Last reviewed · How we verify
ALBUMIN HUMAN
ALBUMIN HUMAN is a drug. It is currently FDA-approved (first approved 1997) for Hypovolemia, Ascites, Hypoalbuminemia including from burns.
Human Albumin 25% contributes to plasma colloid oncotic pressure and transports various substances, stabilizing blood volume.
Albumin Human 25% is a marketed solution used primarily for treating hypovolemia, leveraging its role in maintaining plasma colloid oncotic pressure and stabilizing blood volume. Its key strength lies in its well-established mechanism and essential role in critical care settings, providing a stable and reliable treatment option. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | ALBUMIN HUMAN |
|---|---|
| Modality | Recombinant protein |
| Phase | FDA-approved |
| First approval | 1997 |
Mechanism of action
Human Albumin 25% works by maintaining the plasma colloid oncotic pressure, which helps stabilize circulating blood volume. It also acts as a carrier for hormones, enzymes, medicinal products, and toxins, and has additional roles in antioxidant activities and maintaining capillary membrane integrity.
Approved indications
- Hypovolemia
- Ascites
- Hypoalbuminemia including from burns
- Acute Nephrosis
- Acute Respiratory Distress Syndrome (ARDS)
- Cardiopulmonary Bypass
Common side effects
- Fever
- Chills
- Rash
- Nausea
- Vomiting
- Tachycardia
- Hypotension
- Flushing
- Urticaria
Serious adverse events
- Shock
- Anaphylaxis
Drug interactions
- blood
- blood components
- protein hydrolysates
- alcoholic solutions
- other medicinal products
Key clinical trials
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1) (PHASE1)
- Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (PHASE2)
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
- Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer (PHASE2)
- Role of Anti-mouse PLA2R1 ELISA in Membranous Nephropathy (NA)
- Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy (PHASE2)
- Study of DF1001 in Patients With Advanced Solid Tumors (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ALBUMIN HUMAN CI brief — competitive landscape report
- ALBUMIN HUMAN updates RSS · CI watch RSS
Frequently asked questions about ALBUMIN HUMAN
What is ALBUMIN HUMAN?
How does ALBUMIN HUMAN work?
What is ALBUMIN HUMAN used for?
When was ALBUMIN HUMAN approved?
What development phase is ALBUMIN HUMAN in?
What are the side effects of ALBUMIN HUMAN?
Related
- Indication: Drugs for Hypovolemia
- Indication: Drugs for Ascites
- Indication: Drugs for Hypoalbuminemia including from burns
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing