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ACP-196
ACP-196 is a BTK inhibitor Small molecule drug developed by Acerta Pharma BV. It is currently in Phase 2 development for Chronic lymphocytic leukemia. Also known as: Acalabrutinib, acalabrutinib, Acalabrutinib..
BTK inhibitor
BTK inhibitor Used for Chronic lymphocytic leukemia.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | ACP-196 |
|---|---|
| Also known as | Acalabrutinib, acalabrutinib, Acalabrutinib. |
| Sponsor | Acerta Pharma BV |
| Drug class | BTK inhibitor |
| Target | BTK |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
ACP-196 is a selective, reversible inhibitor of Bruton's tyrosine kinase (BTK), a key component in the B-cell receptor signaling complex.
Approved indications
- Chronic lymphocytic leukemia
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
Key clinical trials
- Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL) (PHASE3)
- Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE2)
- A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy (PHASE2)
- A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM) (PHASE1, PHASE2)
- A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma (PHASE2)
- An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia (PHASE2)
- Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma (PHASE1, PHASE2)
- Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE2)
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:
- ACP-196 CI brief — competitive landscape report
- ACP-196 updates RSS · CI watch RSS
- Acerta Pharma BV portfolio CI
Frequently asked questions about ACP-196
What is ACP-196?
How does ACP-196 work?
What is ACP-196 used for?
Who makes ACP-196?
Is ACP-196 also known as anything else?
What drug class is ACP-196 in?
What development phase is ACP-196 in?
What are the side effects of ACP-196?
What does ACP-196 target?
Related
- Drug class: All BTK inhibitor drugs
- Target: All drugs targeting BTK
- Manufacturer: Acerta Pharma BV — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chronic lymphocytic leukemia
- Also known as: Acalabrutinib, acalabrutinib, Acalabrutinib.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing