TheraRadar
Data updated: May 26, 2026

NOXIVENT (nitric oxide)

Cardiovascular Approved 2018-10-02
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Discontinued
First Approved
2018-10-02
Routes
INHALATION
Dosage Forms
GAS

Companies

VERO BIOTECH INC
Active Ingredient: NITRIC OXIDE

NOXIVENT Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2018 to 2023
Jul 2023 SUPPL
Label · Labeling
Oct 2018 ORIGINAL
Update
FDA Letter

What NOXIVENT Treats

1 FDA approvals

Originally approved for its first indication in 2018 .

  • Other (1)
📋

Clinical Trial Registry

42 trials
Trial Sponsor ID Phase Status Title
NCT04305457 NoCovid results posted NOgas mildCOVID-19 Ph 2 terminated Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19
NCT02836899 MGHK23 results posted MGH K23 K23HL128882-01 Ph 3 completed Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.
NCT06622291 2024-16-20240626 Z191100006619095, 2025AZB6001 Ph 4 completed Perioperative Nitric Oxide Prevents Acute Kidney Injury in Acute Type A Aortic Dissection Patients
NCT03748082 EndoNO Ph 2 withdrawn Effects of Nitric Oxide on the Endothelium During Hemolysis.
NCT04022161 RedOx-NO Ph 2 withdrawn Effects of Prolonged Delivery of Nitric Oxide Gas on Plasma Reduction-Oxidation Reactions in Cardiac Surgical Patients
NCT05109611 results posted COVID-NONS-04 Ph 3 terminated Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection
NCT03023449 DOMINO 824559 Ph 2 active not recruiting Diffuse Optical Monitoring With Inhaled Nitric Oxide
NCT04216927 MOD00004808 Ph 3 recruiting NO During CPB in Neonates to Reduce Risk of AKI
NCT01165047 results posted 1.0 Ph 2 completed Nitric Oxide, GeNO Nitrosyl Delivery System
NCT04181359 iNO Pro00092702 Ph 1, Ph 2 withdrawn The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in Interstitial Lung Disease.
NCT04231773 iNO Pro00092939 Ph 1, Ph 2 completed The Effect of Inhaled Nitric Oxide on Maximal Oxygen Consumption During Exercise in Hypoxia
NCT06120816 NORM-POC-01 Ph 1 completed Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis
NCT02295566 RATNO RHM CHI0548 2010-023529-39, 11/H0502/7 Ph 2 completed RATNO, Reducing Antibiotic Tolerance Using Nitric Oxide in CF - a Phase 2 Pilot Study
NCT03661385 NASO 38017 ACTRN12618000089235p Ph 3 completed Nitric Oxide During Bypass for Arterial Switch Operation
NCT05877313 HPV-Warts-01 Ph 2 completed Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts)
NCT03679312 iNO Pro00078715 Ph 1, Ph 2 completed The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in COPD
NCT05599919 GPL/CT/2021/004/III Ph 3 completed Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Mild COVID-19
NCT04163978 NOSi-CTP-02 Ph 2 completed Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)
NCT03079102 iNOOHCA results posted PRO16100408 Ph 2 terminated Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest
NCT00848731 CMC_kline_iNO1.1 Ph 1 completed Phase I Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
NCT04388683 NO-COVID-19 results posted STUDY00000554 Ph 2 terminated Inhaled Nitric Oxide for Preventing Progression in COVID-19
NCT04383002 20-5449 Ph 1 completed High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)
NCT03455218 results posted 1111115-1NO in CPB 001 Ph 2, Ph 3 completed Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation
NCT04060979 AIT_CP_BRONC_03.01 Ph 2 completed Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis
NCT04290858 NoCovid COVID19 NOgas mild Ph 2 withdrawn Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID19 Infection
NCT03527381 NephroNO NephroNO Ph 1, Ph 2 completed Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery
NCT02871011 results posted SAN-CPT-01 Ph 2 completed Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot
NCT03053388 AIT_CP_BRONC02.01 Ph 3 completed Evaluation of the Efficacy Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation to Subjects With Bronchiolitis
NCT03208764 AIT_ CP_ CFNTM_01 Ph 2 completed Inhaled Nitric Oxide for Patients With MABSC
NCT03500783 NOinCPB NOinCPB Ph 1, Ph 2 completed Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass
NCT02734953 results posted RC6167 Ph 2 completed Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH
NCT01717209 results posted 25471 Ph 4 completed Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
NCT01958944 AIT_ CP_ CF 01 Ph 1, Ph 2 completed Evaluation of the Safety and Tolerability of Inhaled Nitric Oxide to Subjects With Cystic Fibrosis
NCT01768884 AIT_CP_BRONC01.01 Ph 1, Ph 2 completed Evaluation of the Safety and Tolerability of Nitric Oxide (NO) Via Inhalation to Subjects With Bronchiolitis
NCT02217683 BloodiNO Ph 2 withdrawn Use of Inhaled Nitric Oxide to Prevent Pulmonary Hypertension Associated to Stored Blood Transfusion
NCT00585013 results posted CHECP1 Ph 1, Ph 2 completed Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass
NCT01398384 NOMI LCC2010.01 Ph 2 completed Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size
NCT00748423 INOSTA P060701 Ph 2, Ph 3 completed Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study)
NCT01503801 NO-BPD FudanU Ph 2, Ph 3 completed Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia
NCT00771368 CTP 7 Ph 1, Ph 2 terminated Reduction of Bacteria in MRSA Positive Ulcers
NCT00790608 CTP 5 EudraCT 2008-001287-36 Ph 2 terminated Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)
NCT00771342 CTP 6 Ph 2 completed Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

NOXIVENT FDA Label Details

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Data Sources

FDA Approval: ANDA207141 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.