Drug intelligence / Profile preview

milciclib

Development stage
Phase 2
Lead developer
Tiziana Life Sciences
Modality
Small Molecules
Administration
Oral
01

Overview

Milciclib is a potent, orally bioavailable small molecule inhibitor targeting multiple cyclin-dependent kinases (CDKs), including CDK1, CDK2, CDK4, and CDK5; tropomyosin receptor kinase A (TrkA); and Src family kinases. By inhibiting these kinases—key regulators of cell cycle progression and malignant transformation—milciclib induces cell cycle arrest and apoptosis in tumor cells. It has demonstrated antineoplastic activity in preclinical models and clinical trials. Milciclib was originally developed by Nerviano Medical Sciences and is currently being advanced by Tiziana Life Sciences for the treatment of various cancers. The drug has shown safety and tolerability in Phase 1/2 studies involving patients with advanced solid tumors—including thymic carcinoma/thymoma (where it holds orphan drug status) and hepatocellular carcinoma—and has met primary endpoints for disease stabilization in these populations[1][3][8].

Other names
milciclib maleate
02

Targets

CDK2 (Cyclin-dependent kinase 2)CDK5 (Cyclin-dependent kinase 5)NTRK1 (Tropomyosin-related receptor kinase A)SFK (SRC family kinases)CDK1 (Cyclin-dependent kinase 1)CDK4 (Cyclin-dependent kinase 4)

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