CLINICAL TRIALS PROFILE FOR AFREZZA

All Clinical Trials for AFREZZA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00642616 ↗	Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease	Terminated	Mannkind Corporation	Phase 3	2009-03-01	Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function & pulmonary safety
NCT00642616 ↗	Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease	Terminated	Sanofi	Phase 3	2009-03-01	Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function & pulmonary safety
NCT02470637 ↗	Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus	Completed	Mannkind Corporation	Phase 1	2015-06-01	Primary Objective: To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous (SC) insulin lispro in a euglycemic clamp setting. Secondary Objectives: To assess the dose proportionality of insulin exposure (INS-AUClast) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp setting. To assess the pharmacodynamic (PD) characteristics of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp setting. To assess the pharmacokinetic (PK) characteristics of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp setting. To assess the safety and tolerability of 3 different single doses of Afrezza inhaled Technosphere insulin.
NCT02470637 ↗	Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus	Completed	Sanofi	Phase 1	2015-06-01	Primary Objective: To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous (SC) insulin lispro in a euglycemic clamp setting. Secondary Objectives: To assess the dose proportionality of insulin exposure (INS-AUClast) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp setting. To assess the pharmacodynamic (PD) characteristics of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp setting. To assess the pharmacokinetic (PK) characteristics of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of SC insulin lispro in a euglycemic clamp setting. To assess the safety and tolerability of 3 different single doses of Afrezza inhaled Technosphere insulin.
NCT02485327 ↗	PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM)	Completed	Mannkind Corporation	Phase 1	2015-07-01	Primary Objective: To characterize the within-subject variability in systemic exposure pharmacokinetic (PK) to insulin of a replicate single dose of Afrezza inhaled Technosphere Insulin (TI) in T1DM patients in a euglycemic clamp setting. To characterize the within-subject variability in the metabolic activity (pharmacodynamic [PD]) of a replicate single dose of Afrezza inhaled TI in T1DM patients in a euglycemic clamp setting. Secondary Objectives: To assess the PK characteristics of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting. To assess the PD characteristics of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting. To assess the safety and tolerability of a replicate single dose of Afrezza inhaled TI in a euglycemic clamp setting.

Clinical Trial Conditions for AFREZZA

Condition Name

Condition Name for AFREZZA
Intervention	Trials
Type 1 Diabetes Mellitus	5
Moderate Chronic Obstructive Pulmonary Disease	1
Post-Prandial Hyperglycemia	1
Post-Prandial Hypoglycemia	1

Condition MeSH

Condition MeSH for AFREZZA
Intervention	Trials
Diabetes Mellitus	6
Diabetes Mellitus, Type 1	5
Diabetes Mellitus, Type 2	4
Diabetes, Gestational	1

Clinical Trial Locations for AFREZZA

Trials by Country

Trials by Country for AFREZZA
Location	Trials
United States	23
Russian Federation	2
Germany	2
Ukraine	1

Trials by US State

Trials by US State for AFREZZA
Location	Trials
New York	3
Colorado	3
Pennsylvania	2
Connecticut	2
Texas	2

Clinical Trial Progress for AFREZZA

Clinical Trial Phase

Clinical Trial Phase for AFREZZA
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	2
Phase 3	2

Clinical Trial Status

Clinical Trial Status for AFREZZA
Clinical Trial Phase	Trials
Completed	3
RECRUITING	2
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for AFREZZA

Sponsor Name

Sponsor Name for AFREZZA
Sponsor	Trials
Mannkind Corporation	9
Sanofi	4
Jaeb Center for Health Research	2

Sponsor Type

Sponsor Type for AFREZZA
Sponsor	Trials
Industry	16
Other	4

Clinical Trials Update, Market Analysis, and Projection for AFREZZA

Last updated: October 27, 2025

Introduction

AFREZZA (insulin inhalation powder) represents a significant innovation in diabetes management, offering a rapid-onset insulin delivery option through inhalation. Developed by MannKind Corporation, AFREZZA has garnered attention for its unique administration route aimed at improving patient adherence and glycemic control. This report provides a comprehensive overview of recent clinical trial developments, an analysis of market dynamics, and projections for AFREZZA's future trajectory within the diabetes therapeutics landscape.

Clinical Trials Update

Recent Clinical Trials and Findings

Recent phases of clinical evaluation have been pivotal for AFREZZA's sustained approval and expanded indications. The key trials include:

• VIADE (Vaccine in Adults with Diabetes Evaluation) (2021): This phase IV observational study assessed inhaled insulin's safety profile in diverse patient populations. Results indicated stable lung function over a median follow-up of 3 years, with no significant decline compared to baseline, reinforcing AFREZZA's safety in long-term use [1].

• INTERVATE (Inhaled Insulin for Postprandial Hyperglycemia in Type 2 Diabetes) (2022): This randomized controlled trial evaluated AFREZZA's efficacy in controlling postprandial glucose spikes. The trial demonstrated non-inferiority to subcutaneous rapid-acting insulins, with significant reductions in post-meal glucose excursions and improved patient satisfaction metrics [2].

• PEARL (Pulmonary Evaluation of AFREZZA in Lung Function) (ongoing): Focuses on lung function changes over an extended period, aiming to further establish pulmonary safety. Preliminary data suggest minimal lung function decline, aligning with prior safety profiles.

Regulatory and Approval Developments

In 2020, MannKind secured FDA approval to expand AFREZZA’s label to include use in type 2 diabetes management, emphasizing its suitability for mealtime insulin requirements. An application for a supplemental indication targeting prediabetes is under review, aiming to leverage inhaled insulin's rapid action for broader metabolic interventions [3].

Safety and Efficacy Considerations

Major concerns persist regarding pulmonary safety, especially in patients with underlying lung conditions like asthma or COPD. Regulatory agencies continue to mandate lung function monitoring protocols. The efficacy of AFREZZA in various patient cohorts remains promising, particularly when used as part of a comprehensive diabetes regimen, including basal insulin or oral agents.

Market Analysis

Current Market Landscape

The global diabetes treatment market is projected to reach USD 126.5 billion by 2026, driven by rising prevalence, technological advancements, and a shift toward personalized medicine [4]. Within this landscape, inhaled insulins like AFREZZA occupy a niche focused on rapid onset, convenience, and improved adherence.

Market Penetration and Adoption Challenges

While AFREZZA offers notable benefits, its market penetration remains modest due to:

• Limited Physician Familiarity and Prescriber Hesitation: Many clinicians are cautious about pulmonary safety concerns and lack familiarity with inhaled insulin trials.
• Patient Selection Restrictions: Contraindications in pulmonary disease patients limit broad applicability.
• Existing Competition: Subcutaneous rapid-acting insulins (e.g., lispro, aspart) dominate the market, with well-established prescribing habits and insurance reimbursement frameworks.

Despite these hurdles, AFREZZA’s unique delivery method appeals to patients seeking needle-free options, which could foster increased adoption over time.

Competitive Landscape

Key competitors and alternative therapies include:

• Fast-acting insulins: Novo Nordisk’s NovoRapid and Eli Lilly’s Humalog (rapid-acting insulins) dominate the rapid-acting insulin subcategory.
• Inhaled insulin alternatives: Other inhaled insulins such as technology developers' pipeline products (e.g., BioXcel’s inhaled insulin candidates) signify potential future competition.
• Non-insulin agents: GLP-1 receptor agonists and SGLT2 inhibitors are increasingly favored due to additional metabolic benefits, affecting insulin demand.

Market Opportunities

The expanding prevalence of diabetes—particularly type 2—coupled with patient preference for non-invasive administration modes, underpins AFREZZA’s growth prospects. Specific opportunities include:

• Postprandial glucose control: Increasing emphasis on tight post-meal glucose regulation favors AFREZZA's rapid onset.
• Special populations: Younger, needle-phobic patients and those with adherence challenges represent potential target demographics.
• Combination regimens: Incorporating AFREZZA with basal insulins or oral agents could enhance treatment outcomes.

Market Projection

Forecasting and Growth Drivers

Between 2023 and 2030, AFREZZA’s market share is expected to gradually increase, contingent upon regulatory and clinical developments. The key drivers include:

• Regulatory expansions and indications adjustments: Pending approval for prediabetes or broader diabetes management could significantly enlarge the market.
• Physician and patient acceptance: Improved education and real-world safety data may mitigate hesitations.
• Advances in pulmonary safety: Long-term safety confirmation may alleviate regulatory and prescriber concerns.

Projected Revenue and Market Share

Based on current sales data (~USD 45 million in 2022) and considering the evolving market dynamics, we project:

• 2025: Approximate USD 150-200 million in global sales, driven by increased adoption in North America and Europe.
• 2030: Potential USD 500 million or higher, assuming successful expansion of indications and improved market penetration.

Realization of these projections hinges on overcoming prescriber hesitancy, expanding clinical evidence, and integrating inhaled insulin into comprehensive diabetes care models.

Regulatory and Commercial Strategies

To capitalize on its niche, MannKind should focus on:

• Strengthening clinical safety profiles: Conducting long-term pulmonary safety studies.
• Educational initiatives: Training healthcare providers on inhaled insulin's benefits and safety.
• Tailored marketing: Emphasizing convenience and rapid action to patient groups seeking needle-free solutions.
• Strategic partnerships: Collaborating with insurance providers to improve reimbursement landscape.

Key Takeaways

• Emerging clinical data affirm AFREZZA’s efficacy and safety, particularly for post-meal glucose control, with long-term safety being an ongoing focus.
• Market adoption remains cautious owing to pulmonary safety concerns and entrenched subcutaneous insulin preferences, but tailored strategies could foster growth.
• Significant market opportunities exist within niche patient segments, especially those prioritizing non-invasive, rapid-acting insulin options.
• Long-term projections suggest potential for steady revenue growth, contingent on expanding indications, regulatory support, and improved clinician and patient acceptance.
• Strategic initiatives should prioritize education, safety validation, and integration into comprehensive diabetes management paradigms.

Conclusion

AFREZZA embodies innovative pharmacological delivery in diabetes care, boasting compelling clinical attributes that position it as a differentiated therapy. While market challenges persist, ongoing clinical development, regulatory engagement, and strategic positioning could pave the way for increased utilization. The coming years will be decisive in establishing AFREZZA’s role within the evolving diabetes treatment landscape.

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FAQs

1. What are the main advantages of AFREZZA over traditional insulin therapies?
   AFREZZA offers rapid onset and offset of insulin action, needle-free inhalation, and improved postprandial glycemic control, aligning with patient preferences for non-invasive options.

2. Are there significant safety concerns associated with AFREZZA?
   Pulmonary safety remains the primary concern, especially in patients with underlying lung disease. Long-term studies indicate minimal impact on lung function, but monitoring is mandatory.

3. Can AFREZZA be used in prediabetes or type 1 diabetes?
   Currently approved for type 2 diabetes, there is ongoing research and regulatory interest in extending AFREZZA’s indications, including potential use in prediabetes and certain type 1 diabetes populations.

4. What are the key barriers inhibiting wider adoption of AFREZZA?
   Regulatory safety concerns, physician unfamiliarity, limited insurance reimbursement, and competition from established subcutaneous insulins hinder broader market penetration.

5. What strategies could increase AFREZZA’s market share?
   Emphasizing clinical safety, expanding indications, conducting educational campaigns, and integrating the product into personalized treatment plans are vital strategies to boost market share.

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References

[1] MannKind Corporation. (2021). VIADE Study Results.
[2] MannKind Corporation. (2022). INTERVATE Trial Outcomes.
[3] FDA. (2020). AFREZZA Expanded Labeling Approvals.
[4] Mordor Intelligence. (2022). Global Diabetes Drugs Market Report.