Drugs / Golidocitinib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | primary cutaneous T-cell lymphoma | 2023-09-14 | “We are thrilled that our NDA for golidocitinib has been accepted, marking our second successful NDA submission in 2023” dizalpharma.com ↗ “In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL.” dizalpharma.com ↗ |
Trials 44
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-05-31 | Dizal Pharmaceuticals | Results Dizal Presents Positive NSCLC Data for Fourth-Generation EGFR TKI DZD6008 and Golidocitinib in Combination with Anti-PD-1 at ASCO 2026 dizalpharma.com ↗
The other study reported results for golidocitinib, a JAK1-selective inhibitor, combined with an anti-PD-1 antibody as a first-line treatment for PD-L1-positive, advanced NSCLC without driver mutations. |
| 2025-12-09 | Dizal Pharmaceuticals | Results Dizal Showcases its Strong Hematology Pipeline with New Data from Golidocitinib and Birelentinib at ASH 2025 dizalpharma.com ↗
Results from a prospective study showed an ORR of 92.3% and a CR rate of 61.15%. |
| 2025-11-04 | Dizal Pharmaceuticals | Results Dizal to Present Hematology Portfolio Across T-cell and B-cell Lymphomas at ASH 2025 dizalpharma.com ↗
Preliminary results from a phase 2 multicenter study demonstrated that golidocitinib combined with CHOP exhibited profound clinical activity in treatment-naïve monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL). |
| 2025-09-09 | Dizal Pharmaceuticals | Results Dizal Showcases Robust Portfolio of Lung Cancer Studies at 2025 WCLC dizalpharma.com ↗
The study showed a well-tolerated profile, with no DLTs observed in the dose-escalation phase. |
| 2025-06-12 | Dizal Pharmaceuticals | Results Dizal Showcases Two First-in-Class Therapies in Hematologic Malignancies at EHA and ICML 2025 dizalpharma.com ↗
The data suggest that golidocitinib showed promising efficacy in maintaining and enhancing tumor response with an acceptable and manageable safety profile in patients with PTCLs post first-line therapies. |
| 2025-05-15 | Dizal Pharmaceuticals | Results Dizal to Present Promising Clinical Data on Golidocitinib and DZD8586 for the Treatment of Lymphoma at the Coming International Hematology Conferences dizalpharma.com ↗
The results showed that with more than 2 years follow-up, golidocitinib continued to demonstrate a promising effect on maintaining and e |
| 2025-03-20 | Dizal Pharmaceuticals | Results Dizal’s Golidocitinib in Combination with Anti-PD-1 Shows Promise in IO Resistant Non-Small Cell Lung Cancer dizalpharma.com ↗
The preliminary results are very promising and justify further clinical validation. |
| 2024-06-19 | Dizal Pharmaceuticals | Regulatory Golidocitinib Approved in China as First-in-class JAK1 Only Inhibitor for the Treatment of Relapsed or Refractory Peripheral T-Cell Lymphoma dizalpharma.com ↗
To date, golidocitinib is the first and only approved Janus kinase 1 (JAK1) selective inhibitor for r/r PTCL patients globally. |
| 2023-12-12 | Dizal Pharmaceuticals | Results Dizal Impresses with Its Differentiated Hematological Oncology Portfolio at 2023 ASH dizalpharma.com ↗
The results of JACKPOT8 PART B study revealed that golidocitinib demonstrated superior and durable clinical benefits in the treatment of r/r PTCL with a favorable safety profile that outperformed existing treatment options. |
| 2023-12-10 | Dizal Pharmaceuticals | Results Dizal’s Golidocitinib Pivotal Trial Demonstrates Superior and Durable Clinical Benefits for Patients with r/r PTCL in Oral Presentation at 2023 ASH dizalpharma.com ↗
At the cut-off date of August 31, 2023, per independent review committee (IRC) assessment, 70% of patients achieved target lesion size reduction, yielding an overall response rate (ORR) of 44.3%, and a complete response rate (CRR) of 23.9%. |
| 2023-11-03 | Dizal Pharmaceuticals | Results Dizal Highlights Its Advances in Hematological Portfolio at 2023 ASH, Featuring Breakthroughs in Lymphoma Treatment dizalpharma.com ↗
An IRC-assessed overall response rate (ORR) was 44.3%, nearly double the existing treatment options. |
| 2023-09-21 | Dizal Pharmaceuticals | Regulatory Golidocitinib Granted Priority Review by China NMPA for the Treatment of r/r PTCL dizalpharma.com ↗
We are pleased with the CDE’s decision to grant priority review status to golidocitinib, as it recognizes the potential of this groundbreaking drug to improve survival benefits for this underserved patient population. |
| 2023-09-14 | Dizal Pharmaceuticals | Regulatory Dizal Announces China CDE Acceptance of New Drug Application for Golidocitinib for Relapsed or Refractory PTCL dizalpharma.com ↗
“We are thrilled that our NDA for golidocitinib has been accepted, marking our second successful NDA submission in 2023,” said Xiaolin Zhang, Ph.D., Chairman and CEO of Dizal, “Golidocitinib, as a first-in-class JAK1-only inhibitor, has demonstrated a superior efficacy and safety profile. |
| 2023-09-10 | Dizal Pharmaceuticals | Results Dizal Announces Clinical Results of Golidocitinib Published in Annals of Oncology dizalpharma.com ↗
The primary endpoint of the study, objective response rate (ORR) assessed by an independent review committee (IRC), reached 44.3%, with a complete response rate (CRR) of 23.9%. |
| 2023-06-11 | Dizal Pharmaceuticals | Results Dizal to Showcase its Hematological Oncology Pipeline at the 2023 ICML dizalpharma.com ↗
In the efficacy analysis set of 88 patients, the objective response rate (ORR) was 44.3% (39/88) including 21 complete responses (CRR, 23.9%) assessed by independent review committee (IRC). |
| 2023-06-07 | Dizal Pharmaceuticals | Results Dizal Leads China’s Biotech Innovation by Showcasing Strength of its Oncology Pipeline dizalpharma.com ↗
With promising efficacy and favorable safety profile, golidocitinib could be an innovative approach for this difficult-to-treat disease. |
| 2023-05-26 | Dizal Pharmaceuticals | Results Dizal’s Oncology Pipeline Continues to Impress with Two Oral Presentations at 2023 Oncology Meeting In Chicago dizalpharma.com ↗
Golidocitinib demonstrated promising and durable anti-tumor efficacy, making it a superior treatment option to fight against this devastating disease. |
| 2023-01-10 | Dizal Pharmaceuticals | Regulatory Dizal Announces China CDE Approval of IND application for Phase 2 Study of Sunvozertinib in Combination with Golidocitinib for Non-Small Cell Lung Cancer dizalpharma.com ↗ |
| 2022-12-12 | Dizal Pharmaceuticals | Results Dizal Announces Clinical Data of Golidocitinib Presented at the 2022 ASH Annual Meeting dizalpharma.com ↗
21 achieved tumor response (ORR: 42.9%), including 11 complete responses (CR rate: 22.4%). |
| 2022-11-02 | Dizal Pharmaceuticals | Results Dizal to Present Latest Scientific Advancements across its Fast-growing Innovative Pipeline at 2022 CSCO dizalpharma.com ↗
Results from the Phase 1/2 trial, which is evaluating the efficacy and safety of golidocitinib in patients with r/r PTCL, showed golidocitinib yielded an ORR of 42.9% and longest DoR of > 14 months. |
| 2022-05-27 | Dizal Pharmaceuticals | Results Dizal to Demonstrate the Strength and Rapid Acceleration of its Clinical Portfolio at ASCO 2022 dizalpharma.com ↗
Results from the Phase 1/2 trial of sunvozertinib, which is evaluating the efficacy and safety of sunvozertinib in previously treated NSCLC patients with EGFR Ex20ins, showed sunvozertinib yielded a best ORR of 48.4% and DCR of 90.3%. |
| 2022-05-14 | Dizal Pharmaceuticals | Results Dizal Announces New Data from the Phase I/II Study of Golidocitnib in Refractory or Relapsed Peripheral T Cell Lymphoma Selected for Oral Presentation at 2022 EHA Annual Meeting dizalpharma.com ↗
The median duration of treatment (DoR) was not reached, and the longest DoR was >14months. |
| 2022-02-18 | Dizal Pharmaceuticals | Regulatory Dizal Pharmaceutical Receives U.S. FDA Fast Track Designation for DZD4205 (Golidocitinib) for the Treatment of Refractory or Relapsed Peripheral T-Cell Lymphoma dizalpharma.com ↗
Dizal Pharmaceutical Co., Ltd. (SHEX:688192) ("Dizal"), today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation to DZD4205 (Golidocitinib) for the treatment of patients with Refractory or Relapsed Peripheral T-Cell Lymphoma (r/r PTCL). |
All press releases naming this drug 23 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | golidocitinib | “Investigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective...” NCT07639879 ↗36“Golidocitinib combined with Pomalidomide” NCT06855823 ↗ |
| Known as | AZD4205 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05486949 ↗ |
| Known as | AZD4205 free base | ChEMBL registry synonym — accepted as the source's own label CHEMBL4577523 ↗ |
| Known as | 戈利昔替尼 | “Golidocitinib (Chinese name: 戈利昔替尼) is an oral, potent, and highly selective JAK1 inhibitor” NCT07300514 ↗ |
| Action | Inhibit | “Oral Janus Kinase Inhibitor, AZD4205” NCT03450330 ↗ |
| Modality | Small molecule | — CHEMBL4577523 ↗ |
| Route | Oral | “Assessing an Oral Janus Kinase Inhibitor, AZD4205” NCT03450330 ↗ |
| Target | JAK1 | “a highly selective JAK1 inhibitor” PMID 37077916 ↗ Apr 2023 |