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Copanlisib (BAY 80-6946) — Competitive Intelligence Brief

Copanlisib (BAY 80-6946) (Copanlisib (BAY 80-6946)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: PI3K inhibitor. Area: Oncology.

phase 3 PI3K inhibitor PI3K (phosphatidylinositol 3-kinase), pan-class I Oncology Small molecule Live · refreshed every 30 min

Target snapshot

Copanlisib (BAY 80-6946) (Copanlisib (BAY 80-6946)) — Bayer. Copanlisib is a pan-class I phosphatidylinositol 3-kinase (PI3K) inhibitor that blocks PI3K signaling to suppress tumor cell proliferation and survival.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Copanlisib (BAY 80-6946) TARGET Copanlisib (BAY 80-6946) Bayer phase 3 PI3K inhibitor PI3K (phosphatidylinositol 3-kinase), pan-class I
AG20012 AG20012 Ahn-Gook Pharmaceuticals Co.,Ltd phase 3 PI3K inhibitor PI3K
Buparlisib & Paclitaxel Buparlisib & Paclitaxel Adlai Nortye Biopharma Co., Ltd. phase 3 PI3K inhibitor (buparlisib) + taxane chemotherapy (paclitaxel) PI3K (buparlisib); β-tubulin (paclitaxel)
BAY86-4980 BAY86-4980 Bayer phase 3 PI3K inhibitor PI3K (phosphoinositide 3-kinase)
PLC PLC Sigma-Tau Research, Inc. phase 3 PI3K inhibitor PI3K
D-1553 D-1553 InventisBio Co., Ltd phase 3 PI3K inhibitor PI3K
D-2570 D-2570 InventisBio Co., Ltd phase 3 PI3K inhibitor PI3K

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 (PI3K inhibitor class)

  1. Addpharma Inc. · 4 drugs in this class
  2. AstraZeneca · 3 drugs in this class
  3. Bayer · 3 drugs in this class
  4. Ahn-Gook Pharmaceuticals Co.,Ltd · 2 drugs in this class
  5. InventisBio Co., Ltd · 2 drugs in this class
  6. Orient Pharma Co., Ltd. · 2 drugs in this class
  7. Applied Biology, Inc. · 1 drug in this class
  8. Angitia Incorporated Limited · 1 drug in this class
  9. Aevi Genomic Medicine, LLC, a Cerecor company · 1 drug in this class
  10. BPGbio · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Copanlisib (BAY 80-6946) — Competitive Intelligence Brief. https://druglandscape.com/ci/copanlisib-bay-80-6946. Accessed 2026-05-16.

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