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Acid Sphingomyelinase Deficiency (ASMD)

1
Pipeline Programs
1
Companies
7
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

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

On Market (1)

Approved therapies currently available

Sanofi
XENPOZYMEApproved
olipudase alfa-rpcp
Sanofi
injection2022
5M Part D

Competitive Landscape

1 companies ranked by most advanced pipeline stage

Sanofi
SanofiPARIS, France
1 program
1
XENPOZYME(Olipudase alfa)N/A5 trials
Active Trials
NCT04877132Approved For Marketing
NCT06192576Recruiting10Est. Jan 2029
NCT05359276Completed40Est. Dec 2024
+2 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
SanofiOlipudase alfa
SanofiOlipudase alfa
SanofiOlipudase alfa
SanofiOlipudase alfa
SanofiOlipudase alfa
SanofiOlipudase alfa

Clinical Trials (7)

Total enrollment: 134 patients across 7 trials

NCT02004691SanofiOlipudase alfa

Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

Start: Dec 2015Est. completion: Oct 202336 patients
Phase 2/3Completed
NCT06949358SanofiOlipudase alfa

A Study to Evaluate Safety and Tolerability of Olipudase Alfa in Pediatric and Adult Participants With Acid Sphingomyelinase Deficiency (ASMD) Who Completed the DFI12712 or the LTS13632 Study in France

Start: Nov 2021Est. completion: Apr 20253 patients
Phase 2Completed
NCT02004704SanofiOlipudase alfa

A Long-Term Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

Start: Dec 2013Est. completion: Sep 202325 patients
Phase 2Completed
NCT02292654SanofiOlipudase alfa

Safety, Tolerability, PK, and Efficacy Evaluation of Repeat Ascending Doses of Olipudase Alfa in Pediatric Patients <18 Years of Age With Acid Sphingomyelinase Deficiency

Start: May 2015Est. completion: Dec 201920 patients
Phase 1/2Completed
NCT04877132SanofiOlipudase alfa

Compassionate Use Program for Olipudase Alfa Enzyme Replacement Therapy for Patients With Chronic Acid Sphingomyelinase Deficiency (ASMD)

N/AApproved For Marketing
NCT06192576SanofiOlipudase alfa

A Real-world Long-term Safety and Immunogenicity Study of Olipudase Alfa Therapy in Pediatric Patients Less Than 2 Years of Age With Acid Sphingomyelinase Deficiency (ASMD)

Start: Apr 2024Est. completion: Jan 202910 patients
N/ARecruiting
NCT05359276SanofiOlipudase alfa

Data Analysis of Adult and Pediatric Participants With Acid Sphingomyelinase Deficiency (ASMD) on Early Access to Olipudase Alfa in France

Start: Jun 2022Est. completion: Dec 202440 patients
N/ACompleted

Phase Legend

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

Key Insights

1 actively recruiting trials targeting 134 patients
1 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.