NITROGEN, NF (nitrogen)
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-06-23
- Routes
- INHALATION
- Dosage Forms
- GAS
Companies
NITROGEN, NF Approval History
What NITROGEN, NF Treats
14 FDA approvalsOriginally approved for its first indication in 2013 . Covers 14 distinct patient populations.
- Other (14)
Other
(14 approvals)- • Approved indication (Jun 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)
- • Approved indication (Jul 2013)
- • Approved indication (Jul 2013)
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Aug 2013)Letter
- • Approved indication (Aug 2013)Letter
- • Approved indication (Sep 2013)
- • Approved indication (Apr 2018)Letter
- • Approved indication (Aug 2018)Letter
- • Approved indication (Jun 2020)Letter
- • Approved indication (Jun 2022)Letter
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03826693 | 48077 | Ph 2 | recruiting | Efficacy of Nitrous Oxide in OCD: Pilot Study |
| NCT04378426 N2OP results posted | MHBB-009-19S I01CX001789, 53017 | Ph 2 | terminated | Nitrous Oxide for PTSD |
| NCT03079102 iNOOHCA results posted | PRO16100408 | Ph 2 | terminated | Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest |
| NCT00771342 | CTP 6 | Ph 2 | completed | Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot) |
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.
NITROGEN, NF FDA Label Details
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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