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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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Chiglitazar: First Approval.

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  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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This summary is machine-generated.

Chiglitazar, a PPAR agonist, is approved in China for type 2 diabetes management. This oral medication aids glycaemic control alongside diet and exercise, with ongoing research for non-alcoholic steatohepatitis.

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Area of Science:

  • Pharmacology and Drug Development
  • Metabolic Diseases
  • Hepatology

Background:

  • Chiglitazar is an oral, non-thiazolidinedione PPAR agonist targeting alpha, delta, and gamma receptors.
  • It is developed by Chipscreen Biosciences for type 2 diabetes (T2D) and non-alcoholic steatohepatitis (NASH).

Purpose of the Study:

  • To summarize the development milestones of chiglitazar.
  • To highlight its recent approval for type 2 diabetes treatment.

Main Methods:

  • Review of chiglitazar's development pathway.
  • Analysis of clinical development status and regulatory milestones.

Main Results:

  • Chiglitazar received approval in China in October 2021.
  • It is indicated as an adjunct to diet and exercise for glycaemic control in adult T2D patients.
  • Phase 2 clinical development for NASH is ongoing in China.

Conclusions:

  • Chiglitazar represents a significant advancement in T2D treatment.
  • Its multi-PPAR agonism offers a novel therapeutic approach.
  • Further development for NASH is anticipated.