The FDA approved Afrezza (insulin human) Inhalation Powder on May 29, 2026 for children and adolescents aged 6 and older with type 1 and type 2 diabetes. This is the first and only inhaled mealtime insulin approved for pediatric patients.

More than 350,000 children and adolescents in the United States live with diabetes. The majority have type 1 diabetes and require lifelong insulin therapy: often 4 to 7 injections daily when you count mealtime and basal doses. Afrezza eliminates the needle at every meal.

How Inhaled Insulin Works

Afrezza is inhaled at the start of a meal using a small, breath-activated inhaler. It enters the lungs and is absorbed into the bloodstream, reaching peak insulin levels within 12 to 15 minutes. It's designed to cover the glucose spike that happens when you eat.

This doesn't replace basal insulin, the long-acting background dose given once or twice daily. Children using Afrezza still need their basal injection. But the three to five mealtime injections can now be replaced with an inhaler: the ones at school, at friends' houses, at restaurants.

Afrezza was originally approved for adults in 2014. This approval extends it to children 6 and older.

What the INHALE-1 Trial Showed

The approval was supported by the Phase 3 INHALE-1 trial, a 26-week study of 230 children and adolescents with diabetes. 98% had type 1 diabetes, 2% had type 2. Participants were randomized to either Afrezza or standard rapid-acting insulin injections (MDI), both combined with basal insulin.

The trial measured whether Afrezza was non-inferior to injections in controlling HbA1c levels over 26 weeks. The full intent-to-treat analysis exceeded the pre-specified non-inferiority margin due to variability from a single non-adherent patient. A modified analysis excluding that patient met the threshold, establishing non-inferiority.

Secondary findings included stable BMI in the inhaled insulin group compared to weight gain in the injection group, increased treatment satisfaction reported by both adolescents and parents of younger children, and comparable hypoglycemia rates between the two groups.

The American Diabetes Association noted that inhaled insulin was shown as a safe and effective replacement for standard-of-care in children with type 1 diabetes.

What This Means for Families

If your child is 6 or older and uses rapid-acting insulin at meals, Afrezza may be an option. Children with chronic lung conditions like asthma or COPD can't use it, and it requires baseline lung function testing. Your endocrinologist will need to assess whether it's appropriate.

The practical difference is three fewer needles per day for most children. That's fewer disruptions at school, fewer public injections, and fewer moments where the child has to stop what they're doing to manage diabetes visibly.

It's not a cure, and it's not simpler in every dimension. The inhaler requires technique training. Cartridges need to be stored properly. Families will still track blood glucose or use a CGM. But for families where the injection burden is the hardest part of daily management, this changes the equation.

What Families Can Do Now

• Talk to your child's endocrinologist about whether Afrezza is appropriate based on their diabetes type, lung function, and current regimen
• Ask about the $35 per month affordability program: eligible patients can access Afrezza for $35 or less through MannKind's patient assistance program
• Understand that this replaces mealtime insulin only. Your child will still need basal insulin via injection or pump
• Request inhaler technique training before starting, and practice with your child until they can use it independently (if age-appropriate)

The FDA's approval means Afrezza can now be prescribed to children 6 and older. Availability depends on your pharmacy, your insurance formulary, and whether your provider writes the prescription. Some families will start in the next few weeks. Others may need prior authorization or formulary review before their insurer covers it.

This is the first needle-free mealtime insulin option for children, a meaningful shift in what's possible for families managing pediatric diabetes.