Omarigliptin: first global approval.
Omarigliptin [Marizev(®) (Japan)] is a small-molecule dipeptidyl peptidase-4 (DPP-4) inhibitor developed by Merck for the oral treatment of type 2 diabetes (T2DM). Unlike the majority of other approved agents of its class, which are usually administered once daily, omarigliptin can be administered once weekly. Once-weekly omarigliptin has received its first global approval in this indication in Japan, for use in adults. Phase III clinical development of the product is underway in several other countries. This article summarizes the milestones in the development of omarigliptin leading to this first approval for the treatment of T2DM.
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Celeste B
CB
Burness
D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D017277:Drug Approval; D004359:Drug Therapy, Combination; D006574:Heterocyclic Compounds, 2-Ring / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D038622:Internationality; D011714:Pyrans / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*
C587539:2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006574:Heterocyclic Compounds, 2-Ring; D007004:Hypoglycemic Agents; D011714:Pyrans