Nitric oxide
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1999
- First approval year
- 1999
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Nitric oxide
- Molecular weight
- 30.01
- Structure (SMILES)
These details could not be displayed.
- genosyl
- Genosyl
- inomax
- Inomax
- amidogen oxo
- Amidogen, oxo-
- inhaled nitric oxide no
- inovent
- Inovent
- nitric oxide
- Nitric oxide
- Nitric Oxide
- Nitric Oxide (NO) 20 part per million (ppm)
- NITRIC OXIDE [EMA EPAR]
- NITRIC OXIDE [EP MONOGRAPH]
- NITRIC OXIDE [HSDB]
- NITRIC OXIDE [JAN]
- NITRIC OXIDE [MART.]
- NITRIC OXIDE [MI]
- NITRIC OXIDE [ORANGE BOOK]
- NITRIC OXIDE [USAN]
- NITRIC OXIDE [VANDF]
- Nitric oxide [WHO-DD]
- nitric oxide ema epar
- nitric oxide ep monograph
- nitric oxide gel
- nitric oxide hsdb
- nitric oxide jan
- nitric oxide mart
And 19 more, listed on the interactive page.
- CAS registry numbers
- 10102-43-9
- ChEMBL ID
- CHEMBL1200689
- InChIKey
- MWUXSHHQAYIFBG-UHFFFAOYSA-N
- PubChem compound IDs
- 145068
- RxNorm IDs (RxCUI)
- 7442
- FDA ingredient codes (UNII)
- 31C4KY9ESH
- R07AX
- R07AX01
Sources for recorded values
- Applicant
- MALLINCKRODT IRELAND
- Approval date
- 23 Dec 1999
- Application number
- NDA020845
- Status
- Authorised
- Status date
- 1 Aug 2001
- Authorisation date
- 1 Aug 2001
- Approved indications
- INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants ?34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation; as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
- Product number
- EMEA/H/C/000337
- Authorisation holder
- Linde Healthcare AB
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Hypertension, Pulmonary
- Respiratory Insufficiency
European medicines record
- Patents
- 46
- Designations
- 4
- Earliest recorded loss of exclusivity
- 22 Jul 2040
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- NO
- Type
- Inorganic
Administration routes
- topical
- Mechanism
- Soluble guanylate cyclase activator
- Action type
- ACTIVATOR
- Target
- Soluble guanylate cyclase
- Protein identifier
- O75343
- Mechanism
- Soluble guanylate cyclase activator
- Action type
- ACTIVATOR
- Target
- Soluble guanylate cyclase
- Protein identifier
- P33402
- Mechanism
- Soluble guanylate cyclase activator
- Action type
- ACTIVATOR
- Target
- Soluble guanylate cyclase
- Protein identifier
- Q02108
- Mechanism
- Soluble guanylate cyclase activator
- Action type
- ACTIVATOR
- Target
- Soluble guanylate cyclase
- Protein identifier
- Q02153
Open Targets mechanisms
- Mechanism
- Soluble guanylate cyclase activator
- Action type
- ACTIVATOR
- Target
- Soluble guanylate cyclase
DrugCentral mechanisms
- Action type
- ACTIVATOR
- Gene symbol
- GUCY1B2|GUCY1A2|GUCY1A3|GUCY1B3
- Protein identifier
- O75343|P33402|Q02108|Q02153
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Heart Failure
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000373
- Subject identifier
- D006333
- Condition
- Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Respiratory Tract Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000684
- Subject identifier
- D012140
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Stroke
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000712
- Subject identifier
- D020521
- Condition
- Idiopathic Pulmonary Fibrosis
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0000768
- Subject identifier
- D054990
- Condition
- Malaria
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001068
- Subject identifier
- D008288
- Condition
- Hypertension, Pulmonary
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001361
- Subject identifier
- D006976
- Condition
- Coronary Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001645
- Subject identifier
- D003327
- Condition
- Reperfusion Injury
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002687
- Subject identifier
- D015427
- Condition
- Pneumonia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003106
- Subject identifier
- D011014
- Condition
- Lung Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003818
- Subject identifier
- D008171
- Condition
- Pulmonary Embolism
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003827
- Subject identifier
- D011655
- Condition
- Substance-Related Disorders
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003890
- Subject identifier
- D019966
- Condition
- Premature Birth
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003917
- Subject identifier
- D047928
- Condition
- Anemia
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004272
- Subject identifier
- D000740
- Condition
- Death, Sudden, Cardiac
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004278
- Subject identifier
- D016757
- Condition
- Leishmaniasis, Cutaneous
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005046
- Subject identifier
- D016773
- Condition
- Hernias, Diaphragmatic, Congenital
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005207
- Subject identifier
- D065630
- Condition
- Opioid-Related Disorders
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005611
- Subject identifier
- D009293
- Condition
- Neuralgia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005762
- Subject identifier
- D009437
- Condition
- Pressure Ulcer
- Highest recorded phase
- 1
- Condition identifier
- EFO:0007067
- Subject identifier
- D003668
- Condition
- Coronavirus Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007224
- Subject identifier
- D018352
- Condition
- Candidiasis, Oral
- Highest recorded phase
- 1
- Condition identifier
- EFO:0007406
- Subject identifier
- D002180
And 32 more, listed on the interactive page.
- Condition identifier
- EFO_0000341
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000373
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000537
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000684
- Condition identifier
- EFO_0000694
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000712
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001068
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001361
- Condition identifier
- EFO_0001645
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002687
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003106
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003818
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003827
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003890
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003917
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004272
- Condition identifier
- EFO_0004278
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005207
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005611
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005762
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006834
- Highest recorded phase
- 2
And 91 more, listed on the interactive page.
- Event
- acute chest syndrome
- Reports
- 4
- Reporting signal score
- 17.1174
- Event
- blood pressure decreased
- Reports
- 15
- Reporting signal score
- 18.1367
- Event
- cardiac arrest
- Reports
- 11
- Reporting signal score
- 14.4982
- Event
- cardio-respiratory arrest
- Reports
- 16
- Reporting signal score
- 44.1008
- Event
- cardio-respiratory arrest neonatal
- Reports
- 2
- Reporting signal score
- 11.7556
- Event
- death neonatal
- Reports
- 2
- Reporting signal score
- 10.1363
- Event
- device delivery system issue
- Reports
- 99
- Reporting signal score
- 649.85
- Event
- device physical property issue
- Reports
- 4
- Reporting signal score
- 9.99439
- Event
- device power source issue
- Reports
- 8
- Reporting signal score
- 32.7583
- Event
- device temperature issue
- Reports
- 4
- Reporting signal score
- 31.1038
- Event
- device user interface issue
- Reports
- 5
- Reporting signal score
- 40.9116
- Event
- drug level fluctuating
- Reports
- 22
- Reporting signal score
- 118.493
- Event
- exposure to toxic agent
- Reports
- 13
- Reporting signal score
- 71.6213
- Event
- heart rate decreased
- Reports
- 13
- Reporting signal score
- 21.7754
- Event
- hypoxia
- Reports
- 13
- Reporting signal score
- 18.4753
- Event
- intestinal perforation
- Reports
- 6
- Reporting signal score
- 11.8604
- Event
- intraventricular haemorrhage
- Reports
- 9
- Reporting signal score
- 34.1376
- Event
- intraventricular haemorrhage neonatal
- Reports
- 16
- Reporting signal score
- 94.5628
- Event
- methaemoglobinaemia
- Reports
- 5
- Reporting signal score
- 14.7066
- Event
- nausea
- Reports
- 5
- Reporting signal score
- 10.0974
- Event
- necrotising enterocolitis neonatal
- Reports
- 7
- Reporting signal score
- 37.3521
- Event
- neonatal disorder
- Reports
- 11
- Reporting signal score
- 43.8023
- Event
- neonatal hypotension
- Reports
- 5
- Reporting signal score
- 23.8217
- Event
- neonatal hypoxia
- Reports
- 10
- Reporting signal score
- 44.9476
- Event
- occupational exposure to product
- Reports
- 10
- Reporting signal score
- 27.0902
And 21 more, listed on the interactive page.
- NCT00000249
- NCT00000250
- NCT00000251
- NCT00000252
- NCT00005773
- NCT00016523
- NCT00814645
- NCT01165047
- NCT01725269
- NCT01891500
- NCT02652429
- NCT02725372
- NCT02734953
- NCT00041561
- NCT00152542
- NCT00014040
- NCT00159510
- NCT00608322
- NCT00240487
- NCT04305457
- NCT03473314
- NCT00023296
- NCT00094887
- NCT00142051
- NCT00352430
And 80 more, listed on the interactive page.
- Dose
- 20 ppm
- Route
- Inhalation
- How often
- Up to 14 days or until resolved
- Avoid doses greater than 20 ppm
- Do not abruptly discontinue
- Downtitrate gradually to wean
- Monitor methemoglobin, PaO2, and NO2 during administration
- Must be administered using a calibrated, FDA-cleared Nitric Oxide Delivery System
- Hydrogen bond acceptors
- 1
- Hydrogen bond donors
- 0
- Polar surface area
- 39.37
- Calculated partition coefficient (ALogP)
- -0.45
- Calculated partition coefficient (XLogP)
- 0.2
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 0
- Heavy atoms
- 2
- Molecular formula
- NO
- Monoisotopic mass
- 29.997988624
- Natural product
- Yes
- 59579-102
- 64693-002
- 64693-003
- 72385-001
- 72385-002
- 72385-003
- 72385-102
- 82605-006
- 82605-008
- Recorded assays
- 90
- Active assays
- 0
- Bronchodilator Agents
- Free Radical Scavengers
- Neurotransmitter Agents
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
Related records
Trials (174)
- 3 Part Study to Assess Inhaled Nitric Oxide on Functional Pulmonary Imaging in Subj. Pulmonary Hypertension Associated w/ COPD and IPF
- A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control
- A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis
- A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy
- A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19
- A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors
- A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts
- Cardiopulmonary Function Assessment and NO-Based Therapies for Patients With Hemolysis-Associated Pulmonary Hypertension
- Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH
- Clinical Trial for the Treatment of Diabetic Foot Ulcers Using a Nitric Oxide Releasing Patch: PATHON
- Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)
- Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
- Comparison of Vasodilator Response of Inhaled Epoprostenol and Inhaled Nitric Oxide
- Consistency of Electrical Cardiometry and Pulmonary Artery Catheter
- Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis
- Development of a New Method for Steady-State Measurement of NO Lung Diffusing Capacity in Healthy Subjects
- Diffuse Optical Monitoring With Inhaled Nitric Oxide
- Dynamic Assessment of Right Ventricular Function With Inhaled Nitric Oxide During Cardiac MRI
- Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
- Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure
Approved for (4)
- Pulmonary arterial hypertension
- Pulmonary hypertension
- Respiratory failure
- Respiratory system disorder
In development for (42)
- Acute kidney injury Phase 3
- Acute myocardial infarction Phase 2
- Acute respiratory distress syndrome Phase 3
- Anemia Phase 1
- Aspiration pneumonitis Phase 3
- Brain injury Phase 3
- Brain ischemia Phase 1
- Bronchiolitis Phase 3
- Bronchopulmonary dysplasia Phase 3
- Cancer Phase 1
- Cardiac arrest Phase 2
- Chronic obstructive pulmonary disease Phase 1
- Colorectal cancer Phase 1
- Congenital heart disease Phase 3
- Congestive heart failure Phase 2
- Coronary artery disorder Phase 2
- COVID-19 Phase 3
- Cutaneous leishmaniasis Phase 3
- Cystic fibrosis Phase 2
- Decubitus ulcer Phase 1
Other linked conditions (2)
- Hypertensive disorder
- Respiratory distress syndrome in premature infants