alglucerase

Trade name: ceredase

Recombinant proteinapprovedOrphan Drug ^FDA

Approved

Apr 5, 1991

Alglucerase was a biopharmaceutical drug for the treatment of Gaucher's disease. It was a modified form of human β-glucocerebrosidase enzyme, where the non-reducing ends of the oligosaccharide chains have been terminated with mannose residues. — Wikipedia

Clinical trial activity

2 trials · 2 clinical orgs · 1 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Dec 1, 1993 (NCT00001416)

Timeline

1980s

Mar 11, 1985
Orphan Drug Designation

1990s

Apr 5, 1991
Genzyme — Earliest FDA Approval
Apr 5, 1991
Genzyme — NDA Organization
Jan 1, 1993
Earliest Phase 2 Sponsor(trial)

2000s

Jan 1, 2005
Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Gaucher Disease

Studied for

Gaucher Disease · Phase 2

Mechanism of action

GlucocerebrosideHYDROLYTIC ENZYME
Glucocerebroside hydrolytic enzyme
GlucocerebrosideSupplementation
Glucocerebroside supplementation

Approval history

approvedPriority reviewApr 5, 1991

Chemistry & pharmacology

Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Discontinued
Multi-specific: No

Oral

Parenteral

Yes

Topical

Sources

Also known as

alglucerase
alglucerase
alglucerase
alglucerase
alglucerase
alglucerase
alglucerase
alglucerase
ceredase
ceredase
ceredase
ceredase
ceredase
human glucocerebrosidase

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT00258778	Phase 1	Nov 1, 2005	Protalix
NCT00001416	Phase 2	Dec 1, 1993	National Institute of Neurological Disorders and Stroke (NINDS)

Showing 2 of 2 trials

Page 1 / 1

Organizations

Research & Development (2)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
National Institute of Neurological Disorders and Stroke (NINDS)	Government	1	1	1	1993
Protalix	For profit	1	1	1	2005

2 organizations

Page 1 / 1

Marketing (1)

Organization	Org type	Relationship	Date
Genzyme	For profit	NDA	Apr 5, 1991