MannKind Secures Breakthrough T1D Grant for Pediatric Inhaled Insulin Trial
Event summary
- MannKind awarded a grant from Breakthrough T1D to advance the INHALE-1ST trial for Afrezza® in pediatric type 1 diabetes patients.
- The study evaluates Afrezza® combined with basal insulin in youth aged 10 to <18 years newly diagnosed with type 1 diabetes.
- INHALE-1ST is a multi-center clinical trial with primary endpoint measuring time-in-range (TIR) via continuous glucose monitoring.
- Afrezza® was recently FDA-approved for pediatric use (aged 6 and older) in May 2026.
The big picture
MannKind’s grant from Breakthrough T1D underscores growing interest in inhaled insulin as a viable alternative to traditional injection-based therapies for type 1 diabetes. The strategic focus on pediatric patients aligns with broader industry trends toward patient-centric, non-invasive treatment options. Success in this trial could position Afrezza® as a key player in the $35B+ global diabetes market, particularly in addressing unmet needs in pediatric care.
What we're watching
- Clinical Efficacy
- How Afrezza® performs in pediatric patients and whether it achieves superior time-in-range compared to traditional insulin therapies.
- Regulatory Pathway
- The pace at which MannKind can secure additional FDA approvals for expanded use of Afrezza® in younger pediatric populations.
- Market Adoption
- Whether the INHALE-1ST trial results will drive broader acceptance of inhaled insulin in pediatric diabetes care.