FDA Approves Inhaled Insulin for Children, Adolescents With Diabetes

The FDA has approved inhaled insulin (Afrezza; MannKind Corporation) for use in children ages 6 years and older living with type 1 or type 2 diabetes, marking the first needle-free insulin option for pediatric patients in more than 100 years of insulin therapy.^1,2

The approval, based on results from MannKind's phase 3 INHALE-1 (NCT04974528) clinical trial, expands the existing label for Afrezza, which has been FDA-approved for adult patients since June 27, 2014.³ For the millions of children and teenagers who manage their diabetes through multiple daily injections or insulin pump systems, the decision signals a potentially transformative new option at mealtimes.

“We measured treatment satisfaction in the individuals, so in the kids and from their parents, and the individuals on inhaled insulin had higher treatment satisfaction compared to the kids that remained on rapid-acting insulin injection,” Jamie Wood, MD, INHALE-1 principal investigator and medical director of pediatric diabetes at Rainbow Babies and Children's Hospital, said in an interview with The American Journal of Managed Care^® (AJMC^®).

A Decade In the Making

When the FDA first approved Afrezza in 2014, it became the first—and to date only—rapid-acting inhaled mealtime insulin available in the US.

“As a pediatric endocrinologist working with children, adolescents, and their families for more than 30 years, I joined the company 6 years ago to try to bring the inhaled insulin option to people in the pediatric age range,” Kevin Kaiserman, MD, vice president, MannKind, said in an interview with AJMC. “I'm very pleased that the data that we generated in the INHALE-1 study and a very extensive review by the FDA have led to now allowing the use of inhaled insulin, bringing that optionality to people in that age range to use inhaled insulin to treat their diabetes.”

The product works through MannKind's proprietary Technosphere platform: ultra-small fumaryl diketopiperazine (FDKP) particles carry a precise dose of human insulin deep into the lungs in a breath that takes just 2 seconds. Once inhaled, the insulin dissolves rapidly and enters the bloodstream within approximately 1 minute, with peak effect occurring 35 to 45 minutes after dosing and returning to baseline within roughly 1.5 to 3 hours, a profile designed to closely mirror the body's natural mealtime insulin response.

For adult patients with type 1 diabetes, Afrezza must be used in combination with a long-acting insulin. The drug is not recommended for patients who smoke or for the treatment of diabetic ketoacidosis.

What the Pediatric Trial Showed

The supplemental biologics license application (sBLA) was supported by INHALE-1, a 26-week, open-label, randomized phase 3 clinical trial that enrolled 230 children and adolescents between the ages of 4 and 17 with either type 1 or type 2 diabetes.⁴ Participants were randomized to receive either Afrezza plus basal insulin or multiple daily injections (MDI) of a rapid-acting insulin analog in combination with basal insulin.

The trial's primary end point, noninferiority in HbA1c change after 26 weeks, was met. A 26-week extension phase, in which remaining patients with MDIs were switched to Afrezza, provided an additional 52 weeks of combined safety and efficacy data supporting the application. No meaningful differences in lung function parameters were observed between the 2 treatment groups during the study period.

“When we looked at all of the data and included everybody in the trial, we did not reach that primary end point; actually, the A1c was slightly higher in the inhaled insulin group,” Wood explained. “But when we used a pre-specified analysis plan and did what's called a sensitivity analysis, and only included the children who used inhaled insulin and completed the trial, we did meet that primary outcome."

Why It Matters for Young Patients

Pediatric diabetes management presents unique challenges. Children, particularly young ones, often find daily injections distressing and difficult to tolerate consistently.⁵ Insulin pumps, while effective, are expensive, require significant caregiver involvement, and are not universally accessible. Until now, no FDA-approved needle-free insulin option has existed for patients younger than 18 years.

“Youth with type 1 and type 2 diabetes still have a lot of unmet needs, and there are still a lot of challenges managing diabetes in youth,” Wood said. “All youth with diabetes deserve choices in how they manage their diabetes, and some will manage their diabetes with multiple daily injections, some will manage it with automated insulin delivery pumps and continuous glucose monitors, and for some, those may not be the best option. They may need a different way. And so, with the approval of inhaled insulin for pediatrics, they have another choice.”

References

1. 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. News release. MannKind. May 29, 2026. Accessed May 29, 2026. https://www.globenewswire.com/news-release/2026/05/29/3303734/29517/en/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.html

2. MannKind announces US FDA accepts for review its supplemental biologics license application (sBLA) for inhaled insulin (Afrezza) in children and adolescents aged 4–17 years living with diabetes. MannKind Corporation. News release. October 13, 2025.Accessed May 22, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-us-fda-accepts-review-its-supplemental

3. MannKind Corporation announces FDA approval of Afreeza; a novel, rapid-acting inhaled insulin for the treatment of diabetes. MannKind Corporation. June 27, 2014. Accessed May 22, 20026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-corporation-announces-fda-approval-afrezzar-novel-rapid

4. Brooks A. FDA accepts inhaled insulin (Afrezza) sBLA for pediatric diabetes. HCPLive®. October 13, 2025. Accessed May 22, 2026. https://www.hcplive.com/view/fda-accepts-inhaled-insulin-afrezza-sbla-for-pediatric-diabetes

5. Streisand R, Monaghan M. Young children with type 1 diabetes: challenges, research, and future directions. Curr Diab Rep. 2014;14(9):520. doi:10.1007/s11892-014-0520-2