Inomax(nitric oxide)
Genosyl, INOmax, Noxivent, Ulspira (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
Therapeutic Areas
Trade Name
FDA
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Genosyl, Inomax (discontinued: Inomax)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nitric oxide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INOMAX | Mallinckrodt | N-020845 RX | 1999-12-23 | 2 products, RLD, RS |
| GENOSYL | Vero Biotech | N-202860 RX | 2019-12-20 | 1 products, RLD, RS |
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Labels
FDA
EMA
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| newborn respiratory distress syndrome | — | D012127 | P22 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Nitric Oxide, Genosyl, Vero Biotech Inc | |||
| 11672938 | 2040-07-22 | U-3037 | |
| 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 | |
| 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 | |
HCPCS
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Clinical
Clinical Trials
1003 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 22 | 20 | 17 | 15 | 41 | 112 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 8 | 5 | 11 | 88 | 110 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 11 | 12 | 8 | 6 | 17 | 52 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 7 | 8 | 1 | 2 | 16 | 34 |
| Inflammation | D007249 | MP_0001845 | — | 6 | 5 | 2 | 3 | 20 | 34 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 7 | 8 | 3 | 2 | 17 | 34 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 6 | 6 | — | 4 | 18 | 33 |
| Fibrosis | D005355 | — | — | 7 | 10 | 2 | 2 | 10 | 28 |
| Heart failure | D006333 | EFO_0003144 | I50 | 6 | 4 | 2 | 7 | 8 | 27 |
| Coronary artery disease | D003324 | — | I25.1 | 3 | 8 | — | 6 | 10 | 25 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | 4 | 15 | 6 | — | 7 | 28 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 7 | 14 | 4 | — | 3 | 24 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 4 | 5 | 6 | — | 9 | 23 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | 3 | 4 | 6 | — | 8 | 20 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 4 | 4 | 3 | — | 9 | 19 |
| Pulmonary arterial hypertension | D000081029 | — | — | 3 | 5 | 5 | — | 4 | 17 |
| Infections | D007239 | EFO_0000544 | — | 1 | 9 | 3 | — | 5 | 16 |
| Hypoxia | D000860 | — | R09.02 | 6 | 5 | 4 | — | 4 | 15 |
| Ulcer | D014456 | MPATH_579 | — | 5 | 8 | 1 | — | 4 | 15 |
| Congenital heart defects | D006330 | — | Q24.9 | 5 | 5 | 5 | — | 4 | 14 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 15 | 5 | — | — | 22 | 42 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 2 | 6 | — | — | 9 | 15 |
| Blood pressure | D001794 | EFO_0004325 | — | 1 | 1 | — | — | 9 | 10 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 4 | 4 | — | — | 2 | 9 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 1 | 3 | — | — | 6 | 9 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 1 | — | — | 5 | 8 |
| Dyspnea | D004417 | — | R06.0 | 2 | 4 | — | — | 4 | 8 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 2 | 4 | — | — | 2 | 7 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | 1 | 4 | — | — | 3 | 7 |
| Heart disease risk factors | D000082742 | — | — | 4 | 1 | — | — | 1 | 6 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vasodilation | D014664 | — | — | 4 | — | — | — | 8 | 12 |
| Aging | D000375 | GO_0007568 | R41.81 | 3 | — | — | — | 8 | 11 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | 4 | — | — | — | 4 | 8 |
| Vasoconstriction | D014661 | — | — | 4 | — | — | — | 2 | 6 |
| Dermatitis | D003872 | — | L30.9 | 1 | — | — | — | 5 | 6 |
| Neoplasms | D009369 | — | C80 | 4 | — | — | — | 1 | 5 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | 3 | — | — | — | 2 | 5 |
| Fatigue | D005221 | — | R53.83 | 1 | — | — | — | 3 | 4 |
| Postural orthostatic tachycardia syndrome | D054972 | — | G90.A | 3 | — | — | — | — | 3 |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | 1 | — | — | — | 2 | 3 |
Show 47 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyskinesias | D020820 | — | G24 | — | — | — | — | 9 | 9 |
| Ciliary motility disorders | D002925 | EFO_0003900 | — | — | — | — | — | 9 | 9 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 5 | 5 |
| Esophagitis | D004941 | HP_0100633 | K20 | — | — | — | — | 5 | 5 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | — | — | — | 5 | 5 |
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | — | — | — | 4 | 4 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | — | 4 | 4 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | — | — | — | 4 | 4 |
| Hyperemia | D006940 | EFO_0003822 | H34.82 | — | — | — | — | 3 | 3 |
| Cough | D003371 | — | R05 | — | — | — | — | 3 | 3 |
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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
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Financial
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Inomax – Mallinckrodt
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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3,262 adverse events reported
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