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
Aug. 1, 2001	EMA	LINDE HEALTHCARE AB
Dec. 23, 1999	FDA	INO

FDA Adverse Event Reporting System (Female)

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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	145.05	65.27	20	1819	161	63487022
Patent ductus arteriosus	118.87	65.27	27	1812	4223	63482960
Oxygen saturation decreased	116.90	65.27	55	1784	88530	63398653
Device failure	89.64	65.27	23	1816	5988	63481195
Hypoxia	84.57	65.27	39	1800	59753	63427430
Product use issue	74.85	65.27	57	1782	220463	63266720
Pulmonary hypertensive crisis	66.12	65.27	11	1828	333	63486850

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FDA Adverse Event Reporting System (Male)

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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	195.12	63.03	84	1695	63132	34892020
No adverse event	143.53	63.03	51	1728	22876	34932276
Device delivery system issue	140.52	63.03	24	1755	477	34954675
Oxygen saturation decreased	135.15	63.03	62	1717	53756	34901396
Device issue	89.62	63.03	29	1750	9748	34945404
Off label use	80.75	63.03	102	1677	419422	34535730
Neonatal disorder	73.19	63.03	15	1764	815	34954337
Device failure	72.27	63.03	18	1761	2358	34952794
Product use in unapproved indication	69.25	63.03	53	1726	117446	34837706
Pulmonary hypertension	68.12	63.03	29	1750	20895	34934257

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FDA Adverse Event Reporting System (Geriatric)

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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	290.16	51.14	136	2286	209686	79532280
Oxygen saturation decreased	142.46	51.14	72	2350	128975	79612991
Product use in unapproved indication	138.93	51.14	89	2333	250270	79491696
Off label use	126.27	51.14	145	2277	907070	78834896
Hypoxia	89.27	51.14	49	2373	103194	79638772
Device failure	82.81	51.14	22	2400	6239	79735727
Cardiac arrest	80.19	51.14	55	2367	172041	79569925
Drug ineffective for unapproved indication	75.75	51.14	35	2387	51203	79690763
Right ventricular failure	71.95	51.14	27	2395	23470	79718496
Pulmonary hypertension	68.44	51.14	32	2390	48048	79693918

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FDA Adverse Event Reporting System (Pediatric)

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Pharmacologic Action:

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Source	Code	Description
ATC	R07AX01	RESPIRATORY SYSTEM OTHER RESPIRATORY SYSTEM PRODUCTS OTHER RESPIRATORY SYSTEM PRODUCTS Other respiratory system products
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
FDA EPC	N0000175940	Vasodilator

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

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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

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🐶 Veterinary Drug Use

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🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
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
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	GENOSYL	VERO BIOTECH INC	N202860	Dec. 20, 2019	RX	GAS	INHALATION	10124142	Aug. 18, 2025	A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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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

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External reference:

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ID	Source
NO	PDB_CHEM_ID
012088	NDDF
145068	PUBCHEM_CID
17479	MMSL
31C4KY9ESH	UNII
4021248	VUID
4021248	VANDF
405139	RXNORM
409378005	SNOMEDCT_US
47106	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Bio NO Pharm V (Helps improve metabolic disorder and immunity, Lettuce fermented powder)	HUMAN OTC DRUG LABEL	1	83202-3285	CAPSULE	100 mg	TOPICAL	unapproved drug other	6 sections
Dr. GNO All Care 200 (Brightening, Wrinckle care, and Moisturizing effect, Pain relief, Acne Treatment, Fermented Cabbage Extract)	HUMAN OTC DRUG LABEL	1	83202-5147	LIQUID	100 mg	TOPICAL	unapproved drug other	6 sections
Dr. GNO All Care 500 (Brightening, Wrinckle care, and Moisturizing effect, Pain relief, Acne Treatment, Fermented Cabbage Extract)	HUMAN OTC DRUG LABEL	1	83202-2149	LIQUID	400 mg	TOPICAL	unapproved drug other	1 sections
Dr. GNO CLEANSER (Helps cleanse sensitive skin, clears skin troubles, especially acne, fermented cabbage extract, mesoporous silica nanoparticle, zinc)	HUMAN OTC DRUG LABEL	1	83202-2139	SOAP	50 mg	TOPICAL	unapproved drug other	6 sections
Dr. GNO Deep Moisturizing Cream (Brightening, Wrinckle care, and Moisturizing effect, Acne Treatment, Fermented Cabbage Extract, Mesoporous Silica Nanoparticle, Zinc, Gold)	HUMAN OTC DRUG LABEL	1	83202-3585	LIQUID	30 mg	TOPICAL	unapproved drug other
Dr. GNO Deep Moisturizing Essence (Brightening, Wrinckle care, and Moisturizing effect, Acne Treatment, Fermented Cabbage Extract, Mesoporous Silica Nanoparticle, Zinc, Gold)	HUMAN OTC DRUG LABEL	1	83202-1583	LIQUID	40 mg	TOPICAL	unapproved drug other
Dr. GNO Deep Moisturizing Mist (Brightening, Wrinckle care, and Moisturizing effect, Acne Treatment, Fermented Cabbage Extract, Mesoporous Silica Nanoparticle, Zinc, Gold)	HUMAN OTC DRUG LABEL	1	83202-2349	LIQUID	12 mg	TOPICAL	unapproved drug other
Dr. GNO Essence (Brightening, Wrinckle care, and Moisturizing effect, Acne treatment, Fermented Lettuce Extract)	HUMAN OTC DRUG LABEL	1	83202-2922	LIQUID	10 mg	TOPICAL	unapproved drug other	6 sections
Dr. GNO Recovery Oil (Brightening, Wrinckle care, and Moisturizing effect, Acne Treatment, Fermented Cabbage Extract)	HUMAN OTC DRUG LABEL	1	83202-2952	LIQUID	8 mg	TOPICAL	unapproved drug other	6 sections
Dr. GNO Refreshing Mist (For skin care, and dry skin, safe to use it in the eye, Acne treatment, Fermented Sunflower seed Extract)	HUMAN OTC DRUG LABEL	1	83202-1857	LIQUID	50 mg	TOPICAL	unapproved drug other	6 sections

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