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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Therapeutic Areas
Trade Name
FDA
EMA
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 |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bio no more yeast infection (helps improve vaginal yeast infection, fermented cabbage powder) | unapproved drug other | 2024-03-19 |
| genosyl | New Drug Application | 2024-12-06 |
| inomax | New Drug Application | 2024-12-05 |
| nitric oxide nitrogen mix | unapproved medical gas | 2011-03-11 |
| now st | unapproved drug other | 2022-11-16 |
| noxivent 101 | ANDA | 2025-01-17 |
| noxivent 102 | ANDA | 2025-01-24 |
| ulspira | ANDA | 2024-10-03 |
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
No data
Clinical
Clinical Trials
990 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 | 4 | 2 | 3 | 1 | 1 | 10 |
| Hypertension | D006973 | EFO_0000537 | I10 | 3 | 1 | 4 | 1 | 1 | 9 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | — | 3 | 1 | — | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | 1 | 1 | 1 | 3 |
| Persistent fetal circulation syndrome | D010547 | EFO_1001103 | P29.3 | — | — | 1 | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | — | 4 | — | 1 | 6 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | 1 | — | 4 | — | 1 | 6 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | 4 | 1 | — | — | 5 |
| Congenital heart defects | D006330 | — | Q24.9 | 2 | 2 | 2 | — | — | 4 |
| Bronchopulmonary dysplasia | D001997 | — | P27.8 | 1 | 2 | 3 | — | — | 4 |
| Hypoxia | D000860 | — | R09.02 | 1 | 1 | 3 | — | — | 4 |
| Reperfusion injury | D015427 | — | — | — | 2 | 2 | — | 1 | 4 |
| Syndrome | D013577 | — | — | — | 2 | 3 | — | — | 4 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | 2 | 1 | 1 | — | — | 3 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 2 | 1 | — | — | 3 |
Show 15 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | 1 | 2 | — | — | — | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 2 | — | — | — | 2 |
| Infarction | D007238 | EFO_0009463 | — | — | 2 | — | — | — | 2 |
| Lung transplantation | D016040 | — | — | — | 2 | — | — | — | 2 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | 2 | — | — | — | 2 |
| Embolism | D004617 | — | — | — | 2 | — | — | — | 2 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | — | — | — | 1 |
| St elevation myocardial infarction | D000072657 | — | — | — | 1 | — | — | — | 1 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | 1 | — | — | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | — | — | — | 1 |
Show 14 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute kidney injury | D058186 | — | N17 | 1 | — | — | — | — | 1 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Birth weight | D001724 | EFO_0004344 | — | — | — | — | — | 1 | 1 |
| Raynaud disease | D011928 | EFO_1001145 | I73.0 | — | — | — | — | 1 | 1 |
| Crest syndrome | D017675 | — | M34.1 | — | — | — | — | 1 | 1 |
| Calcinosis | D002114 | — | — | — | — | — | — | 1 | 1 |
| Calcinosis cutis | D000092182 | — | L94.2 | — | — | — | — | 1 | 1 |
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
No data
Financial
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Inomax – Mallinckrodt
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Trends
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Safety
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No Black-box warning
Adverse Events
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2,883 adverse events reported
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