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Hypophosphatasia

9
Pipeline Programs
9
Companies
25
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
1
4
0
1
2
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

AstraZeneca
STRENSIQApproved
asfotase alfa
AstraZeneca
Tissue-nonspecific Alkaline Phosphatase [EPC]injection2015
259M Part D

Competitive Landscape

9 companies ranked by most advanced pipeline stage

AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
5 programs
1
1
1
1
STRENSIQ(asfotase alfa)APPROVED_FOR_MARKETING5 trials
ALXN1850Phase 31 trial
ENB-0040Phase 21 trial
ALXN1850Phase 11 trial
Unraveling Genetics of HypoPhosPhatasia (HPP Genetics)N/A1 trial
Active Trials
NCT02496689Approved For Marketing
NCT06015750Withdrawn0Est. Mar 2030
NCT06079372Active Not Recruiting43Est. Feb 2028
+6 more trials
Innovation Pharmaceuticals
1 program
1
Asfotase AlfaPhase 21 trial
Active Trials
NCT02456038Completed13Est. Jul 2015
Sandoz
SandozAustria - Kundl
1 program
1
BPS804Phase 21 trial
Active Trials
NCT01406977Completed8Est. Sep 2012
AM-Pharma
AM-PharmaNetherlands - Utrecht
1 program
1
ilofotase alfaPhase 22 trials
Active Trials
NCT06168799Completed271Est. Dec 2025
NCT05890794Completed12Est. Jul 2023
Alesta Therapeutics
Alesta TherapeuticsNetherlands - Leiden
1 program
1
ALE1Phase 1/21 trial
Active Trials
NCT07179640Recruiting120Est. Jan 2027
CENTOGENE
CENTOGENEGermany - Rostock
1 program
Unraveling Genetics of HypoPhosPhatasia (HPP Genetics)N/A
Mereo BioPharma
Mereo BioPharmaUK - London
1 program
BPS804PHASE_2
Ultragenyx Pharmaceutical
1 program
BPS804PHASE_2
Novartis
NovartisBASEL, Switzerland
1 program
BPS804PHASE_2

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
AstraZenecaasfotase alfa
AstraZenecaasfotase alfa
AstraZenecaasfotase alfa
AstraZenecaALXN1850
AstraZenecaasfotase alfa
AstraZenecaasfotase alfa
AM-Pharmailofotase alfa
AstraZenecaasfotase alfa
Innovation PharmaceuticalsAsfotase Alfa
SandozBPS804
AstraZenecaasfotase alfa
AstraZenecaasfotase alfa
AstraZenecaasfotase alfa
AstraZenecaENB-0040
AstraZenecaasfotase alfa

Showing 15 of 24 trials with date data

Clinical Trials (25)

Total enrollment: 811 patients across 25 trials

Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia

Start: Jul 2026Est. completion: Mar 20300
Phase 4Withdrawn

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

Start: Apr 2020Est. completion: Aug 20220
Phase 4Withdrawn

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

Start: Jun 2015Est. completion: Nov 201513 patients
Phase 4Completed

Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP

Start: May 2024Est. completion: Aug 202830 patients
Phase 3Active Not Recruiting

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

Start: Apr 2024Est. completion: Feb 202843 patients
Phase 3Active Not Recruiting

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

Start: Jul 2010Est. completion: Sep 201669 patients
Phase 2/3Completed
NCT06168799AM-Pharmailofotase alfa

Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery

Start: Dec 2023Est. completion: Dec 2025271 patients
Phase 2Completed

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

Start: Jun 2016Est. completion: Jun 201727 patients
Phase 2Completed

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

Start: Aug 2014Est. completion: Jul 201513 patients
Phase 2Completed

Dose Escalation Study to Evaluate the Safety and Tolerability of Multiple Infusions of BPS804 in Adults With Hypophosphatasia (HPP)

Start: Jul 2011Est. completion: Sep 20128 patients
Phase 2Completed

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

Start: Jun 2010Est. completion: Jun 201619 patients
Phase 2Completed

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

Start: Apr 2010Est. completion: Jun 201612 patients
Phase 2Completed

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

Start: Sep 2009Est. completion: Jul 201013 patients
Phase 2Completed

Safety and Efficacy Study of ENB-0040 in Juvenile Patients With Hypophosphatasia (HPP)

Start: Jul 2009Est. completion: Dec 20140
Phase 2Withdrawn

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

Start: Apr 2009Est. completion: Aug 201610 patients
Phase 2Completed

A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALE1 in Healthy Adults and Adults With Hypophosphatasia in Order to Identify Suitable Doses of ALE1

Start: Sep 2025Est. completion: Jan 2027120 patients
Phase 1/2Recruiting
NCT05890794AM-Pharmailofotase alfa

Pilot Trial of Single Dose Ilofotase Alfa in Hypophosphatasia

Start: May 2023Est. completion: Jul 202312 patients
Phase 1/2Completed

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

Start: Sep 2008Est. completion: May 201011 patients
Phase 1/2Completed

Study of ALXN1850 in Participants With Hypophosphatasia (HPP)

Start: Sep 2021Est. completion: Aug 202215 patients
Phase 1Completed

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

Start: Aug 2008Est. completion: Feb 20096 patients
Phase 1Completed

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

N/AApproved For Marketing

A Prospective Sub-Study of the Global Hypophosphatasia Registry

Start: Aug 2022Est. completion: Jul 202830 patients
N/ARecruiting
NCT04925804AstraZenecaUnraveling Genetics of HypoPhosPhatasia (HPP Genetics)

Unraveling Genetics of HypoPhosPhatasia (HPP Genetics)

Start: Jun 2021Est. completion: Dec 202116 patients
N/ACompleted

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

Start: Nov 2019Est. completion: Apr 202450 patients
N/ACompleted

Evaluate and Monitor Physical Performance of Adults Treated With Asfotase Alfa for Hypophosphatasia

Start: Sep 2018Est. completion: May 202123 patients
N/ACompleted

Related Jobs

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
2 actively recruiting trials targeting 811 patients
9 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.