Orelabrutinib

Overview

Orelabrutinib is under investigation in clinical trial NCT04305197 (A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)).

Indication

⑴既往至少接受过一种治疗的成人套细胞淋巴瘤（MCL）患者。 ⑵既往至少接受过一种治疗的成人慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis	2025/07/16	NCT07067463	Not Applicable	Not yet recruiting	Beijing InnoCare Pharma Tech Co., Ltd.
Methotrexate or Thiotepa Combined With R-CHOP and Orelabrutinib in CNSL Patients	2025/03/30	NCT06901999	Phase 2	Not yet recruiting	Ruijin Hospital
MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL	2025/01/27	NCT06793189	Phase 2	Not yet recruiting	Ruijin Hospital
CR-CHOP+X in Previously Untreated DEL	2024/11/22	NCT06701357	Phase 2	Recruiting	Ruijin Hospital
Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial	2024/11/22	NCT06700798	Phase 2	Recruiting	Fei Li
A Prospective, Single-Center Study Evaluating the Efficacy and Safety of Glofitamab Combined With Orelabrutinib and Bortezomib in Patients With High-Risk Mantle Cell Lymphoma	2024/10/24	NCT06656221	Phase 2	Not yet recruiting	Ruijin Hospital
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）	2024/10/18	NCT06647940	Phase 2	Recruiting	Sun Yat-sen University
Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma	2024/09/04	NCT06583837	Phase 2	Recruiting	Fudan University
Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL	2024/07/31	NCT06530511	Phase 2	Recruiting	Affiliated Hospital of Nantong University
A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL	2024/07/24	NCT06516978	Phase 2	Not yet recruiting	The First Affiliated Hospital with Nanjing Medical University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
HIBRUKA TABLET 50MG	WuXi STA Pharmaceutical Co., Ltd., Changzhou SynTheAll Pharmaceutical Co., Ltd. (ASD Manufacturing)	SIN16645P	TABLET	50 mg	11/22/2022

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

InnoCare Presents Promising Clinical Data for Multiple Oncology Pipeline Candidates at Major Medical Conferences

3 months ago

InnoCare presented clinical data for multiple oncology pipeline candidates at the 2025 ASCO Annual Meeting and EHA 2025 Congress, demonstrating significant therapeutic potential across various cancer types.

Novel BTK Inhibitor Combination Shows Promise in Primary CNS Lymphoma Trial

4 months ago

A phase II trial of orelabrutinib combined with rituximab and high-dose methotrexate achieved a 71.4% overall response rate in newly diagnosed primary central nervous system lymphoma patients.

Promising Pipeline for Mantle Cell Lymphoma Treatment: 22+ Therapies Under Development by 20+ Companies

4 months ago

DelveInsight's latest report reveals a robust pipeline with 20+ companies developing 22+ therapies for mantle cell lymphoma, highlighting significant advancement in treatment options for this rare blood cancer.

InnoCare's Orelabrutinib Shows Over 90% Reduction in MS Brain Lesions in Phase II Trial

6 months ago

Orelabrutinib demonstrated remarkable efficacy in Phase II trials, reducing new brain lesions by 90.4% at 12 weeks and 92.3% at 24 weeks compared to placebo in RRMS patients.

InnoCare's BCL2 Inhibitor ICP-248 Combination Therapy Advances to Phase III Trial for First-line CLL/SLL Treatment in China