Breakthrough T1D awarded MannKind a grant to support the INHALE-1ST trial evaluating Afrezza inhaled insulin in newly diagnosed children and adolescents with type 1 diabetes.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
MannKind Corporation has secured funding from Breakthrough T1D through its Industry Discovery and Development Partnership (IDDP) program to support the ongoing INHALE-1ST clinical trial evaluating Afrezza® (insulin human) Inhalation Powder in newly diagnosed pediatric patients with type 1 diabetes (T1D).
The grant provides additional support for a study investigating whether initiating inhaled insulin soon after diagnosis can improve glycemic control and treatment experience in children and adolescents.
The announcement follows the recent U.S. FDA approval of Afrezza for children aged six years and older, expanding access to the only approved ultra rapid-acting inhaled insulin therapy.
Inhaled Insulin May Offer a New Approach for Early Diabetes Management
Type 1 diabetes is an autoimmune disease that destroys insulin-producing beta cells in the pancreas, requiring lifelong insulin replacement therapy. More than 350,000 children and adolescents in the United States live with diabetes, most of whom have T1D.
Afrezza delivers human insulin through the lungs using MannKind’s proprietary Technosphere® dry-powder delivery platform. Unlike injected mealtime insulin, Afrezza is inhaled at the start of meals and rapidly enters systemic circulation through the pulmonary route. Its pharmacokinetic profile more closely resembles the body’s natural first-phase insulin response, offering faster onset and shorter duration of action.
The therapy received its initial FDA approval for adults with diabetes in 2014 and gained pediatric approval in May 2026.
About the INHALE-1ST Study
INHALE-1ST (NCT07224321) is a single-arm, multi-center clinical study evaluating Afrezza in combination with once-daily injected basal insulin in children and adolescents aged 10 to under 18 years who were recently diagnosed with type 1 diabetes.
Participants are followed for 13 weeks during the primary study period, with an optional extension phase allowing continued treatment for up to 26 additional weeks.
The primary endpoint measures the proportion of participants achieving continuous glucose monitor (CGM) time-in-range (70–180 mg/dL) of at least 70% during the 14 days preceding the week-13 assessment. Investigators will also evaluate broader clinical outcomes alongside patient and caregiver satisfaction with mealtime glucose management.
MannKind recently completed enrollment in the pilot phase of the study, marking an important operational milestone as the program advances.
Strategic Significance Beyond Funding
The support from Breakthrough T1D extends beyond financial assistance and reflects growing interest in evaluating inhaled insulin earlier in the disease course. MannKind believes the collaboration strengthens confidence in Afrezza’s potential role among newly diagnosed pediatric patients.
Michael Castagna, PharmD, Chief Executive Officer of MannKind, said the partnership represents meaningful external validation of both Afrezza and the INHALE-1ST program. Breakthrough T1D researchers noted that reducing the daily burden of diabetes management remains a key priority and that early use of inhaled insulin could help children achieve favorable glucose control while improving treatment experience.
Regulatory Path Forward
With pilot-phase enrollment completed, MannKind will continue evaluating safety, glycemic outcomes, and patient satisfaction in the ongoing trial. Positive findings could further support the integration of inhaled insulin into pediatric diabetes management and provide clinicians with an additional option for mealtime insulin therapy soon after diagnosis.
The study may also determine whether early adoption of inhaled insulin can improve time-in-range outcomes and simplify diabetes care during a critical period following diagnosis.
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About the Writer
Samiksha Vikram Jadhav (LinkedIn) is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting.