Alpha 1-Antitrypsin Deficiency

16
Pipeline Programs
9
Companies
16
Clinical Trials
2 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
0
9
0
2
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Grifols
GrifolsNEW YORK, NY
3 programs
1
2
Alpha-1 MPPhase 31 trial
alpha-1 proteinase inhibitorPhase 31 trial
Alpha1-Proteinase InhibitorPhase 21 trial
Active Trials
NCT00263887CompletedEst. Jan 2007
NCT00295061CompletedEst. Feb 2007
NCT00301366CompletedEst. Mar 2007
Arrowhead Pharmaceuticals
3 programs
1
2
ARO-AATPhase 21 trial
Fazisiran InjectionPhase 21 trial
ARO-AAT InjectionPhase 11 trial
Active Trials
NCT03362242Completed45Est. Mar 2020
NCT03946449Completed16Est. Dec 2023
NCT03945292Completed40Est. Sep 2023
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
3 programs
1
2
BelcesiranPhase 21 trial
BelcesiranPhase 21 trial
belcesiranPhase 11 trial
Active Trials
NCT04174118Completed30Est. Mar 2023
NCT05146882Withdrawn0Est. May 2022
NCT04764448Terminated16Est. May 2024
VP
2 programs
1
1
VX-814Phase 21 trial
VX-634Phase 11 trial
Active Trials
NCT05579431Completed127Est. Nov 2023
NCT04167345Terminated48Est. Nov 2020
Sanofi
SanofiPARIS, France
2 programs
2
SAR447537Phase 21 trial
SAR447537Phase 21 trial
Active Trials
NCT05856331Completed99Est. Aug 2025
NCT05897424Recruiting185Est. Sep 2028
Octapharma
OctapharmaAustria - Vienna
1 program
1
OctaAlpha1Phase 21 trial
Active Trials
NCT03385395Withdrawn0Est. Dec 2019
BioMarin Pharmaceutical
1 program
1
BMN 349Phase 11 trial
Active Trials
NCT06738017Recruiting12Est. Sep 2025
Beacon Therapeutics
Beacon TherapeuticsMA - Cambridge
1 program
1
rAAV1-CB-hAATPhase 11 trial
Active Trials
NCT00430768CompletedEst. Jan 2015

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Grifolsalpha-1 proteinase inhibitor
GrifolsAlpha-1 MP
SanofiSAR447537
SanofiSAR447537
Novo NordiskBelcesiran
Novo NordiskBelcesiran
Vertex PharmaceuticalsVX-814
Arrowhead PharmaceuticalsARO-AAT
Arrowhead PharmaceuticalsFazisiran Injection
OctapharmaOctaAlpha1
GrifolsAlpha1-Proteinase Inhibitor
BioMarin PharmaceuticalBMN 349
Vertex PharmaceuticalsVX-634
Novo Nordiskbelcesiran
Arrowhead PharmaceuticalsARO-AAT Injection

Showing 15 of 16 trials with date data

Clinical Trials (16)

Total enrollment: 618 patients across 16 trials

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 2007
Phase 3Completed

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

Start: May 2006Est. completion: Feb 2007
Phase 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 2Recruiting

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 2007
Phase 2Completed

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

Start: Feb 2025Est. completion: Sep 202512 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

Experimental Gene Transfer Procedure to Treat Alpha 1-Antitrypsin (AAT) Deficiency

Start: Feb 2006Est. completion: Jan 2015
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
2 actively recruiting trials targeting 618 patients
9 companies competing in this space