Drug Profile

Orelabrutinib - InnoCare Pharma

Alternative Names: BIIB-135; ICP 022; INNOBRUKA; YINUOKAI

Latest Information Update: 05 Nov 2025

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At a glance

Originator InnoCare Pharma
Class Amides; Anti-inflammatories; Antineoplastics; Antirheumatics; Eye disorder therapies; Phenyl ethers; Piperidines; Pyridines; Small molecules
Mechanism of Action Agammaglobulinaemia tyrosine kinase inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Mantle-cell lymphoma
New Molecular Entity Yes

Marketed Chronic lymphocytic leukaemia; Mantle-cell lymphoma; Marginal zone B-cell lymphoma
Preregistration Waldenstrom's macroglobulinaemia
Phase III Diffuse large B cell lymphoma; Idiopathic thrombocytopenic purpura; Multiple sclerosis
Phase II Lymphoma; Neuromyelitis optica; Non-Hodgkin's lymphoma; Systemic lupus erythematosus
Phase I/II B-cell lymphoma; Follicular lymphoma
Discontinued Rheumatoid arthritis

08 Oct 2025 Orelabrutinib licensed to Zenas BioPharma worldwide
08 Oct 2025 InnoCare Pharma plans a phase III trial for Multiple sclerosis in first quarter of 2026 (PO)
30 Sep 2025 Phase-III clinical trials in Multiple sclerosis (PO), in September 2025 (NCT07067463)

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