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.
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	Sanofi	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
Glucose Metabolism Disorders	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

AFREZZA (insulin human inhalation) Clinical Trials Update, Market Analysis, and Projection

Last updated: April 25, 2026

What is AFREZZA and how is it positioned clinically?

AFREZZA is an inhaled, rapid-acting insulin human product used to improve glycemic control in adults with diabetes mellitus who require prandial (mealtime) insulin. Commercial use centers on post-prandial glucose management rather than basal coverage.

Key product mechanics used in market positioning:

• Onset: rapid, designed for mealtime dosing
• Dosing pattern: pre-meal inhalation for prandial insulin needs
• Label scope (adults): mealtime glycemic control in diabetes mellitus (product and regulatory labels)
  Sources: AFREZZA U.S. prescribing information [1]

What is the clinical trial and development update for AFREZZA?

No new large, late-stage (Phase 3) AFREZZA registration trials are indicated in publicly accessible trial reporting through major registries in the way newer pipeline candidates typically show. The clinical narrative has shifted to post-approval evidence, real-world use, and comparative outcomes versus standard-of-care prandial insulin strategies.

The most actionable way the clinical evidence for AFREZZA continues to evolve in practice is through:

• Refinements in dosing protocols and titration strategies in routine care settings
• Evidence generation around glycemic outcomes, hypoglycemia rates, and patient preference for inhaled insulin versus injections
• Ongoing safety monitoring consistent with inhaled insulin risk management frameworks (notably pulmonary considerations and dosing/titration safety)

The remaining public trial footprint generally consists of smaller studies and observational analyses rather than new pivotal Phase 3 datasets that would materially change labeling. The core clinical dataset underpinning use remains anchored in the established AFREZZA program that supported approval and label expansion to use cases described in current U.S. labeling.
Sources: AFREZZA prescribing information [1]

Practical takeaway for R&D and competitive strategy: absent a fresh pivotal trial wave, AFREZZA’s clinical value proposition in the near term rests on differentiated administration and rapid prandial coverage, not on new efficacy expansions evidenced by new Phase 3 filings.

How big is AFREZZA’s market today and what demand drivers matter?

AFREZZA’s market is shaped by three forces:

1. Patient selection: inhaled insulin is a use-case fit for patients who need prandial insulin but prefer inhalation versus injection. This narrows the eligible addressable base compared with broad injectable prandial insulin penetration.
2. Competitive intensity: the prandial insulin landscape is crowded (rapid-acting analogs, newer insulin formulations, and combination strategies). AFREZZA competes for a share of prandial insulin budgets rather than owning an entirely separate category.
3. Execution risk in pulmonary tolerability and device adherence: inhaled insulin requires consistent inhalation technique and monitoring for respiratory effects per label guidance, which constrains uptake in some patient cohorts.

Demand and adoption drivers to watch (leading indicators):

• Reimbursement coverage stability and payer formulary access for inhaled insulin
• Real-world persistence and adherence to inhaled dosing vs injection burden
• Provider confidence supported by safety protocols in the label
• Uptake in insulin-naïve or intensification pathways where patients are open to non-injection routes

What does AFREZZA’s commercial trajectory likely look like in the next 5 years?

With no clearly visible new pivotal clinical expansions, AFREZZA’s near-term market outlook is primarily a function of:

• Patient penetration in existing eligible cohorts
• Competitive churn in prandial insulin prescribing
• Real-world adoption of inhaled administration among patients who are injection averse or have preference for rapid mealtime coverage

A defensible projection structure is to model AFREZZA as a category share product within rapid-acting prandial insulin, where growth depends less on label expansion and more on sustained access, adherence, and provider adoption.

Market projection framework (directional, scenario-based)

Base case (most likely):

• Modest share gains or stable share in pockets with strong preference for inhaled insulin
• Limited net growth from overall market expansion, because category substitution remains strong
• Revenue growth tracks price and incremental patient uptake, not large new trial-driven demand surges

Upside case:

• Better payer coverage and lower barriers to prescribing
• Evidence or post-marketing adoption that improves persistence
• Clinician uptake driven by practical titration protocols and patient preference outcomes

Downside case:

• Intensifying substitution by competing prandial insulins (including formulations that reduce dosing friction)
• Patient discontinuation driven by respiratory tolerability or technique variability
• Restrictive payer policies that narrow access

What competitive dynamics could reshape AFREZZA’s market?

AFREZZA competes in a crowded prandial insulin market against rapid-acting injectable insulins and alternative insulin regimens. Competitive outcomes depend on:

• How payers compare total cost of care (drug + monitoring + downstream utilization)
• How clinicians balance glycemic control targets with hypoglycemia avoidance
• How well AFREZZA’s inhaled administration meets patient preference and adherence outcomes in routine practice

In the near term, the most likely competitive shifts are incremental:

• More aggressive use of rapid-acting insulin analogs where convenience is improved through delivery devices
• Increased use of diabetes management strategies that reduce prandial insulin reliance (where appropriate), which can cap inhaled insulin growth

What regulatory and safety considerations affect commercialization?

AFREZZA’s commercial durability is tied to adherence to label safety and patient monitoring requirements. The U.S. label includes guidance on:

• Pulmonary function considerations and respiratory adverse reactions associated with inhaled insulin therapy
• Contraindications and warnings aligned with inhaled insulin risk controls
• Dosing, titration, and instructions for use intended to ensure safe and effective prandial coverage

Sources: AFREZZA prescribing information [1]

What are the actionable investment and R&D signals from the clinical and market picture?

For decision-makers, AFREZZA does not currently present the hallmark signal of an evolving clinical opportunity (no clear new Phase 3 pivot in the public record). The investment case, where pursued, is therefore more about:

• Securing and defending formulary access
• Optimizing patient selection and adherence pathways
• Building evidence around real-world persistence, tolerability, and patient preference

For competitors planning R&D strategy:

• The differentiator is administration route plus rapid prandial coverage
• The key risk to neutralize is tolerability and consistent delivery technique
• Payer decisioning will likely remain cost-and-outcomes driven rather than efficacy-only

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Key Takeaways

• AFREZZA’s near-term value proposition is stable: it targets rapid prandial insulin needs in adults who can use inhaled insulin safely.
• Clinical development appears steady rather than catalytic: the public-facing clinical story is dominated by label-backed evidence and post-approval experience rather than a new Phase 3 wave.
• Market growth depends on access and adoption: reimbursement, payer coverage, adherence, and pulmonary tolerability protocols determine whether inhaled insulin can expand beyond its current niche.
• Projection outlook favors modest movement: absent new pivotal data or label expansion, AFREZZA’s revenue trajectory is most likely to track modest share and access dynamics within prandial insulin.

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FAQs

1) Who is AFREZZA indicated for?

AFREZZA is indicated for improving glycemic control in adults with diabetes mellitus who require prandial (mealtime) insulin. [1]

2) Does AFREZZA replace basal insulin?

AFREZZA is used for prandial insulin needs. Basal insulin is handled by other insulin products or regimens as appropriate for the patient’s diabetes management plan. [1]

3) What are the main safety considerations specific to inhaled insulin?

The U.S. prescribing information emphasizes respiratory-related considerations tied to inhaled insulin use, including pulmonary effects and monitoring guidance. [1]

4) What would most likely change AFREZZA’s market trajectory?

Substantial label expansion supported by new pivotal trials, major payer coverage changes that improve access, or real-world evidence that improves persistence and tolerability would be the strongest demand shifters. [1]

5) Why does competition stay intense for AFREZZA despite its rapid action?

Because the prandial insulin market is crowded with rapid-acting injectable options and evolving diabetes management strategies, substitution pressures remain strong where payer and clinical pathways favor alternatives. [1]

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References

[1] MannKind Corporation. AFREZZA (insulin human inhalation powder) Prescribing Information. U.S. Food and Drug Administration. (Most recent version accessible via FDA label repository).