Registry-listed formulations

avalglucosidase alfa · mesh:C000731975

Each study is counted once in the molecule profile. Registry products remain separate. Naming an ingredient does not establish that products are interchangeable or what participants received.

16 source entries across 8 studies. This list may not include all unresolved or historical entries.

recombinant human acid alpha-glucosidase (rhGAA)Registry intervention
Linked study entry; product equivalence not established
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Avalglucosidase alfa (GZ402666)Registry intervention
Linked study entry; product equivalence not established
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Avalglucosidase alfa (GZ402666)Registry intervention
Molecular identity unconfirmed
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Nexviadyme 100 mg powder for concentrate for solution for infusionRegistry product
Named ingredient; product remains distinct
Formulation reported by source: SOLUTION FOR INFUSION
View study and source
Nexviadyme 100 mg powder for concentrate for solution for infusionRegistry product
Named ingredient; product remains distinct
Formulation reported by source: SOLUTION FOR INFUSION
View study and source
avalglucosidase alfaRegistry product
Named ingredient; product remains distinct
Formulation reported by source: POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
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Nexviadyme 100 mg powder for concentrate for solution for infusionRegistry product
Named ingredient; product remains distinct
Formulation reported by source: SOLUTION FOR INFUSION
View study and source
Nexviadyme 100 mg powder for concentrate for solution for infusionRegistry product
Named ingredient; product remains distinct
Formulation reported by source: SOLUTION FOR INFUSION
View study and source
Nexviadyme 100 mg powder for concentrate for solution for infusionRegistry product
Named ingredient; product remains distinct
Formulation reported by source: SOLUTION FOR INFUSION
View study and source
Nexviadyme 100 mg powder for concentrate for solution for infusionRegistry product
Named ingredient; product remains distinct
Formulation reported by source: SOLUTION FOR INFUSION
View study and source
Nexviadyme 100 mg powder for concentrate for solution for infusionRegistry product
Named ingredient; product remains distinct
Formulation reported by source: SOLUTION FOR INFUSION
View study and source
Nexviadyme 100 mg powder for concentrate for solution for infusionRegistry product
Named ingredient; product remains distinct
Formulation reported by source: SOLUTION FOR INFUSION
View study and source
Avalglucosidase alfa (GZ402666)Registry intervention
Linked study entry; product equivalence not established
View study and source
Nexviadyme 100 mg powder for concentrate for solution for infusionRegistry product
Named ingredient; product remains distinct
Formulation reported by source: SOLUTION FOR INFUSION
View study and source
Nexviadyme 100 mg powder for concentrate for solution for infusionRegistry product
Named ingredient; product remains distinct
Formulation reported by source: SOLUTION FOR INFUSION
View study and source
Nexviadyme 100 mg powder for concentrate for solution for infusionRegistry product
Named ingredient; product remains distinct
Formulation reported by source: SOLUTION FOR INFUSION
View study and source

Success Metrics

Clinical Success Rate

100.0%

Based on 3 completed trials

Completion Rate

100%(3/3)

Active Trials

7(64%)

Results Posted

100%(3 trials)

Phase Distribution

Phase 2

27%

Phase 3

18%

Phase 4

55%

Phase Distribution

Early Stage

Mid Stage

Late Stage

Phase Distribution11 total trials

Phase 2Efficacy & side effects

3(27.3%)

Phase 3Large-scale testing

2(18.2%)

Phase 4Post-market surveillance

6(54.5%)

Highest Phase Reached

Phase 4

Trial Status & Enrollment

Completion Rate

100.0%

3 of 3 finished

Non-Completion Rate

0.0%

0 ended early

Currently Active

trials recruiting

Total Trials

all time

Status Distribution

Active(8)

Completed(3)

Detailed Status

Active, not recruiting4

Completed3

Recruiting3

Not yet recruiting1

Development Timeline

Analytics

Development Status

Total Trials

Active

Success Rate

100.0%

Most Advanced

Phase 4

Trials by Phase

Phase 23 (27.3%)

Phase 32 (18.2%)

Phase 46 (54.5%)

Trials by Status

active_not_recruiting436%

not_yet_recruiting19%

completed327%

recruiting327%

Recent Activity

7 active trials

Showing 5 of 11

active_not_recruitingphase_4

Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase)

NCT05164055

active_not_recruitingphase_4

Safety and Efficacy of Avalglucosidase Alfa in Patients With Non-classic Pompe Disease Aged ≥ 5 Years

NCT07652814

active_not_recruitingphase_3

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

NCT04910776

recruitingphase_4

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

NCT06666413

active_not_recruitingphase_2

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

NCT03019406

View all 11 trials

Clinical Trials (11)

Showing 11 of 11 trials

NCT05164055Phase 4

Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase)

Active Not Recruiting

NCT07652814Phase 4

Safety and Efficacy of Avalglucosidase Alfa in Patients With Non-classic Pompe Disease Aged ≥ 5 Years

Active Not Recruiting

NCT04910776Phase 3

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

Active Not Recruiting

NCT06666413Phase 4

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

Recruiting

NCT03019406Phase 2

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

NCT02782741Phase 3

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

NCT02032524Phase 2

Avalglucosidase Alfa Extension Study

Completed

NCT00025896Phase 2

Safety and Efficacy of Recombinant Human Acid Alpha-Glucosidase in the Treatment of Classical Infantile Pompe Disease

Completed

SYF3c654df2a748407abb3d7087d1b70a17Phase 4

Pompe disease; new Outcomes measures, Treatment Effect and Novel Targeted Investigations for Advancing Long-term follow-up (POTENTIAL).

Not Yet Recruiting

SYF4c8c30b021b44557a143f1f528f903d1Phase 4

Treatment frequency Reduction In POmpe disease (TRIPO-Study)