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orelabrutinib

Generic: Bruton's Tyrosine Kinase inhibitor·Code: ZB020

orelabrutinib: developed by 1 company · 7 clinical trials tracked.

orelabrutinib evidence translation

What we can confirm

What it means

Source-backed records connect orelabrutinib to ZBIO; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could orelabrutinib → ZBIO affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 2 study sponsors

Related indications

Secondary Progressive Multiple Sclerosis; Multiple Sclerosis (MS) Primary ProgressiveHematologic Malignancies
Development Pipeline (1)
CompanyPhase
Zenas BioPharma, Inc. (ZBIO)
Secondary Progressive Multiple Sclerosis; Multiple Sclerosis…
Phase 3
Clinical Trials (7)

A Randomized, Multicenter, Open-label, Phase 3 Study to Compare ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL)

NCT07784101·Phase 3·TECH
Not yet recruiting

Primary endpoint: Progression-free survival (PFS) as assessed by Independent Review Committee (IRC).

InterventionalRandomizedopen280 targetStarted 2026-10Completion 2033-1224 sites · ChinaBeijing InnoCare Pharma Tech Co., Ltd.

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis

NCT07067463·Phase 3·ZBIO
Recruiting

Primary endpoint: Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)

InterventionalRandomizedquadruple705 targetStarted 2026-03Completion 2030-0750 sites · Bulgaria, Croatia, Czechia, Estonia…Zenas BioPharma (USA), LLC

A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis

NCT07299019·Phase 3·ZBIO
Recruiting

Primary endpoint: Time to onset of confirmed disability progression (CDP) events, confirmed over at least 24 weeks

InterventionalRandomizedquadruple990 targetStarted 2026-03Completion 2030-0737 sites · Croatia, Czechia, Estonia, Lithuania…Zenas BioPharma (USA), LLC

A Multicenter, Open-Label, Single-Arm, Prospective Clinical Study of PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) in the Treatment of Newly Diagnosed Primary Central Nervous System Lymphoma (ND-PCNSL) and Secondary Central Nervous System Lymphoma (SCNSL)

NCT07410520·Phase 2·ENTA
Recruiting

Primary endpoint: 1 year Progression free survival (PFS)

Interventionalopen50 targetStarted 2026-02Completion 2029-121 site · ChinaThe First Affiliated Hospital with Nanjing Medical University

A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

NCT06378138·Phase 2/Phase 3·TECH
Recruiting

Primary endpoint: Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria

Interventionalopen226 targetStarted 2024-05Completion 2031-0750 sites · ChinaBeijing InnoCare Pharma Tech Co., Ltd.

A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed/Refractory Marginal Zone Lymphoma

NCT06082102·Phase 3·TECH
Recruiting

Primary endpoint: IRC-assessed PFS

InterventionalRandomizedopen324 targetStarted 2023-12Completion 2030-0219 sites · ChinaBeijing InnoCare Pharma Tech Co., Ltd.

A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma

NCT05051891·Phase 3·TECH
Completed

Primary endpoint: PFS

InterventionalRandomizedopen3 enrolledStarted 2021-12Completion 2025-0622 sites · ChinaBeijing InnoCare Pharma Tech Co., Ltd.

Frequently asked questions

Who is developing orelabrutinib?

orelabrutinib is being developed by Zenas BioPharma, Inc..

How many clinical trials involve orelabrutinib?

BioSniper tracks 7 clinical trials involving orelabrutinib.