Poractant alfa
Curosurf (poractant alfa) is an unknown pharmaceutical. Poractant alfa was first approved as Curosurf on 1999-11-18. It is used to treat newborn respiratory distress syndrome in the USA.
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Commercial
Therapeutic Areas
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Curosurf
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)
Poractant alfa
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Curosurf | poractant alfa | Chiesi Farmaceutici | N-20744 RX | 1999-11-18 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| curosurf | Biologic Licensing Application | 2025-12-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| newborn respiratory distress syndrome | — | D012127 | P22 |
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Clinical
Clinical Trials
54 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 | — | 5 | 7 | 13 | 16 | 40 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | — | 5 | 6 | 11 | 13 | 34 |
| Syndrome | D013577 | — | — | — | 4 | 4 | 6 | 8 | 21 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | 3 | 4 | 7 | 14 |
| Bronchopulmonary dysplasia | D001997 | — | P27.8 | — | 1 | 2 | 4 | 1 | 8 |
| Pulmonary atelectasis | D001261 | — | J98.1 | — | — | — | 1 | 2 | 3 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | — | 1 | 1 | — | 2 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | 1 | — | 1 | — | 2 |
| Patent ductus arteriosus | D004374 | — | Q25.0 | — | — | — | 1 | — | 1 |
| Meconium aspiration syndrome | D008471 | EFO_1001037 | P24.0 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute lung injury | D055371 | EFO_0004610 | — | — | 2 | 1 | — | — | 3 |
| Bronchiolitis | D001988 | — | — | — | — | 1 | — | — | 1 |
| Viral bronchiolitis | D001990 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyaline membrane disease | D006819 | EFO_1000644 | P22.0 | — | 2 | — | — | 1 | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Congenital heart defects | D006330 | — | Q24.9 | 1 | — | — | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | 1 | — | — | — | — | 1 |
| Hypoplastic left heart syndrome | D018636 | — | Q23.4 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | — | — | — | 1 | 1 |
| Newborn infant diseases | D007232 | — | — | — | — | — | — | 1 | 1 |
| Birth weight | D001724 | EFO_0004344 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Poractant alfa |
| INN | — |
| Description | Poractant alfa is a pulmonary surfactant sold under the brand name Curosurf by Chiesi Farmaceutici. Poractant alfa is an extract of natural porcine lung surfactant. As with other surfactants, marked improvement on oxygenation may occur within minutes of the administration of poractant alfa.
The new generic form of surfactant is SLS (Sheep Lung Surfactant) developed in PersisGen Co. and commercialized by ArnaGen Pharmad. It has fully comparable quality profile with Curosurf.
|
| Classification | Protein |
| Drug class | pulmonary surfactants; tachykinin (neurokinin) receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201622 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09113 |
| UNII ID | — |
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722 adverse events reported
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