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Alpha 1-Antitrypsin Deficiency

8
Pipeline Programs
13
Companies
19
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
1
1
1
2
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Kamada
KamadaIsrael - Negev
2 programs
1
1
Alpha 1-AntitrypsinPhase 3
Kamada-APIPhase 2/31 trial
Active Trials
NCT00460096Completed50Est. Sep 2007
Syneos Health
Syneos HealthNC - Morrisville
1 program
1
Alpha 1-AntitrypsinPhase 31 trial
Active Trials
NCT04204252Recruiting220Est. Jun 2031
Arrowhead Pharmaceuticals
2 programs
1
1
fazirsiranPhase 22 trials
ARO-AAT InjectionPhase 11 trial
Active Trials
NCT03362242Completed45Est. Mar 2020
NCT03946449Completed16Est. Dec 2023
NCT03945292Completed40Est. Sep 2023
Adverum Biotechnologies
Adverum BiotechnologiesCA - Redwood City
1 program
1
ADVM-043Phase 1/21 trial
Active Trials
NCT02168686Completed6Est. Aug 2019
Baxter
BaxterCosta Rica - Cartago
1 program
1
Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase InhibitorPhase 1
Krystal Biotech
Krystal BiotechPA - Pittsburgh
1 program
1
KB408Phase 11 trial
Active Trials
NCT06049082Recruiting15Est. Dec 2026
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
3 programs
belcesiranPHASE_11 trial
BelcesiranPHASE_21 trial
BelcesiranPHASE_21 trial
Active Trials
NCT04174118Completed30Est. Mar 2023
NCT05146882Withdrawn0Est. May 2022
NCT04764448Terminated16Est. May 2024
Grifols
GrifolsNEW YORK, NY
3 programs
Alpha1-Proteinase InhibitorPHASE_21 trial
Alpha-1 MPPHASE_31 trial
alpha-1 proteinase inhibitorPHASE_31 trial
Active Trials
NCT00263887Completed77Est. Jan 2007
NCT00295061Completed24Est. Feb 2007
NCT00301366Completed38Est. Mar 2007
Vertex Pharmaceuticals
2 programs
VX-634PHASE_11 trial
VX-814PHASE_21 trial
Active Trials
NCT05579431Completed127Est. Nov 2023
NCT04167345Terminated48Est. Nov 2020
Sanofi
SanofiPARIS, France
2 programs
SAR447537PHASE_21 trial
SAR447537PHASE_21 trial
Active Trials
NCT05897424Active Not Recruiting185Est. Sep 2028
NCT05856331Completed99Est. Aug 2025
BioMarin Pharmaceutical
1 program
BMN 349PHASE_11 trial
Active Trials
NCT06738017Recruiting12Est. Sep 2025
Octapharma
OctapharmaAustria - Vienna
1 program
OctaAlpha1PHASE_21 trial
Active Trials
NCT03385395Withdrawn0Est. Dec 2019

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Syneos HealthAlpha 1-Antitrypsin
Grifolsalpha-1 proteinase inhibitor
GrifolsAlpha-1 MP
KamadaKamada-API
SanofiSAR447537
SanofiSAR447537
Novo NordiskBelcesiran
Novo NordiskBelcesiran
Vertex PharmaceuticalsVX-814
Arrowhead Pharmaceuticalsfazirsiran
Arrowhead Pharmaceuticalsfazirsiran
OctapharmaOctaAlpha1
GrifolsAlpha1-Proteinase Inhibitor
Adverum BiotechnologiesADVM-043
BioMarin PharmaceuticalBMN 349

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 1,048 patients across 19 trials

NCT04204252Syneos HealthAlpha 1-Antitrypsin

Phase III, Efficacy and Safety of "Kamada-AAT for Inhalation"

Start: Nov 2019Est. completion: Jun 2031220 patients
Phase 3Recruiting
NCT00301366Grifolsalpha-1 proteinase inhibitor

The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency

Start: Jun 2006Est. completion: Mar 200738 patients
Phase 3Completed

Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults

Start: May 2006Est. completion: Feb 200724 patients
Phase 3Completed

Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency

Start: Mar 2007Est. completion: Sep 200750 patients
Phase 2/3Completed

Long-term, Open-label Study of SAR447537 (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency Emphysema

Start: Jun 2024Est. completion: Sep 2028185 patients
Phase 2Active Not Recruiting

Study of SAR447537 (INBRX-101) Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema

Start: Oct 2023Est. completion: Aug 202599 patients
Phase 2Completed

An Extension Study of Belcesiran in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATLD)

Start: Dec 2021Est. completion: May 20220
Phase 2Withdrawn

A Study of Belcesiran in Patients With AATLD

Start: Feb 2021Est. completion: May 202416 patients
Phase 2Terminated

Evaluation of the Efficacy and Safety of VX-814 in Subjects With the PiZZ Genotype

Start: Jan 2020Est. completion: Nov 202048 patients
Phase 2Terminated

Study of Fazirsiran (TAK-999, ARO-AAT) in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD)

Start: Oct 2019Est. completion: Dec 202316 patients
Phase 2Completed

Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)

Start: Aug 2019Est. completion: Sep 202340 patients
Phase 2Completed

Study Comparing Weekly Intravenous Administration of OctaAlpha1 With a Marketed Preparation Glassia® in Subjects With Alpha-1-antitrypsin Deficiency

Start: Jul 2018Est. completion: Dec 20190
Phase 2Withdrawn
NCT00263887GrifolsAlpha1-Proteinase Inhibitor

Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)

Start: Dec 2003Est. completion: Jan 200777 patients
Phase 2Completed

Safety Dose Finding Study of ADVM-043 Gene Therapy to Treat Alpha-1 Antitrypsin (A1AT) Deficiency

Start: Nov 2017Est. completion: Aug 20196 patients
Phase 1/2Completed

Study of BMN 349 Single Dose in PiZZ and PiMZ/MASH Adult Participants

Start: Feb 2025Est. completion: Sep 202512 patients
Phase 1Recruiting

A Study of KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency

Start: Feb 2024Est. completion: Dec 202615 patients
Phase 1Recruiting

A Phase 1, First-in-human Study of VX-634

Start: Oct 2022Est. completion: Nov 2023127 patients
Phase 1Completed

Study of DCR-A1AT in Healthy Adult Volunteers

Start: Oct 2019Est. completion: Mar 202330 patients
Phase 1Completed

Study of ARO-AAT in Normal Adult Volunteers

Start: Mar 2018Est. completion: Mar 202045 patients
Phase 1Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
3 actively recruiting trials targeting 1,048 patients
13 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.