FDA Approves First and Only Mealtime Inhaled Insulin for Pediatrics

The FDA approved Afrezza (insulin human) Inhalation Powder, officially expanding its indication for use in children and adolescents 6 years and older living with type 1 and type 2 diabetes.¹

This regulatory milestone establishes inhaled insulin as the first and only noninjectable mealtime insulin option for children and adolescents, providing a significant alternative for a population that has historically relied solely on subcutaneous injections or insulin pumps for their care.

“We've had many innovations when it comes to long-acting insulins. Now, we have several long actings that can be taken just once a day. We have insulin glargine and degludec, and we also have the glargine U300, which is a more concentrated form of that insulin, which allows it to last longer in the body,” Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, told Drug Topics®.² “We also have the inhaled insulin, which is actually the fastest-acting insulin of all of them and also a nice option for someone that doesn't want to inject at meal times.”

About the FDA Approval of Afrezza

The clinical significance of this approval is rooted in the unique psychological and physiological challenges faced by younger patients managing diabetes. Traditional injectable rapid-acting insulin often imposes a heavy psychological burden, including needle-related anxiety and a fear of hypoglycemia, which frequently leads to suboptimal glycemic control. Adherence often plummets during adolescence, a period where patients typically show the highest hemoglobin A_1C (HbA_1C) levels across all age groups.^3,4

Inhaled insulin addresses these barriers by offering a discreet delivery method that can be used quickly in school or social settings, reducing the social stigma and embarrassment often associated with uncovering an injection site. Furthermore, its rapid-on, rapid-off profile mirrors the body's natural insulin response and dissipates faster than injectable analogs, which significantly lowers the risk of late postprandial hypoglycemia during exercise or at bedtime.^3,4

The regulatory decision was primarily supported by results from the INHALE-1 (NCT04974528) phase 3 trial, an open-label, randomized study evaluating 230 patients between the ages of 4 and 18 years over a 26-week period. The trial met its primary end point of noninferiority to multiple daily injections of rapid-acting insulin analog as measured by the change in HbA_1C from baseline to week 26. Throughout the study, researchers observed no significant safety concerns or differences between the treatment groups regarding hypoglycemia or lung function parameters. Although the initial analysis required a modification to account for patient nonadherence, the final data confirmed that the inhaled powder performed as effectively as traditional injections in maintaining glycemic targets.⁵

The approval was also based on additional safety, efficacy, and long‑term exposure data from studies evaluating inhaled insulin over the past 2 decades of development, according to the news release.¹

The Role of the Pharmacist

From a clinical and dosing perspective, health care providers and pharmacists must guide families through a therapeutic profile that differs substantially from traditional injectable regimens. Although standard labels may suggest a conservative conversion ratio, clinical data indicates that a higher ratio is often necessary to achieve bioequivalence because cartridge units reflect powdered insulin content rather than the specific amount absorbed by the lungs. For example, studies have shown that optimized doses may require a ratio as high as 2.8 to 1 after titration.⁴

Safety remains a critical component of the updated pediatric label, as inhaled insulin is strictly contraindicated in patients with chronic lung diseases such as asthma or chronic obstructive pulmonary disease. Before initiating therapy, all pediatric patients must undergo a medical history review, physical examination, and spirometry to identify any potential underlying lung disease. Pharmacists must also educate families on strict logistical management, including the requirement that the inhaler device be replaced every 15 days and that opened blister cards be used within 3 days.^2,4

“[Insulin] is not an easy drug to give and to take. For starters, almost all insulin is injectable. We thought people hated injectables, but it turns out [that] with GLP-1s, they're more willing to do it,” Isaacs said.⁶ “With insulin, people aren't always so excited to inject. There is one form that is inhaled, so I think that's important to know, but the inhaled form is only for mealtime insulin. Insulin also can be administered through an insulin pump, and that would be fast-acting insulin.”

READ MORE: Diabetes Resource Center

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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://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-afrezzar-first-and-only-inhaled

2. MannKind announces FDA approval of updated Afrezza label providing starting dose guidance when switching from multiple daily injections (MDI) or insulin pump mealtime therapy. News release. MannKind. January 26, 2026. Accessed May 29, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-updated-afrezzar-label-providing

3. Nowosielski B, Isaacs D. Q&A: current advancements in insulin delivery for patients with diabetes. Drug Topics. July 11, 2025. Accessed May 29, 2026. https://www.drugtopics.com/view/current-advancements-in-insulin-delivery-for-patients-with-diabetes

4. Gallagher A. Inhaled insulin increases accessibility to diabetes care. Drug Topics. February 3, 2026. Accessed May 29, 2026. https://www.drugtopics.com/view/inhaled-insulin-increases-accessibility-to-diabetes-care

5. Meara K. Inhaled insulin for pediatric patients shows positive results in phase 3 trial. Drug Topics. December 18, 2024. Accessed May 29, 2026. https://www.drugtopics.com/view/inhaled-insulin-for-pediatric-patients-shows-positive-results-in-phase-3-trial

6. Nowosielski B, Isaacs D. QQ&A: the challenges, importance of insulin delivery for people with diabetes. Drug Topics. July 9, 2025. Accessed May 29, 2026. https://www.drugtopics.com/view/the-challenges-importance-of-insulin-delivery-for-people-with-diabetes