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ICP-022
ICP-022 is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK signaling to suppress B-cell and myeloid cell activation in hematologic malignancies.
ICP-022 is a Bruton's tyrosine kinase (BTK) inhibitor that blocks BTK signaling to suppress B-cell and myeloid cell activation in hematologic malignancies. Used for Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL), Mantle cell lymphoma (MCL).
At a glance
| Generic name | ICP-022 |
|---|---|
| Also known as | Orelabrutinib, orelabrutinib |
| Sponsor | Beijing InnoCare Pharma Tech Co., Ltd. |
| Drug class | Bruton's tyrosine kinase (BTK) inhibitor |
| Target | BTK (Bruton's tyrosine kinase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
BTK is a critical enzyme in the B-cell receptor signaling pathway and is overactive in many B-cell lymphomas and leukemias. By inhibiting BTK, ICP-022 reduces proliferation and survival of malignant B cells while also modulating the tumor microenvironment. This mechanism has demonstrated efficacy in chronic lymphocytic leukemia and other B-cell malignancies.
Approved indications
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Mantle cell lymphoma (MCL)
Common side effects
- Infection
- Diarrhea
- Fatigue
- Hemorrhage
- Atrial fibrillation
Key clinical trials
- Orelabrutinib Plus Low-Dose Radiotherapy Or Rituximab For Ocular Adnexal MALT Lymphoma (PHASE2)
- Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial (PHASE2)
- Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma (PHASE2)
- A Study of ICP-022 in Patients With R/R DLBCL (PHASE2)
- A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL) (PHASE2)
- A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia (PHASE2)
- A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell Lymphoma (PHASE3)
- Orelabrutinib Therapy in Patients With r/r B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ICP-022 CI brief — competitive landscape report
- ICP-022 updates RSS · CI watch RSS
- Beijing InnoCare Pharma Tech Co., Ltd. portfolio CI