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INHALE-1: A 26-week Primary Treatment Phase, With 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza Versus Rapid-acting Insulin Analog Injections, Both in Combination With a Basal Insulin, in Pediatric Subjects With Type 1 or Type 2 Diabetes Mellitus

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Trial Profile

INHALE-1: A 26-week Primary Treatment Phase, With 26-week Extension, Open-label, Randomized Clinical Trial Evaluating the Efficacy and Safety of Afrezza Versus Rapid-acting Insulin Analog Injections, Both in Combination With a Basal Insulin, in Pediatric Subjects With Type 1 or Type 2 Diabetes Mellitus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2025

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At a glance

  • Drugs Insulin (Primary) ; Insulin detemir (Primary) ; Insulin aspart
  • Indications Type 1 diabetes mellitus; Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Acronyms INHALE-1
  • Sponsors MannKind Corporation

Most Recent Events

  • 13 Oct 2025 According to a MannKind Corporation media release, Full results will be shared at the International Society for Pediatric and Adolescent Diabetes (ISPAD) in early November.
  • 13 Oct 2025 According to a MannKind Corporation media release,based on data from this trial, the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) seeking approval for Afrezza (insulin human) Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2026.
  • 06 Aug 2025 According to a MannKind Corporation media release, topline results from the full pediatric study including the safety extension have been submitted for presentation at a medical meeting in 2H 2025

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