Albumin human

Overview

Human serum albumin is the primary protein present in human blood plasma. The main function of albumin is to maintain the oncotic pressure of blood . It binds to water, cations (such as Ca2+, Na+ and K+), fatty acids, hormones, bilirubin, thyroxine (T4) and pharmaceuticals (including barbiturates). Albumin represents approximately 50% of the total protein content in healthy humans . Human albumin is a small globular protein (molecular weight: 66.5 kDa), consisting of a single chain of 585 amino acids organized in three repeated homolog domains (sites I, II, and III). Each domain comprises two separate sub-domains (A and B) . There are various preparations of albumin that are well established and widely available in the clinical setting , , . Also known as Albuminex 5% or 25%, one brand of human serum albumin is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US . This is a biosimilar drug to existing human serum albumin and was approved for a biological license at both 5% and 25% concentrations by the FDA on June 21, 2018 .

Indication

Albuminex solution is indicated for adults and children for hypovolemia, ascites, hypoalbuminemia including from burns, acute nephrosis, acute respiratory distress syndrome and cardipulmonary bypass .

Associated Conditions

Acute Pyelonephritis(APN)
Burns
Hemolytic Disease of the Newborn
Hypoalbuminemia
Hypoproteinemia
Hypovolaemia
Shock, Hypovolemic
Acute fulminant liver failure
Central volume depletion
Post-operative albumin loss

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Recombinant Human Albumin Injection to Treat Hypoalbuminemia in Cirrhotic Patients With Ascites	2025/04/04	NCT06911554	Phase 3	Completed	Tonghua Anrate Biopharmaceutical Co., Ltd.
PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS	2024/10/08	NCT06630923	Phase 3	Recruiting	Democritus University of Thrace
Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites	2024/08/14	NCT06553456	Phase 2	Not yet recruiting	Protgen Ltd
Human Albumin for Clinical Outcome in Aneurysmal Subarachnoid Hemorrhages	2024/08/12	NCT06548477	Not Applicable	Recruiting	Hamad Medical Corporation
Effect of Early Administration of Albumin 20% Versus Crystalloid	2024/04/17	NCT06370078	Not Applicable	Recruiting	Egymedicalpedia
A Novel COMBinATorial Therapy with Albumin and Enoxaparin in Patients with Decompensated Cirrhosis At High-risk of Poor Outcome (COMBAT Trial).	2023/06/08	NCT05895136	Phase 2	Recruiting	European Foundation for Study of Chronic Liver Failure
Phase II/III of Recombinant Human Serum Albumin	2023/05/15	NCT05858853	Phase 2	Completed	Protgen Ltd
Human Albumin Treatment in Adult Septic Shock. A Study Evaluating Immune Response and Organ Failure.	2022/12/12	NCT05645887	Phase 2	Withdrawn	Albimmune SL
Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects	2022/02/21	NCT05249374	Phase 1	Completed	Protgen Ltd
Recombinant Human Serum Albumin in Healthy Subjects	2022/01/05	NCT05179265	Phase 1	Completed	Protgen Ltd

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ALBUTEIN	GRIFOLS USA, LLC	68516-5217	INTRAVENOUS	12.5 g in 250 mL	5/28/2025
ALBUTEIN	GRIFOLS USA, LLC	68516-5219	INTRAVENOUS	12.5 g in 250 mL	5/28/2025
Albumin (Human)	Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.	67467-643	Intravenous	250 g in 1000 mL	8/1/2008
ALBUTEIN	GRIFOLS USA, LLC	68516-5214	INTRAVENOUS	12.5 g in 250 mL	5/28/2025
ALBUMINEX	BPL	64208-2510	INTRAVENOUS	0.05 g in 1 mL	8/31/2018
ALBUMINEX	BPL	64208-2512	INTRAVENOUS	0.25 g in 1 mL	8/15/2018
ALBUTEIN	GRIFOLS USA, LLC	68516-5215	INTRAVENOUS	10 g in 50 mL	5/28/2025
ALBUTEIN	GRIFOLS USA, LLC	68516-5218	INTRAVENOUS	12.5 g in 250 mL	5/28/2025
Albumin (Human)	Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.	67467-623	Intravenous	50 g in 1000 mL	8/1/2008
ALBUTEIN	GRIFOLS USA, LLC	68516-5214	INTRAVENOUS	12.5 g in 250 mL	5/28/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ZENALB 20 HUMAN ALBUMIN SOLUTION 20% w/v	BIO PRODUCTS LABORATORY LIMITED	SIN07171P	INJECTION	20% w/v	10/9/1992
ZENALB 4.5 HUMAN ALBUMIN SOLUTION 4.5% w/v	BIO PRODUCTS LABORATORY LIMITED	SIN07170P	INJECTION	4.5% w/v	10/9/1992
ALBUTEIN INFUSION 5%	GRIFOLS BIOLOGICALS LLC.	SIN01177P	INJECTION	12.5 g/250 ml	5/13/1988
ALBUMIN SG INJECTION 20%	SK Plasma Co.,Ltd.	SIN16765P	INJECTION	10g/50mL	4/20/2023
Niuliva Solution For Infusion 250 I.U./ml	INSTITUTO GRIFOLS, S.A.	SIN14069P	INJECTION, SOLUTION	250 I.U./ml	12/30/2011
HUMAN ALBUMIN GRIFOLS 20%	INSTITUTO GRIFOLS SA, Grifols Biologicals LLC (Optional manufacturer of Fraction V)	SIN01180P	INFUSION, SOLUTION	0.2 g/ml	5/13/1988
ALBURX SOLUTION FOR INFUSION 25%	CSL Behring AG (Bulk Production and Primary Packager), CSL Behring L.L.C	SIN15907P	INFUSION, SOLUTION	250 g/L	3/11/2020
Uman Albumin Solution for Infusion 200 g/l	Kedrion S.p.A.	SIN14044P	INFUSION, SOLUTION	200 g/l	11/3/2011
HUMAN ALBUMIN GRIFOLS INJECTION 5%	INSTITUTO GRIFOLS SA, Grifols Biologicals LLC (Optional manufacturer of Fraction V)	SIN11285P	INJECTION	5%	2/15/2000
ALBUTEIN INFUSION 25%	GRIFOLS BIOLOGICALS LLC.	SIN01178P	INJECTION	12.5 g/50 ml	5/13/1988

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
HUMAN ALBUMIN "BIOTEST" INFUSION 20%	N/A	CHONG LAP (H.K.) COMPANY LIMITED	N/A	N/A	12/14/1981
HUMAN ALBUMIN GRIFOLS INJ 20%	N/A	LUEN CHEONG HONG	N/A	N/A	1/12/1999

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ALBUMIN (HUMAN) 5% SOLUTION, USP	基立福	02223694	Solution - Intravenous	5 %	5/6/1997
PLASBUMIN-25	基立福	02189119	Solution - Intravenous	250 MG / ML	1/17/1997
OCTALBIN 5%	octapharma pharmazeutika produktionsges m b h	02302705	Solution - Intravenous	5 %	1/6/2015
TISSEEL KIT VH	osterreichisches institut fur haemoderivate ges m.b.h.	00677558	Jelly - Topical	50 MG / PCK	12/31/1986
OPTISON	tyco healthcare	02239574	Suspension - Intravenous	5 %	6/22/2000
HUMAN ALBUMIN GRIFOLS 20%	INSTITUTO GRIFOLS SA	02263661	Solution - Intravenous	20 %	N/A
ALBUMINAR-25	zlb behring llc	00624608	Solution - Intravenous	25 G / 100 ML	12/31/1985
BUMINATE 5%	BAXTER HEALTHCARE CORPORATION	00118311	Solution - Intravenous	5 %	12/31/1955
ALBUMIN (HUMAN) 5% SOLUTION	Baxter AG	00427675	Solution - Intravenous	5 %	12/30/1989
DILUENT FOR ALLERGENIC EXTRACT STERILE ALBUMIN SALINE WITH PHENOL	JUBILANT HOLLISTERSTIER LLC	02223732	Liquid - Subcutaneous , Intradermal	0.03 %	12/16/1996

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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