TheraRadar
Data updated: May 26, 2026

NITROUS OXIDE, USP (nitrous oxide)

Trial Activity: Stable 7 active trials
Other Approved 2013-06-16
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Washington University School of Medicine conducting 3 trials (10%)
52 indications explored (Broad Platform)
→ major depressive disorder (4 trials)
→ depression (4 trials)
→ anesthesia (2 trials)
6
Indications
--
Phase 3 Trials
12
Years on Market

Details

Status
Prescription
First Approved
2013-06-16
Routes
INHALATION
Dosage Forms
GAS

Companies

NITROUS OXIDE OF CANADA MATHESON TRI-GAS INC PRAXAIR DISTRIBUTION INC AIR LIQUIDE AMERICA SPECIALITY GASES NITROUS OXIDE CORP STRATA MEDICAL INNOVATIONS
Active Ingredient: NITROUS OXIDE

NITROUS OXIDE, USP Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2013 to 2017
Mar 2017 ORIGINAL
Update · Medical Gas
FDA Letter
Jan 2017 ORIGINAL
Update
FDA Letter
Nov 2014 ORIGINAL
Update · Medical Gas
FDA Letter

What NITROUS OXIDE, USP Treats

6 FDA approvals

Originally approved for its first indication in 2013 . Covers 6 distinct patient populations.

  • Other (6)
📋

Clinical Trial Registry

27 trials
Trial Sponsor ID Phase Status Title
NCT02994433 201606120 Ph 1 recruiting NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits
NCT06498908 N20A Ph 3 withdrawn Intracervical Balloon Placement With Nitrous Oxide Administration
NCT06867068 2014-3556 Ph 1 completed Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery
NCT05895383 SANO-VAS 2023P-000328 Ph 4 recruiting Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
NCT03736538 201710183 Ph 1 enrolling by invitation Nitrous Oxide- Suicidal Ideation
NCT01581450 2011-000966-37 Ph 1 completed Hyperalgesia and Pain
NCT03826693 48077 Ph 2 recruiting Efficacy of Nitrous Oxide in OCD: Pilot Study
NCT05383495 ALICE DFS05081977 Ph 3 recruiting Anxiolysis for Laceration Repair in Children
NCT06118567 2020H0368 Ph 2 recruiting Effect of Nitrous Oxide on Aggression.
NCT03869736 438/19 Ph 2 completed Nitrous Oxide for the Treatment of Major Depressive Disorder
NCT06430489 PROTORISC DR230123 Ph 2 not yet recruiting Treatment of Suicidal Ideation in the Emergency Department Using Nitrous Oxide
NCT03879538 results posted 19-150 Ph 3 completed Nitrous Oxide for the Treatment of Complex Regional Pain Syndrome
NCT05430750 EC/05/22/2063 Ph 4 completed Global Warming Impact of Nitrous Oxide
NCT02351869 435-2013 Ph 2 terminated Nitrous Oxide as a Putative Novel Dual-Mechanism Treatment for Bipolar Disorder
NCT04378426 N2OP results posted MHBB-009-19S I01CX001789, 53017 Ph 2 terminated Nitrous Oxide for PTSD
NCT03085563 results posted 16-1909 Ph 4 completed A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department
NCT04884893 HUMANOID R18097M Ph 1 completed Effect of Nitrous Oxide on EEG
NCT03932825 18-05-04-XY-0001 Ph 2 completed Nitrous Oxide for Major Depressive Disorder
NCT02489097 ISEP NAC 08-021 Enigma II nested NCT00430989 Ph 4 terminated International Substudy Enigma2 on Postoperative Cognitive Disorders
NCT03375294 tN2O results posted 41822 Ph 2 completed Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
NCT03513757 results posted CHW 959242-5 Ph 4 completed Dexmedetomidine and Propofol for Pediatric MRI Sedation
NCT02139540 results posted 201204023 Ph 2 completed Nitrous Oxide as Treatment for Major Depression - a Pilot Study
NCT03502915 results posted 16-1569 Ph 3 completed Nitrous Oxide for External Cephalic Version
NCT02703233 602966 Ph 4 withdrawn Effectiveness of Nitrous Oxide in the ED
NCT01735669 REMIVER REMIVER Ph 3 completed Open Randomized Controlled Trial to Evaluate the Efficacy and Safety of Remifentanil Versus Nitrous Oxide in External Cephalic Version at Term in Singleton Pregnancy in Breech Presentation
NCT00948103 PROTOTOX P050701 Ph 3 completed The Interest of the Nitrous Oxide During Intravesical Injection of Botulinum Toxin A
NCT00967694 results posted IRB00005402 Ph 4 completed Effect of Nitrous Oxide (N2O) on Intraocular Pressure in Healthy Volunteers
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

NITROUS OXIDE, USP FDA Label Details

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Data Sources

FDA Approval: NDA206014 → Label: DailyMed → Trials: ClinicalTrials.gov →

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