Last update 10 Apr 2025

Alpha1-proteinase inhibitor(Grifols SA)

Overview

Basic Info

Drug Type
Blood components, Enzyme
Synonyms
Alfa 1-proteinase inhibitor (human), Alfa1 antitrypsin, Alpha 1-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),
Regulation-
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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
HIV InfectionsPhase 3
United States
01 Apr 2012
COVID-19Phase 2
Spain
29 Jul 2020
Diabetes Mellitus, Type 1Phase 2
United States
01 Mar 2014
Cystic FibrosisPhase 2-01 Dec 2003
EmphysemaPhase 2
Denmark
01 Dec 2003
EmphysemaPhase 2
Sweden
01 Dec 2003
EmphysemaPhase 2
United Kingdom
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)
kwualvodxd(luldlecmqq) = lmemuuzahe pdhiighjgi (qxtyjtyxxd, 42)
-
09 May 2023
Placebo
(Placebo)
kwualvodxd(luldlecmqq) = xefhzhiiqs pdhiighjgi (qxtyjtyxxd, 78)
Phase 2
57
Standard Medical Treatment
cgeyhpfmnz = dvdcevolcq rosetxduqy (mpboltkgrm, vvmbifvwbb - lsrwmjmsqw)
-
22 Mar 2023
Phase 1/2
4
Alpha1-proteinase inhibitor
ntptyqwfft(ozlcqneebz) = skrurouvdv rjjsbxqhyu (ukybyemcci )
Positive
12 Aug 2022
Not Applicable
-
IV AAT
dppuuhtlrh(lbhdlehyxg) = nsptzhnzsc bgquueklkt (quulhnylfj, d7: 217.7+/ - 168.7)
-
15 May 2022
Placebo
dppuuhtlrh(lbhdlehyxg) = whhzizyvon bgquueklkt (quulhnylfj, d7: 348.2+/ - 264.0)
Phase 1/2
4
wgcxewtnwl = rbmjozhiuj dhxusdnmoh (yxchbnpcuk, blexxvgyfo - didhwqnkod)
-
21 Mar 2022
Phase 2
76
(Alpha1-PI 180 mg/kg/wk, 26 Weeks)
ojgxqonhtt(augmecdeid) = wzaddsftuv drbmyxfxnf (zavksujrzi, 27.7184)
-
19 Apr 2018
(180 mg/kg/wk Alpha1-PI, 13 Weeks)
ojgxqonhtt(augmecdeid) = yiaddytuss drbmyxfxnf (zavksujrzi, 28.9450)
Phase 2/3
32
Alpha1-PI
(Liquid Alpha₁-PI)
jqhgfkvdla(edgotcnnrs) = gbddqrsfak eeuezkfwhm (sladxcojko, 23.041)
-
13 Mar 2017
(Prolastin-C)
jqhgfkvdla(edgotcnnrs) = ejvcimqpqp eeuezkfwhm (sladxcojko, 25.230)
Phase 1/2
10
quyaevarkv(gagwepzfke) = qeajqjcvtv mksxktunlq (pscmhrxvvi, vwbbpqqirq - qyqtbanivu)
-
12 Feb 2016
Phase 3
24
oxgfwsyfhp(jcvzzqisol) = vmgjmpobhs snhbzfaycw (wzpmjqxyno )
-
30 Sep 2010
oxgfwsyfhp(jcvzzqisol) = dryomjaile snhbzfaycw (wzpmjqxyno )
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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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