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Nitric Oxide

Generic Name
Nitric Oxide
Brand Names
Inomax, Kinox, Noxivent, INOmax
Drug Type
Small Molecule
Chemical Formula
NO
CAS Number
10102-43-9
Unique Ingredient Identifier
31C4KY9ESH

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

Published: Jul 18, 2025

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.

Continue reading the full research report

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.

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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