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Insulin - MannKind Corporation

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Drug Profile

Insulin - MannKind Corporation

Alternative Names: Afresa®; Afrezza; Insulin human - MannKind Corporation; Insulin inhalation - MannKind Corporation; Technosphere® Insulin

Latest Information Update: 16 Oct 2025

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At a glance

  • Originator MannKind Corporation
  • Developer Cipla; MannKind Corporation
  • Class Antihyperglycaemics; Hepatoprotectants; Insulins; Pancreatic hormones
  • Mechanism of Action Ornithine decarboxylase stimulants; Phosphokinase stimulants; Protein tyrosine kinase stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Type 1 diabetes mellitus; Type 2 diabetes mellitus

Most Recent Events

  • 13 Oct 2025 FDA assigns PDUFA action date of 29/05/2026 for Insulin for Type I diabetes mellitus and Type II diabetes mellitus (In adolescents, In children) (Inhalation, Powder)
  • 13 Oct 2025 US FDA accepts sBLA for Insulin for Type I diabetes mellitus and Type II diabetes mellitus (In adolescents, In children) (Inhalation, Powder) for review
  • 06 Aug 2025 MannKind Corporation announces intention to receive acceptance decision for sBLA for Type I diabetes mellitus and Type II diabetes mellitus (In adolescents, In children) (Inhalation, Powder) in early fourth quarter of 2025

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