Avalglucosidase alfa

ApprovedProtein / enzyme

Avalglucosidase alfa is a protein / enzyme that works as a Recombinant Acid Alpha-Glucosidase.[2] It is being used across 4 indications, with its most advanced program in Approved.[1]

Avalglucosidase alfa is one of 89 enzyme replacement programs targeting Efficacy and Safety. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Efficacy and SafetyActive, not recruiting

Glycogen Storage Disease Type IIActive, not recruiting

Pompe DiseaseActive, not recruiting

ARTRecruiting

Efficacy and SafetyPhase 3

Active, not recruiting

Glycogen Storage Disease Type IIApproved

Active, not recruiting

Pompe DiseasePhase 2

Active, not recruiting

ARTApproved

Recruiting

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Rinvoq

AbbVie

Phase 3

4 2

Mounjaro

Eli Lilly

Phase 3

1 3

Rilutek

AAzurity Pharmaceuticals

Phase 3

3 4

Glypressin

MMallinckrodt

Phase 3

1 5

Avalglucosidase alfa

Sanofi

Approved

1 6

Becotatug Vedotin

FFudan University

Phase 3

1 7

S1,

CChinese Academy of Medical Sciences

Phase 3

1 8

Sodium Oligomannate

GGreen Valley (Shanghai) Pharmaceuticals Co., Ltd.

Phase 3

2 9

CAM2029

CCamurus AB

Phase 3

1 10

Tinlarebant

BBelite Bio, Inc

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

ApprovedActive, not recruiting

Glycogen Storage Disease Type II

NCT05164055

Q3 2027

Phase 3Active, not recruiting

Efficacy and Safety

NCT04910776

Phase 2Active, not recruiting

Pompe Disease

NCT03019406

Q2 2028

Post-ApprovalRecruiting

ART

NCT06666413

Q4 2032

Recruiting

Pregnancy

NCT05734521

Clinical

Trials by Indication[1]

Pompe Disease2 trials

Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease

Completed· Sanofi logo

Sanofi·Phase 3·NCT02782741·101 enrolled

A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT03019406·22 enrolled

Pregnancy1 trial

Avalglucosidase Alfa Pregnancy Study

Recruiting· Sanofi logo

Sanofi··NCT05734521·100 enrolled

Efficacy and Safety1 trial

Clinical Study for Treatment-naïve IOPD Babies to Evaluate Efficacy and Safety of ERT With Avalglucosidase Alfa

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT04910776·17 enrolled

ART1 trial

China Post-approval Commitment (PAC) Study of Avalglucosidase Alfa in Participants With IOPD

Recruiting· Sanofi logo

Sanofi·Phase 4·NCT06666413·13 enrolled

Glycogen Storage Disease Type II1 trial

A French Multicenter Open Label Phase 4 Extension Study of Long-term Safety and Efficacy in Patients With Pompe Disease Who Previously Participated in Avalglucosidase Alfa Development Studies in France

Active, not recruiting· Sanofi logo

Sanofi·Approved·NCT05164055·17 enrolled

1 more indication

Unspecified1 trial

Avalglucosidase Alfa Extension Study

Completed· Sanofi logo

Sanofi·Phase 2·NCT02032524·19 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 6, 2021

NEXVIAZYME

NDA BLA761194

Sep 15, 2023

NEXVIAZYME

NDA BLA761194

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Avalglucosidase alfa. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Avalglucosidase alfa compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Avalglucosidase alfa. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA761194). U.S. Food & Drug Administration.
[5]
PubMed — 1 publication indexed for Avalglucosidase alfa. U.S. National Library of Medicine.
[6]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Recombinant Acid Alpha-Glucosidase[2]
Modality: Protein / enzyme[2]
Highest Phase: Approved[1]
Company: Sanofi

Key Publications[5]

Avalglucosidase Alfa vs Alglucosidase Alfa in Late-Onset Pompe: COMET

Lancet NeurolJul 14, 2022DOI: 10.1016/S1474-4422(22)00211-5

Avalglucosidase alfa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q2 2028

Q4 2032

Trials by Indication[1]

Pompe Disease2 trials

Pregnancy1 trial

Efficacy and Safety1 trial

ART1 trial

Glycogen Storage Disease Type II1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Key Publications[5]

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