Drug intelligence / Profile preview

golidocitinib

Development stage
Phase 3
Lead developer
Dizal Pharmaceutical
Modality
Small Molecules
Administration
Oral
01

Overview

Golidocitinib is a highly selective, next-generation small molecule inhibitor of Janus kinase 1 (JAK1). It blocks the JAK/STAT signaling pathway by inhibiting JAK1-mediated phosphorylation of STAT3 and related downstream signals, thereby suppressing tumor cell proliferation. Golidocitinib is the world’s first approved JAK inhibitor specifically for T-cell lymphoma and was developed to address relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) in adults who have received at least one prior systemic therapy. The drug demonstrates high selectivity for JAK1 over other family members (200–400 times), a long half-life (~50 hours), and strong anti-tumor activity across multiple PTCL subtypes. Clinical trials showed an objective response rate (ORR) of 44.3% and a complete response rate of 23.9%, with durable responses observed in various subtypes of PTCL[1][3][4][6]. Golidocitinib was conditionally approved in China in June 2024 based on these results; it has also received Fast Track designation from the US FDA[3][6].

Brand names
高瑞哲
Other names
戈利昔替尼Golidocitinib Capsules
02

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