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Incretins include glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which stimulate insulin secretion post-meals. In type 2 diabetes, GIP's efficacy is reduced, making GLP-1 a viable drug target. GIP originates from preproGIP.
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Dipeptidyl peptidase 4 (DPP-4) is a serine protease widely distributed in the body. It's involved in the inactivation of GLP-1 and GIP hormones, which are crucial for insulin regulation. DPP-4 inhibitors, such as sitagliptin (Januvia), saxagliptin (Onglyza), linagliptin (Tradjenta), alogliptin (Nesina), and vildagliptin (Galvus), help increase the proportion of active GLP-1, enhancing insulin secretion. These inhibitors work by competitively binding to DPP-4. This binding causes a significant...
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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients
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Lixisenatide: first global approval.

Shelley Elkinson1, Gillian M Keating

  • 1Adis R&D Insight, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand. DRU@adis.com

Drugs
|April 6, 2013
PubMed
Summary
This summary is machine-generated.

Lixisenatide, a glucagon-like peptide-1 receptor agonist, is approved for type 2 diabetes. This once-daily treatment mimics natural GLP-1 to improve glycemic control.

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Area of Science:

  • Pharmacology
  • Endocrinology
  • Metabolic Disorders

Background:

  • Lixisenatide is a selective, once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist developed for type 2 diabetes mellitus.
  • It mimics the endogenous hormone GLP-1, which regulates glucose metabolism by stimulating insulin secretion and suppressing glucagon production.
  • Native GLP-1 also plays a role in slowing gastric emptying, contributing to postprandial glucose control.

Purpose of the Study:

  • To summarize the key milestones in the development of lixisenatide.
  • To highlight the regulatory journey leading to its first approval for type 2 diabetes treatment.

Main Methods:

  • Review of developmental milestones.
  • Summary of regulatory submissions and approvals.

Main Results:

  • Lixisenatide has received approval in the EU, Iceland, Liechtenstein, Norway, and Mexico for treating type 2 diabetes.
  • The drug is currently under regulatory review in several other countries, including the USA, Canada, and Japan.

Conclusions:

  • Lixisenatide represents a significant advancement in the treatment of type 2 diabetes.
  • Its development and approval mark a milestone in the therapeutic options available for managing this chronic condition.