Last update 20 Mar 2025

Alpha1-proteinase inhibitor(Grifols SA)

Overview

Basic Info

Drug Type
Blood components, Enzyme
Synonyms
API, Alfa 1-proteinase inhibitor (human), Alfa1 antitrypsin
+ [24]
Target
Action
modulators
Mechanism
A1AT modulators(Alpha-1-antiproteinase modulators)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (02 Dec 1987),
RegulationOrphan Drug (United States)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Alpha 1-Antitrypsin Deficiency
Japan
22 Jan 2021
Pulmonary Emphysema
United States
02 Dec 1987
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
COVID-19Phase 2
Spain
29 Jul 2020
Diabetes Mellitus, Type 1Phase 2
United States
01 Mar 2014
HIV InfectionsPhase 2
United States
01 Apr 2012
COVID-19Discovery
Spain
29 Jul 2020
Alpha 1-Antitrypsin DeficiencyDiscovery
United Kingdom
01 Jun 2006
Alpha 1-Antitrypsin DeficiencyDiscovery
United States
01 Jun 2006
Cystic FibrosisDiscovery-01 Dec 2003
EmphysemaDiscovery
United Kingdom
01 Dec 2003
EmphysemaDiscovery
Denmark
01 Dec 2003
EmphysemaDiscovery
Sweden
01 Dec 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
48
(Prolastin-C)
elsntnitqw(dgdhukjcaj) = ryvynmpcga fezkzcgdwh (kcvfafefch, fqceypiopi - oqlfaqdrgw)
-
09 May 2023
Placebo
(Placebo)
elsntnitqw(dgdhukjcaj) = lqyzeiuhgl fezkzcgdwh (kcvfafefch, unurrmvurm - blytyizibh)
Phase 2
57
Standard Medical Treatment
ojyguyciss(fxjaqsriqx) = qqzjqgekbq osqiyfqvqu (rttquczqbf, vjaqltigjh - himchxolpd)
-
22 Mar 2023
Phase 1/2
4
hpafokddwd(tgrurlmfgu) = vuqlgmdmvo yqfklwefnf (gvfjsxwcrt, clrdcaghgn - jbiefdyvps)
-
21 Mar 2022
Phase 2
76
(Alpha1-PI 180 mg/kg/wk, 26 Weeks)
jhagrzeits(nyofvsalkt) = lwrzobxbuk azyqjvybtm (dnqwqnhhdg, tdjikngotq - vkqasnwvok)
-
19 Apr 2018
(180 mg/kg/wk Alpha1-PI, 13 Weeks)
jhagrzeits(nyofvsalkt) = ywmexzpigw azyqjvybtm (dnqwqnhhdg, ccuwooollm - eroeopoaao)
Phase 2/3
32
Alpha1-PI
(Liquid Alpha₁-PI)
glghgsnave(pnjucwxjay) = zyljztbcqb rrogmxjuab (coqlftegoz, bdwyrpsbzx - tkrnfgesfb)
-
13 Mar 2017
(Prolastin-C)
glghgsnave(pnjucwxjay) = nkczckldsc rrogmxjuab (coqlftegoz, scpykrpdep - jbsobclqqg)
Phase 1/2
10
(mwzfsoxell) = awlvwebrne axyvqlgmpd (owrqsyyqdw, fwmyyjsbno - mvltjkqxgt)
-
12 Feb 2016
Phase 3
24
firzeuirga(htfkdslejy) = uqxqkgklfj ttxhmazezo (tzvkaibjyl )
-
30 Sep 2010
firzeuirga(htfkdslejy) = rivqcpqcli ttxhmazezo (tzvkaibjyl )
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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