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
Therapeutic Areas
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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
FDA
EMA
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 | 2025-09-16 |
| 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
2855 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemophilia a | D006467 | EFO_0007267 | D66 | 2 | 3 | 5 | — | — | 7 |
| Hemophilia b | D002836 | — | D67 | 2 | 3 | 5 | — | — | 7 |
| Graft vs host disease | D006086 | — | D89.81 | — | 1 | 2 | — | — | 2 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | — | 1 | — | — | 1 |
| Chronic inflammatory demyelinating polyradiculoneuropathy | D020277 | EFO_1000868 | G61.81 | — | — | 1 | — | — | 1 |
| Polyradiculoneuropathy | D011129 | EFO_1001116 | — | — | — | 1 | — | — | 1 |
| Afibrinogenemia | D000347 | — | D68.2 | — | 1 | 1 | — | — | 1 |
| Dermatomyositis | D003882 | EFO_0000398 | M33 | — | — | 1 | — | — | 1 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 1 | — | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | — | — | 1 |
Show 14 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | 1 | — | — | 1 | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Factor vii deficiency | D005168 | — | D68.2 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | — | — | 1 | 1 |
| Sclerosis | D012598 | — | — | — | — | — | — | 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 750,343 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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4,696 adverse events reported
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