Inomax(nitric oxide)
Genosyl, INOmax (nitric oxide) is a small molecule pharmaceutical. Nitric oxide was first approved as Inomax on 1999-12-23. It is used to treat newborn respiratory distress syndrome in the USA. It has been approved in Europe to treat pulmonary hypertension and respiratory insufficiency. It is known to target potassium channel subfamily K member 17 and potassium channel subfamily K member 16.
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Commercial
Trade Name
FDA
EMA
Genosyl, Inomax (generic drugs available since 2018-10-02)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| genosyl | New Drug Application | 2023-01-11 |
| inomax | New Drug Application | 2019-02-25 |
| noxivent 102 | ANDA | 2020-10-29 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Nitric Oxide, Inomax, Mallinckrodt Hosp | |||
| 9770570 | 2036-05-03 | U-2148 | |
| 9279794 | 2034-02-19 | DP | U-1823 |
| 8291904 | 2031-01-06 | DP | U-1226 |
| 8573209 | 2031-01-06 | DP | |
| 8573210 | 2031-01-06 | DP | U-1453 |
| 8776794 | 2031-01-06 | DP | U-1226 |
| 8776795 | 2031-01-06 | DP | U-1226 |
| 9265911 | 2031-01-06 | DP | U-1824 |
| 9295802 | 2031-01-06 | DP | U-1226 |
| 9408993 | 2031-01-06 | DP | U-1824 |
| 8282966 | 2029-06-30 | U-1286 | |
| 8293284 | 2029-06-30 | U-1286 | |
| 8431163 | 2029-06-30 | U-1286 | |
| 8795741 | 2029-06-30 | U-1286 | |
| 8846112 | 2029-06-30 | U-1286 | |
| Nitric Oxide, Genosyl, Vero Biotech Inc | |||
| 10213572 | 2036-02-12 | DP | |
| 10737051 | 2035-10-20 | DP | |
| 8607785 | 2030-07-14 | DP | |
| 11103669 | 2030-06-21 | DP | |
| 11511252 | 2029-09-21 | DP | |
| 8944049 | 2029-08-13 | DP | |
| 9604028 | 2029-08-13 | U-2793 | |
| 10926054 | 2029-08-13 | DP | |
| 9701538 | 2029-01-28 | DP | |
| 7560076 | 2027-04-21 | DP | |
| 7618594 | 2026-10-17 | DP | |
| 7947227 | 2026-10-17 | U-3037 | |
| 8057742 | 2026-01-18 | U-3037 | |
| 10814092 | 2025-10-17 | U-3037 | |
| 8226916 | 2025-08-18 | U-3037 | |
| 8609028 | 2025-08-18 | U-3037 | |
| 8821801 | 2025-08-18 | DP | |
| 9522249 | 2025-08-18 | DP | |
| 9956373 | 2025-08-18 | U-3037 | |
| 10124142 | 2025-08-18 | U-3037 | |
| 11291793 | 2025-08-18 | DP | |
| 11383059 | 2025-08-18 | U-3037 | |
| 11554241 | 2025-08-18 | U-3037 | |
HCPCS
No data
Clinical
Clinical Trials
219 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 5 | 6 | 4 | 2 | 5 | 21 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | — | 2 | 14 | 17 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 4 | 2 | — | 1 | 5 | 11 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | 1 | 3 | 1 | — | 5 |
| Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | — | 2 | 2 | — | 4 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | — | 1 | — | 2 |
| Neoplasms | D009369 | C80 | 1 | — | — | 1 | — | 2 | |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | — | 1 | — | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | 1 | — | 1 |
| Diaphragmatic hernias congenital | D065630 | Q79.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | 2 | 8 | 3 | — | 2 | 13 | |
| Pulmonary arterial hypertension | D000081029 | — | 5 | 3 | — | 1 | 9 | ||
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | 1 | 4 | 5 | — | 2 | 8 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | 6 | 1 | — | — | 7 |
| Hypoxia | D000860 | R09.02 | 3 | 4 | 2 | — | 1 | 7 | |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | 3 | — | 2 | 6 |
| Sepsis | D018805 | A41.9 | 2 | — | 2 | — | 1 | 5 | |
| Bronchopulmonary dysplasia | D001997 | P27.8 | 1 | 4 | 3 | — | — | 5 | |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 2 | 3 | 2 | — | — | 5 |
| Reperfusion injury | D015427 | — | 1 | 2 | — | 2 | 4 |
Show 20 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | 1 | 4 | — | — | 2 | 6 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 1 | 4 | — | — | 1 | 5 |
| Dyspnea | D004417 | HP_0002094 | R06.0 | 2 | 3 | — | — | 2 | 5 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 2 | 4 | — | — | 1 | 5 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | 1 | 3 | — | — | 1 | 5 |
| Idiopathic pulmonary fibrosis | D054990 | J84.112 | 2 | 1 | — | — | — | 3 | |
| Coronary artery disease | D003324 | I25.1 | 2 | 2 | — | — | — | 2 | |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | 2 | 2 | — | — | — | 2 |
| Varicose ulcer | D014647 | — | 2 | — | — | — | 2 | ||
| Sars-cov-2 | D000086402 | — | 1 | — | — | 1 | 2 |
Show 39 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | — | — | — | — | 3 | ||
| Heart arrest | D006323 | EFO_0009492 | I46 | 1 | — | — | — | — | 1 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | 1 | — | — | — | — | 1 |
| Bacteriuria | D001437 | R82.71 | 1 | — | — | — | — | 1 | |
| Pulmonary diffusing capacity | D011653 | 1 | — | — | — | — | 1 | ||
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | — | 1 |
| Hypercholesterolemia | D006937 | HP_0003124 | 1 | — | — | — | — | 1 | |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | — | — | — | 1 |
| Septic shock | D012772 | A48.3 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | — | 3 | 3 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 2 | 2 |
| Nasal polyps | D009298 | HP_0100582 | J33 | — | — | — | — | 2 | 2 |
| Pulmonary ventilation | D012123 | — | — | — | — | 1 | 1 | ||
| Bronchial hyperreactivity | D016535 | — | — | — | — | 1 | 1 | ||
| Cough | D003371 | HP_0012735 | R05 | — | — | — | — | 1 | 1 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | 1 | 1 | |
| Hiv | D006678 | O98.7 | — | — | — | — | 1 | 1 | |
| Adiposity | D050154 | — | — | — | — | 1 | 1 | ||
| Spirometry | D013147 | — | — | — | — | 1 | 1 |
Show 23 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | NITRIC OXIDE |
| INN | — |
| Description | Genosyl, Inomax, INOmax (nitric oxide) is a small molecule pharmaceutical. Nitric oxide was first approved as Genosyl on 2001-08-01. It is used to treat newborn respiratory distress syndrome in the USA. It has been approved in Europe to treat pulmonary hypertension and respiratory insufficiency. It is known to target potassium channel subfamily K member 17 and potassium channel subfamily K member 16. Inomax's patents are valid until 2036-02-12 (FDA). |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | [N]=O |
Identifiers
| PDB | — |
| CAS-ID | 10102-43-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200689 |
| ChEBI ID | 16480 |
| PubChem CID | 945 |
| DrugBank | DB00435 |
| UNII ID | — |
Target
Agency Approved
No data
Alternate
KCNK17
KCNK17
KCNK16
KCNK16
Organism
Homo sapiens
Gene name
KCNK17
Gene synonyms
TALK2, TASK4
NCBI Gene ID
Protein name
potassium channel subfamily K member 17
Protein synonyms
2P domain potassium channel Talk-2, Acid-sensitive potassium channel protein TASK-4, potassium channel, two pore domain subfamily K, member 17, TALK-2, TWIK-related acid-sensitive K(+) channel 4, TWIK-related acid-sensitive K+ 4, TWIK-related alkaline pH-activated K(+) channel 2
Uniprot ID
Mouse ortholog
Gm2048 (100039106)
—
Variants
Clinical Variant
No data
Financial
Inomax - Mallinckrodt
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Trends
PubMed Central
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Additional graphs summarizing 348,766 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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869 adverse events reported
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