Alpha-1-proteinase inhibitor

Overview

Human alpha-1 proteinase inhibitor or alpha-1-antitrypsin, prepared from human plasma via Cohn alcohol fractionation followed by PEG and zinc chloride fractionation.

Indication

For chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor (A1-PI) deficiency and clinical evidence of emphysema.

Associated Conditions

Emphysema

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Effect of Alpha-1 Antitrypsin Supplementation in Alcohol-Associated Hepatitis-A prospective Pilot Study	2025/01/15	2024-515794-99-00	Phase 2	Recruiting	Medizinische Universitaet Innsbruck
Phase 2 study comparing SAR447537 to plasma-derived A1PI therapy for AATD emphysema	2023/05/12	2023-508084-76-00	Phase 2	Completed	Sanofi AATD Inc.
Aralast NP With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection	2020/12/19	NCT04675086	Phase 3	Withdrawn	Blessing Corporate Services, Inc
Phase III, Efficacy and Safety of "Kamada-AAT for Inhalation"	2019/12/18	NCT04204252	Phase 3	Recruiting	Kamada, Ltd.
A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD	2018/03/08	NCT03459040	Phase 2	Completed	John Levine
Study Comparing Weekly Intravenous Administration of OctaAlpha1 With a Marketed Preparation Glassia® in Subjects With Alpha-1-antitrypsin Deficiency	2017/12/28	NCT03385395	Phase 2	Withdrawn	Octapharma
Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)	2017/06/01	NCT03172455	N/A	NO_LONGER_AVAILABLE	Impatients N.V. trading as myTomorrows
Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis	2016/10/27	NCT02947087	Phase 1	Completed	Medical University of South Carolina
Anti-inflammatory Therapy to Improve Outcomes After TPIAT	2016/03/21	NCT02713997	Phase 4	Completed	University of Minnesota
Study to Evaluate the Safety and Efficacy of Intravenous Glassia® Treatment in Lung Transplantation	2015/11/25	NCT02614872	Phase 2	Completed	Kamada, Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CSL US ZEMAIRA human alpha1-proteinase inhibitor 1000 mg powder for injection vial with diluent vial	356861	CSL Behring (Australia) Pty Ltd	Medicine	A	3/16/2021
PROLASTIN C LIQUID alpha-1-proteinase inhibitor (human) 4000 mg solution for injection for intravenous infusion vial	371339	Grifols Australia Pty Ltd	Medicine	A	5/27/2022
PROLASTIN C LIQUID alpha-1-proteinase inhibitor (human) 1000 mg solution for injection for intravenous infusion vial	305253	Grifols Australia Pty Ltd	Medicine	A	7/1/2019
ZEMAIRA human alpha1-proteinase inhibitor 5 g powder for injection vial with diluent vial	315073	CSL Behring (Australia) Pty Ltd	Medicine	A	5/14/2020
ZEMAIRA human alpha1-proteinase inhibitor 1000 mg powder for injection vial with diluent vial	273182	CSL Behring (Australia) Pty Ltd	Medicine	A	2/13/2017
ZEMAIRA human alpha1-proteinase inhibitor 4 g powder for injection vial with diluent vial	315059	CSL Behring (Australia) Pty Ltd	Medicine	A	5/14/2020
PROLASTIN C LIQUID alpha-1-proteinase inhibitor (human) 500 mg solution for injection for intravenous infusion vial	371334	Grifols Australia Pty Ltd	Medicine	A	5/27/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ZEMAIRA	csl behring canada inc	02457911	Powder For Solution , Kit - Intravenous	1000 MG / VIAL	N/A
PROLASTIN-C	基立福	02204606	Powder For Solution - Intravenous	1000 MG / VIAL	11/11/1996
ALPHA1-PROTEINASE INHIBITOR (HUMAN)	基立福	02223643	Powder For Solution - Intravenous	500 MG / VIAL	N/A
ZEMAIRA	csl behring canada inc	02494779	Powder For Solution , Kit - Intravenous	5000 MG / VIAL	N/A
GLASSIA	takeda canada inc	02522438	Solution - Intravenous	1000 MG / 50 ML	1/2/2024
PROLASTIN INJ 25.0MG/ML	cutter biological, division of miles lab inc.	00803529	Powder For Solution - Intravenous	25 MG / ML	12/31/1988
PROLASTIN-C LIQUID	基立福	02488787	Solution - Intravenous	1000 MG / 20 ML	N/A
ZEMAIRA	csl behring canada inc	02494760	Kit , Powder For Solution - Intravenous	4000 MG / VIAL	N/A
ALPHA1-PROTEINASE INHIBITOR (HUMAN)	基立福	02223651	Powder For Solution - Intravenous	1 G / VIAL	N/A
PRONEXTICA LIQUID	基立福	02543028	Solution - Intravenous	1000 MG / 20 ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
PROLASTINA 5.000 MG POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Grifols Deutschland Gmbh	89085	POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
PROLASTINA 4.000 MG POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Grifols Deutschland Gmbh	89084	POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
PROLASTINA 1000 mg, POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN.	Grifols Deutschland Gmbh	68087	POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

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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