Calfactant
Infasurf (calfactant) is an unknown pharmaceutical. Calfactant was first approved as Infasurf on . It is used to treat newborn respiratory distress syndrome in the USA.
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Trade Name
FDA
EMA
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 |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| infasurf | Biologic Licensing Application | 2020-06-17 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
43 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | 1 | 4 | 5 |
| Analgesia | D000698 | — | — | — | 1 | — | 1 | ||
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | — | — | 1 | — | 1 |
| Primary hyperparathyroidism | D049950 | EFO_0008519 | E21.0 | — | — | — | 1 | — | 1 |
| Hypercalcemia | D006934 | E83.52 | — | — | — | 1 | — | 1 | |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | 1 | — | 1 |
| Rib fractures | D012253 | — | — | — | 1 | — | 1 | ||
| Hypothyroidism | D007037 | EFO_0004705 | E03.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | 2 | — | 4 | — | — | 6 | |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 2 | 1 | 2 | — | — | 5 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 1 | 2 | — | — | 3 |
| Postmenopause | D017698 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Calcinosis | D002114 | — | 1 | — | — | — | 1 | ||
| Giant cell granuloma | D006101 | K06.8 | — | 1 | — | — | — | 1 | |
| Metabolic bone diseases | D001851 | HP_0000938 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine without aura | D020326 | EFO_0005296 | G43.0 | — | — | — | — | 2 | 2 |
| Migraine with aura | D020325 | EFO_0005295 | G43.1 | — | — | — | — | 2 | 2 |
| Nephrogenic diabetes insipidus | D018500 | N25.1 | — | — | — | — | 1 | 1 | |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
| Brain concussion | D001924 | S06.0 | — | — | — | — | 1 | 1 | |
| Post-traumatic headache | D051298 | G44.3 | — | — | — | — | 1 | 1 | |
| Cluster headache | D003027 | HP_0012199 | G44.00 | — | — | — | — | 1 | 1 |
| Familial hypophosphatemic rickets | D053098 | — | — | — | — | 1 | 1 | ||
| Hypophosphatemia | D017674 | HP_0002148 | — | — | — | — | 1 | 1 | |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | — | 1 | 1 |
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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 | — |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 478 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7 adverse events reported
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