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alpha-1 antitrypsin

Trade name: Prolastin

BiologicalapprovedOrphan Drug FDA

Approved

Dec 2, 1987

Kamada is a Japanese surname. Notable people with the surname include:Daichi Kamada , Japanese footballer Hiroko Kamada , Japanese fencer Makoto Kamada , Japanese sport wrestler Michiaki Kamada , Imperial Japanese Navy admiral Satoru Kamada , Japanese motorcycle racer Yasuji Kamada , Japanese photographer — Wikipedia

Clinical trial activity

73 trials · 62 clinical orgs · 4 marketing orgs

Phase 1
18
Phase 2
48
Phase 3
15
Phase 4
11

Earliest trial started Jan 1, 2003 (NCT00161707)

Timeline

1980s

  1. Dec 7, 1984

    Orphan Drug Designation

  2. Jun 1, 1987

    Baxter — First NDA Organization

  3. Jun 1, 1987

    Baxter — NDA Organization

  4. Dec 2, 1987

    Earliest FDA Approval

  5. Dec 2, 1987

    Grifols — NDA Secondary Org

2000s

  1. Dec 23, 2002

    Takeda — NDA Secondary Org

  2. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2003

    Grifols — Earliest Phase 2 Sponsor(trial)

  4. Jul 8, 2003

    CSL Behring — NDA Secondary Org

  5. Jan 1, 2006

    Grifols — Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 2, 1987

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • aerosolized, recombinant alpha 1-antitrypsin
  • alfa1 antitrypsin
  • alpha-1-antiproteinase
  • alpha 1 antitrypsin
  • alpha 1-antitrypsin
  • alpha 1-antitrypsin
  • alpha-1 antitrypsin
  • alpha-1-antitrypsin
  • alpha-1 hc
  • alpha-1 mp
  • alpha-1 protease inhibitor
  • alpha 1-proteinase inhibitor
  • alpha-1 proteinase inhibitor
  • alpha-1-proteinase inhibitor
  • alpha1- proteinase inhibitor
  • alpha1-proteinase inhibitor
  • alpha1-proteinase inhibitor
  • alpha 1-proteinase inhibitor (human)
  • alpha 1-proteinase inhibitor, human
  • alpha-1 proteinase inhibitor (human)
  • alpha-1 proteinase inhibitor (human)
  • alpha-1-proteinase inhibitor human
  • alpha-1-proteinase inhibitor (human)
  • alpha-1-proteinase inhibitor (human)
  • alpha-1-proteinase inhibitor,human
  • alpha-1-proteinase inhibitor, human
  • alpha1-proteinase inhibitor human
  • alpha1-proteinase inhibitor (human)
  • api
  • api
  • aralast
  • aralast
  • glassia
  • human alpha1-proteinase inhibitor
  • human, plasma-derived alpha-1 antitrypsin
  • kamada
  • prolastin
  • prolastin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07125664Phase 2Oct 1, 2025University of Pavia
NCT06582329Phase 2Jan 31, 2025Medical University Innsbruck
NCT06568302Phase 3Jul 11, 2024Centessa
NCT05856331Phase 2Oct 12, 2023Inhibrx, Inc.
NCT05789537Phase 2Jul 28, 2023Centessa
NCT05789524Phase 2Jul 6, 2023Centessa
NCT05485155Phase 2Jan 31, 2023CSL Behring, National Institutes of Health (NIH), University of Cincinnati
NCT05466747Phase 4Jan 16, 2023Takeda
NCT05582798Phase 4Nov 1, 2022University of Dundee
NCT04722887Phase 1/Phase 2 (Phase 2)Aug 13, 2021Grifols
NCT04440488Phase 4Mar 8, 2021Shire
NCT04675086Phase 3Jan 31, 2021Blessing Corporate Services, Inc, Takeda, University of Bern
NCT04547140Phase 2Dec 31, 2020Grifols
NCT04495101Phase 2Jul 29, 2020Grifols
NCT04385836Early Phase 1 (Phase 1)Jun 1, 2020Government of Saudi Arabia
NCT04167514Phase 3Dec 31, 2019Blood and Marrow Transplant Clinical Trials Network, CSL Behring, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
NCT04204252Phase 3Nov 25, 2019Kamada, Ltd., Leiden University, Syneos Health
NCT04073498Phase 1/Phase 2 (Phase 2)Aug 31, 2019Centessa
NCT03805789Phase 2/Phase 3 (Phase 3)Mar 27, 2019CSL Behring
NCT03459040Phase 2Aug 17, 2018Icahn School of Medicine at Mount Sinai, National Cancer Institute (NCI)
Showing 20 of 73 trials
Page 1 / 4

Organizations

Research & Development (62)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GrifolsFor profit161522003
Kamada, Ltd.For profit11832007
BaxaltaFor profit10942003
CSL BehringFor profit8442006
CentessaFor profit4422019
National Cancer Institute (NCI)Government3022013
Tel Aviv UniversityAcademic/Hospital3212011
University of FloridaAcademic/Hospital3012003
Arriva Pharmaceuticals, Inc.For profit2012003
Arrowhead PharmaceuticalsFor profit2222015
Hebrew UniversityAcademic/Hospital2012007
Icahn School of Medicine at Mount SinaiAcademic/Hospital2122006
Immune Tolerance NetworkAcademic/Hospital2022010
Joslin Diabetes CenterAcademic/Hospital2022010
Juvenile Diabetes Research FoundationAcademic/Hospital2022010
Leiden UniversityAcademic/Hospital2012009
Medical University of South CarolinaAcademic/Hospital2012010
National Heart, Lung, and Blood Institute (NHLBI)Government2022013
National Institute of Allergy and Infectious Diseases (NIAID)Government2222010
National Institutes of Health (NIH)Government2022019
62 organizations
Page 1 / 4

Marketing (4)

OrganizationOrg typeRelationshipDate
BaxterFor profitNDAJun 1, 1987
CSL BehringFor profitNDA2Jul 8, 2003
GrifolsFor profitNDA2Dec 2, 1987
TakedaFor profitNDA2Dec 23, 2002