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Acalabrutinib (ACP-196) — Competitive Intelligence Brief

Acalabrutinib (ACP-196) (Acalabrutinib (ACP-196)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: BTK inhibitor. Area: Oncology.

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)

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DrugGenericSponsorPhaseClassTargetApproval / 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)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (BTK inhibitor class)

  1. Acerta Pharma BV · 4 drugs in this class
  2. AstraZeneca · 4 drugs in this class
  3. AbbVie · 2 drugs in this class
  4. Eli Lilly and Company · 1 drug in this class
  5. Fuji Yakuhin Co., Ltd. · 1 drug in this class
  6. Genzyme, a Sanofi Company · 1 drug in this class
  7. GlaxoSmithKline · 1 drug in this class
  8. Janssen Research & Development, LLC · 1 drug in this class
  9. National Taiwan University Hospital · 1 drug in this class
  10. 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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