MannKind Corporation (MNKD) has enrolled the first patient in INHALE-1ST, a pediatric clinical study evaluating the early initiation of Afrezza (insulin human) Inhalation Powder in youth newly diagnosed with type 1 diabetes. The study is designed to assess the safety, efficacy, and treatment experience of starting Afrezza shortly after diagnosis in patients ages 10 to under 18 years. Investigators will evaluate clinical outcomes as well as participant and caregiver satisfaction when Afrezza is used for mealtime glucose control alongside once-daily injectable basal insulin.
The first patient was enrolled at the Barbara Davis Center for Diabetes in Aurora, Colorado, one of roughly 10 clinical sites expected to participate across the United States. The trial aims to enroll approximately 100 patients.
MannKind highlighted the potential benefit of reducing the burden of multiple daily injections for newly diagnosed youth. The company noted that Afrezza, already supported by nearly a decade of adult safety and real-world experience, may offer a needle-free alternative during the early adjustment period following diagnosis.
INHALE-1ST is a single-arm, multi-center study with a 13-week main phase, followed by an optional extension phase of up to 26 weeks for participants who continue using Afrezza with basal insulin. The primary endpoint is the percentage of CGM-monitored participants who achieve at least 70% time-in-range of 70-180 mg/dL during the 14 days before the 13-week visit.
The FDA is currently reviewing a supplemental Biologics License Application for Afrezza in children and adolescents with type 1 or type 2 diabetes. The agency's decision is expected by May 29, 2026. If approved, Afrezza would become the first needle-free insulin option for pediatric patients in more than a century of insulin therapy.
Afrezza generated $18.5 million in Q3 2025, up from $15.0 million in the prior-year quarter, representing a 23% increase, all of which reflects adult commercial use.
MNKD has traded between $3.38 and $6.51 over the past year. The stock closed Friday (February 6, 2026) trading at $5.78, up 4.90%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.