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ONO-4059 — Competitive Intelligence Brief

ONO-4059 (ONO-4059) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: PI3K inhibitor. Area: Oncology.

phase 3 PI3K inhibitor PI3K (phosphoinositide 3-kinase) Oncology Small molecule Live · refreshed every 30 min

Target snapshot

ONO-4059 (ONO-4059) — Ono Pharmaceutical Co. Ltd. ONO-4059 is a small-molecule inhibitor of phosphoinositide 3-kinase (PI3K) 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
ONO-4059 TARGET ONO-4059 Ono Pharmaceutical Co. Ltd phase 3 PI3K inhibitor PI3K (phosphoinositide 3-kinase)
NALIRI NALIRI Cancer Institute and Hospital, Chinese Academy of Medical Sciences phase 3 PI3K inhibitor PI3K
AD-2022 AD-2022 Addpharma Inc. phase 3 PI3K inhibitor PI3K
BAY86-4980 BAY86-4980 Bayer phase 3 PI3K inhibitor PI3K (phosphoinositide 3-kinase)
AD-2281 AD-2281 Addpharma Inc. phase 3 PI3K inhibitor PI3K
AD-2021 AD-2021 Addpharma Inc. phase 3 PI3K inhibitor PI3K
1PC111 1PC111 Orient Pharma 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). ONO-4059 — Competitive Intelligence Brief. https://druglandscape.com/ci/ono-4059. Accessed 2026-05-21.

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