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 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
2972 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 164 | 219 | 40 | 5 | 18 | 366 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 59 | 198 | 46 | 9 | 33 | 312 |
| Non-small-cell lung carcinoma | D002289 | — | — | 58 | 133 | 42 | 3 | 8 | 212 |
| Neoplasms | D009369 | — | C80 | 128 | 78 | 9 | 4 | 20 | 195 |
| Triple negative breast neoplasms | D064726 | — | — | 29 | 79 | 26 | 1 | 3 | 120 |
| Adenocarcinoma | D000230 | — | — | 42 | 74 | 10 | 2 | 5 | 110 |
| Carcinoma | D002277 | — | C80.0 | 23 | 71 | 13 | 4 | 10 | 106 |
| Lung neoplasms | D008175 | — | C34.90 | 28 | 70 | 14 | 3 | 7 | 105 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 3 | 22 | 16 | 12 | 55 | 97 |
| Pancreatic ductal carcinoma | D021441 | — | — | 42 | 49 | 11 | 2 | 4 | 87 |
Show 164 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Esophageal neoplasms | D004938 | — | C15 | 12 | 44 | 2 | — | 4 | 53 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 25 | 24 | 3 | — | 1 | 48 |
| Hepatic insufficiency | D048550 | — | — | 10 | 9 | 4 | — | 21 | 38 |
| Covid-19 | D000086382 | — | U07.1 | 6 | 13 | 5 | — | 15 | 37 |
| Neoadjuvant therapy | D020360 | — | — | 1 | 27 | 4 | — | 3 | 33 |
| Uterine cervical neoplasms | D002583 | — | — | 4 | 18 | 3 | — | 4 | 27 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | 4 | 8 | 3 | — | 16 | 26 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 9 | 11 | 1 | — | 4 | 23 |
| Urinary bladder neoplasms | D001749 | — | C67 | 8 | 13 | 2 | — | 3 | 21 |
| Small cell lung carcinoma | D055752 | — | — | 7 | 14 | 2 | — | 2 | 21 |
Show 146 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | — | — | 9 | 10 | — | — | 2 | 16 |
| Lymphoma | D008223 | — | C85.9 | 10 | 3 | — | — | 3 | 15 |
| Wounds and injuries | D014947 | — | T14.8 | 5 | 5 | — | — | 9 | 15 |
| Prostatic neoplasms | D011471 | — | C61 | 8 | 6 | — | — | 2 | 14 |
| Left ventricular dysfunction | D018487 | — | — | 4 | 7 | — | — | 3 | 10 |
| Multiple myeloma | D009101 | — | C90.0 | 3 | 3 | — | — | 4 | 9 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 6 | 2 | — | — | 1 | 8 |
| Mouth neoplasms | D009062 | EFO_0003868 | C06.9 | 1 | 5 | — | — | 2 | 8 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 4 | — | — | 3 | 8 |
| Sclerosis | D012598 | — | — | 2 | 2 | — | — | 5 | 8 |
Show 209 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | — | — | — | 14 | 16 |
| Infertility | D007246 | EFO_0000545 | — | 1 | — | — | — | 7 | 8 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | 1 | — | — | — | 7 | 8 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | — | — | — | 6 | 7 |
| Hodgkin disease | D006689 | — | C81 | 5 | — | — | — | 1 | 6 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | 2 | — | — | — | 3 | 5 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | — | — | — | 4 | 5 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | — | — | — | 4 | 5 |
| Multiple organ failure | D009102 | EFO_1001373 | — | 1 | — | — | — | 3 | 4 |
| Bariatric surgery | D050110 | — | — | 1 | — | — | — | 3 | 4 |
Show 89 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 8 | 8 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 7 | 7 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | — | 7 | 7 |
| Gestational diabetes | D016640 | — | O24.4 | — | — | — | — | 7 | 7 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 6 | 6 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 6 | 6 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | — | 6 | 6 |
| Intestinal diseases | D007410 | — | K63.9 | — | — | — | — | 6 | 6 |
| Emergence delirium | D000071257 | — | — | — | — | — | — | 5 | 5 |
| Acidosis | D000138 | EFO_1000014 | E87.2 | — | — | — | — | 5 | 5 |
Show 315 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 | 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
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Trends
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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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