albumin (Human)
Trade name: Plasbumin
Biologicalapproved
Approved
Oct 21, 1942
Human serum albumin is the serum albumin found in human blood. It is the most abundant protein in human blood plasma; it constitutes about half of serum protein. It is produced in the liver. It is soluble in water, and it is monomeric. — Wikipedia
Clinical trial activity
236 trials · 223 clinical orgs · 8 marketing orgs
Phase 1
26
Phase 2
86
Phase 3
50
Phase 4
53
Earliest trial started Jul 1, 1996 (NCT00708747)
Timeline
1940s
1950s
- Mar 3, 1954
Takeda — NDA Secondary Org
1970s
- Jul 23, 1976
CSL Behring — NDA Secondary Org
- Sep 7, 1979
Netherlands Red Cross — NDA Secondary Org
1990s
- Dec 31, 1997
General Electric — NDA Secondary Org
2000s
2010s
- Jun 3, 2011
Kedrion SpA — NDA Secondary Org
- Jun 19, 2018
Bio Products Laboratory — NDA Secondary Org
Indications
Approved for
Studied for
- Abortion, Habitual · Phase 2
- Abortion, Spontaneous · Phase 2
- Acute Kidney Injury · Phase 4
- Acute Lung Injury · Phase 3
- Acute-On-Chronic Liver Failure · Phase 4
- Adrenoleukodystrophy · Phase 2/Phase 3
- Albumins · Phase 3
- alpha 1-Antitrypsin Deficiency · Phase 2
- Alzheimer Disease · Phase 3
- Amyotrophic Lateral Sclerosis · Phase 2
- Anastomotic Leak · Phase 2
- Arterial Occlusive Diseases · Phase 1
- Ascites · Phase 4
- Bacterial Infections · Phase 4
- Blood Loss, Surgical · Phase 4
- Body Fluids · Phase 4
- Bronchoscopy · Phase 4
- Burns · Phase 4
- Carcinoma · Phase 4
- Carcinoma, Hepatocellular · Phase 4
- Cardiomyopathies · Phase 3
- Cardiopulmonary Bypass · Phase 4
- Cardiovascular Diseases · Phase 2
- Cerebral Hemorrhage · Phase 2
- Cerebral Infarction · Phase 2
- Chickenpox · Phase 3
- Cholangitis · Phase 4
- Colitis, Ulcerative · Early Phase 1
- Colorectal Neoplasms · Phase 4
- Community-Acquired Infections · Phase 3
- Consciousness Disorders · Phase 4
- Coronary Artery Disease · Phase 4
- COVID-19 · Phase 2
- Critical Care · Phase 4
- Critical Illness · Phase 4
- Delivery, Obstetric · Phase 4
- Dermatology · Phase 3
- Diabetes Mellitus · Phase 2
- Diabetes Mellitus, Type 2 · Phase 2
- Edema · Phase 4
- Endothelium · Phase 4
- Endovascular Procedures · Phase 1
- Fertilization in Vitro · Phase 2
- Fibrosis · Phase 4
- Gastric Emptying · Phase 2
- Gastroparesis · Phase 2
- General Surgery · Phase 4
- Genital Neoplasms, Female · Phase 4
- Graft vs Host Disease · Phase 2/Phase 3
- Head and Neck Neoplasms · Phase 1/Phase 2
- Head Injuries, Closed · Phase 2/Phase 3
- Healthy Volunteers · Phase 1
- Heart Failure · Phase 3
- Heart Failure, Systolic · Phase 1/Phase 2
- Heart Valve Diseases · Phase 4
- Hemorrhage · Phase 4
- Hepatic Encephalopathy · Phase 4
- Hepatitis B, Chronic · Phase 1/Phase 2
- Hepatorenal Syndrome · Phase 4
- HIV Infections · Phase 1/Phase 2
- Hypoalbuminemia · Phase 4
- Hyponatremia · Phase 4
- Hypoproteinemia · Phase 3
- Hypotension · Phase 4
- Hypovolemia · Phase 4
- Hypoxia · Phase 4
- Immune System Diseases · Phase 2
- Infertility · Phase 2
- Inflammation · Phase 4
- Insulin Resistance · Phase 1
- Intensive Care Units · Phase 4
- Intestinal Diseases · Phase 4
- Intestinal Neoplasms · Phase 4
- Intraoperative Complications · Phase 4
- Ischemic Stroke · Phase 3
- Kidney Failure, Chronic · Phase 2
- Liver Cirrhosis · Phase 4
- Liver Neoplasms · Phase 4
- Liver Transplantation · Phase 4
- Macular Degeneration · Phase 2
- Measles · Phase 3
- Mesenchymal Stem Cells · Phase 1/Phase 2
- Multiple Sclerosis, Relapsing-Remitting · Phase 2
- Mumps · Phase 3
- Myocardial Infarction · Phase 1/Phase 2
- Neoplasms · Phase 4
- Nerve Degeneration · Phase 3
- Non-alcoholic Fatty Liver Disease · Phase 1
- Obesity · Phase 1
- Pancreatectomy · Phase 4
- Pancreatic Fistula · Phase 2
- Pancreatic Neoplasms · Phase 4
- Pancreaticoduodenectomy · Phase 3
- Papillomaviridae · Phase 1/Phase 2
- Paracentesis · Phase 3
- Parvovirus B19, Human · Phase 3
- Peptic Ulcer · Phase 4
- Peritonitis · Phase 4
- Pharmacology · Phase 3
- Pleural Effusion · Phase 4
- Pneumonia · Phase 4
- Polyneuropathies · Phase 1
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Phase 3
- Postoperative Complications · Phase 4
- Postural Orthostatic Tachycardia Syndrome · Phase 3
- Prediabetic State · Phase 1
- Pre-Eclampsia · Phase 4
- Pressure Ulcer · Phase 1/Phase 2
- Pulmonary Disease, Chronic Obstructive · Phase 4
- Pulmonary Edema · Phase 4
- Renal Insufficiency · Phase 4
- Renal Replacement Therapy · Phase 2
- Respiratory Distress Syndrome · Phase 4
- Risk Factors · Phase 1/Phase 2
- Rubella · Phase 3
- Scleroderma, Systemic · Phase 2
- Sepsis · Phase 4
- Severe Dengue · Phase 3
- Shock · Phase 4
- Shock, Septic · Phase 4
- Squamous Cell Carcinoma of Head and Neck · Phase 1/Phase 2
- Staphylococcal Infections · Phase 4
- Stomach Neoplasms · Phase 2
- Streptococcal Infections · Phase 4
- Subarachnoid Hemorrhage · Phase 1
- Systemic Inflammatory Response Syndrome · Phase 4
- Thoracic Surgery · Phase 4
- Urination Disorders · Phase 4
- Urogenital Neoplasms · Phase 4
- Urologic Diseases · Phase 2
- Urologic Neoplasms · Phase 4
- Vascular Diseases · Phase 2
Mechanism of action
- Serum albuminSupplementation
ALB supplementation
- BloodSupplementation
Blood supplementation
Approval history
- approvedOct 21, 1942
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaHuman serum albumin ↗
- NCATSZIF514RVZR ↗
- ChEMBLCHEMBL2108890 ↗
- ChEMBLCHEMBL1201451 ↗
Also known as
- albumin
- albumin
- albumin
- albumin, aggregated
- albuminar-5
- albumin, blood
- albumin human
- albumin human
- albumin human
- albumin (human)
- albumin (human)
- albumin, human
- albumin, human
- albumin microspheres, human
- buminate
- human albumin
- human albumin
- human serum albumin
- human serum albumin
- human serum albumin
- kedbumin
- microspheres of human albumin
- microspheres of human albumin
- plasbumin
- plasbumin
- plasmanate
- plasmanate
- plasma protein fraction
- plasma protein fraction (human)
- plasma protein fraction (human)
- plasmatein plasma protein fraction
- serum albumin
- serum protein
- vasculocis
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07294391 | Phase 2 | Dec 10, 2025 | The First Hospital of Qinhuangdao, Tianjin Huanhu Hospital |
| NCT07212582 | Phase 3 | Dec 1, 2025 | Mahidol University |
| NCT07263308 | Phase 3 | Nov 27, 2025 | Capital Medical University |
| NCT07139392 | Phase 3 | Sep 1, 2025 | Minia University |
| NCT07153133 | N/A | Sep 1, 2025 | Mansoura University |
| NCT06853522 | Early Phase 1 (Phase 1) | May 30, 2025 | Huazhong University of Science and Technology |
| NCT07002827 | N/A | May 30, 2025 | Institute of Liver and Biliary Sciences, India |
| NCT07150858 | N/A | May 25, 2025 | Alexandria University |
| NCT06667999 | Phase 4 | Mar 1, 2025 | Aalborg University, Aarhus University, Gødstrup Hospital, Government of Denmark, Karolinska Institute, Randers Regional Hospital, Region Syddanmark, Region Zealand, Steno Diabetes Center Copenhagen, University of Basel, University of Copenhagen, University of Groningen, University of Oslo, University of Southern Denmark, University of Tampere, Viborg Regional Hospital |
| NCT06812390 | Phase 2 | Feb 28, 2025 | Department of Veteran Affairs |
| NCT06809088 | N/A | Jan 31, 2025 | Institute of Liver and Biliary Sciences, India |
| NCT06710353 | N/A | Dec 4, 2024 | Seoul National University |
| NCT06535945 | Phase 4 | Nov 1, 2024 | Government of France, University of Rennes |
| NCT07119463 | Phase 2 | Oct 29, 2024 | Jinlin University |
| NCT06654687 | N/A | Oct 27, 2024 | Mansoura University |
| NCT06483737 | N/A | Oct 1, 2024 | People's Liberation Army of China |
| NCT06553456 | Phase 2/Phase 3 (Phase 3) | Aug 13, 2024 | Capital Medical University, Protgen Ltd |
| NCT06538844 | Phase 2 | Aug 3, 2024 | Capital Medical University |
| NCT06548477 | N/A | Aug 1, 2024 | Hamad Medical Corporation |
| NCT06489015 | Early Phase 1 (Phase 1) | Jun 28, 2024 | Protgen Ltd |
Showing 20 of 236 trials
Page 1 / 12
Organizations
Research & Development (223)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences, India | Academic/Hospital | 25 | 25 | 1 | 2012 |
| Grifols | For profit | 19 | 11 | 4 | 2002 |
| University of Barcelona | Academic/Hospital | 12 | 9 | 4 | 2004 |
| Capital Medical University | Academic/Hospital | 8 | 4 | 3 | 2013 |
| University of Copenhagen | Academic/Hospital | 7 | 5 | 4 | 2003 |
| Baxalta | For profit | 6 | 4 | 3 | 2008 |
| Fresenius | For profit | 5 | 4 | 2 | 2005 |
| Protgen Ltd | For profit | 5 | 5 | 2 | 2021 |
| Department of Veteran Affairs | Government | 4 | 4 | 2 | 2003 |
| Huazhong University of Science and Technology | Academic/Hospital | 4 | 3 | 2 | 2020 |
| Jinlin University | Academic/Hospital | 4 | 3 | 3 | 2020 |
| Linkoping University | Academic/Hospital | 4 | 3 | 1 | 2016 |
| Tianjin Huanhu Hospital | Academic/Hospital | 4 | 4 | 3 | 2023 |
| University of London | Academic/Hospital | 4 | 1 | 3 | 2008 |
| Baylor University | Academic/Hospital | 3 | 3 | 3 | 2006 |
| Columbia University | Academic/Hospital | 3 | 2 | 3 | 2004 |
| Fortune Rock | For profit | 3 | 3 | 2 | 2013 |
| Government of France | Government | 3 | 0 | 3 | 2008 |
| Hamilton Health Sciences Corporation | Academic/Hospital | 3 | 1 | 2 | 2009 |
| Healthgen Biotechnology Corp. | For profit | 3 | 3 | 3 | 2019 |
223 organizations
Page 1 / 12
Marketing (9)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bio Products Laboratory | For profit | NDA2 | Jun 19, 2018 |
| CSL Behring | For profit | NDA2 | Jul 23, 1976 |
| General Electric | For profit | NDA2 | Dec 31, 1997 |
| Grifols | For profit | NDA2 | Oct 21, 1942 |
| Grifols | For profit | NDA | Oct 21, 1942 |
| Kedrion SpA | For profit | NDA2 | Jun 3, 2011 |
| Netherlands Red Cross | Academic/Hospital | NDA2 | Sep 7, 1979 |
| Octapharma | For profit | NDA2 | Oct 17, 2006 |
| Takeda | For profit | NDA2 | Mar 3, 1954 |