Calfactant
Infasurf (calfactant) is an unknown pharmaceutical. Calfactant was first approved as Infasurf on 1998-07-01. It is used to treat newborn respiratory distress syndrome in the USA.
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Infasurf
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Calfactant
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Infasurf | calfactant | ONY Biotech | N-20521 RX | 1998-07-01 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| infasurf | Biologic Licensing Application | 2025-01-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| newborn respiratory distress syndrome | — | D012127 | P22 |
Agency Specific
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Clinical
Clinical Trials
23 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | 2 | 5 | 1 | 5 | 14 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | 1 | 1 | 5 | 1 | 5 | 13 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bronchopulmonary dysplasia | D001997 | — | P27.8 | 1 | 2 | 2 | — | 1 | 5 |
| Syndrome | D013577 | — | — | 1 | 1 | 2 | — | 1 | 5 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | 1 | 2 | — | — | 4 |
| Acute lung injury | D055371 | EFO_0004610 | — | — | 1 | 2 | — | — | 2 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | — | 1 | — | — | 1 |
| Lung injury | D055370 | — | S27.30 | — | 1 | 1 | — | — | 1 |
| Lung transplantation | D016040 | — | — | — | 1 | 1 | — | — | 1 |
| Primary graft dysfunction | D055031 | — | — | — | 1 | 1 | — | — | 1 |
| Perinatal death | D066087 | — | — | — | — | 1 | — | — | 1 |
| Intratracheal intubation | D007442 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | — | — | — | 1 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bronchiolitis | D001988 | — | — | 1 | — | — | — | — | 1 |
| Skin and connective tissue diseases | D017437 | — | — | 1 | — | — | — | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | 1 | — | — | — | — | 1 |
| Hyaline membrane disease | D006819 | EFO_1000644 | P22.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 1 | 1 |
| Pulmonary atelectasis | D001261 | — | J98.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Calfactant |
| INN | — |
| Description | Calfactant, also known as Infasurf, is an intratracheal suspension derived from the natural surfactant in calf lungs. It is used in premature infants with lung surfactant deficiency that causes infant respiratory distress syndrome (IRDS).
|
| Classification | Small molecule |
| Drug class | pulmonary surfactants; tachykinin (neurokinin) receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 183325-78-2 |
| RxCUI | 232539 |
| ChEMBL ID | CHEMBL1201447 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06415 |
| UNII ID | — |
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Safety
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103 adverse events reported
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