Afrezza (recombinant human insulin inhalation) / MannKind - LARVOL DELTA

Experiences With Inhaled Insulin in a Real-World Sample of Adults With Type 1 Diabetes in the T1D Exchange Registry. (PubMed, Sci Diabetes Self Manag Care) - "In a real-world sample of people with T1D and LADA, current users felt that Afrezza positively impacted their daily lives. Still, barriers to access remain. Efforts to reduce financial and obtainment obstacles may support broader use of inhaled insulin."

Journal • Real-world evidence • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus

AFREZZA® (Insulin Human) Inhalation Powder: Pediatric First Approval. (PubMed, Paediatr Drugs) - "More recently (29 May 2026), AFREZZA® (insulin human) inhalation powder received its first pediatric approval in the USA to improve glycemic control in pediatric patients 6 years of age and older with diabetes mellitus. This article summarizes the milestones in the development of AFREZZA® (insulin human) inhalation powder leading to this first pediatric approval for diabetes mellitus."

Journal • Review • Diabetes • Metabolic Disorders • Pediatrics

INHALE-AIDEx: Effect of Inhaled Technosphere Insulin vs RAA Insulin on Exercise-Induced Hypoglycemia in Adults With T1D Using Automated Insulin Delivery (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Jaeb Center for Health Research | Trial completion date: May 2026 ➔ Dec 2026 | Trial primary completion date: May 2026 ➔ Oct 2026

Trial completion date • Trial primary completion date • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Inhaled Insulin: Place in Therapy. (PubMed, J Pak Med Assoc) - "It classifies its use as initiation, interchange and intensification strategies, suggests homologous (purist) and heterologous (hybrid) structured regimens, and proposes fixed, formative and flexible styles of usage. This frame work supports and simplifies the use of inhaled insulin in clinical practice.2."

Journal • Diabetes • Metabolic Disorders

Inhaled Insulin Demonstrates Earlier Completion of Total Pharmacodynamic Effect Compared with Lispro (ADA 2026) - "The objective was to analyze clamp data as cumulative percent of total PD effect by time to characterize early versus late insulin action. Clamp data from a randomized crossover study comparing inhaled Technosphere Insulin (TI) and subcutaneous insulin lispro in adults with type 1 diabetes were reviewed... PD data as cumulative percent of total effect provides a complementary view to AUC‑based summaries by making differences in the timing and completion of insulin action more apparent. TI delivered the majority of its PD effect within the first 60 minutes, consistent with its rapid onset and earlier offset. For clinicians, these data suggest that TI action is largely completed much earlier in the post‑prandial period than lispro, supporting further evaluation of whether additional dosing decisions may be made sooner with less risk for insulin stacking and subsequent hypoglycemia."

Late-breaking abstract • PK/PD data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Inhaled Technosphere Insulin (TI) Compared with Rapid-Acting Analog Insulin (RAA) in Gestational Diabetes (GDM) (ADA 2026) - "In this interim analysis of the first crossover RCT in GDM directly comparing PP glucose responses between TI vs RAA with a fixed breakfast meal, comparable effectiveness was demonstrated with a trend toward reduced glucose excursions and fewer hypoglycemic events with TI. Further investigation of a larger sample will further support safety and efficacy of TI as an alternative to RAA in GDM."

Diabetes • Gestational Diabetes • Hypoglycemia • Metabolic Disorders

Impact of the Inflation Reduction Act on Afrezza Access: A Retrospective Review of TRx Distribution from Baseline Q4 2022 to Q1 2024 (ADA 2026) - "The introduction of the IRA insulin cost cap was associated with an early increase in Afrezza utilization among Medicare Part D beneficiaries, evidenced by a rising share of Part D TRx and growing total prescription volume. From a pharmacist's perspective, the improved affordability meaningfully reduces barriers for patients needing ultra rapid‑acting mealtime insulin options. These findings support the value of policy‑driven cost reductions in expanding access to innovative insulin delivery systems such as inhaled Afrezza."

Retrospective data • Review • Metabolic Disorders

Participants Achieving HbA1c <8% in Youth Report Greater Treatment Satisfaction with Inhaled Technosphere Insulin vs. Rapid‑Acting Analogs (ADA 2026) - "In pediatric participants achieving HbA1c <8%, TI produced statistically greater increases in treatment satisfaction in teens and parents of younger participants than RAA, despite similar overall glycemic outcomes. These findings suggest TI may offer quality-of-life benefits beyond glycemic targets compared to RAA, which may be an important factor when discussing insulin options for youth."

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Inhaled Insulin Demonstrates Lower Variability and Faster Onset Compared with Subcutaneous Rapid-Acting Analogs (ADA 2026) - "Introduction and Objective: Inhaled Technosphere Insulin (TI) is an ultra rapid‑acting insulin requiring individualized titration to reach glycemic goals... TI titration over 17 weeks resulted in higher individualized U/kg dosing and may better reflect real‑world postprandial insulin needs. Across strata, TI‑low performed similarly to UC, indicating that under‑dosing TI yields comparable glycemic outcomes to standard therapies. In contrast, TI‑high demonstrated significantly improved postprandial excursions, suggesting that some individuals may require higher U/kg TI dosing for optimal meal coverage."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Inhaled Insulin Assessment of Incident Lung Cancer Risk among Adults with Type 2 Diabetes (T2D) Compared with Other Therapies for Diabetes Using Real-World Evidence (ADA 2026) - "Introduction and Objective: Technosphere Insulin (TI) is an ultra rapid-acting insulin and the only inhaled insulin currently approved by the US FDA... This interim RWE analysis did not demonstrate increased incident lung cancer proportions in TI users versus multiple other T2D cohorts."

Clinical • HEOR • Real-world • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Exploratory Evaluation of Technosphere Insulin with Automated Insulin Delivery: Impact of Total Daily Dose Algorithms (ADA 2026) - "These data demonstrated when using TI for prandial and correction dosing in conjunction with AID systems, the outcomes may vary whether the AID algorithm depends on TDD. The small sample size and exploratory design preclude inference regarding significance. Larger trials are warranted to define algorithm‑specific performance and optimize clinical implementation."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Efficacy and Safety of Inhaled Technosphere Insulin (TI) vs. Rapid-Acting Analog in Youth with HbA1c ≤9.5%: Subgroup Analysis from INHALE-1 (ADA 2026) - "Among youth with baseline HbA1c ≤9.5%, inhaled TI demonstrated comparable efficacy and safety to RAA, supporting TI as an alternative prandial insulin option for youth with diabetes. When considering therapy options, it's essential to align treatment with the patient's preferences, readiness, and goals. Their engagement and comfort with the chosen therapy may contribute to achieving successful outcomes."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Inhaled Insulin Dosing in a Randomized Trial in Adults With Type 1 Diabetes. (PubMed, AACE Endocrinol Diabetes) - "Technosphere insulin (TI) is an ultrarapid-acting inhaled insulin available in 4, 8, and 12 U cartridges...In a multicenter, randomized trial, adults with type 1 diabetes were assigned to TI plus insulin degludec or usual care...Most participants who initiated TI at a higher conversion dose still required additional TI uptitration for glucose management. This study highlights the need for higher TI unit dosing requirements in clinical practice to support individualized titration to reach glycemic goals."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Efficacy and Safety of Inhalational Insulin Compared With Rapid-Acting Insulin Analogs: A Systematic Review and Meta-Analysis. (PubMed, Clin Ther) - "TI provides comparable glycaemic control to RAIA, with no evidence of superior efficacy in HbA1c reduction. Therefore, the clinical value of inhaled insulin may depend less on glycaemic control and more on its role as a patient-preferred, noninvasive alternative offering a distinct risk-benefit balance, potentially enhancing adherence and quality of life in selected individuals. Limitations include the small number of eligible trials and heterogenous safety outcome reporting. Future research should prioritize long-term pulmonary safety."

Journal • Retrospective data • Review • Cough • Diabetes • Hypoglycemia • Metabolic Disorders • Respiratory Diseases • Type 2 Diabetes Mellitus

Afrezza (insulin human) Inhalation Powder generated $15.3 million in net sales (GlobeNewswire) - "Afrezza pediatric indication PDUFA target action date of May 29, 2026...Completed pilot phase of INHALE-1st pediatric study evaluating Afrezza for newly diagnosed type 1 diabetes."

PDUFA • Sales • Trial completion • Type 1 Diabetes Mellitus

Comparable Glycemic Risk Index (GRI) with Inhaled Insulin and Usual Care in Adults with Type 1 Diabetes (INHALE-3) (AACE 2026) - "Background The Glycemic Risk Index (GRI), a recently described single composite metric integrating continuous glucose monitoring (CGM) of hyperglycemia and hypoglycemia exposure to quantify overall glycemic risk based on clinician risk rating, was applied to outcomes from the INHALE-3 trial in adults with type 1 diabetes randomized to inhaled technosphere insulin (TI) versus continuing usual care (UC) after 17 weeks of treatment...The greater proportion of INHALE-3 TI users in zone A suggests potential benefits in reducing glycemic variability. The significant difference in the MDI/SAP"

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Mannkind Corporation | Trial primary completion date: Nov 2026 ➔ Mar 2027

Trial primary completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Inhaled Technosphere Insulin Reduces Postmeal Glucose Excursion in Youth Living with Type 1 Diabetes. (PubMed, Diabetes Technol Ther) - "In children with type 1 diabetes, the postmeal glucose excursion following a TI bolus was similar to the postmeal glucose excursion that occurs with TI in adults and significantly lower than the excursion that has been observed with RAA in adults. These findings are consistent with the known pharmacokinetic profile of TI."

Journal • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

INHALED INSULIN DOSING IN YOUTH WITH TYPE 1 DIABETES (ATTD 2026) - "Background and Aims: Inhaled Technosphere® insulin (TI) is an ultra-rapid-acting insulin approved for adults with diabetes... TI's unique delivery and pharmacokinetics result in different unit effects compared to RAA. Many patients require additional titration to meet glycemic targets. These findings provide practical guidance for clinicians initiating TI in youth."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

INHALED INSULIN USE IN PEDIATRICS – INHALE 1 STUDY (ATTD 2026) - "Abstract Body: Inhalation of Technosphere insulin (TI) has a more rapid onset of action and more rapid dissipation of effect than subcutaneous rapid acting analogue (RAA) insulin...Safety outcomes included severe hypoglycemia events, DKA events, pulmonary-related adverse events, and change in forced expiration volume in one section (FEV1). Results of the RCT and the extension phase will be presented."

Clinical • Diabetes • Metabolic Disorders • Pediatrics • Severe Hypoglycemia

INHALED INSULIN DOSING & POST-PRANDIAL GLUCOSE EXCURSIONS ACROSS MULTIPLE STUDIES (ATTD 2026) - "Background and Aims: Inhaled Technosphere® insulin (TI) is an ultra-rapid-acting insulin approved for adults with diabetes... Across diverse T1D populations, TI dosed at a higher conversion than USPI reduced 2-hour post-prandial AUC versus RAA in adults and TI AUC was similar between studies. Additionally, AUC was lower in pediatrics with TI (1808-mg·min/dL) than in adult arms (4007-mg·min/dL, average), suggesting further potential efficacy. These findings underscore the potential of optimized TI dosing to improve post-prandial glucose control—a key aspect of overall glycemic control."

Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

MOVING FORWARD WITH EXERCISE: INSULIN AND EDUCATION STRATEGIES FOR GLYCEMIC MANAGEMENT (ATTD 2026) - "In parallel, our proof-of-concept trial (INHALE-AIDEx) evaluating Technosphere insulin (TI) as an adjunct to AID aims to address the second critical need...Enabling adults with T1D to exercise safely and effectively has potential to meaningfully improve health across the lifespan. By advancing both the behavioral and physiological aspects of exercise management, this work supports a future in which people with T1D can engage fully in the activities they enjoy, equipped with tools, insights, and therapies designed to meet the dynamic challenges of real-world physical activity."

Cardiovascular • Diabetes • Hypoglycemia • Metabolic Disorders • Mood Disorders • Type 1 Diabetes Mellitus

Beyond the Needle: Reimagining Insulin Delivery and the Evolution of Inhaled Insulins. (PubMed, Cureus) - "Technosphere® insulin (Afrezza®; Mannkind Corporation, Danbury, CT, USA) is the only available inhaled insulin that has regulatory approval for the treatment of adult individuals with diabetes mellitus and has been available for more than a decade. This review article provides an overview of the pulmonary route of administration and charts the developmental journey of inhaled insulins, with a focus on Technosphere® insulin."

Journal • Review • Diabetes • Metabolic Disorders

INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Mannkind Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

Inhaled Technosphere Insulin in Children with Diabetes: The INHALE-1 Extension Study. (PubMed, Diabetes Technol Ther) - "The INHALE-1 extension phase showed no safety concerns. Although HbA1c levels deteriorated slightly during the study, in view of the safety profile and increased patient satisfaction in the RCT portion of the trial, TI may be a useful treatment option for some pediatric patients with diabetes, particularly for those who choose not to or are unable to use an AID system."

Journal • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus