Overview
Nitric oxide or Nitrogen monoxide is a chemical compound with chemical formula NO. This gas is an important signaling molecule in the body of mammals including humans and is an extremely important intermediate in the chemical industry. It is also a toxic air pollutant produced by automobile engines and power plants. Nitric oxide (NO) should not be confused with nitrous oxide (N2O), a general anaesthetic, or with nitrogen dioxide (NO2) which is another poisonous air pollutant. The nitric oxide molecule is a free radical, which is relevant to understanding its high reactivity. It reacts with the ozone in air to form nitrogen dioxide, signalled by the appearance of the reddish-brown color.
Indication
For the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure
Associated Conditions
- Hypoxic Respiratory Failure
Research Report
Nitric Oxide (DB00435): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Therapeutic Frontiers
Executive Summary
Nitric Oxide (NO), a simple diatomic molecule, occupies a unique and paradoxical position in medicine. It is simultaneously a fundamental endogenous signaling molecule essential for vascular homeostasis and a high-risk therapeutic gas requiring complex administration and monitoring. Its primary, evidence-backed clinical role is as a selective pulmonary vasodilator for the treatment of term and near-term neonates with persistent pulmonary hypertension (PPHN) and hypoxic respiratory failure (HRF). In this specific indication, inhaled nitric oxide (iNO) has demonstrably improved oxygenation and reduced the need for invasive extracorporeal membrane oxygenation (ECMO).
The therapeutic action of iNO is rooted in its ability to mimic the endogenous NO pathway, activating soluble guanylate cyclase to produce cyclic guanosine monophosphate (cGMP), which leads to smooth muscle relaxation. The genius of the therapy lies in its pulmonary selectivity; delivered via inhalation, the gas acts locally on the pulmonary vasculature and is then rapidly inactivated upon entering the bloodstream, preventing significant systemic hypotension. This elegant mechanism, however, is also the source of its primary risks. The interaction with hemoglobin that ensures its selectivity can also lead to the formation of methemoglobin, causing methemoglobinemia. Its chemical reactivity with oxygen can produce toxic nitrogen dioxide (NO2), and its role as a supplement to a physiological pathway means that abrupt withdrawal can trigger severe rebound pulmonary hypertension.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/15 | Not Applicable | Recruiting | Pedro de Figueiredo Buchalla | ||
2025/07/29 | N/A | Not yet recruiting | |||
2025/07/03 | Not Applicable | Recruiting | |||
2025/07/01 | Not Applicable | Not yet recruiting | |||
2025/03/19 | Phase 2 | Not yet recruiting | |||
2024/11/05 | N/A | Not yet recruiting | |||
2024/10/28 | N/A | Active, not recruiting | Zhongnan Hospital | ||
2024/10/16 | N/A | ENROLLING_BY_INVITATION | |||
2024/10/09 | Phase 1 | Completed | |||
2024/10/02 | Phase 4 | Recruiting | Beijing Anzhen Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
VERO BIOTECH, INC. | 72385-002 | RESPIRATORY (INHALATION) | 0.98 mg in 1 L | 12/1/2022 | |
Airgas Specialty Gases | 67989-011 | RESPIRATORY (INHALATION) | 5 mL in 1 L | 3/11/2011 | |
Airgas Therapeutics, LLC | 82605-006 | RESPIRATORY (INHALATION) | 0.8 mL in 100 L | 11/30/2023 | |
Linde Gas & Equipment Inc | 59579-102 | RESPIRATORY (INHALATION) | 800 mg in 1 L | 1/19/2023 | |
INO THERAPEUTICS LLC | 64693-002 | RESPIRATORY (INHALATION) | 0.98 mg in 1 L | 4/12/2023 | |
Linde Gas & Equipment Inc | 59579-101 | RESPIRATORY (INHALATION) | 100 mg in 1 L | 1/19/2023 | |
INO THERAPEUTICS LLC | 64693-003 | RESPIRATORY (INHALATION) | 6 mg in 1 L | 4/12/2023 | |
VERO BIOTECH, INC. | 72385-001 | RESPIRATORY (INHALATION) | 0.98 mg in 1 L | 12/19/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 8/1/2001 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
VasoKINOX nitric oxide 450 ppm mol/mol medicinal gas compressed gas cylinder | 235184 | Medicine | A | 1/16/2017 | |
INOmax nitric oxide 800 ppm medicinal gas for inhalation cylinder | 128136 | Medicine | A | 11/22/2007 | |
BOC NITRIC OXIDE 1000ppm medicinal gas cylinder | 59602 | Medicine | A | 4/11/1997 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
NOXIVENT | Praxair Canada Inc | 02451417 | Gas - Inhalation | 100 PPM / CYLR | 3/10/2016 |
INOMAX | ino therapeutics | 02270838 | Gas - Inhalation | 100 PPM / CYLR | 11/23/2005 |
NOXIVENT | Praxair Canada Inc | 02451425 | Gas - Inhalation | 800 PPM / CYLR | 3/10/2016 |
KINOX | 02451328 | Gas - Inhalation | 800 PPM / CYLR | 5/3/2016 | |
INOMAX | ino therapeutics | 02270846 | Gas - Inhalation | 800 PPM / CYLR | 11/23/2005 |
KINOX | 02451301 | Gas - Inhalation | 100 PPM / CYLR | 5/3/2016 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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