Data updated: Sep 20, 2026
Respiratory
Approved 2026-02-02
2
Indications
--
Phase 3 Trials
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-02-02
- Routes
- INHALATION
- Dosage Forms
- GAS
AIR Approval History
Original
New Indication
New Form
Label Update
2 FDA actions from 2026 to 2026
What AIR Treats
2 FDA approvalsOriginally approved for its first indication in 2026 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05150418 | 1_08-06-2021 | Ph 1 | completed | Supplemental Oxygen in Hypovolemia |
| NCT03171142 | R/17.01.55 | Ph 3 | completed | Effect of Heliox on RSV Bronchiolitis |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
AIR FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.