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Drug

Orelabrutinib

Approved medicine
ClassTyrosine-protein kinase BTK inhibitorResearchOngoing clinical research

Also known as Aobutini, 奥布替尼, obutinib.

RxNorm2471433ChEMBLCHEMBL4650321ATCL01EL04UNIIWJA5UO9E10
38
Active clinical trials
Tyrosine-protein kinase BTK
Primary target
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL) ：a Single Arm, Open Label, Multi-center Phase II Study

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

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

Clinical trial2026-07-30Results expected Q2 2030 · ClinicalTrials.gov

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

Clinical trial2026-07-10Results expected Q2 2030 · ClinicalTrials.gov

A Phase I/II，Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

A Multicenter Exploratory Clinical Study on the Treatment of Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide

Clinical trial2026-05-14Results expected Q4 2029 · ClinicalTrials.gov

Ultra-low-dose Radiation Therapy Followed by Orelabrutinib as First-line Treatment for Stage Ⅰ-Ⅱ MALT Lymphoma: A Prospective, Multicenter Phase Ⅱ Study

Clinical trial2026-05-11Results expected Q1 2028 · ClinicalTrials.gov

A Randomized, Open-Label Phase II Clinical Study of Orelabrutinib Combined With Rituximab Versus R-CVP in the Treatment of Newly Diagnosed Marginal Zone Lymphoma (MZL).

Clinical trial2026-05-04Primary completion · ClinicalTrials.gov

Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Nervous System Involvement

Clinical trial2026-04-30Primary completion · ClinicalTrials.gov

Orelabrutinib Combined With Anti-CD20 Monoclonal Antibody-CVP Regimen for the Treatment of Previously Untreated Marginal Zone Lymphoma:A Pospective, Multicenter, Open-label Phase II Clinical Study

Clinical trial2026-04-02Results expected Q4 2029 · ClinicalTrials.gov

A Prospective, Exploratory Clinical Study of Genetic Subtype-matched Precision Targeted Therapy in Newly Diagnosed DLBCL With TP53 Mutation

Clinical trial2026-03-30Results expected Q4 2027 · ClinicalTrials.gov

A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy in Previously Untreated CLL/SLL

Clinical trial2026-03-26Primary completion · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Orelabrutinib
Aliases & brands
Aobutini奥布替尼obutinib
RxNorm CUI
2471433
ChEMBL ID
CHEMBL4650321
ATC codes
L01EL04
UNII
WJA5UO9E10
Primary mechanism
Tyrosine-protein kinase BTK inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tyrosine-protein kinase BTK
BTK · Q06187
INHIBITORTyrosine-protein kinase BTK inhibitor

Clinical trials

59 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
59
registered trials across all phases
LATEST COMPLETION 2024
38
Active studies
33
Recruiting
15
Late-stage (III+)
1
Completed
20
Discontinued
PHASE DISTRIBUTIONn = 59
Phase 13Phase 1 / 24Phase 237Phase 2 / 32Phase 39Phase 41Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma:A Phase II, Prospective, Multicenter, Single-Arm Clinical Study

RecruitingPH IVBeijing Tongren Hospitaln=882028

A Randomized, Open-label, Multicenter, Phase III Clinical Study Comparing Rocbrutinib Monotherapy Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (PRIME Study)

RecruitingPH IIIGuangzhou Lupeng Pharmaceutical Company LTD.n=3942033

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma

RecruitingPH IIIInnoCare Pharma Inc.n=4762032

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

RecruitingPH II/IIIBeijing InnoCare Pharma Tech Co., Ltd.n=2262031

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

RecruitingPH IIIZenas BioPharma (USA), LLCn=9902030

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma

CompletedPH IIInnoCare Pharma Inc.n=402024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials