Data updated: May 26, 2026
OXYGEN, USP (oxygen)
Trial Activity: Stable 11 active trials
Respiratory
Approved 2013-06-16
Development Insights
Brigham and Women's Hospital conducting 4 trials (7%)
95 indications explored (Broad Platform)
→ anesthesia (3 trials)
→ laparotomy (3 trials)
→ down syndrome (2 trials)
16
Indications
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Prescription
- First Approved
- 2013-06-16
- Routes
- INHALATION
- Dosage Forms
- GAS
Companies
AIR LIQUID INDUSTRIAL US LP LINDE NORTH AMERICA INC AIR PRODUCTS AND CHEMICALS INC AIR LIQUIDE CANADA INC AIR LIQUIDE AMERICA LP PRAXAIR INC ASPEN AIR NORCO INC LINDE GAS PUERTO RICO INC AIRGAS MERCHANTS GASES LLC MATHESON TRI-GAS INC PRAXAIR CANADA INC UNIVERSAL INDUSTRIAL GASES, INC AIRGAS USA LLC CRISTAL ASU LLC AIR LIQUIDE LARGE INDUSTRIES US LP PRAXAIR MEXICO ABSOLUTE AIR, LLC
Active Ingredient: OXYGEN
Website: ↗
OXYGEN, USP Approval History
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
20 FDA actions from 2013 to 2022
Sep 2013 ORIGINAL
Update
What OXYGEN, USP Treats
16 FDA approvalsOriginally approved for its first indication in 2013 . Covers 16 distinct patient populations.
- Other (16)
Other
(16 approvals)- • Approved indication (Jun 2013)Letter
- • Approved indication (Jun 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • Approved indication (Jul 2013)Letter
- • 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 (Sep 2017)Letter
- • Approved indication (Aug 2018)Letter
- • Approved indication (Sep 2018)Letter
- • Approved indication (Jun 2020)Letter
- • Approved indication (Jun 2022)Letter
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Clinical Trial Registry
51 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05613218 REDOX-AHF | REDOX | Ph 2, Ph 3 | completed | Oxygen Targets in Acute Heart Failure With Pulmonary Congestion |
| NCT06248645 OXYTAHANE | APHP230673 | Ph 2 | completed | Oxygen as an Acute Treatment in Alternating Hemiplegia of Childhood |
| NCT07280468 EDIT OSA | STUDY00007297 IDD-2024C1-37111 | Ph 4 | recruiting | Endotype DIrected Treatment for OSA in Down Syndrome |
| NCT06498908 | N20A | Ph 3 | withdrawn | Intracervical Balloon Placement With Nitrous Oxide Administration |
| NCT05185115 TOP-ANK | RC21_0129 | Ph 3 | active not recruiting | Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study. |
| NCT04299893 O3NPIQ | 2018-156-1 PI 19/00458, 016/2019 | Ph 2, Ph 3 | recruiting | Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: RCT (O3NPIQ) |
| NCT06327373 SOPHIE | Pro00114903 | Ph 1, Ph 2 | not yet recruiting | A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia |
| NCT04216927 | MOD00004808 | Ph 3 | recruiting | NO During CPB in Neonates to Reduce Risk of AKI |
| NCT03189173 | 2017P001037 15SDG25890059, R01HL128658 | Ph 2 | completed | Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea |
| NCT06043440 DOSA | 2023P000062 | Ph 2 | recruiting | Down Syndrome Obstructive Sleep Apnea |
| NCT05052125 | 2019-002498-80 substudy | Ph 4 | terminated | Substudy of Protocol 2019-002498-80 - NCT04223050: Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation (O2flow-COPD) |
| NCT04256798 PENGUIN | RG_19-223 | Ph 3 | recruiting | Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery |
| NCT00515281 NOVA2 results posted | 15405A | Ph 2, Ph 3 | terminated | Inhaled Nitric Oxide and Neuroprotection in Premature Infants |
| NCT03841084 BLENDER | ANZIC-RC/DP001 | Ph 2 | completed | Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial |
| NCT04207593 SOPHA | 2018-11SO* | Ph 2 | completed | The Effect of Oxygen Therapy on 6MWD in PAH and CTEPH Patients With Hypoxemia |
| NCT05430620 HMPO2 | 2021/21MAI/239 | Ph 3 | recruiting | Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys |
| NCT03879538 results posted | 19-150 | Ph 3 | completed | Nitrous Oxide for the Treatment of Complex Regional Pain Syndrome |
| NCT03552627 PULSE Ox | CRI0358 | Ph 4 | active not recruiting | Perioperative UtiLisation of SupplEmental Oxygen |
| NCT03745898 results posted | U24HL140412-01_UG3 U24HL140412-01 | Ph 3 | terminated | The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea |
| NCT05505032 | 2022-05/1838 | Ph 4 | completed | Oxygen Reserve Index and Prevention of Hyperoxemia |
| NCT04378426 N2OP results posted | MHBB-009-19S I01CX001789, 53017 | Ph 2 | terminated | Nitrous Oxide for PTSD |
| NCT02468752 | DYK 14-16 | Ph 2, Ph 3 | completed | Reduction of Venous Emboli Load After Breathing Normobaric Oxygen Compared to Air |
| NCT03660657 O3Cardio | O3Cardio 2018-000201-24, 2018-000201-24 | Ph 2, Ph 3 | terminated | Ozone Therapy in Refractory Ischemic Heart Disease. |
| NCT03174002 HOT-ICU | AAUH-ICU-01 2017-000632-34 | Ph 4 | completed | Handling Oxygenation Targets in the Intensive Care Unit |
| NCT02143687 | ID 2013-0088V2A3C | Ph 4 | completed | Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Exercise Performance |
| NCT03494387 VIXIE | VIXIE2018 | Ph 4 | completed | VitamIn and oXygen Interventions and Cardiovascular Events |
| NCT02321072 O2-ICU | 2014/459 2014-003468-19 | Ph 4 | completed | Optimal Oxygenation in the Intensive Care Unit |
| NCT02562781 HYPEROXIA | ÖrebroU | Ph 3 | completed | Is Peri-operative Hyperoxemia a Risk Factor for Postoperative Complications? |
| NCT03015051 | High flow RCT | Ph 4 | terminated | High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis |
| NCT02473354 (OIRD) | Pro00060429 | Ph 1 | completed | Predictors of Opioid-Induced Respiratory Depression (OIRD) |
| NCT03268590 results posted | CON215044 FA8650-12-D6280 TO0052 | Ph 4 | completed | Neuroimaging During Pure Oxygen Breathing |
| NCT01298921 results posted | 2010-0205 | Ph 1 | terminated | A Pilot Study of Demand Valve Oxygen Inhalation Therapy for Cluster Headache |
| NCT02949531 STOP-EF | R1965 | Ph 2 | completed | Use of Oxygen in Heart Failure With Preserved Ejection Fraction |
| NCT02143609 | 2013-0088V2A3 | Ph 4 | completed | Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance |
| NCT02150590 | 2013-0088V2A3B | Ph 4 | completed | Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Breathing and Sleep |
| NCT03102827 FLOAT-CS | HDZNRW-KA_006-TB | Ph 3 | terminated | High-Flow-Therapy for the Treatment of Cheyne-Stokes-Respiration in Chronic Heart Failure |
| NCT02273830 | 20131001 | Ph 4 | completed | Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation During Exercise. |
| NCT02290080 DETO2X-bio | DETO2X-biomarkers 2012/287-12 | Ph 3 | completed | Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction by Biomarkers |
| NCT01787110 DETO2X-AMI | DETO2X-AMI 2012/287-12 | Ph 3 | completed | An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction |
| NCT02378545 HO2T or NO2T | 15/P/020 2015-000629-35 | Ph 4 | completed | Trial of Hyperoxic O2 Therapy vs. Normoxic O2 Therapy in Sepsis |
| NCT02499042 EXACT | CF14/2953-2014001634 | Ph 2 | completed | rEduction of oXygen After Cardiac arresT: a Pilot Study |
| NCT02356900 results posted | Pro00060147 | Ph 2 | terminated | Hyperbaric VO2max Study |
| NCT01542307 results posted | 2009P000380 2009P000380 | Ph 2 | completed | Normobaric Oxygen (NBO) Therapy in Acute Migraine |
| NCT01261377 | 2010-P001753 | Ph 1, Ph 2 | withdrawn | Cardiac Hemodynamics in Overlap Syndrome (COPD With Obstructive Sleep Apnea) |
| NCT01423929 SOCCER | 2011-001452-11 | Ph 4 | completed | Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion |
| NCT02424773 RESPIR-OH | K101201 | Ph 3 | completed | Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients |
| NCT02668029 | WalkO2 | Ph 2 | completed | Effect of Ambulatory Oxygen on the Walking Test in Patients With Pulmonary Fibrosis |
| NCT01722370 OM-COPD | RG-11-132 | Ph 4 | completed | Ambulatory Oxygen Effects on Muscles in COPD |
| NCT00948103 PROTOTOX | P050701 | Ph 3 | completed | The Interest of the Nitrous Oxide During Intravesical Injection of Botulinum Toxin A |
| NCT01157624 | nasalo2 | Ph 1 | completed | Application of Nasal Cannula With Oxygen Versus Air During Eye Surgery Under Local Anaesthetic |
Showing 50 of 51 trials
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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.
OXYGEN, USP 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