Taliglucerase Alfa

Summary

Taliglucerase Alfa (CHEMBL1964120) is an approved enzyme (ATC A16AB11); indicated across 1 condition including gaucher disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Enzyme
• ATC class: A16AB11
• Indications: 1 condition
• Clinical trials: 10

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1964120
Name	Taliglucerase Alfa
Type	Enzyme
Max phase	4
ATC	A16AB11

Also known as: Elelyso, PRGC-D, PRGCD, PRX-112, Taliglucerasa alfa, Taliglucerase alfa, Uplyso, TALIGLUCERASE ALFA

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 approved indication. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
Gaucher disease	4	MONDO:0018150	MONDO:0018150

Clinical trials

Total trials: 10.

Phase distribution

Phase	Trials
PHASE3	4
PHASE4	3
PHASE2	1
PHASE1	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT01132690	PHASE4	COMPLETED	A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
NCT03021941	PHASE4	WITHDRAWN	Pharmacokinetics, Pharmacodynamics And Safety Study Of Elelyso(tm) In Pediatric Subjects With Type 1 Gaucher Disease
NCT04002830	PHASE4	COMPLETED	A Multicenter, Safety and Efficacy Study of Taliglucerase Alfa in Subjects With Type 3 Gaucher Disease
NCT00705939	PHASE3	COMPLETED	Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial
NCT00712348	PHASE3	COMPLETED	Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase
NCT01411228	PHASE3	COMPLETED	A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
NCT01422187	PHASE3	COMPLETED	A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease
NCT02107846	PHASE2	COMPLETED	An Open-Label, Dose Escalation Study to Evaluate the Safety and the Pharmacokinetics of Oral PRX-112
NCT01747980	PHASE1	COMPLETED	Safety and Pharmacokinetics of Oral PRX-112 in Gaucher Disease Patients
NCT04353466	Not specified	COMPLETED	Assessing the Impact of Elelyso on Bone Involvement Currently Treated With Other ERTs

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).