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Placebo, MK-0431/ONO-5435 — Competitive Intelligence Brief

Placebo, MK-0431/ONO-5435 (Placebo, MK-0431/ONO-5435) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: DPP-4 inhibitor. Area: Diabetes.

phase 3 DPP-4 inhibitor DPP-4 (Dipeptidyl peptidase-4) Diabetes Small molecule Live · refreshed every 30 min

Target snapshot

Placebo, MK-0431/ONO-5435 (Placebo, MK-0431/ONO-5435) — Ono Pharmaceutical Co. Ltd. MK-0431/ONO-5435 is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases incretin hormone levels to improve blood glucose control in type 2 diabetes.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Placebo, MK-0431/ONO-5435 TARGET Placebo, MK-0431/ONO-5435 Ono Pharmaceutical Co. Ltd phase 3 DPP-4 inhibitor DPP-4 (Dipeptidyl peptidase-4)
Metformin and Saxagliptin Metformin and Saxagliptin ikfe-CRO GmbH marketed Biguanide + DPP-4 inhibitor combination Metformin: mitochondrial glycerophosphate dehydrogenase; Saxagliptin: DPP-4 (dipeptidyl peptidase-4)
MET + Vildagliptin Group MET + Vildagliptin Group Hospital de Clinicas de Porto Alegre marketed Combination antidiabetic agent (biguanide + DPP-4 inhibitor) Metformin: mitochondrial glycerophosphate dehydrogenase; Vildagliptin: DPP-4 (dipeptidyl peptidase-4)
Januvia (sitagliptin) Januvia (sitagliptin) Zealand University Hospital marketed DPP-4 inhibitor DPP-4 (dipeptidyl peptidase-4)
Dapagliflozin/Sitagliptin Dapagliflozin/Sitagliptin Boryung Pharmaceutical Co., Ltd marketed SGLT2 inhibitor / DPP-4 inhibitor combination SGLT2 (sodium-glucose cotransporter 2) and DPP-4 (dipeptidyl peptidase-4)
alogliptin + pioglitazone alogliptin + pioglitazone Kun-Ho Yoon marketed DPP-4 inhibitor + thiazolidinedione DPP-4 and PPAR-γ
SGLT2i+Metformin+Cofrogliptin SGLT2i+Metformin+Cofrogliptin Huazhong University of Science and Technology marketed SGLT2 inhibitor + Biguanide + DPP-4 inhibitor (fixed-dose combination) SGLT2, mitochondrial complex I, DPP-4

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 (DPP-4 inhibitor class)

  1. Merck Sharp & Dohme LLC · 5 drugs in this class
  2. Daewoong Pharmaceutical Co. LTD. · 4 drugs in this class
  3. AstraZeneca · 4 drugs in this class
  4. LG Life Sciences · 2 drugs in this class
  5. Tanabe Pharma Corporation · 2 drugs in this class
  6. Ain Shams University · 2 drugs in this class
  7. Ono Pharmaceutical Co. Ltd · 2 drugs in this class
  8. Cinnagen · 1 drug in this class
  9. GRADE Study Group · 1 drug in this class
  10. CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Placebo, MK-0431/ONO-5435 — Competitive Intelligence Brief. https://druglandscape.com/ci/placebo-mk-0431-ono-5435. Accessed 2026-05-16.

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