Cipaglucosidase alfa

Phase 3Protein / enzyme

Cipaglucosidase alfa is a protein / enzyme that works as a Recombinant Acid Alpha-Glucosidase.[2] It is being investigated across 1 indication, with its most advanced program in Phase 3.[1]

Cipaglucosidase alfa is one of 40 enzyme replacement programs targeting Immunogenicity. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

ImmunogenicityRecruiting

ImmunogenicityPhase 3

Recruiting

Competition

Competitive Landscape

98 competitors in Immunogenicity

#DrugCompanyPhaseTrials

Perjeta

Roche

Phase 3

2 2

Rabies Vaccine

Novartis

Phase 3

12 3

Prolia

OOrganon and Co

Phase 3

2 4

Rsvpref

Pfizer

Phase 3

5 5

HPV Vaccine

SShanghai Zerun Biotechnology Co.,Ltd

Phase 3

3 6

PCV21

Sanofi

Phase 3

2 7

Bexsero

GSK

Phase 3

8 8

Gardasil-9

BBeijing Health Guard Biotechnology, Inc

Phase 3

2 9

Opfolda

Johnson & Johnson

Phase 3

1 10

Gardasil

Merck & Co.

Phase 3

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

Timeline

Expected Milestones

Q3 2027

Phase 3Recruiting

Immunogenicity

NCT04808505

Phase 3Active, not recruiting

Pompe Disease (late-Onset)

NCT03911505

Q4 2034

Recruiting

Pompe Disease

NCT06121011

Clinical

Trials by Indication[1]

Pompe Disease2 trials

A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease

Completed·AAmicus Therapeutics·Phase 3·NCT03729362·125 enrolled

A Global Prospective Observational Registry of Patients With Pompe Disease

Recruiting·AAmicus Therapeutics··NCT06121011·500 enrolled

Immunogenicity1 trial

A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects Aged 0 to <18

Recruiting·AAmicus Therapeutics·Phase 3·NCT04808505·36 enrolled

Pompe Disease (Late-onset)1 trial

An Open-label Study of the Safety, Pharmacokinetics, Efficacy, Pharmacodynamics, and Immunogenicity of Cipaglucosidase Alfa/Miglustat in Pediatric Subjects Aged 0 to < 18 Years With Late-onset Pompe Disease

Active, not recruiting·AAmicus Therapeutics·Phase 3·NCT03911505·21 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 28, 2023

POMBILITI

NDA BLA761204

Jul 25, 2024

POMBILITI

NDA BLA761204

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Cipaglucosidase alfa. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cipaglucosidase alfa compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cipaglucosidase alfa. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA761204). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Amicus Therapeutics 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: Phase 3[1]
Company: AAmicus Therapeutics

Cipaglucosidase alfa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2034

Trials by Indication[1]

Pompe Disease2 trials

Immunogenicity1 trial

Pompe Disease (Late-onset)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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