.ALPHA.1-PROTEINASE INHIBITOR HUMAN

Summary

.Alpha.1-Proteinase Inhibitor Human (CHEMBL4297879) is an approved protein (ATC B02AB02); indicated across 13 conditions including hereditary disease and lung disorder.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• ATC class: B02AB02
• Indications: 13 conditions
• Clinical trials: 28

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297879
Name	.ALPHA.1-PROTEINASE INHIBITOR HUMAN
Type	Protein
Max phase	4
ATC	B02AB02

Also known as: .alpha.-1 protease inhibitor, Alfa1 antitrypsin, Alpha-1 protease inhibitor, Alpha-1 proteinase inhibitor (human), Aralast, Atc-b02ab02, Glassia, Prolastin, Prolastin-c, Respreeza, Serpin a1, Serpina1 expressed protein

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

13 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
hereditary disease	4	MONDO:0003847	EFO:0000508
lung disorder	4	MONDO:0005275	EFO:0003818
chronic obstructive pulmonary disease	3	MONDO:0005002	EFO:0000341
alpha 1-antitrypsin deficiency	3	MONDO:0013282	Orphanet:60
graft versus host disease	2	MONDO:0013730	MONDO:0013730
severe acute respiratory syndrome	2	MONDO:0005091	MONDO:0100096
type 1 diabetes mellitus	2	MONDO:0005147	MONDO:0005147
cystic fibrosis	2	MONDO:0009061	MONDO:0009061
chronic pancreatitis	1	MONDO:0005003	EFO:0000342
acute myocardial infarction	1	MONDO:0004781	EFO:0008583

3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 28.

Phase distribution

Phase	Trials
PHASE2	11
PHASE3	6
PHASE4	5
PHASE1/PHASE2	3
PHASE2/PHASE3	2
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00261833	PHASE4	COMPLETED	Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency
NCT00313144	PHASE4	TERMINATED	Aralast alpha1-proteinase Inhibitor Surveillance Study
NCT00396006	PHASE4	COMPLETED	Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)
NCT01651351	PHASE4	COMPLETED	GLASSIA Infusion Rate Study
NCT02713997	PHASE4	COMPLETED	Anti-inflammatory Therapy to Improve Outcomes After TPIAT
NCT04204252	PHASE3	RECRUITING	Phase III, Efficacy and Safety of Kamada-AAT for Inhalation
NCT00295061	PHASE3	COMPLETED	Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
NCT00301366	PHASE3	COMPLETED	The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency
NCT02282527	PHASE2/PHASE3	COMPLETED	A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency
NCT02525861	PHASE3	COMPLETED	GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
NCT02722304	PHASE3	TERMINATED	Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency
NCT02956122	PHASE2/PHASE3	TERMINATED	A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
NCT04675086	PHASE3	WITHDRAWN	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
NCT06582329	PHASE2	NOT_YET_RECRUITING	Effect of Alpha-1 Antitrypsin Supplementation on Alcohol-Associated Hepatitis
NCT00263887	PHASE2	COMPLETED	Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)
NCT00486837	PHASE2	COMPLETED	Deposition of Inhaled Prolastin in Cystic Fibrosis Patients
NCT01213043	PHASE2	COMPLETED	Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency
NCT01700036	PHASE2	COMPLETED	A Pilot Study of Alpha-1-Antitrypsin (AAT) in Steroid Refractory Acute Graft vs Host Disease
NCT01936896	PHASE1/PHASE2	COMPLETED	Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction
NCT02010411	PHASE2	TERMINATED	Alpha1 Antitrypsin Aerosol Therapy in Cystic Fibrosis
NCT02191839	PHASE1/PHASE2	UNKNOWN	Single Dose Administration of Alpha-1 Anti-Trypsin for the Amelioration of Organ Injury in Patients Undergoing Cardiac Surgery
NCT02464878	PHASE2	COMPLETED	Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant
NCT02947087	PHASE1/PHASE2	COMPLETED	Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis
NCT03385395	PHASE2	WITHDRAWN	Study Comparing Weekly Intravenous Administration of OctaAlpha1 With a Marketed Preparation Glassia® in Subjects With Alpha-1-antitrypsin Deficiency
NCT03459040	PHASE2	COMPLETED	A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD
NCT04495101	PHASE2	COMPLETED	Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19
NCT05856331	PHASE2	COMPLETED	Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
NCT03172455	Not specified	NO_LONGER_AVAILABLE	Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).