nitric oxide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	1948	10102-43-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: nitric oxide nitrogen oxide nitrogen monoxide INOmax	A free radical gas produced endogenously by a variety of mammalian cells, synthesized from ARGININE by NITRIC OXIDE SYNTHASE. Nitric oxide is one of the ENDOTHELIUM-DEPENDENT RELAXING FACTORS released by the vascular endothelium and mediates VASODILATION. It also inhibits platelet aggregation, induces disaggregation of aggregated platelets, and inhibits platelet adhesion to the vascular endothelium. Nitric oxide activates cytosolic GUANYLATE CYCLASE and thus elevates intracellular levels of CYCLIC GMP. It has been shown to have in vitro activity against severe acute res-piratory syndrome corona-virus (SARS-CoV-1) but evidence supporting the use of inhaled nitric oxide in COVID-19 patients is currently limited. Molecular weight: 30.01 Formula: NO CLOGP: 0.74 LIPINSKI: None HAC: 2 HDO: 0 TPSA: 34.14 ALOGS: ROTB: 0

Molecule

Description

Molfile Inchi Smiles

Synonyms:

nitric oxide
nitrogen oxide
nitrogen monoxide
INOmax

A free radical gas produced endogenously by a variety of mammalian cells, synthesized from ARGININE by NITRIC OXIDE SYNTHASE. Nitric oxide is one of the ENDOTHELIUM-DEPENDENT RELAXING FACTORS released by the vascular endothelium and mediates VASODILATION. It also inhibits platelet aggregation, induces disaggregation of aggregated platelets, and inhibits platelet adhesion to the vascular endothelium. Nitric oxide activates cytosolic GUANYLATE CYCLASE and thus elevates intracellular levels of CYCLIC GMP. It has been shown to have in vitro activity against severe acute res-piratory syndrome corona-virus (SARS-CoV-1) but evidence supporting the use of inhaled nitric oxide in COVID-19 patients is currently limited.

Molecular weight: 30.01
Formula: NO
CLOGP: 0.74
LIPINSKI: None
HAC: 2
HDO: 0
TPSA: 34.14
ALOGS:
ROTB: 0

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Dec. 23, 1999	FDA	INO

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Intraventricular haemorrhage neonatal	140.71	53.43	19	1318	143	50603644
Oxygen saturation decreased	108.87	53.43	48	1289	73200	50530587
Device failure	83.64	53.43	21	1316	5507	50598280
Patent ductus arteriosus	75.53	53.43	18	1319	3802	50599985
Product use issue	57.06	53.43	40	1297	149435	50454352
Pneumothorax	56.30	53.43	19	1318	14015	50589772

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Product use issue	141.13	59.37	62	1368	51382	29521715
Oxygen saturation decreased	109.78	59.37	50	1380	44887	29528210
Device delivery system issue	94.48	59.37	16	1414	318	29572779
No adverse event	89.15	59.37	33	1397	17445	29555652
Neonatal disorder	74.47	59.37	15	1415	788	29572309
Off label use	70.72	59.37	79	1351	300721	29272376
Device issue	68.05	59.37	22	1408	7758	29565339
Hypertrophic cardiomyopathy	67.27	59.37	14	1416	865	29572232
Device failure	65.80	59.37	16	1414	2000	29571097
Pulmonary haemorrhage	64.27	59.37	22	1408	9248	29563849
Product use in unapproved indication	64.12	59.37	44	1386	86831	29486266
Pulmonary hypertension	62.58	59.37	26	1404	18582	29554515

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Product use issue	206.26	51.81	95	1721	151620	64345296
Product use in unapproved indication	118.60	51.81	69	1747	176549	64320367
Oxygen saturation decreased	111.37	51.81	56	1760	107120	64389796
Off label use	101.22	51.81	105	1711	632701	63864215
Device failure	71.99	51.81	19	1797	5673	64491243
Right ventricular failure	68.82	51.81	25	1791	21446	64475470
Cardiac arrest	62.72	51.81	44	1772	154020	64342896
Pulmonary arterial hypertension	57.71	51.81	23	1793	25344	64471572
Pulmonary hypertension	55.04	51.81	26	1790	43113	64453803

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	R07AX01	RESPIRATORY SYSTEM OTHER RESPIRATORY SYSTEM PRODUCTS OTHER RESPIRATORY SYSTEM PRODUCTS Other respiratory system products
FDA PE	N0000009909	Vasodilation
MeSH PA	D018927	Anti-Asthmatic Agents
MeSH PA	D000975	Antioxidants
MeSH PA	D001993	Bronchodilator Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D045462	Endothelium-Dependent Relaxing Factors
MeSH PA	D016166	Free Radical Scavengers
MeSH PA	D064426	Gasotransmitters
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018373	Peripheral Nervous System Agents
MeSH PA	D019141	Respiratory System Agents
MeSH PA	D014665	Vasodilator Agents
FDA EPC	N0000175940	Vasodilator
CHEBI has role	CHEBI:25512	neurotransmitters
CHEBI has role	CHEBI:35523	bronchodilator
CHEBI has role	CHEBI:35620	vasodilator agents
CHEBI has role	CHEBI:48578	free radical scavengers
CHEBI has role	CHEBI:62488	signal molecules
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:76971	Escherichia coli metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Pulmonary hypertension	indication	70995007	DOID:6432
Persistent pulmonary hypertension of the newborn	indication	233815004	DOID:13042
Methemoglobinemia	contraindication	38959009	DOID:10783
Left heart failure	contraindication	85232009
Congenital Heart Defect Requiring Open Patent Ductus Arteriosus	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
800PPM	GENOSYL	VERO BIOTECH	N202860	Dec. 20, 2019	RX	GAS	INHALATION	10124142	Aug. 18, 2025	A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM	GENOSYL	VERO BIOTECH	N202860	Dec. 20, 2019	RX	GAS	INHALATION	8226916	Aug. 18, 2025	A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM	GENOSYL	VERO BIOTECH	N202860	Dec. 20, 2019	RX	GAS	INHALATION	8609028	Aug. 18, 2025	A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM	GENOSYL	VERO BIOTECH	N202860	Dec. 20, 2019	RX	GAS	INHALATION	9956373	Aug. 18, 2025	A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM	GENOSYL	VERO BIOTECH	N202860	Dec. 20, 2019	RX	GAS	INHALATION	10814092	Oct. 17, 2025	A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM	GENOSYL	VERO BIOTECH	N202860	Dec. 20, 2019	RX	GAS	INHALATION	8057742	Jan. 18, 2026	A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
800PPM	GENOSYL	VERO BIOTECH	N202860	Dec. 20, 2019	RX	GAS	INHALATION	7947227	Oct. 17, 2026	A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	DISCN	GAS	INHALATION	8282966	June 30, 2029	A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	DISCN	GAS	INHALATION	8293284	June 30, 2029	A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	DISCN	GAS	INHALATION	8431163	June 30, 2029	A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	DISCN	GAS	INHALATION	8795741	June 30, 2029	A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	DISCN	GAS	INHALATION	8846112	June 30, 2029	A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	8282966	June 30, 2029	A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	8293284	June 30, 2029	A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	8431163	June 30, 2029	A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	8795741	June 30, 2029	A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	8846112	June 30, 2029	A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
800PPM	GENOSYL	VERO BIOTECH	N202860	Dec. 20, 2019	RX	GAS	INHALATION	9604028	Aug. 13, 2029	A METHOD FOR DELIVERING NITRIC OXIDE TO A PATIENT WITH PULMONARY HYPERTENSION OR HYPOXIA
100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	DISCN	GAS	INHALATION	8291904	Jan. 6, 2031	A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	DISCN	GAS	INHALATION	8573210	Jan. 6, 2031	A METHOD OF TREATING HYPOXIC RESPIRATORY FAILURE BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	DISCN	GAS	INHALATION	8776794	Jan. 6, 2031	A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
100PPM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	DISCN	GAS	INHALATION	8776795	Jan. 6, 2031	A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	8291904	Jan. 6, 2031	A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	8573210	Jan. 6, 2031	A METHOD OF TREATING HYPOXIC RESPIRATORY FAILURE BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	8776794	Jan. 6, 2031	A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	8776795	Jan. 6, 2031	A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	9265911	Jan. 6, 2031	A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	9295802	Jan. 6, 2031	A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	9408993	Jan. 6, 2031	A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	9279794	Feb. 19, 2034	A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY COMPENSATING LONG-TERM SENSITIVITY DRIFT OF ELECTROCHEMICAL GAS SENSORS USED IN SYSTEMS FOR DELIVERING THERAPEUTIC NITRIC OXIDE TO A PATIENT
800PPM	INOMAX	MALLINCKRODT HOSP	N020845	Dec. 23, 1999	RX	GAS	INHALATION	9770570	May 3, 2036	A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY MEASURING AND DISPLAYING AN INDICATION OF THE CALCULATED DELIVERY CONCENTRATION OF NITIRIC OXIDE AS COMPARED TO THE DESIRED DELIVERY CONCENTRATION OF NITRIC OXIDE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Soluble guanylate cyclase	Enzyme	O75343 P33402 Q02108 Q02153	GCYB2_HUMAN GCYA2_HUMAN GCYA3_HUMAN GCYB1_HUMAN	ACTIVATOR				CHEMBL	CHEMBL

External reference:

ID	Source
31C4KY9ESH	UNII
4021248	VUID
N0000148689	NUI
D00074	KEGG_DRUG
4021248	VANDF
C0028128	UMLSCUI
CHEBI:16480	CHEBI
NO	PDB_CHEM_ID
CHEMBL1200689	ChEMBL_ID
145068	PUBCHEM_CID
DB00435	DRUGBANK_ID
D009569	MESH_DESCRIPTOR_UI
405139	RXNORM
17479	MMSL
47106	MMSL
d04508	MMSL
012088	NDDF
409378005	SNOMEDCT_US
6710000	SNOMEDCT_US
CHEMBL1234579	ChEMBL_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Noxivent 101	HUMAN PRESCRIPTION DRUG LABEL	1	59579-101	GAS	100 mg	RESPIRATORY (INHALATION)	ANDA	16 sections
Noxivent 102	HUMAN PRESCRIPTION DRUG LABEL	1	59579-102	GAS	800 mg	RESPIRATORY (INHALATION)	ANDA	16 sections
INOmax	HUMAN PRESCRIPTION DRUG LABEL	1	64693-002	GAS	0.98 mg	RESPIRATORY (INHALATION)	NDA	23 sections
Nitric Oxide Nitrogen Mix	HUMAN PRESCRIPTION DRUG LABEL	2	67989-011	GAS	5 mL	RESPIRATORY (INHALATION)	unapproved medical gas	1 sections
GENOSYL	HUMAN PRESCRIPTION DRUG LABEL	1	72385-001	GAS	0.98 mg	RESPIRATORY (INHALATION)	NDA	23 sections
NOW st	HUMAN OTC DRUG LABEL	1	80519-301	LIQUID	1.12 g	TOPICAL	unapproved drug other	12 sections