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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Trade Name
FDA
EMA
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 USA, Inc. | N-20744 RX | 1999-11-18 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| curosurf | Biologic Licensing Application | 2020-04-03 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
345 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | EFO_0004272 | D64.9 | — | 5 | 37 | 11 | 2 | 55 |
| Colonoscopy | D003113 | — | 2 | 11 | 12 | 15 | 40 | ||
| Constipation | D003248 | HP_0002019 | K59.0 | 1 | 5 | 5 | 21 | 2 | 33 |
| Dry eye syndromes | D015352 | H04.12 | — | 2 | — | 5 | 7 | 14 | |
| Colonic neoplasms | D003110 | C18 | 1 | 2 | 4 | 2 | 4 | 12 | |
| Colorectal neoplasms | D015179 | 2 | 1 | 2 | 3 | 2 | 10 | ||
| Chronic renal insufficiency | D051436 | N18 | — | 1 | — | 1 | 4 | 6 | |
| Colonic polyps | D003111 | K63.5 | — | — | 1 | 2 | 3 | 6 | |
| Hepatic encephalopathy | D006501 | K72.91 | — | — | — | 3 | 2 | 5 | |
| Colonic diseases | D003108 | — | — | — | 3 | 1 | 4 |
Show 20 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 5 | — | 1 | — | 1 | 7 | ||
| Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | — | 2 | — | 4 | 7 | |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | — | 1 | — | — | 1 |
| Critical illness | D016638 | — | — | 1 | — | — | 1 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | — | 1 |
| Pregnancy complications | D011248 | — | 1 | 1 | — | — | 1 | ||
| Shock | D012769 | R57.1 | — | — | 1 | — | — | 1 | |
| Systemic inflammatory response syndrome | D018746 | EFO_1001478 | R65.10 | — | — | 1 | — | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | 1 | — | — | 1 |
| Endometrial hyperplasia | D004714 | N85.0 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | 3 | — | — | — | 3 |
| Autism spectrum disorder | D000067877 | F84.0 | 1 | 3 | — | — | — | 3 | |
| Lung neoplasms | D008175 | C34.90 | 1 | 1 | — | — | — | 2 | |
| Radiodermatitis | D011855 | L58 | — | 1 | — | — | 1 | 2 | |
| Peripheral nerve injuries | D059348 | 2 | 1 | — | — | — | 2 | ||
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | 1 | — | — | — | 1 | |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | — | — | — | 1 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 1 | — | — | — | 1 |
| Adenomatous polyps | D018256 | D28 | — | 1 | — | — | — | 1 | |
| Klebsiella pneumoniae | D007711 | NCBITaxon_573 | B96.1 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | 1 | — | — | — | — | 1 | ||
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | — | 1 |
| Malaria | D008288 | EFO_0001068 | B54 | 1 | — | — | — | — | 1 |
| Surgical wound infection | D013530 | 1 | — | — | — | — | 1 | ||
| Diverticulitis | D004238 | EFO_1001460 | K57 | 1 | — | — | — | — | 1 |
| Gastric emptying | D005746 | 1 | — | — | — | — | 1 | ||
| Hyperuricemia | D033461 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 2 | 2 |
| Hemolytic-uremic syndrome | D006463 | D59.3 | — | — | — | — | 1 | 1 | |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 1 | 1 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | — | — | 1 | 1 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Microbiota | D064307 | — | — | — | — | 1 | 1 | ||
| Polyps | D011127 | EFO_0000662 | — | — | — | — | 1 | 1 | |
| Urinary bladder neoplasms | D001749 | C67 | — | — | — | — | 1 | 1 | |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 1 | 1 |
| Rectal neoplasms | D012004 | — | — | — | — | 1 | 1 |
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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 | 129069-19-8 |
| RxCUI | 236381 |
| ChEMBL ID | CHEMBL1201622 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09113 |
| UNII ID | — |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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50,275 adverse events reported
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