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Nublexa

(Orelabrutinib)

Phase 3Small molecule

BBeijing InnoCare Pharma Tech Co., Ltd.

It is used to treat certain types of blood cancers, specifically chronic lymphocytic leukemia and marginal zone lymphoma. It works by blocking a protein that helps cancer cells grow and survive.[1] Nublexa is currently being investigated across 22 indications[3], with its most advanced program in Phase 3.[1]

Nublexa is one of 458 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Phase 3.

22

Indications

60

Total Trials

38

Active Trials

457

Competitors

Pipeline

Status by Indication[3][1]

Indication

Systemic Lupus ErythematosusActive, not recruiting

Nodal Marginal Zone B-Cell LymphomaActive, not recruiting

Central Nervous System LymphomaActive, not recruiting

LymphomaActive, not recruiting

MALT LymphomaActive, not recruiting

Relapsing-Remitting Multiple SclerosisActive, not recruiting

B-Cell Non-Hodgkins LymphomaActive, not recruiting

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaActive, not recruiting

Primary Progressive Multiple SclerosisActive, not recruiting

Neuromyelitis OpticaActive, not recruiting

Systemic Lupus ErythematosusPhase 2

Active, not recruiting

Nodal Marginal Zone B-Cell LymphomaPhase 2

Active, not recruiting

Central Nervous System LymphomaPhase 3

Active, not recruiting

LymphomaPhase 2

Active, not recruiting

MALT LymphomaPhase 2

Active, not recruiting

Relapsing-Remitting Multiple SclerosisPhase 2

Active, not recruiting

B-Cell Non-Hodgkins LymphomaPreclinical

Active, not recruiting

Chronic Lymphocytic Leukemia/small Lymphocytic LymphomaPreclinical

Active, not recruiting

Primary Progressive Multiple SclerosisPhase 3

Active, not recruiting

Neuromyelitis OpticaPreclinical

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Nublexa

BBeijing InnoCare Pharma Tech Co., Ltd.

Oncaspar

Velban

EEastern Cooperative Oncology Group

Norvir

Tafasitamab

Nuvigil

NNuvo Research GmbH

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Systemic Therapy

Bristol-Myers Squibb

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

PEG-Intron

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Treatment

NCT06530511

Q4 2026

Phase 2Not yet recruiting

Monotherapy

NCT06476899

Phase 2Recruiting

Central Nervous System Lymphoma

NCT04961515

Q1 2027

Phase 2Recruiting

DLBCL

NCT06647940

Q3 2027

Phase 3Recruiting

Treatment

NCT06496308

Phase 2Active, not recruiting

MALT Lymphoma

NCT06583837

Clinical

Trials by Indication[1]

Lymphoma7 trials

Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma

Recruiting·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 3·NCT06082102·324 enrolled

Application of Orelabrutinib With or Without CD20 Monoclonal Antibody in Previously Untreated Marginal Zone Lymphoma

Recruiting·—·Phase 4·NCT07355699·88 enrolled

Orelabrutinib Therapy in Patients With r/r B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors

Unknown status·PPeking University People's Hospital··NCT05495828·30 enrolled

Show 4 more trials

A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma

Unknown status·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 1/2·NCT04304040·43 enrolled

Orelabrutinib in Combination With Thiotepa in Refractory and Relapsed Primary CNS Lymphoma

Unknown status·HHuiqiang Huang·Phase 1/2·NCT05021770·29 enrolled

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

Recruiting·RRuijin Hospital·Phase 2·NCT05926427·25 enrolled

Orelabrutinib in Combination With R2 Regimen for R/R CD20+ B-cell Lymphoma

Unknown status·PPuyang Oilfield General Hospital·Phase 2·NCT05014100·55 enrolled

Mantle Cell Lymphoma6 trials

Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma

Recruiting·PPeking University Third Hospital·N/A·NCT07257510·34 enrolled

Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease

Recruiting·RRuijin Hospital·Phase 2·NCT07272499·25 enrolled

A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·GGuangzhou Lupeng Pharmaceutical Company LTD.·Phase 3·NCT07377578·394 enrolled

Show 3 more trials

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

Not yet recruiting·RRuijin Hospital·Phase 2·NCT06656221·29 enrolled

A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL

Recruiting·IInnoCare Pharma Inc.·Phase 3·NCT06363994·476 enrolled

Evaluating Different Doses of Orelabrutinib in MCL

Unknown status·IInnoCare Pharma Inc.·Phase 2·NCT05978739·40 enrolled

Treatment5 trials

Genotype-guided Treatment in DLBCL

Recruiting·RRuijin Hospital·Phase 3·NCT05351346·1,100 enrolled

Treatment of BTKi+Hi-CVP Regimen for Previously Untreated MZL

Active, not recruiting·—·Phase 2·NCT07480863·65 enrolled

Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment

Recruiting·RRuijin Hospital·Phase 3·NCT06496308·78 enrolled

Show 2 more trials

Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL

Recruiting·—·Phase 2·NCT06530511·30 enrolled

Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07441993·30 enrolled

Newly Diagnosed5 trials

PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL.

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07410520·50 enrolled

Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL

Not yet recruiting·HHuashan Hospital·Phase 2/3·NCT07185373·215 enrolled

Orelabrutinib and Obinutuzumab Plus FC Regimen in Treating Newly Diagnosed CLL/SLL

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT05322733·25 enrolled

Show 2 more trials

Orelabrutinib Combined With Zebetuzumab and Lenalidomide for the Treatment of Newly Diagnosed MZL

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07208981·169 enrolled

Orelabrutinib With R-CHOP-like Regimen for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05498259·46 enrolled

Central Nervous System Lymphoma4 trials

Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

Unknown status·RRuijin Hospital·Phase 3·NCT05334238·174 enrolled

Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT05600660·28 enrolled

Phase II Study of Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT04899427·32 enrolled

Show 1 more trial

Orelabrutinib, Sintilimab and Temozolomide in Relapsed or Refractory Central Nervous System Lymphoma

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT04961515·19 enrolled

29 more indications

Immune Thrombocytopenia3 trials

Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy

Not yet recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07400250·28 enrolled

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia

Recruiting·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 3·NCT06004856·195 enrolled

A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia

Unknown status·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 2·NCT05232149·30 enrolled

MALT lymphoma2 trials

Orelabrutinib Followed by Response-adapted Ultra-low Dose 4Gy Radiation as First-line Treatment of MALT Lymphoma

Active, not recruiting·FFudan University·Phase 2·NCT06583837·50 enrolled

Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma

Active, not recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT07247383·39 enrolled

Methotrexate2 trials

New-diagnosed PCNSL Treated With Methotrexate (MTX) and Orelabrutinib-based Regimen

Completed·HHuashan Hospital··NCT06115824·136 enrolled

Methotrexate or Thiotepa Combined With R-CHOP and Orelabrutinib in CNSL Patients

Not yet recruiting·RRuijin Hospital·Phase 2·NCT06901999·23 enrolled

Pilot Study1 trial

A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL

Active, not recruiting·HHuashan Hospital·Phase 1·NCT05036577·15 enrolled

Nodal Marginal Zone B-Cell Lymphoma1 trial

The Treatment of Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma by Orelabrutinib and Radiotherapy

Recruiting·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University·Phase 2·NCT06503276·50 enrolled

Elderly Patients1 trial

Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients

Recruiting·TThe First Affiliated Hospital of Soochow University·N/A·NCT05809180·35 enrolled

Cardiac Repolarization1 trial

Evaluate the Effect of Orelabrutinib on Cardiac Repolarization in Healthy Subjects

Unknown status·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 1·NCT05660720·48 enrolled

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)

Recruiting·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 2/3·NCT06378138·226 enrolled

Monotherapy1 trial

A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy

Not yet recruiting·FFei Li·Phase 2·NCT06476899·60 enrolled

Pomalidomide1 trial

Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

Recruiting·PPeking Union Medical College Hospital·Phase 2·NCT05390749·50 enrolled

Targeted Therapy1 trial

MZL-IPI Risk-adapted Targeted Therapy in Untreated MZL

Recruiting·RRuijin Hospital·Phase 2·NCT06793189·145 enrolled

Neuromyelitis Optica1 trial

A Study of Orelabrutinib in Patients With AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder

Unknown status·PPeking Union Medical College Hospital·N/A·NCT05284175·23 enrolled

Lenalidomide1 trial

Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07448324·50 enrolled

Clinical Trial1 trial

A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP

Unknown status·SShandong University·Phase 2·NCT05020288·40 enrolled

Chronic Lymphocytic Leukemia1 trial

Phase IV Observational Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Cell Lymphoma

Unknown status·WWang Xin··NCT05920668·20 enrolled

Efficacy and Safety1 trial

A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL

Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06516978·528 enrolled

CLL/SLL1 trial

A Study of Orelabrutinib in CLL/SLL Patients Who Are Slowly Responding to Ibrutinib

Unknown status·PPeking University People's Hospital·Phase 2·NCT05491044·30 enrolled

Relapsing-Remitting Multiple Sclerosis1 trial

A Phase 2 Study of Orelabrutinib in Patients With Relapsing-Remitting Multiple Sclerosis

Unknown status·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 2·NCT04711148·160 enrolled

DLBCL1 trial

Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）

Recruiting·SSun Yat-sen University·Phase 2·NCT06647940·39 enrolled

Autologous Hematopoietic Stem Cell Transplantation1 trial

Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment

Recruiting·RRuijin Hospital·Phase 2·NCT07199296·45 enrolled

Randomized1 trial

Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial

Recruiting·FFei Li·Phase 2·NCT06700798·90 enrolled

Cohort Study1 trial

An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University··NCT06015464·81 enrolled

ITP1 trial

A Study of Orelabrutinib in Patients With ITP

Unknown status·PPeking University People's Hospital·Phase 1/2·NCT05124028·10 enrolled

Follicular Lymphoma1 trial

Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)

Unknown status·SSun Yat-sen University·Phase 2·NCT04989621·32 enrolled

Hepatic Impairment1 trial

Study to Evaluate Orelabrutinib Tablets in Subjects With Hepatic Impairment and Healthy Subject

Unknown status·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 1·NCT05684653·34 enrolled

Tyrosine Kinase Inhibitor1 trial

A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies

Unknown status·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 1/2·NCT04014205·81 enrolled

Systemic Lupus Erythematosus1 trial

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Systemic Lupus Erythematosus

Recruiting·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 2·NCT05688696·186 enrolled

Multiple Sclerosis (MS) Primary Progressive1 trial

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

Recruiting·ZZenas BioPharma (USA), LLC·Phase 3·NCT07067463·705 enrolled

Secondary Progressive Multiple Sclerosis1 trial

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

Recruiting·ZZenas BioPharma (USA), LLC·Phase 3·NCT07299019·990 enrolled

Sources

References

[1]
ClinicalTrials.gov — 60 trial records for Orelabrutinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Orelabrutinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Orelabrutinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Beijing InnoCare Pharma Tech Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tyrosine-Protein Kinase BTK Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BBeijing InnoCare Pharma Tech Co., Ltd.

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