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Acalabrutinib (ACP-196) — Competitive Intelligence Brief
phase 3
BTK inhibitor
BTK (Bruton's tyrosine kinase)
Oncology
Small molecule
Live · refreshed every 30 min
Target snapshot
Acalabrutinib (ACP-196) (Acalabrutinib (ACP-196)) — Acerta Pharma BV. Acalabrutinib is a selective inhibitor of Bruton's tyrosine kinase (BTK) that blocks B-cell proliferation and survival signaling.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Acalabrutinib (ACP-196) TARGET | Acalabrutinib (ACP-196) | Acerta Pharma BV | phase 3 | BTK inhibitor | BTK (Bruton's tyrosine kinase) | |
| (G) BQ-L14 | (G) BQ-L14 | National Taiwan University Hospital | marketed | BTK inhibitor | BTK | |
| R-miniCHOP + Acalabrutinib | R-miniCHOP + Acalabrutinib | Universität des Saarlandes | phase 3 | Combination therapy: monoclonal antibody + chemotherapy + BTK inhibitor | CD20 (rituximab component); Bruton tyrosine kinase / BTK (acalabrutinib component) | |
| Ibrutinib combined with As2O3 | Ibrutinib combined with As2O3 | Peking University People's Hospital | phase 3 | BTK inhibitor combined with arsenic compound | BTK (Bruton's tyrosine kinase); As2O3 has multiple targets including PML-RARA fusion protein and mitochondrial pathways | |
| V0034CR01B | V0034CR01B | Pierre Fabre Medicament | phase 3 | BTK inhibitor | BTK | |
| Orelabrutinib + R-CHOP | Orelabrutinib + R-CHOP | Beijing InnoCare Pharma Tech Co., Ltd. | phase 3 | BTK inhibitor, chemotherapy regimen | Bruton's tyrosine kinase (BTK) | |
| FFI-1010 | FFI-1010 | Fuji Yakuhin Co., Ltd. | phase 3 | BTK inhibitor | BTK |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (BTK inhibitor class)
- Acerta Pharma BV · 4 drugs in this class
- AstraZeneca · 4 drugs in this class
- AbbVie · 2 drugs in this class
- Eli Lilly and Company · 1 drug in this class
- Fuji Yakuhin Co., Ltd. · 1 drug in this class
- Genzyme, a Sanofi Company · 1 drug in this class
- GlaxoSmithKline · 1 drug in this class
- Janssen Research & Development, LLC · 1 drug in this class
- National Taiwan University Hospital · 1 drug in this class
- Pfizer · 1 drug in this class
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Cite this brief
Drug Landscape (2026). Acalabrutinib (ACP-196) — Competitive Intelligence Brief. https://druglandscape.com/ci/acalabrutinib-acp-196. Accessed 2026-05-16.
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