Albumin human
Optison (albumin human) is a protein pharmaceutical. Albumin human was first approved as Optison on 1997-12-31.
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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 | New Drug Application | 2024-11-04 |
| draximage maa | Biologic Licensing Application | 2024-02-13 |
| flexbumin | Biologic Licensing Application | 2007-06-15 |
| human albumin grifols | Biologic Licensing Application | 2010-09-08 |
Show 9 more
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
No data
ATC Codes
No data
HCPCS
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Clinical
Clinical Trials
2815 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 72 | 203 | 78 | 13 | 32 | 363 |
| Carcinoma | D002277 | — | C80.0 | 73 | 185 | 51 | 2 | 13 | 293 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 89 | 130 | 20 | 4 | 16 | 216 |
| Non-small-cell lung carcinoma | D002289 | — | — | 49 | 123 | 57 | 3 | 6 | 213 |
| Neoplasms | D009369 | — | C80 | 119 | 67 | 8 | 5 | 21 | 190 |
| Lung neoplasms | D008175 | — | C34.90 | 35 | 103 | 44 | 3 | 9 | 176 |
| Squamous cell carcinoma | D002294 | — | — | 28 | 97 | 21 | 1 | 6 | 138 |
| Triple negative breast neoplasms | D064726 | — | — | 30 | 69 | 23 | 3 | 3 | 116 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 3 | 22 | 16 | 12 | 58 | 99 |
| Fibrosis | D005355 | — | — | 2 | 20 | 14 | 10 | 50 | 85 |
Show 180 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 52 | 109 | 40 | — | 7 | 175 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 44 | 63 | 26 | — | 3 | 124 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 28 | 44 | 21 | — | 4 | 90 |
| Recurrence | D012008 | — | — | 22 | 49 | 18 | — | 3 | 83 |
| Fallopian tube neoplasms | D005185 | — | — | 22 | 30 | 20 | — | 1 | 66 |
| Uterine cervical neoplasms | D002583 | — | — | 9 | 22 | 12 | — | 2 | 40 |
| Peritoneal neoplasms | D010534 | — | — | 17 | 10 | 11 | — | 2 | 37 |
| Covid-19 | D000086382 | — | U07.1 | 6 | 13 | 5 | — | 15 | 37 |
| Pancreatic ductal carcinoma | D021441 | — | — | 17 | 24 | 3 | — | 2 | 35 |
| Serous cystadenocarcinoma | D018284 | — | — | 9 | 17 | 13 | — | — | 34 |
Show 160 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 8 | 8 | — | — | 3 | 17 |
| Sclerosis | D012598 | — | — | 3 | 10 | — | — | 6 | 17 |
| Lymphoma | D008223 | — | C85.9 | 9 | 2 | — | — | 3 | 14 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 11 | 5 | — | — | 1 | 14 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | 1 | — | — | 13 | 14 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 3 | 5 | — | — | 3 | 10 |
| Left ventricular dysfunction | D018487 | — | — | 4 | 7 | — | — | 3 | 10 |
| Ventricular dysfunction | D018754 | — | — | 4 | 7 | — | — | 2 | 9 |
| Leukemia | D007938 | — | C95 | 3 | 4 | — | — | 2 | 8 |
| Multiple myeloma | D009101 | — | C90.0 | 2 | 2 | — | — | 4 | 8 |
Show 199 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatty liver | D005234 | EFO_0003934 | — | 1 | — | — | — | 9 | 10 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 1 | — | — | — | 8 | 9 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | — | — | — | 6 | 7 |
| Malaria | D008288 | EFO_0001068 | B54 | 5 | — | — | — | — | 5 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | 2 | — | — | — | 3 | 5 |
| Hodgkin disease | D006689 | — | C81 | 3 | — | — | — | 1 | 4 |
| Multiple organ failure | D009102 | EFO_1001373 | — | 1 | — | — | — | 3 | 4 |
| Bariatric surgery | D050110 | — | — | 1 | — | — | — | 3 | 4 |
| Cysts | D003560 | — | — | 1 | — | — | — | 3 | 4 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | 1 | — | — | — | 3 | 4 |
Show 106 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 7 | 7 |
| Intestinal diseases | D007410 | — | K63.9 | — | — | — | — | 7 | 7 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 6 | 6 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 6 | 6 |
| Gestational diabetes | D016640 | — | O24.4 | — | — | — | — | 6 | 6 |
| Emergence delirium | D000071257 | — | — | — | — | — | — | 5 | 5 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 5 | 5 |
| Acidosis | D000138 | EFO_1000014 | E87.2 | — | — | — | — | 5 | 5 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | — | — | 4 | 4 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | — | 4 | 4 |
Show 283 more
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 | — |
| 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
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Additional graphs summarizing 728,645 documents
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Safety
Black-box Warning
Black-box warning for: 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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8,039 adverse events reported
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