Albumin human
Optison (albumin human) is a protein pharmaceutical. Albumin human was first approved as Optison on 1997-12-31.
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Commercial
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Trade Name
FDA
EMA
Albuked, plasbumin, plasbumin, plasbumin, Albuminex, Alburx, Albutein, Buminate, flexbumin, Human albumin grifols, Idelvion, Kedbumin, N/a, Optison (discontinued: Albuminar, albuminar, albuminar, albuminar, Albutein, Chromalbin, Human albumin grifols)
CombinationsAdvate, Xyntha, xyntha solofuse
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Albumin human
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OPTISON | GE Healthcare | N-020899 RX | 1997-12-31 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| albumin (human) | Biologic Licensing Application | 2010-01-07 |
| albumin (human) 20% | Biologic Licensing Application | 2009-12-16 |
| albumin (human) 25% | Biologic Licensing Application | 2009-12-22 |
| albuminex | Biologic Licensing Application | 2024-12-31 |
| alburx | Biologic Licensing Application | 2009-01-06 |
| albutein | Biologic Licensing Application | 2008-07-01 |
| beizray beizray | New Drug Application | 2025-12-17 |
| draximage maa | Biologic Licensing Application | 2024-02-13 |
| flexbumin | Biologic Licensing Application | 2007-06-15 |
| human albumin grifols | Biologic Licensing Application | 2010-09-08 |
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ALBUMIN HUMAN, OPTISON, GE HEALTHCARE | |||
| 2028-05-09 | NPP | ||
| 2028-05-09 | NPP | ||
| 2028-05-09 | NPP | ||
| 2028-05-09 | NPP | ||
| 2028-05-09 | NPP | ||
| 2028-05-09 | NPP | ||
Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
2987 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 1 | 1 | 1 | 5 |
| Fibrosis | D005355 | — | — | — | 2 | 1 | 1 | 1 | 5 |
| Ascites | D001201 | — | R18 | — | — | 1 | 1 | — | 2 |
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | — | — | 1 | — | 1 |
| Acute kidney injury | D058186 | — | N17 | — | — | — | 1 | — | 1 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | 1 | — | 1 |
| Iron overload | D019190 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 2 | 1 | — | — | 2 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | 1 | — | 1 | 2 |
| Septic shock | D012772 | — | A48.3 | — | — | 1 | — | 1 | 2 |
| Chronic inflammatory demyelinating polyradiculoneuropathy | D020277 | EFO_1000868 | G61.81 | — | — | 1 | — | — | 1 |
| Acute-on-chronic liver failure | D065290 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 2 | — | — | — | 2 |
| Hepatic encephalopathy | D006501 | — | K72.91 | — | 2 | — | — | — | 2 |
| Postural orthostatic tachycardia syndrome | D054972 | — | G90.A | 1 | 1 | — | — | — | 1 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | — | 1 | — | — | — | 1 |
| Alpha 1-antitrypsin deficiency | D019896 | — | E88.01 | — | 1 | — | — | — | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 1 | — | — | — | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 1 | — | — | — | 1 |
| Lung transplantation | D016040 | — | — | — | 1 | — | — | — | 1 |
| Agammaglobulinemia | D000361 | — | D80.1 | — | 1 | — | — | — | 1 |
| Brain diseases | D001927 | — | G93.40 | — | 1 | — | — | — | 1 |
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver failure | D017093 | — | K72.9 | — | — | — | — | 1 | 1 |
| Thoracic surgical procedures | D019616 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Albumin human |
| INN | perflutren |
| Description | Albuked (albumin human) is a protein pharmaceutical. It is currently being investigated in clinical studies. |
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 200-941-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201451 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | CK0N3WH0SR (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 775,347 documents
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Safety
Black-box Warning
Black-box warning for: Beizray beizray, Optison, Paclitaxel, Paclitaxel protein bound particles albumin bound, Paclitaxel protein-bound particles for injectable suspension (albumin-bound), Sterile diluent for allergenic extract
Adverse Events
Top Adverse Reactions
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4,811 adverse events reported
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