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Ono Pharmaceutical Co. Ltd — Portfolio Competitive Intelligence Brief

Ono Pharmaceutical Co. Ltd pipeline: 2 marketed, 0 filed, 11 Phase 3, 8 Phase 2. Recent regulatory actions, upcoming PDUFA, patent timeline, top competitor overlap.

2 marketed 0 filed 11 Phase 3 8 Phase 2 15 Phase 1 Live · 30-min refresh

Portfolio leaders (marketed + Phase 3 / filed)

DrugGenericPhaseClassTargetAreaFirst approval
Sivelestat sodium hydrate Sivelestat sodium hydrate marketed
Adlumiz ANAMORELIN marketed Growth hormone secretagogue receptor type 1 Oncology
ONO-8025 (KRP-197) ONO-8025 (KRP-197) phase 3 Prostacyclin analog / IP receptor agonist Prostanoid IP receptor Cardiovascular
FOY-305 FOY-305 phase 3 Direct thrombin inhibitor Factor IIa (Thrombin) Cardiovascular
imidafenacin, KRP-197/ONO-8025 imidafenacin, KRP-197/ONO-8025 phase 3 Antimuscarinic M3 receptor Urology
Minodronic acid hydrate Minodronic acid hydrate phase 3 Bisphosphonate Farnesyl pyrophosphate synthase Bone metabolism / Osteoporosis
ONO-1101 ONO-1101 phase 3 PD-1 inhibitor PD-1 Oncology
ONO-4059 ONO-4059 phase 3 PI3K inhibitor PI3K (phosphoinositide 3-kinase) Oncology
Docetaxel/Paclitaxel Docetaxel/Paclitaxel phase 3 Taxane (microtubule-stabilizing chemotherapy) β-tubulin / microtubules Oncology
ONO-5920 ONO-5920 phase 3 Prostanoid IP receptor agonist Prostanoid IP receptor Cardiovascular
ONO-4538 ONO-4538 phase 3 PD-1 inhibitor PD-1 Oncology
MK-0431/ONO-5435 MK-0431/ONO-5435 phase 3 DPP-4 inhibitor DPP-4 (Dipeptidyl peptidase-4) Diabetes

Therapeutic area mix

Recent regulatory actions (last 90 days)

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

Upcoming PDUFA dates (next 180 days)

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

Patent timeline (forward window)

No upcoming patent expiries for this portfolio.

Competitive overlap (companies sharing drug classes)

  1. Merck Sharp & Dohme LLC · 3 shared drug classes
  2. Sanofi · 3 shared drug classes
  3. Canadian Cancer Trials Group · 2 shared drug classes
  4. Amgen · 2 shared drug classes
  5. Bayer · 2 shared drug classes
  6. CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · 2 shared drug classes
  7. Addpharma Inc. · 2 shared drug classes
  8. Ahn-Gook Pharmaceuticals Co.,Ltd · 2 shared drug classes

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Every new pipeline event for Ono Pharmaceutical Co. Ltd:

Cite this brief

Drug Landscape (2026). Ono Pharmaceutical Co. Ltd — Portfolio Competitive Intelligence Brief. https://druglandscape.com/ci/company/ono-pharmaceutical-co-ltd. Accessed 2026-06-10.

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