Asfotase Alfa

Summary

Asfotase Alfa (CHEMBL2108311) is an approved enzyme (ATC A16AB13); indicated across 1 condition including hypophosphatasia.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Enzyme
• ATC class: A16AB13
• Indications: 1 condition
• Clinical trials: 16

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2108311
Name	Asfotase Alfa
Type	Enzyme
Max phase	4
ATC	A16AB13

Also known as: ALXN-1215, ALXN1215, Asfotasa alfa, Asfotase alfa, ENB-0040, Strensiq, ASFOTASE 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
hypophosphatasia	4	MONDO:0018570	MONDO:0018570

Clinical trials

Total trials: 16.

Phase distribution

Phase	Trials
PHASE2	7
Not specified	3
PHASE4	2
PHASE2/PHASE3	1
PHASE3	1
PHASE1/PHASE2	1
PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02531867	PHASE4	COMPLETED	Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan
NCT04189315	PHASE4	WITHDRAWN	Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease
NCT06079372	PHASE3	ACTIVE_NOT_RECRUITING	Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa
NCT01176266	PHASE2/PHASE3	COMPLETED	Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)
NCT00744042	PHASE1/PHASE2	COMPLETED	Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP)
NCT00894075	PHASE2	WITHDRAWN	Safety and Efficacy Study of ENB-0040 in Juvenile Patients With Hypophosphatasia (HPP)
NCT00952484	PHASE2	COMPLETED	Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)
NCT01163149	PHASE2	COMPLETED	Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)
NCT01203826	PHASE2	COMPLETED	Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)
NCT01205152	PHASE2	COMPLETED	Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
NCT02456038	PHASE2	COMPLETED	Safety and Efficacy of Asfotase Alfa in Patients With Hypophosphatasia (HPP)
NCT02797821	PHASE2	COMPLETED	Pharmacokinetic and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia (HPP)
NCT00739505	PHASE1	COMPLETED	Safety Study of Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein Asfotase Alfa in Adults With Hypophosphatasia (HPP)
NCT05234567	Not specified	RECRUITING	A Prospective Sub-Study of the Global Hypophosphatasia Registry
NCT02496689	Not specified	APPROVED_FOR_MARKETING	Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP)
NCT04195763	Not specified	COMPLETED	Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (Asfotase Alfa)

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).