ELELYSO

(Taliglucerase alfa)

ApprovedProtein / enzyme

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

ELELYSO is one of 23 small molecule programs targeting Gaucher Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Gaucher DiseaseActive, not recruiting

Gaucher DiseaseApproved

Active, not recruiting

Competition

Competitive Landscape

36 competitors in Gaucher Disease

#DrugCompanyPhaseTrials

Busulfex

Akero Therapeutics

Approved

—2

Cytoxan

BBaxter Healthcare Corporation

Opfolda

2 4

Aquasol E

NNational Eye Institute (NEI)

Phase 3

1 5

ELELYSO

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

3 6

Cerdelga

GGenzyme, a Sanofi Company

Phase 3

4 7

Cerezyme

Sanofi

Approved

4 8

CEREZYME

GGenzyme, a Sanofi Company

Phase 3

3 9

Gene Therapy

CCapsida Biotherapeutics, Inc.

Phase 3

1 10

Elelyso

SShaare Zedek Medical Center

Approved

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

Clinical

Trials by Indication[1]

Gaucher Disease3 trials

A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease

Completed· Pfizer logo

Pfizer·Phase 3·NCT01422187·19 enrolled

A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

Completed· Pfizer logo

Pfizer·Phase 3·NCT01411228·15 enrolled

A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

Completed· Pfizer logo

Pfizer·Phase 4·NCT01132690·11 enrolled

T Cell2 trials

Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial

Completed· Pfizer logo

Pfizer·Phase 3·NCT00705939·45 enrolled

Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase

Completed· Pfizer logo

Pfizer·Phase 3·NCT00712348·31 enrolled

Regulatory

FDA Approval Timeline[4]

May 1, 2012

ELELYSO

BLA BLA022458

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Taliglucerase alfa. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Taliglucerase alfa compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Taliglucerase alfa. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA022458). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Approved[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

ELELYSO

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Gaucher Disease3 trials

T Cell2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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