AFREZZA (insulin recombinant human)
AFREZZA is a rapid-acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus. It serves as a therapeutic option for managing blood sugar levels, though it is not recommended for the treatment of diabetic ketoacidosis. Use of this medication is also not recommended in patients who smoke or who have recently stopped smoking.
How AFREZZA Works
This medication lowers blood glucose levels by stimulating peripheral glucose uptake in skeletal muscle and fat and by inhibiting hepatic glucose production. It further regulates metabolism by inhibiting lipolysis in adipocytes and inhibiting proteolysis. Additionally, the insulin enhances protein synthesis to assist in glycemic management.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-06-27
- PDUFA Date
- 2026-05-29 (3d)
- Routes
- INHALATION
- Dosage Forms
- POWDER
AFREZZA Approval History
What AFREZZA Treats
1 indicationsAFREZZA is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
AFREZZA Boxed Warning
RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (COPD) [see Warnings and Precautions ( 5.1 )]. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD [see Contraindications ( 4 )]. Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV 1 ) to identify potential lung disease in all...
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (COPD) [see Warnings and Precautions ( 5.1 )]. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD [see Contraindications ( 4 )]. Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV 1 ) to identify potential lung disease in all patients [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE See full prescribing information for complete boxed warning. Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (COPD). ( 5.1 ) AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. ( 4 ) Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV 1 ) to identify potential lung disease in all patients. ( 2.5 ), ( 5.1 )
AFREZZA Competitive Set
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Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in AFREZZA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AFREZZA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AFREZZA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04974528 INHALE-1 | MKC-TI-155 Part 2 | Ph 3 | completed | Afrezza® INHALE-1 Study in Pediatrics |
| NCT05904743 | MKC-TI-193 | Ph 4 | completed | INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes |
| NCT02527265 results posted | MKC-TI-155 Part 1 U1111-1166-5528 | Ph 2 | completed | Afrezza Safety and Pharmacokinetics Study in Pediatric Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AFREZZA FDA Label Details
Indications & Usage
FDA Label (PDF)AFREZZA is indicated for the treatment of Diabetes.
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and Chronic Obstructive Pulmonary Disease (COPD) [see Warnings and Precautions ( 5.1 )]. AFREZZA is contraindicated in patients with chronic lung dis...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment