FDA
FDA clears first inhaled mealtime insulin for children with diabetes
For many pediatric patients with diabetes, the burden of multiple daily injections can undermine adherence and quality of life. A rapid-acting inhaled insulin introduces a needle-free alternative at mealtimes, potentially improving treatment acceptance and day-to-day glycemic management.
On May 29, 2026, FDA approved Afrezza (insulin human) Inhalation Powder for children and adolescents aged 6 years and older with type 1 or type 2 diabetes, making it the first and only inhaled mealtime insulin available for pediatric patients. The manufacturer said the ultra rapid-acting insulin can be administered at the start of a meal and is designed to more closely mimic the body’s natural insulin response.
More than 350,000 children and adolescents in the US live with diabetes, most of whom require lifelong insulin therapy. The approval introduces a needle-free mealtime insulin option that the company says can help address challenges related to unpredictable eating patterns, activity levels, and daily routines.
“Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary,” said Desmond Schatz, MD, professor of pediatrics at the University of Florida College of Medicine. “With its rapid onset and dosing at the start of a meal, Afrezza may help clinicians better match insulin therapy to how children and families live day to day, while offering a needle-free mealtime option.”
The approval was supported by findings from the phase 3 INHALE-1 trial, which randomized 230 patients aged 4 to 17 years with diabetes to inhaled Technosphere insulin or rapid-acting analog insulin for 26 weeks while continuing basal insulin therapy. Investigators found no significant differences between groups in continuous glucose monitoring time in range or pulmonary function. Although the study didn’t meet its prespecified noninferiority criterion for HbA1c reduction, inhaled insulin was associated with significantly greater treatment satisfaction and less weight gain and BMI increase compared with injected rapid-acting insulin. Severe hypoglycemia rates were low in both groups. Researchers concluded that inhaled insulin demonstrated an acceptable safety profile and may be an appropriate treatment option for selected pediatric patients with type 1 diabetes.
Sources:
MannKind Corp. (2026, May 29). Press release. MannKind Announces FDA Approval of Afrezza®, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabetes
Bode BW, et al. (2025, November 12). Diabetes Care. INHALE-1: A Multicenter Randomized Trial of Inhaled Technosphere Insulin in Children With Type 1 Diabetes. Diabetes Care