FDA Approves Updated Prescribing Information for Inhaled Insulin Powder, Including New Starting Dose Guidance

The US Food and Drug Administration (FDA) has approved an update to the prescribing information for inhaled human insulin powder (Afrezza), revising recommended starting mealtime dosing for adults transitioning from subcutaneous mealtime insulin regimens, including multiple daily injections or insulin pump therapy, according to an announcement from MannKind Corporation.

The label update, cleared January 26, 2026, introduces a revised conversion table intended to provide clearer guidance for clinicians initiating inhaled mealtime insulin in adults previously treated with injected rapid-acting insulin. The updated recommendations are based on clinical trial data demonstrating improved postprandial glycemic outcomes using the revised starting doses.

Clinical data supporting the label update

According to the company, the revised dosing guidance is supported by modeling data and in vivo results from the Dose Optimization study, as well as findings from the INHALE-3 trial. These studies showed significantly improved mealtime glycemic excursions following conversion to inhaled insulin using the newly approved dose recommendations compared with prior starting doses.

The updated conversion table provides recommended starting doses based on a patient’s current subcutaneous mealtime insulin requirements. For example, patients previously using up to 3 units of injected mealtime insulin are advised to initiate inhaled insulin at 4 units, while those using 8 units or more may start at 16 units. The guidance is intended to support a clinically appropriate and safe transition for adult patients initiating inhaled therapy.

Intended use and clinical considerations

Inhaled human insulin powder is approved to improve glycemic control in adults with diabetes mellitus and is administered at the beginning of meals using a portable inhaler. The product is characterized by a rapid onset and short duration of action, designed to more closely approximate physiologic insulin secretion in response to meals.

The prescribing information continues to emphasize important safety considerations, including contraindications in patients with chronic lung disease such as asthma or chronic obstructive pulmonary disease, due to the risk of acute bronchospasm. Baseline pulmonary assessment with spirometry is required prior to initiation, with follow-up testing recommended after 6 months of therapy and annually thereafter.

Hypoglycemia remains the most common adverse reaction associated with insulin therapy, including inhaled insulin, and changes in insulin regimens may increase the risk of hypoglycemia or hyperglycemia, according to the updated label.

Implications for clinical practice

The FDA-approved label revision is intended to assist clinicians in selecting an appropriate starting dose when transitioning adult patients from injectable mealtime insulin to inhaled therapy. By aligning dosing recommendations with clinical trial evidence, the update may help reduce postprandial glucose excursions during treatment initiation while maintaining established safety monitoring requirements.

MannKind stated that the revised guidance is expected to support appropriate initiation of therapy while reinforcing the product’s existing clinical profile.

Reference: MannKind Announces FDA Approval of Updated Afrezza® Label Providing Starting Dose Guidance when Switching from Multiple Daily Injections (MDI) or Insulin Pump Mealtime Therapy. MannKind Corporation. January 26, 2026. Accessed January 26, 2026. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-fda-approval-updated-afrezzar-label-providing