Zenas BioPharma (USA), LLC — Biomedical Watch V2

Traitements3programmes

Essais2liés

Publications4liées

SourceDBlocale

Traitements

3

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
OrelabrutinibOrelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.	SEP	Phase 3	Immunomodulation	United States, Croatia, Czechia, Estonia, Italy, Lithuania, Poland, Puerto Rico, …	À vérifier
OrelabrutinibOrelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.	SEP	Phase 3	Immunomodulation	United States, Croatia, Czechia, Estonia, Italy, Lithuania, Poland, Puerto Rico, Serbia	À vérifier
OrelabrutinibOrelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.	SEP	Phase 3	Immunomodulation	United States, Bulgaria, Croatia, Czechia, Estonia, Georgia, Germany, Italy, Netherlands, Poland, Puerto Rico, Romania, Serbia, Slovakia, Spain, Ukraine	À vérifier

Essais cliniques

2

Molécule	Indication / population	Phase	NCT	Titre	Statut
Orelabrutinib	SEP	Phase 3	NCT07067463	A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis	RECRUITING
Orelabrutinib	SEP	Phase 3	NCT07299019	A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis	RECRUITING

Publications

4

Molécule	Indication / population	Titre	Journal	Date
Orelabrutinib		A UHPLC-MS/MS method for the simultaneous quantification of BTK inhibitors and their active metabolite in human plasma and cerebrospinal fluid.	Bioanalysis
Orelabrutinib		Successful treatment of pure red cell aplasia with Orelabrutinib following major ABO-incompatible hematopoietic stem cell transplantation for acute myeloid leukemia: A case report.	Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis
Orelabrutinib		Immune thrombocytopenia: Evolving mechanistic understanding and clinical development of new therapies.	Tzu chi medical journal
Orelabrutinib		Pretreatment With BTK Inhibitors Improved the Sensitivity of DLBCL Cells to CAR-T Cells in a Coculture System by Downregulating the Polarisation of M2 Macrophages.	Journal of cellular and molecular medicine