MannKind Targets Newly Diagnosed Youth With Afrezza: What Investors Should Watch

MannKind Corporation (MNKD) announced an update on their ongoing clinical study.

Study Overview

MannKind Corporation has launched a Phase 2 study called “INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes.” The goal is to see how safe and effective inhaled Afrezza, used with standard long-acting insulin, is for children and teens aged 10 to under 18 who are newly diagnosed with type 1 diabetes. The study also looks at how easy this treatment is to live with for both patients and parents, which is key for long-term diabetes control in a young population.

Intervention/Treatment

The treatment being tested is Afrezza, an inhaled rapid-acting insulin (Technosphere Insulin) used at mealtimes, combined with injected basal (long-acting) insulin. Afrezza is designed to control blood sugar spikes around meals while basal insulin manages background blood sugar throughout the day and night. The aim is to offer a less burdensome option than multiple daily injections, while keeping blood sugar in range.

Study Design

This is an interventional trial with one treatment group only. All participants receive Afrezza plus basal insulin; there is no comparison or placebo group. The study is open-label, meaning doctors, patients, and families all know which treatment is being used. The main purpose is treatment-focused: to see how well this combination works and how safe it is in real-world use for newly diagnosed youth.

Study Timeline

The study was first submitted on October 31, 2025, signaling the start of formal planning and regulatory review. The trial is currently listed as “Not Yet Recruiting,” so enrollment has not started. Participants will be followed for 13 weeks in the main phase, with an optional extension up to 26 weeks for those continuing Afrezza. The most recent update was posted on January 14, 2026, confirming that the protocol and planning details have been refreshed ahead of site activation.

Market Implications

For investors, this early-stage pediatric trial broadens the long-term growth story for MannKind’s Afrezza franchise. Success in newly diagnosed youth would support a wider label and stronger physician confidence, especially in a segment with high lifetime therapy value. While Phase 2 data alone will not immediately transform revenue, a positive safety and satisfaction profile could boost sentiment and support higher valuation multiples as the pipeline de-risks. This move also positions MannKind more firmly against larger diabetes players offering injection and pump-based insulin, by highlighting a differentiated inhaled option that may ease treatment burden for families. Near term, the update mainly signals execution on strategy rather than a near-term earnings driver, but it adds an incremental positive to the company’s longer-term outlook.

The study remains active in planning and setup, with the latest information available on the ClinicalTrials portal as the trial moves toward enrollment.

To learn more about MNKD’s potential, visit the MannKind Corporation drug pipeline page.