Alpha 1-Antitrypsin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Respreeza | — | 2015-08-20 | europa.eu ↗ |
Trials 55 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT02087813 | Mar 2014 → Mar 2016 | neuromyelitis optica | Stanford University | Withdrawn | No outcome recorded |
| Phase 1 | NCT01347190 | Apr → Aug 2011 | cystic fibrosis | CSL Behring | Completed | No outcome recorded |
| Phase 1 | NCT01319331 | Oct 2010 → Oct 2015 | type 1 diabetes mellitus | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1 | NCT01183468 | Oct 2010 → Jul 2013 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 1/29 trials | ||||||
| Phase 1/2 | NCT04722887 | Aug 2021 → Aug 2025 | alpha 1-antitrypsin deficiency | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT02870309 | Jul 2016 → Mar 2017 | alpha 1-antitrypsin deficiency | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT02870348 | Jul 2016 → Feb 2021 | alpha 1-antitrypsin deficiency | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT02520076 | Aug 2015 → Sep 2019 | type 1 diabetes mellitus | University of Alberta | Completed | No outcome recorded |
| Phase 1/2 | NCT01936896 | Dec 2013 → Jun 2014 | acute myocardial infarction | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1/2 | NCT01523821 | Oct 2013 → Jan 2017 | chronic graft versus host disease | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01304537 | Jun 2011 → Nov 2012 | type 1 diabetes mellitus | Kamada, Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT00157092 | Mar → Oct 2004 | alpha 1-antitrypsin deficiency | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 1/2 | NCT00161707 | Jan → Oct 2003 | alpha 1-antitrypsin deficiency | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 219 trials | ||||||
| Phase 2 | NCT07125664 | Oct 2025 → Oct 2027 expected | chronic obstructive pulmonary disease | Fondazione IRCCS Policlinico San Matteo di Pavia | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05485155 | May 2025 → Oct 2026 expected | eosinophilic esophagitis | Children's Hospital Medical Center, Cincinnati | Recruiting | No outcome recorded |
| Phase 2 | NCT06582329 | Apr → Jul 2025 overdue | alcoholic hepatitis | Medical University Innsbruck | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04547140 | Jan → Dec 2021 | COVID-19 | Grifols Therapeutics LLC | Terminated | No outcome recorded |
| Phase 2 | NCT04495101 | Jul 2020 → Apr 2021 | COVID-19 | Grifols, S.A. | Completed | No outcome recorded |
| Phase 2 | NCT03459040 | Aug 2018 → Aug 2020 | graft versus host disease | John Levine | Completed | No outcome recorded |
| Phase 2 | NCT02464878 | Jan 2017 → Nov 2022 | type 1 diabetes mellitus | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02614872 | Jul 2016 → Apr 2019 | transplant rejection | Kamada, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02005848 | Apr 2014 → Feb 2017 | type 1 diabetes mellitus | Kamada, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02001688 | Apr 2014 → Feb 2016 | alpha 1-antitrypsin deficiency | Kamada, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02093221 | Mar 2014 → Jan 2017 | type 1 diabetes mellitus | Grifols Therapeutics LLC | Terminated | No outcome recorded |
| Phase 2 | NCT01700036 | Jul 2013 → Oct 2016 | graft versus host disease | University of Michigan Rogel Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01661192 | Jan 2013 → Jan 2017 | type 1 diabetes mellitus | Rabin Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01669421 | Jul 2012 → May 2016 | alpha 1-antitrypsin deficiency | Michael Campos, MD | Completed | No outcome recorded |
| Phase 2 | NCT01394835 | Sep 2011 → Sep 2012 | bronchiolitis obliterans syndrome | Rabin Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT01183455 | Oct 2010 → Aug 2014 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 2 | NCT00499837 | Sep 2007 → Jul 2008 | cystic fibrosis | Kamada, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00486837 | Dec 2003 → Jun 2004 | cystic fibrosis | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT00263887 | Dec 2003 → Jan 2007 | alpha 1-antitrypsin deficiency | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 2/36 trials | ||||||
| Phase 2/3 | NCT02956122 | Apr 2017 → May 2018 | acute graft versus host disease | Baxalta now part of Shire | Terminated | No outcome recorded |
| Phase 2/3 | NCT02282527 | Oct 2014 → Jan 2016 | alpha 1-antitrypsin deficiency | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 2/3 | NCT01731691 | Apr 2012 → Jul 2014 | HIV infectious disease | Institute for Human Genetics and Biochemistry | Terminated | No outcome recorded |
| Phase 2/3 | NCT01217671 | Dec 2009 → Nov 2014 | pulmonary emphysema | Kamada, Ltd. | Completed | No outcome recorded |
| Phase 2/3 | NCT00460096 | Mar → Sep 2007 | alpha 1-antitrypsin deficiency | Kamada, Ltd. | Completed | No outcome recorded |
| Phase 2/3 | NCT01370018 | Dec 2006 → Feb 2007 | HIV infectious disease | Institute for Human Genetics and Biochemistry | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT07555483 | May 2026 → Sep 2027 expected | alpha 1-antitrypsin deficiency | Grifols Therapeutics LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT04675086 | Jan → Sep 2021 | COVID-19, viral pneumonia | Blessing Corporate Services, Inc | Withdrawn | No outcome recorded |
| Phase 3 | NCT04167514 | Jan 2020 → Sep 2023 | graft versus host disease | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT02722304 | Nov 2016 → Sep 2018 | alpha 1-antitrypsin deficiency, chronic obstructive pulmonary disease | Baxalta now part of Shire | Terminated | No outcome recorded |
| Phase 3 | NCT02796937 | Jul 2016 → Sep 2028 expected | pulmonary emphysema | Grifols Therapeutics LLC | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT02525861 | Mar 2016 → Jul 2020 | alpha 1-antitrypsin deficiency | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 3 | NCT01983241 | Nov 2013 → Aug 2026 overdue | pulmonary emphysema | Grifols Therapeutics LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00301366 | Jun 2006 → Mar 2007 | alpha 1-antitrypsin deficiency | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT07326592 | Jul 2026 → Sep 2033 expected | alpha 1-antitrypsin deficiency, pulmonary emphysema | CSL Behring | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04440488 | Mar 2021 → Sep 2025 | alpha 1-antitrypsin deficiency, chronic obstructive pulmonary disease | Shire | Withdrawn | No outcome recorded |
| Phase 4 | NCT02713997 | Dec 2016 → Jul 2023 | chronic pancreatitis | University of Minnesota | Completed | No outcome recorded |
| Phase 4 | NCT01651351 | Jul 2012 → Jan 2013 | alpha 1-antitrypsin deficiency | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT00670007 | Apr 2008 → Sep 2014 | alpha 1-antitrypsin deficiency, pulmonary emphysema | CSL Behring | Completed | No outcome recorded |
| Phase 4 | NCT00396006 | Oct 2006 → Dec 2007 | alpha 1-antitrypsin deficiency | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 4 | NCT00313144 | Jun 2006 → Dec 2008 | alpha 1-antitrypsin deficiency | Baxalta now part of Shire | Terminated | No outcome recorded |
| Phase 4 | NCT00261833 | Mar 2006 → Sep 2012 | alpha 1-antitrypsin deficiency, pulmonary emphysema | CSL Behring | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03172455 | — | acute graft versus host disease, alpha 1-antitrypsin deficiency | Impatients N.V. trading as myTomorrows | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00242385 Comparator | Dec 2005 → Jun 2006 | alpha 1-antitrypsin deficiency | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02191839 Comparator | Jul 2014 → Jul 2015 | post-cardiac arrest syndrome | Soroka University Medical Center | Unknown | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05856331 Comparator | Oct 2023 → Aug 2025 | alpha 1-antitrypsin deficiency, pulmonary emphysema | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT03385395 Comparator | Jul 2018 → Dec 2019 | alpha 1-antitrypsin deficiency | Octapharma | Withdrawn | No outcome recorded |
| Phase 2 | NCT01213043 Comparator | Nov 2010 → Jan 2012 | alpha 1-antitrypsin deficiency, pulmonary emphysema | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT02010411 Comparator | Jun → Oct 2004 | cystic fibrosis | University of Sherbrooke | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04204252 Comparator | Nov 2019 → Dec 2028 expected | alpha 1-antitrypsin deficiency | Kamada, Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT00295061 Comparator | May 2006 → Feb 2007 | alpha 1-antitrypsin deficiency | Grifols Therapeutics LLC | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05466747 Comparator | Jan 2024 → Apr 2027 | alpha 1-antitrypsin deficiency, chronic obstructive pulmonary disease | Takeda | Withdrawn | No outcome recorded |
| Phase 4 | NCT05582798 Comparator | Nov 2022 → Aug 2024 | bronchiectasis | University of Dundee | Completed | No outcome recorded |
Press releases naming this drug 27 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-17 | Sanofi | Press Release: Sanofi’s efdoralprin alfa earns orphan designation in the EU for alpha-1 antitrypsin deficiency related emphysema sanofi.com ↗ |
| 2025-12-01 | Regeneron Pharmaceuticals | Regeneron and Tessera Therapeutics to Jointly Develop TSRA-196, an Investigational Gene Editing Therapy for Alpha-1 Antitrypsin Deficiency (AATD) regeneron.com ↗ |
| 2025-10-22 | Sanofi | Press Release: Sanofi’s efdoralprin alfa met all primary and key secondary endpoints in alpha-1 antitrypsin deficiency emphysema phase 2 study sanofi.com ↗ |
| 2024-01-23 | Sanofi | Press Release: Sanofi to acquire Inhibrx, Inc., adding potential best-in- class rare disease asset for Alpha-1 Antitrypsin Deficiency to pipeline sanofi.com ↗ |
| 2024-01-02 | CSL Behring | CSL Behring Demonstrates Continued Commitment to Alpha-1 Community with Addition of ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)] 4- and 5-Gram Vials csl.com ↗ |
| 2023-01-09 | Takeda | Arrowhead and Takeda Announce Topline Results from SEQUOIA Phase 2 Study of Fazirsiran in Patients with Alpha-1 Antitrypsin Deficiency-Associated Liver Disease takeda.com ↗ |
| 2022-10-11 | Vertex Pharmaceuticals Incorporated | Vertex Advances Program Targeting Alpha-1 Antitrypsin Deficiency vrtx.com ↗ |
| 2022-06-27 | Takeda | Results from Phase 2 Study of Fazirsiran in Patients with Alpha-1 Antitrypsin Deficiency Published in New England Journal of Medicine takeda.com ↗ |
| 2021-06-10 | Vertex Pharmaceuticals Incorporated | Vertex Announces Primary Endpoint Achieved in Phase 2 Study of VX-864 in Alpha-1 Antitrypsin Deficiency vrtx.com ↗ |
| 2020-10-14 | Vertex Pharmaceuticals Incorporated | Vertex Provides Update on its Clinical Programs Targeting Alpha-1 Antitrypsin Deficiency vrtx.com ↗ |
| 2020-10-08 | Takeda | Takeda and Arrowhead Collaborate to Co-Develop and Co-Commercialize ARO-AAT for Alpha-1 Antitrypsin-Associated Liver Disease takeda.com ↗ |
| 2020-04-06 | Alnylam Pharmaceuticals | Alnylam and Dicerna Form RNAi Therapeutics Collaboration on Alpha-1 Antitrypsin Deficiency-Associated Liver Disease and Complete Cross-License Agreement for Primary Hyperoxaluria Programs alnylam.com ↗ |
| 2019-04-25 | CSL Behring | CSL Behring Delivers on its Continued Commitment to Alpha 1 Patients with FDA Approval of Convenient Single-Vial Dosing for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)] csl.com ↗ |
| 2018-10-03 | Alnylam Pharmaceuticals | Alnylam Submits Clinical Trial Authorization (CTA) Application for ALN-AAT02, an Investigational RNAi Therapeutic for the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease (Alpha-1 Liver Disease) alnylam.com ↗ |
| 2016-12-02 | CSL Behring | The Lancet Respiratory Medicine Publishes RAPID Extension Study Data Confirming Disease-modifying Effect of Respreeza® [Alpha1-Proteinase Inhibitor (Human)] in Patients with Alpha-1 Antitrypsin Deficiency (AATD) csl.com ↗ |
| 2016-06-15 | Takeda | Shire and Kamada announce FDA approval of expanded label for self-infusion of Glassia for the treatment of emphysema due to severe AAT deficiency takeda.com ↗ |
| 2015-09-28 | CSL Behring | New Clinical Data on Treatment to Slow the Progression of Emphysema in Patients with Alpha-1 Antitrypsin Deficiency Presented at European Respiratory Society International Congress in Amsterdam csl.com ↗ |
| 2015-07-27 | Alnylam Pharmaceuticals | Alnylam Initiates Phase 1/2 Clinical Trial for ALN-AAT, an Investigational RNAi Therapeutic for the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease (Alpha-1 Liver Disease) alnylam.com ↗ |
| 2015-06-29 | CSL Behring | CSL Behring Receives Positive CHMP Opinion for Respreeza® as Maintenance Treatment for Severe Alpha-1 Antitrypsin Deficiency Patients in Europe csl.com ↗ |
| 2015-06-01 | CSL Behring | The Lancet Publishes CSL Behring’s Alpha-1 Antitrypsin Deficiency Study Data csl.com ↗ |
| 2015-05-17 | Alnylam Pharmaceuticals | Alnylam Files Clinical Trial Application (CTA) for ALN-AAT, an Investigational RNAi Therapeutic for the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease (Alpha-1 Liver Disease) alnylam.com ↗ |
| 2014-06-19 | Alnylam Pharmaceuticals | Alnylam and The Alpha-1 Project (TAP) Form Collaboration for Advancement of ALN-AAT, an RNAi Therapeutic in Development for the Treatment of Alpha-1 Antitrypsin (AAT) Deficiency-Associated Liver Disease alnylam.com ↗ |
| 2014-05-06 | Alnylam Pharmaceuticals | Alnylam Advances Development Candidate for ALN-AAT, a Subcutaneously Administered RNAi Therapeutic Targeting Alpha-1 Antitrypsin (AAT) in Development for the Treatment of AAT Deficiency-Associated Liver Disease alnylam.com ↗ |
| 2014-04-05 | CSL Behring | CSL Behring Presents Data on RAPID Trial Extension and Supports Alpha-1 International Research and Patient Conference csl.com ↗ |
| 2013-11-25 | CSL Behring | CSL Behring Launches Innovative Test Kit Designed to Improve Diagnosis of Alpha-1 csl.com ↗ |
| 2013-11-02 | Alnylam Pharmaceuticals | Alnylam Presents New Pre-clinical Data on ALN-AAT, an RNAi Therapeutic Targeting Alpha-1-Antitrypsin (AAT) for the Treatment of AAT Deficiency Liver Disease alnylam.com ↗ |
| 2012-11-14 | Alnylam Pharmaceuticals | Alnylam Presents New Pre-clinical Data on RNAi Therapeutics for the Treatment of Alpha-1 Antitrypsin (AAT) Deficiency alnylam.com ↗ |
Evidence & citations 44 cited values
Every value below carries the sentence it was read from. 80 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | alpha-1 antitrypsin | “Intravenous augmentation therapy with purified preparations of AAT (Alpha1-antitrypsin) derived from human plasma is a well consolidated specific therapeutic option to treat...” NCT07125664 ↗30“Phase II, Double-Blind, Placebo-Controlled Study to Explore the ELF and Plasma Concentration as Well as Safety of Inhaled Alpha 1 Antitrypsin in Alpha-1 Antitrypsin Deficiency Subjects” NCT02001688 ↗ “Alpha1-Proteinase Inhibitor (Human), AralastÔ, is a sterile, stable, lyophilized preparation of purified human alpha1-proteinase inhibitor (a1-PI), also known as alpha1-antitrypsin.” NCT04675086 ↗ “Augmentation therapy with intravenous AAT (alpha-1 antitrypsin) is the only specific therapy for individuals with pulmonary disease from AAT deficiency (AATD).” PMID 30965011 ↗ Aug 2019 “Safety and Efficacy of Inhaled Alpha-1 Antitrypsin in Preventing Bronchiolitis Obliterable Syndrome in Lung Transplant Recipients” NCT01394835 ↗ “Alpha-1 Antitrypsin (A1AT) acts as an anti-inflammatory protein by inhibiting the generation of pro-inflammatory cytokines.” NCT06582329 ↗ “This clinical trial will study the safety and efficacy of using the drug Zemaira, an Alpha 1-Antitrypsin (AAT) medication” NCT01700036 ↗ “plasma-derived alpha-1 antitrypsin (AAT) inhibits the inflammatory injury in myocardial ischemia and reperfusion.” PMID 29634656 ↗ Jun 2018 “Alpha-1 MP is a stable, sterile, lyophilized preparation of human alpha1-PI, also known as alpha1-antitrypsin.” NCT02870348 ↗ “Alpha-1 antitrypsin (A1AT) reduces inflammatory cytokines” NCT02713997 ↗ “Human, Alpha-1 Antitrypsin (AAT) [GLASSIA®] Treatment” NCT02614872 ↗ “a drug called alpha-1-antitrypsin (AAT)” NCT03459040 ↗ “Alpha-1 anti-trypsin (AAT)” NCT01936896 ↗ “Drug: Alpha -1 Antitrypsin” NCT01394835 ↗ “Alpha-1 Antitrypsin (AAT)” NCT01217671 ↗ |
| Known as | A1AT | “Alpha-1 Antitrypsin (A1AT) acts as an anti-inflammatory protein by inhibiting the generation of pro-inflammatory cytokines.” NCT06582329 ↗1“Alpha-1 antitrypsin (A1AT) reduces inflammatory cytokines” NCT02713997 ↗ |
| Known as | A1PI | “INTRODUCTION: Augmentation therapy with plasma-derived α1-proteinase inhibitor (A1PI) products is currently the only approved disease-specific therapy for α1-antitrypsin...” PMID 36001294 ↗ Aug 20224“Patients who had received either A1PI treatment (Zemaira or Respreeza; early-start group) or placebo (delayed-start group) in the RAPID-RCT trial were included in this 2-year...” PMID 27916480 ↗ Dec 2016 “Alpha1-Proteinase Inhibitor (Human), AralastÔ, is a sterile, stable, lyophilized preparation of purified human alpha1-proteinase inhibitor (a1-PI), also known as alpha1-antitrypsin.” NCT04675086 ↗ “GLASSIA (human alpha-1 proteinase inhibitor (A1PI), also known as human alpha-1 antitrypsin, Kamada-AAT or Kamada-API) is a, liquid, ready-to-use preparation of human A1PI.” NCT03172455 ↗ “α1 proteinase inhibitor (A1PI) augmentation treatment” PMID 26026936 ↗ May 2015 |
| Known as | A1PI-GLASSIA | “In this study, a new, high-purity (≥90% A1PI in monomeric form), ready-to-use, liquid formulation of A1PI-GLASSIA (Kamada, Ness Ziona, Israel) was compared to PROLASTINÆ...” PMID 23822603 ↗ Jul 2013 |
| Known as | AAT | “Intravenous augmentation therapy with purified preparations of AAT (Alpha1-antitrypsin) derived from human plasma is a well consolidated specific therapeutic option to treat...” NCT07125664 ↗10“Augmentation therapy with intravenous AAT (alpha-1 antitrypsin) is the only specific therapy for individuals with pulmonary disease from AAT deficiency (AATD).” PMID 30965011 ↗ Aug 2019 “This clinical trial will study the safety and efficacy of using the drug Zemaira, an Alpha 1-Antitrypsin (AAT) medication” NCT01700036 ↗ “plasma-derived alpha-1 antitrypsin (AAT) inhibits the inflammatory injury in myocardial ischemia and reperfusion.” PMID 29634656 ↗ Jun 2018 “Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients” NCT00499837 ↗ “Human, Alpha-1 Antitrypsin (AAT) [GLASSIA®] Treatment” NCT02614872 ↗ “Alpha-1 Antitrypsin 40mg (AAT, Glassia®)” NCT01304537 ↗ “low AAT (Alpha 1 Antitrypsin)” NCT06582329 ↗ “AAT( Alpha 1 Antitrypsin)” NCT01661192 ↗ “Alpha-1 Antitrypsin (AAT)” NCT01217671 ↗ “Drug: AAT” NCT01394835 ↗ |
| Known as | Alfa1 Antitrypsin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06582329 ↗ |
| Known as | Alpha-1 | “the abundant blood protein α1proteinase inhibitor (α1PI, α1-antitrypsin, Alpha-1)” PMID 31824943 ↗ Nov 2019 |
| Known as | Alpha-1 antitrypsin (AAT) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04167514 ↗ |
| Known as | Alpha-1 Antitrypsin (human) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01669421 ↗ |
| Known as | ALPHA-1 ANTITRYSIN | “Intervenous ALPHA-1 ANTITRYSIN (AAT)Glasia™ in Type 1 Diabetes Mellitus” NCT01661192 ↗ |
| Known as | Alpha-1 MP | “This is a multi-center, open-label study to evaluate the long-term safety of weekly intravenous (IV) infusions of 60 mg/kg alpha1-PI (human), modified process (Alpha-1 MP) in...” NCT02870348 ↗4“Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP” NCT00295061 ↗ |
| Known as | Alpha-proteinase inhibitor | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05485155 ↗ |
| Known as | alpha1 -PI [human] | “Because alpha1 -PI [human] (alpha1 -PI[h]) therapy can inhibit pro-inflammatory mediators associated with β-cell destruction and reduced insulin production” PMID 33244872 ↗ Dec 2020 |
| Known as | alpha1 -PI[h] | “Because alpha1 -PI [human] (alpha1 -PI[h]) therapy can inhibit pro-inflammatory mediators associated with β-cell destruction and reduced insulin production” PMID 33244872 ↗ Dec 2020 |
| Known as | Alpha1-PI | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02093221 ↗ |
| Known as | alpha1-proteinase inhibitor | “single dose ARALAST alpha1-proteinase inhibitor 60 mg/kg” NCT00242385 ↗9“Alpha1-Proteinase Inhibitor Subcutaneous (Human), 15%” NCT07555483 ↗ “ARALAST Alpha1-Proteinase Inhibitor” NCT00313144 ↗ |
| Known as | alpha1-proteinase inhibitor (human) | “A Multi-center, Randomized, Double-blind, Crossover Study to Assess the Safety and Pharmacokinetics of Liquid Alpha₁-Proteinase Inhibitor (Human) Compared to Prolastin®-C in...” NCT02282527 ↗11“Alpha1-Proteinase Inhibitor (Human), AralastÔ, is a sterile, stable, lyophilized preparation of purified human alpha1-proteinase inhibitor (a1-PI), also known as alpha1-antitrypsin.” NCT04675086 ↗ “Biochemical efficacy and safety of a new, ready-to-use, liquid alpha-1-proteinase inhibitor, GLASSIA (alpha1-proteinase inhibitor (human), intravenous).” PMID 23822603 ↗ Jul 2013 “Alpha1-Proteinase Inhibitor (Human), 15%, Subcutaneous infusion” NCT04722887 ↗ “Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002)” NCT01347190 ↗ “Alpha 1-Proteinase Inhibitor Human” NCT01183455 ↗ |
| Known as | Alpha1-proteinase Inhibitor (Human), Modified Process | “Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process)” NCT02870309 ↗ |
| Known as | Alpha1-Proteinase Inhibitor, Modified Process | “Alpha1-Proteinase Inhibitor, Modified Process (Alpha-1 MP) is used for augmentation therapy” PMID 30416054 ↗ Nov 2018 |
| Known as | Another Available A1PI | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05466747 ↗ |
| Known as | Aralast | “The Effect of Augmentation Therapy With ARALAST Fraction IV-1 (ARALAST) Alpha1-Proteinase Inhibitor (α1-PI) on the Level of α1-PI and Other Analytes in the Bronchoalveolar...” NCT00396006 ↗ |
| Known as | ARALAST Fr. IV-1 | “ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor (ARALAST Fr. IV-1)” NCT00242385 ↗ |
| Known as | ARALAST NP | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02722304 ↗ |
| Known as | AralastÔ | “Alpha1-Proteinase Inhibitor (Human), AralastÔ, is a sterile, stable, lyophilized preparation of purified human alpha1-proteinase inhibitor (a1-PI), also known as alpha1-antitrypsin.” NCT04675086 ↗ |
| Known as | CE1226 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07326592 ↗ |
| Known as | CR002 | “Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002)” NCT01347190 ↗ |
| Known as | Glasia | “Intervenous ALPHA-1 ANTITRYSIN (AAT)Glasia™ in Type 1 Diabetes Mellitus” NCT01661192 ↗ |
| Known as | Glassia | “A Randomized, Double-blind, Parallel-group, Multicenter, Pharmacokinetic Study Comparing Weekly Intravenous Administration of OctaAlpha1 (Octapharma) With a Marketed...” NCT03385395 ↗10“GLASSIA (human alpha-1 proteinase inhibitor (A1PI), also known as human alpha-1 antitrypsin, Kamada-AAT or Kamada-API) is a, liquid, ready-to-use preparation of human A1PI.” NCT03172455 ↗ “Biochemical efficacy and safety of a new, ready-to-use, liquid alpha-1-proteinase inhibitor, GLASSIA (alpha1-proteinase inhibitor (human), intravenous).” PMID 23822603 ↗ Jul 2013 “Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]” NCT01523821 ↗ “Human, Alpha-1 Antitrypsin (AAT) [Glassia®]” NCT02005848 ↗ “Alpha-1 Antitrypsin 40mg (AAT, Glassia®)” NCT01304537 ↗ |
| Known as | human alpha-1 antitrypsin | “GLASSIA (human alpha-1 proteinase inhibitor (A1PI), also known as human alpha-1 antitrypsin, Kamada-AAT or Kamada-API) is a, liquid, ready-to-use preparation of human A1PI.” NCT03172455 ↗ |
| Known as | human alpha-1 proteinase inhibitor | “GLASSIA (human alpha-1 proteinase inhibitor (A1PI), also known as human alpha-1 antitrypsin, Kamada-AAT or Kamada-API) is a, liquid, ready-to-use preparation of human A1PI.” NCT03172455 ↗ |
| Known as | Kamada-AAT | “GLASSIA (human alpha-1 proteinase inhibitor (A1PI), also known as human alpha-1 antitrypsin, Kamada-AAT or Kamada-API) is a, liquid, ready-to-use preparation of human A1PI.” NCT03172455 ↗ |
| Known as | Kamada-AAT for Inhalation | “This is a randomised , placebo controlled, double blind , multicentre, Phase II/III study evaluating the safety and efficacy of Kamada AAT for inhalation in patients with...” NCT01217671 ↗1“Daily inhalation of 80 mg/day "Kamada-AAT for Inhalation" for 104 weeks” NCT04204252 ↗ |
| Known as | Kamada-API | “GLASSIA (human alpha-1 proteinase inhibitor (A1PI), also known as human alpha-1 antitrypsin, Kamada-AAT or Kamada-API) is a, liquid, ready-to-use preparation of human A1PI.” NCT03172455 ↗ |
| Known as | Liquid Alpha1-Proteinase Inhibitor (Human) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04547140 ↗ |
| Known as | Prolastin | “Augmentation therapy with Prolastin® (Alpha₁-Proteinase Inhibitor [Human]) to increase the levels of alpha₁-PI has been used to treat individuals with AAT deficiency for over 20 years.” PMID 20920295 ↗ Sep 20103“alpha1-proteinase inhibitor, produced from the plasma of human donors (Prolastin 1000 mg, powder and solvent for solution for infusion)” NCT07125664 ↗ |
| Known as | Prolastin-C | “Patients will be randomly assigned to receive Prolastin-C 120mg/kg (n=10 patients) by weekly intravenous infusions, Prolastin-C 180mg/kg (n=10 patients) by weekly intravenous...” NCT05582798 ↗3“A Multi-center, Randomized, Double-blind, Crossover Study to Assess the Safety and Pharmacokinetics of Liquid Alpha₁-Proteinase Inhibitor (Human) Compared to Prolastin®-C in...” NCT02282527 ↗ |
| Known as | rAAT | “The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with...” NCT00161707 ↗ |
| Known as | Zemaira | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05856331 ↗ |
| Known as | α-1-antitrypsin | “α-1 antitrypsin (AAT) has been shown to reduce inflammatory markers, promote a semimature LPS-induced DC phenotype, facilitate Treg expansion, and protect pancreatic islets...” PMID 22634621 ↗ May 20127“α1Proteinase inhibitor (α1PI or α1antitrypsin) therapy has been the standard treatment for people with insufficient α1PI blood levels.” NCT01731691 ↗ “Efficacy and safety of inhaled α1-antitrypsin in patients with severe α1-antitrypsin deficiency and frequent exacerbations of COPD.” PMID 31467115 ↗ Nov 2019 “We conducted a multicenter proof-of-concept "preemptive" treatment trial of α-1-antitrypsin (AAT), a serine protease inhibitor” PMID 33351103 ↗ Dec 2020 “Similar to aprotinin, α1-Antitrypsin (AAT) is a 52-kDa circulating serine protease inhibitor classified as a SERPIN protein.” NCT02191839 ↗ “Long-term safety of α-1 antitrypsin therapy in children and adolescents with Type 1 diabetes.” PMID 30236025 ↗ Sep 2018 “the abundant blood protein α1proteinase inhibitor (α1PI, α1-antitrypsin, Alpha-1)” PMID 31824943 ↗ Nov 2019 “α1-Antitrypsin (AAT), a naturally abundant serine protease inhibitor” PMID 29437593 ↗ Feb 2018 |
| Known as | α1PI | “The Effect of Augmentation Therapy With ARALAST Fraction IV-1 (ARALAST) Alpha1-Proteinase Inhibitor (α1-PI) on the Level of α1-PI and Other Analytes in the Bronchoalveolar...” NCT00396006 ↗1“the abundant blood protein α1proteinase inhibitor (α1PI, α1-antitrypsin, Alpha-1)” PMID 31824943 ↗ Nov 2019 |
| Known as | α1proteinase inhibitor | “INTRODUCTION: Augmentation therapy with plasma-derived α1-proteinase inhibitor (A1PI) products is currently the only approved disease-specific therapy for α1-antitrypsin...” PMID 36001294 ↗ Aug 20224“BACKGROUND: Purified α1 proteinase inhibitor (A1PI) slowed emphysema progression in patients with severe α1 antitrypsin deficiency in a randomised controlled trial (RAPID-RCT),...” PMID 27916480 ↗ Dec 2016 “α1Proteinase inhibitor (α1PI or α1antitrypsin) therapy has been the standard treatment for people with insufficient α1PI blood levels.” NCT01731691 ↗ “the abundant blood protein α1proteinase inhibitor (α1PI, α1-antitrypsin, Alpha-1)” PMID 31824943 ↗ Nov 2019 “α1 proteinase inhibitor (A1PI) augmentation treatment” PMID 26026936 ↗ May 2015 |
| Action | Restore | “Inhalation of AAT may restore protective levels in the lungs.” PMID 19251783 ↗ Feb 2009 |
| Modality | Protein / enzyme biologic | “Recombinant Alpha 1-Antitrypsin” NCT00157092 ↗ |
| Route | Inhaled | “administered via nebulization” NCT00157092 ↗ |