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MK-0431/ONO-5435 — Competitive Intelligence Brief

MK-0431/ONO-5435 (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

MK-0431/ONO-5435 (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
MK-0431/ONO-5435 TARGET MK-0431/ONO-5435 Ono Pharmaceutical Co. Ltd phase 3 DPP-4 inhibitor DPP-4 (Dipeptidyl peptidase-4)
exenatide and sitagliptin exenatide and sitagliptin AstraZeneca marketed GLP-1 receptor agonist and DPP-4 inhibitor combination GLP-1 receptor (exenatide); DPP-4 (sitagliptin)
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
Anagliptin BID Treatment Anagliptin BID Treatment JW Pharmaceutical marketed DPP-4 inhibitor Dipeptidyl peptidase-4 (DPP-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)
Janumet, Lantus Janumet, Lantus Chinese University of Hong Kong marketed DPP-4 inhibitor + biguanide (Janumet); long-acting basal insulin (Lantus) DPP-4 enzyme, metformin (AMPK pathway), insulin receptor (Lantus)
Sitagliptin combined with metformin Sitagliptin combined with metformin Sun Yat-sen University marketed DPP-4 inhibitor combined with biguanide DPP-4 enzyme; metformin acts on multiple targets including mitochondrial complex I

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). MK-0431/ONO-5435 — Competitive Intelligence Brief. https://druglandscape.com/ci/mk-0431-ono-5435. Accessed 2026-05-17.

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