STRENSIQ

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

13 competitors in Hypophosphatasia

#DrugCompanyPhaseTrials

1

Trexall

Alnylam Pharmaceuticals

Approved

12

Rituxan

Roche

Approved

13

Folvite

Eli Lilly

Approved

14

Fosrenol

Takeda

Approved

—5

Velcade

SShilpa Grover, MD, MPH

Approved

16

Ivig

Argenx

Approved

17

ALXN1850

AstraZeneca

Phase 3

28

BPS804

Ultragenyx

Phase 2

19

Ilofotase Alfa

AAM-Pharma

Phase 2

110

STRENSIQ

AstraZeneca

Preclinical

14

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Hypophosphatasia14 trials

Pharmacokinetic and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia (HPP)

Completed·AstraZeneca·Phase 2·NCT02797821·27 enrolled

Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP)

Completed·AstraZeneca·Phase 1/2·NCT00744042·11 enrolled

Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)

Completed·AstraZeneca·Phase 2·NCT01205152·10 enrolled

Show 11 more trials

Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (Asfotase Alfa)

Completed·AstraZeneca··NCT04195763·50 enrolled

Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP)

Approved for marketing·AstraZeneca··NCT02496689

Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)

Completed·AstraZeneca·Phase 2/3·NCT01176266·69 enrolled

Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)

Completed·AstraZeneca·Phase 2·NCT01163149·19 enrolled

Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)

Completed·AstraZeneca·Phase 2·NCT01203826·12 enrolled

Safety Study of Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein Asfotase Alfa in Adults With Hypophosphatasia (HPP)

Completed·AstraZeneca·Phase 1·NCT00739505·6 enrolled

Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease

Withdrawn·AstraZeneca·Phase 4·NCT04189315

Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)

Completed·AstraZeneca·Phase 2·NCT00952484·13 enrolled

A Prospective Sub-Study of the Global Hypophosphatasia Registry

Recruiting·AstraZeneca··NCT05234567·30 enrolled

Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan

Completed·AstraZeneca·Phase 4·NCT02531867·13 enrolled

Safety and Efficacy of Asfotase Alfa in Patients With Hypophosphatasia (HPP)

Completed·TTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan·Phase 2·NCT02456038·13 enrolled

Pediatric1 trial

Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

Active, not recruiting·AstraZeneca·Phase 3·NCT06079372·43 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Related News