Janus kinase 1 (JAK1) inhibitor being developed by Dizal (Jiangsu) Pharmaceutical Co., Ltd for the treatment of cancer, including peripheral T cell lymphoma (PTCL). In June 2024, golidocitinib received conditional approval in China for the treatment of adult patients with relapsed or refractory (r/r) PTCL who have received at least one line of systemic treatment. This article summarizes the milestones in the development of golidocitinib leading to this first approval for the treatment of adults with PTCL.

01 Oct 2024·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Pd(II) coordination molecule modified g-C3N4 for boosting photocatalytic hydrogen production

Article

Author: Zhou, Xiaoqin ; Yu, Xiaoxing ; Luo, Jin ; Ning, Xiaomei ; Zhou, Xunfu ; Fan, Xuliang ; Peng, Lanzhen ; Zhou, Xiaosong

The photocatalytic H₂ production activity of polymer carbon nitride (g-C₃N₄) is limited by the rapid recombination of photoelectron-hole pairs and slow surface reduction dynamic process. Here, a supramolecular complex (named R-TAP-Pd(II)) was fabricated via self-assembly of (R)-N-(1-phenylethyl)-4-(4-(pyridin-2-yl)-1H-1,2,3-triazol-1-yl)benzamide (R-TAP) with Pd(II) and used to modify g-C₃N₄. In the R-TAP-Pd(II)@g-C₃N₄ composite photocatalyst, the spin polarization of R-TAP-Pd(II) can promote charge transfer and inhibit photogenerated carrier recombination, as confirmed by spectral tests and photoelectrochemical performance tests. Electrochemical tests and in situ X-ray photoelectron spectroscopy (XPS) tests proved that the Pd(II) ion in the R-TAP-Pd(II) molecule can serve as active sites to accelerate H₂ production. The R-TAP-Pd(II)@g-C₃N₄ presented a photocatalytic H₂ generation rate of 1085 μmol g^-1 h^-1 when exposed to visible light, which was a about 278-fold increase compared with g-C₃N₄. This work finds a new approach to boost the photocatalytic efficiency of g-C₃N₄ via supramolecular self-assembly.

15 Apr 2024·Cancer

Golidocitinib favorable for relapsed/refractory T‐cell lymphoma

Author: Nierengarten, Mary Beth

Dolidocitinib, an oral selective JAK1 tyrosine kinase inhibitor, shows promising antitumor activity in patients with refractory or relapsed peripheral T-cell lymphoma (PTCL) and warrants further study in randomized clin. trials to confirm its activity and efficacy in this setting, report investigators in a phase 2, open-label study published in Lancet Oncol.Among 88 heavily pretreated patients with relapsed/ refractory PTCL treated with golidocitinib, 44% achieved an objective response rate (ORR) and 24% a complete response rate (CRR) (per an independent review committee), at a median follow-up of 13.3 mo.All patients received oral golidocitinib (150 mg once daily) until experiencing disease progression or meeting other discontinuation criteria.Sixty-one of the 104 patients included in the safety anal. (59%) had grade 3-4 drug-related adverse events, which included decreases in neutrophil (29%), white blood cell (26%), lymphocyte (21%), and platelet counts (20%).All these events were clin. manageable and reversible according to the investigators.Serious treatment-related adverse events occurred in 24% of the patients, and three patients died (two of pneumonia and one of a confusional state).Results that the ORR and CRR with golidocitinib were in line with the efficacy preliminarily observed with other new agents in an advanced stage of development in this setting, namely duvelisib and valemetostat.The preliminary data on those agents showing an ORR of approx. 50% and a CRR of approx. 30%-35% are confirmed, all three agents will be well positioned to move the field forward and be competitive for regulatory approval, adding much needed options to the treatment landscape for PTCL.Similarly to other phase 2 trials in this setting, however, he notes that the study lacked patients with rare subtypes such as monomorphic epitheliotropic intestinal T-cell lymphoma and hepatosplenic T-cell lymphoma.

News (Medical) associated with Golidocitinib

22 Oct 2024

·www.prnewswire.com

JAK Inhibitors Clinical Trial Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 50+ Companies Working in the Domain

JAK inhibitors are a class of medications that work by blocking Janus kinases (JAKs), enzymes that are involved in the signaling pathways of various cytokines and growth factors. JAK inhibitors offer a more targeted approach to treating immune-mediated diseases compared to traditional therapies like corticosteroids or conventional immunosuppressants; this specificity reduces side effects and increases efficacy and is a major driver for the demand for JAK inhibitors. LAS VEGAS, Oct. 22, 2024 /PRNewswire/ -- DelveInsight's ' JAK Inhibitors Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline JAK inhibitors in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the JAK inhibitors pipeline domain. Key Takeaways from the JAK Inhibitors Pipeline Report DelveInsight's JAK inhibitors pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline JAK inhibitors. Key JAK inhibitors companies such as Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical and others are evaluating new JAK Inhibitors drugs to improve the treatment landscape. Promising pipeline JAK inhibitors such as Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others are under different phases of JAK inhibitors clinical trials. In October 2024, Pelabresib in combination with ruxolitinib showed benefit in treating patients with JAK Inhibitor-Naïve Myelofibrosis significantly reduced splenomegaly, and improved anemia that has not been previously treated with Janus kinase inhibitors (JAKis). In September 2024, Eli Lilly and Company and EVA Pharma announced that the companies have agreed to expand access to baricitinib to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. In May 2024, Ajax Therapeutics, Inc., announced that it had received clearance for its Investigational New Drug application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical study of AJ1–11095, a first-in-class Type II JAK2 inhibitor, for the treatment of patients with myelofibrosis. In February 2024, Novartis announced that it intends to acquire MorphoSys. The acquisition, which was unanimously approved by the boards of both Novartis and MorphoSys, is expected to close in the first half of 2024, subject to customary closing conditions. In January 2024, NS Pharma received orphan drug designation (ODD) from the European Commission (EC) for NS-229, which is being developed to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease. In December 2023, Sun Pharmaceuticals Inc. announced that it has entered a licensing agreement with Aclaris Therapeutics Inc., the company announced in a regulatory filing. Under the agreement, Aclaris granted Sun Pharma exclusive rights under certain patents for the use of deuruxolitinib, Sun Pharma's JAK inhibitor, or other isotopic forms of ruxolitinib, to treat alopecia areata (AA) or androgenetic alopecia (AGA). Request a sample and discover the recent advances in JAK inhibitors drugs @ JAK Inhibitors Pipeline Report The JAK inhibitors pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage JAK inhibitors drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the JAK inhibitors clinical trial landscape. JAK Inhibitors Overview Janus kinase (JAK) inhibitors are a class of medications designed to interfere with the activity of the Janus kinase family of enzymes, which play a crucial role in the signaling pathways of immune responses. These enzymes are key mediators in transmitting signals from cytokines and growth factors, which regulate blood cell production and immune system function. By blocking these signals, JAK inhibitors help to control the overactive immune response seen in several inflammatory and autoimmune diseases. They have shown significant efficacy in treating conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, among others. The most common JAK inhibitors include tofacitinib, baricitinib, and upadacitinib, which are administered orally. Beyond their role in autoimmune diseases, JAK inhibitors are also being explored for use in treating certain cancers and myeloproliferative disorders, where abnormal JAK signaling contributes to uncontrolled cell growth. In diseases like myelofibrosis and polycythemia vera, JAK inhibitors can help reduce symptoms and improve quality of life. However, there are potential side effects associated with their use, including increased susceptibility to infections, blood clots, and cardiovascular risks, given their impact on the immune system. As research continues, the therapeutic potential of JAK inhibitors is expanding, offering new hope for patients with difficult-to-treat conditions. Find out more about JAK inhibitors drugs @ JAK Inhibitors Analysis A snapshot of the Pipeline JAK Inhibitors Drugs mentioned in the report: Learn more about the emerging JAK inhibitors @ JAK Inhibitors Clinical Trials JAK Inhibitors Therapeutics Assessment The JAK inhibitors pipeline report proffers an integral view of the emerging JAK inhibitors segmented by stage, product type, molecule type, and route of administration. Scope of the JAK Inhibitors 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, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Key JAK Inhibitors Companies: Incyte Corporation, Celon Pharma, Aclaris Therapeutics, Sareum, AstraZeneca, Incyte Corporation, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Incyte Corporation, Arcutis Biotherapeutics/Reistone Biopharma, Esker Therapeutics, Bristol-Myers Squibb, Chia Tai Tianqing Pharmaceutical, and others. Key JAK Inhibitors Pipeline Therapies: Povorcitinib, CPL409116, ATI-2138, SDC 1802, AZD 4604, INCB-160058, Research programme: JAK2 inhibitors, Ritlecitinib, Momelotinib, DZD4205, ATI 2138, CPL 409116, Itacitinib, Ivarmacitinib, ESK 001, Repotrectinib, Rovadicitinib, and others. Dive deep into rich insights for new JAK inhibitors, visit @ JAK Inhibitors Drugs Table of Contents For further information on the JAK inhibitors pipeline therapeutics, reach out @ JAK Inhibitors Therapeutics Related Reports JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Eli Lilly and Company, Suzhou Zelgen Biopharmaceuticals Co., Ltd, Incyte Corporation, Kartos Therapeutics, Inc., Dompé Farmaceutici S.p.A, Sanofi, Kiniksa Pharmaceuticals, Ltd., Celgene, Abivax S.A., Telios Pharma, Inc., AstraZeneca, Karyopharm Therapeutics Inc, TWi Biotechnology, Inc., Geron Corporation, Ajax Therapeutics, Inc., among others. JAK Inhibitors Competitive Landscape JAK Inhibitors Competitive Landscape – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key JAK inhibitors companies, including Pfizer, Sierra Oncology, Theravance Biopharma, Dizal Pharmaceutical, Aclaris Therapeutics, Celon Pharma, Incyte Corporation, AbbVie, Galapagos, among others. KRAS Inhibitors Market KRAS Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key KRAS inhibitors companies, including Novartis, Roche, Genentech, Verastem Oncology, Revolution Medicines, Cardiff Oncology, Immuneering Corporation, Jacobio Pharmaceuticals, BridgeBio Pharma, Mirati Therapeutics, Deciphera Pharmaceuticals, Elicio Therapeutics, InventisBio, Gritstone Bio, D3 Bio , among others. PD/L-1 Inhibitors Market PD/L-1 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PD/L-1 inhibitors companies, including Merck, Laekna Therapeutics, Genentech, Tracon Pharmaceuticals Inc., Celgene, MedImmune, Hangzhou Sumgen Biotech, among others. 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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1License out/inAcquisitionOrphan Drug

26 Jun 2024

·www.fiercepharma.com

Despite J&J's Rybrevant full nod, FDA encourages Dizal to file rival lung cancer drug for accelerated approval

The FDA confirmed the accelerated approval pathway for Dizal's sunvozertinib in previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations The FDA in March converted Johnson & Johnson’s Rybrevant use in previously treated EGFR exon20 insertion-mutated non-small cell lung cancer into a full nod. But the door to an accelerated approval in the same indication remains open, according to Dizal Pharma. “The FDA actually encouraged us […] to submit as soon as possible,” Dizal CEO Xiaolin Zhang, Ph.D., told Fierce Pharma on the sidelines of the American Society of Clinical Oncology (ASCO) annual meeting in Chicago early June. Dizal is developing the EGFR tyrosine kinase inhibitor sunvozertinib, which was approved in China in August for pretreated NSCLC with EGFR exon 20 insertion mutations. After a positive global pivotal trial readout and what Zhang described as a successful pre-NDA meeting with the FDA, the AstraZeneca spinout is on the verge of filing for an accelerated approval in the U.S. The FDA confirmed the accelerated approval pathway and then granted breakthrough therapy designation to sunvozertinib as a frontline treatment after the agency had handed J&J’s Rybrevant its full nod, which came hand-in-hand with a first-line approval. “Clearly, the FDA views there are patients’ needs for alternative or better therapies for this disease,” Zhang said. The FDA has in the past turned away accelerated approval applications when a full approval was already in place. Back in 2021, Agenus was forced to pull a cervical cancer submission for balstilimab after the FDA granted full approval to Merck’s Keytruda in the same indication. While both balstilimab and Keytruda are PD-1 inhibitors, sunvozertinib and Rybrevant are different, as the J&J drug is an EGFR-MET bispecific antibody. With an FDA filing around the corner, Dizal has been in discussion with multiple larger pharma companies to team up on sunvozertinib, Zhang said. Many potential partners were waiting for results from the global WU-KONG1B trial presented at ASCO 2024 and were asking questions about the first-line setting, where the drug’s key opportunity lies. Dizal is open to all deal types, Zhang said. As to whether the biotech can take U.S. commercialization in its own hands, the CEO said he’s comfortable with the company’s cash flow, especially now that sunvozertinib has started generating revenue. “We’re going to do the best deal that maximizes that potential of sunvozertinib commercially and benefit our patients,” Zhang said. “We are not going to do a deal for the sake of it.” Sunvozertinib has proven its worth in the single-arm, pivotal WU-KONG1B trial, which enrolled more than 40% non-Asian patients. As of a data cut in March, investigators recorded a best overall response rate (ORR) of 53.3% and a confirmed ORR of 44.9%, including two confirmed complete responses, among 107 patients who received sunvozertinib at the recommended 300mg dose. Notably, the drug showed anti-tumor effect regardless of prior treatment with Rybrevant. The best ORRs for those with or without prior exposure to the J&J drug were similar at 50% and 53.8%, respectively. The median duration of response was not reached, and 57% of patients were in remission for at least nine months. Dizal can’t file just yet because the FDA wants at least six-month follow-up for the last responder. And Dizal could have that additional data late June, Zhang said. When Rybrevant got its accelerated approval in 2021, the drug’s ORR was 40% with a median response duration of 11.1 months. Sunvozertinib’s tumor shrinkage data also appeared to be far better than Takeda’s disgraced small-molecule drug Exkivity, which got a conditional nod based on a 28% ORR. Takeda has decided to pull Exkivity off the market after failing a confirmatory phase 3 trial in the first-line setting. Dizal designed sunvozertinib in a flexible way to accommodate different types of EGFR exon 20 insertions, as well as some potency against wild-type EGFR, Zhang explained. Other drugs that focus on certain more sensitive insertions may have strong inhibition in those subtypes but may be too weak elsewhere. To shoot for an accelerated approval, the FDA has been requiring that a confirmatory trial be underway. The phase 3 WU-KONG28 trial could serve that purpose, and it’s already 70% enrolled, according to Zhang. The study is evaluating sunvozertinib monotherapy versus platinum-based doublet chemotherapy in first-line EGFR exon 20-mutated NSCLC. J&J’s Rybrevant succeeded in the first line as part of a combination with chemotherapy, while Takeda’s Exkivity flopped as a monotherapy. Still, Zhang believes single-agent sunvozertinib is the right approach because in newly diagnosed patients, quality of life is important. “Our view is that in the first line, the goal of treatment is different from later lines,” Zhang explained. “You want to keep the [progression-free survival] as long as you can, and the patient sill have very good quality of life because these are patients who generally have a reasonable daily life. So, we don’t think, if possible, that first-line combo with chemo is a desirable strategy. Once you have chemo, then that patient’s quality [of life] immediately goes down.” At last year’s European Society of Medical Oncology annual meeting, Dizal unveiled a pooled analysis of early-phase data for sunvozertinib monotherapy in first-line EGFR exon 20 NSCLC, showing a median progression-free survival of 12.4 months. The result compared favorable to Rybrevant-plus-chemo’s 11.4 months from J&J’s phase 3 PAPILLON trial. J&J is also angling Rybrevant for the more common EGFR mutations involving exon 19 and exon 21, which is currently dominated by AstraZeneca’s Tagrisso. Zhang, who previously led AZ’s China innovation center before its spinoff into Dizal, knows Tagrisso very well. Tagrisso has established itself very well in common EGFR mutations, Zhang said, “so we focus on second-line treatment after Tagrisso failure.” And that’s where Dizal will explore combinations with sunvozertinib. These include pairings with chemotherapy and with Dizal’s JAK1 inhibitor golidocitinib, which last week won Chinese approval for peripheral T-cell lymphoma. And the company has DZD6008, an EGFR inhibitor specifically designed for post-Tagrisso treatment.

Phase 3Clinical ResultDrug ApprovalBreakthrough TherapyASCO

20 Jun 2024

·www.pharmaceutical-technology.com

China NMPA approves Dizal’s golidocitinib for PTCL treatment

PTCL represents a diverse group of aggressive non-Hodgkin lymphomas, with patients at a high risk of disease relapse. Credit: Nemes Laszlo / Shutterstock. The National Medical Products Administration (NMPA) of China has approved Dizal’s golidocitinib for adults with relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL). This is the first global approval of a Janus kinase 1 (JAK1) selective inhibitor for r/r PTCL patients whose disease has advanced following a minimum of one previous systemic therapy or who were refractory to this. PTCL represents a diverse group of aggressive non-Hodgkin lymphomas, with patients at a high risk of disease relapse. The approval is based on the data from the multinational JACKPOT8 Part B study to assess the safety and efficacy of golidocitinib monotherapy in r/r PTCL patients. Objective response rate (ORR) was the trial’s primary endpoint. See Also: SGNB-7H4V by Pfizer for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer): Likelihood of Approval SGNB-7H4V by Pfizer for Epithelial Ovarian Cancer: Likelihood of Approval Golidocitinib offered superior and lasting antitumor efficacy and had a favourable safety profile versus current treatments. The ORR was 44.3% with a complete response rate of 23.9%, according to an independent review committee. Patients across a range of PTCL subtypes experienced tumour responses, with a median duration of response of 20.7 months. Notably, 53.8% of patients were still responding at the time of the analysis. Dizal CEO Xiaolin Zhang said: “We are thrilled to bring golidocitinib, the world’s first JAK1-only inhibitor, to patients in China, marking the second approved innovative drug from Dizal. “Golidocitinib yields good antitumour efficacy across different subtypes of PTCL, which differentiate golidocitinib from other targeted therapies. At Dizal, we aspire to discover and develop first-in-class and groundbreaking new medicines to address unmet medical needs around the world. With the US FDA fast track designation, we are expediting global development of golidocitinib to bring this exciting drug to patients worldwide.”

Fast TrackDrug ApprovalClinical Result

100 Deals associated with Golidocitinib

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Peripheral T-Cell Lymphoma	CN	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	18 Jun 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
PD-L1 positive Non-Small Cell Lung Cancer	Phase 2	CN	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	01 Jan 2024
T-cell lymphoma recurrent	Phase 2	CN	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	31 May 2022
Cutaneous T-Cell Lymphoma	Phase 2	CN	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	23 Dec 2021
EGFR-mutated non-small Cell Lung Cancer	Phase 2	AU	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	16 Apr 2018
Crohn Disease	Preclinical	CN	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	-
Non-Small Cell Lung Cancer	Preclinical	GB	AstraZeneca PLC	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04105010 (JACKPOT8 Part B, Pubmed) Manual	Phase 2	Peripheral T-Cell Lymphoma Second line	104	Golidocitinib 150 mg	vpkotsunyb(xoupvetwaa) = neutrophil count decreased (30 [29%]), white blood cell count decreased (27 [26%]), lymphocyte count decreased (22 [21%]), and platelet count decreased (21 [20%]), which were clinically manageable and reversible. Two (2%) due to pneumonia (one case with fungal infection [related to golidocitinib] and another one with COVID-19 infection) and one (1%) due to confusional state. zbuarfesdk (ekshlsqtqf )	Positive	01 Jan 2024
CTR20213318 (JACKPOT26, ASH2023)	Phase 2	Peripheral T-Cell Lymphoma Maintenance	48	Golidocitinib 150 mg	wtqasxwtcs(wzyhpqoysh) = dudfzixmkq zrcuhniimy (dzaroklrda ) View more	-	11 Dec 2023
NCT04105010 (JACKPOT8, ASH2023) Manual	Phase 2	Peripheral T-Cell Lymphoma Second line	112	Golidocitinib 150 mg	qpsewlgdht(zgivvpjikk) = hswfbbkcdl aixjhvqohb (klcyymlzyp, 33.7 - 55.3) View more	Positive	09 Dec 2023
NCT04105010 (JACKPOT8, ICML2023)	Phase 2	Peripheral T-Cell Lymphoma	104	Golidocitinib 150 mg	pvtgqmeluu(wpgpenlhzc) = efffqyrcrv ptlmnuuhpl (knqlpkuivf ) View more	Positive	09 Jun 2023
NCT04105010 (JACKPOT8, ASCO2023) Manual	Phase 2	Peripheral T-Cell Lymphoma	104	Golidocitinib	kaziwwnffb(ildqjovnsf) = nojqkpfrxn hqpgcipfxl (jawfwrfoul ) View more	Positive	26 May 2023
NCT04105010 (ASCO2022) Manual	Phase 1/2	Peripheral T-Cell Lymphoma	51	GolidocitinibGolidocitinib 150 or 250 mg QD	yrdsuzvcbs(zweyzgexfz) = fpyhrwjlhn xbpqfzjqlj (oesvrmmhvy ) View more	Positive	02 Jun 2022
NCT04105010 (EHA2022)	Phase 1/2	Peripheral T-Cell Lymphoma	51	Golidocitinib	qlbomkovcd(tssrhtwhno) = wpfrvltqqg iiurunijym (ubqrnwgynd ) View more	-	12 May 2022
JACKPOT8 (CSCO2021)	Phase 1/2	Peripheral T-Cell Lymphoma	47	DZD4205 150 mg	ddvjeakhfb(ueobjithph) = 41 cases (87.2%) reported at least 1 TEAE during treatment, with 24 cases (51.1%) reporting ≥ CTCAE grade 3 TEAE. 16 cases (34.0%) reported ≥ CTCAE grade 3 TEAE possibly related to DZD4205. The most common (≥10%) ≥ CTCAE grade 3 TEAEs included decreased platelet count (23.4%), decreased neutrophil count (17.0%), and infectious pneumonia (12.8%). The majority of TEAEs were fully recoverable or clinically manageable through dose adjustment. teqmmytcuw (iutvfluunq )	-	25 Sep 2021
JACKPOT8 (CSCO2021)	Phase 1/2	Peripheral T-Cell Lymphoma	47	DZD4205 250 mg		-	25 Sep 2021
NCT04105010 (JACKPOT8, ICML2021)	Phase 1/2	Peripheral T-Cell Lymphoma	47	DZD4205 150 mg	dlzxcgqxaf(ocrkmzbrfl) = dqvljcwiou rrqsnuwtpp (hbhibpkeyl ) View more	Positive	17 Jun 2021
NCT04105010 (JACKPOT8, ICML2021)	Phase 1/2	Peripheral T-Cell Lymphoma	47	DZD4205 250 mg	dlzxcgqxaf(ocrkmzbrfl) = gnwjxnkgbx rrqsnuwtpp (hbhibpkeyl ) View more	Positive	17 Jun 2021

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis