Last reviewed · How we verify
ICP-022
ICP-022 is a Bruton's tyrosine kinase (BTK) inhibitor Small molecule drug developed by Beijing InnoCare Pharma Tech Co., Ltd.. It is currently in Phase 3 development for Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL), Mantle cell lymphoma (MCL). Also known as: Orelabrutinib, orelabrutinib.
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).
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
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
Frequently asked questions about ICP-022
What is ICP-022?
How does ICP-022 work?
What is ICP-022 used for?
Who makes ICP-022?
Is ICP-022 also known as anything else?
What drug class is ICP-022 in?
What development phase is ICP-022 in?
What are the side effects of ICP-022?
What does ICP-022 target?
Related
- Drug class: All Bruton's tyrosine kinase (BTK) inhibitor drugs
- Target: All drugs targeting BTK (Bruton's tyrosine kinase)
- Manufacturer: Beijing InnoCare Pharma Tech Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chronic lymphocytic leukemia (CLL)
- Indication: Drugs for Small lymphocytic lymphoma (SLL)
- Indication: Drugs for Mantle cell lymphoma (MCL)
- Also known as: Orelabrutinib, orelabrutinib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing