Hypophosphatasia
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CLINICAL_TRIALS research · 2026-04-14Clinical Trial Update: United States Hypophosphatasia Molecular Research Center
A United States clinical trial for hypophosphatasia remains active but not recruiting. The study is sponsored by Children's Mercy Hospital K…
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CLINICAL_TRIALS research · 2026-04-14Clinical Trial Update: The Effect of Monoallelic Variants in the ALPL Gene on the Natural Course of Hypophosphatasia in Russia
AstraZeneca is conducting a clinical trial in Russia to assess how monoallelic ALPL gene variants affect the natural course of hypophosphata…
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EMA approval · 2026-03-18EMA Authorised: Strensiq (asfotase alfa) — Alexion Europe SAS
The EMA authorised Strensiq (asfotase alfa) for the treatment of hypophosphatasia. The marketing authorisation holder is Alexion Europe SAS,…
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CLINICAL_TRIALS research · 2026-03-12Clinical Trial Update: Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa [Phase 3]
Phase 3 study evaluating ALXN1850 in pediatric patients with hypophosphatasia who were previously treated with asfotase alfa; the trial is a…
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CLINICAL_TRIALS trial_result · 2026-03-12Clinical Trial Update: Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa [Phase 3]
Phase 3 trial of ALXN1850 versus placebo in adolescents and adults with hypophosphatasia who have not previously been treated with asfotase …
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CLINICAL_TRIALS research · 2026-03-05Clinical Trial Update: Natural History Study of Patients With Hypophosphatasia (HPP)
ClinicalTrials.gov reports a natural history observational study of hypophosphatasia sponsored by Duke University, and the trial is currentl…
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CLINICAL_TRIALS research · 2026-02-27Clinical Trial Update: Registry of Patients With Hypophosphatasia
This is a patient registry for hypophosphatasia sponsored by Alexion Pharmaceuticals, with enrollment currently by invitation.
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CLINICAL_TRIALS research · 2026-02-18Clinical Trial Update: Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP [Phase 3]
Phase 3 trial of ALXN1850 in treatment-naïve pediatric participants with hypophosphatasia is currently not recruiting.
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CLINICAL_TRIALS research · 2026-02-09Clinical Trial Update: A Prospective Sub-Study of the Global Hypophosphatasia Registry
A prospective sub-study within the Global Hypophosphatasia Registry is underway, sponsored by Alexion Pharmaceuticals, to collect data on in…
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CLINICAL_TRIALS research · 2026-01-30Clinical Trial Update: 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 [Phase 1, Phase 2]
A Phase 1/2 clinical trial is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALE1 in healthy adults and adult…
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CLINICAL_TRIALS withdrawal · 2025-12-18Clinical Trial Update: Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia [Phase 4]
A Phase 4 clinical trial to mitigate immune-mediated loss of response to asfotase alfa (STRENSIQ) for hypophosphatasia has been withdrawn.
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CLINICAL_TRIALS research · 2025-12-16Clinical Trial Update: Prospective, Longitudinal, Observational Registry of Adult Patients With Hypophosphatasia (REG-HYPO)
A prospective, longitudinal observational registry enrolling adults with hypophosphatasia to study disease course and outcomes.
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CLINICAL_TRIALS trial_result · 2025-02-27Clinical Trial Update: Pilot Trial of Single Dose Ilofotase Alfa in Hypophosphatasia [Phase 1, Phase 2]
A Phase 1/2 pilot trial evaluating a single-dose Ilofotase alfa for hypophosphatasia has completed, and the results have been posted.
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CLINICAL_TRIALS research · 2025-02-10Clinical Trial Update: Characteristics of Hypophosphatasia in Adult Patients in Rheumatology and Their Value in Developing an Algorithm to HPP-diagnosis - the COHIR Multi-center Study
A multi-center study led by the University of Bonn is characterizing adult hypophosphatasia in rheumatology patients to inform an algorithm …
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CLINICAL_TRIALS trial_result · 2024-12-27Clinical Trial Update: Study of ALXN1850 in Participants With Hypophosphatasia (HPP) [Phase 1]
Phase 1 trial of ALXN1850 in hypophosphatasia has completed, and results have been posted.
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CLINICAL_TRIALS trial_result · 2024-11-14Clinical Trial Update: Serum Alkaline Phosphatase Levels In Healthy Turkish Children [NA]
A completed clinical trial in Turkey assessed serum alkaline phosphatase levels in healthy children in the context of alkaline phosphatase d…
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FDA label_change · 2024-07-10FDA Approved: STRENSIQ — Supplemental Application (Alexion Pharmaceuticals, Inc.)
The FDA approved a supplemental application for STRENSIQ (asfotase alfa) from Alexion Pharmaceuticals, resulting in updated labeling for the…
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CLINICAL_TRIALS trial_result · 2024-07-10Clinical Trial Update: Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (Asfotase Alfa)
A completed clinical trial update examining patient-reported outcomes in adults with pediatric-onset hypophosphatasia treated with Strensiq …
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CLINICAL_TRIALS trial_result · 2022-09-16Clinical Trial Update: Dose Escalation Study to Evaluate the Safety and Tolerability of Multiple Infusions of BPS804 in Adults With Hypophosphatasia (HPP) [Phase 2]
Phase 2 dose-escalation trial evaluating safety and tolerability of multiple infusions of BPS804 in adults with hypophosphatasia completed.
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FDA label_change · 2020-06-12FDA Approved: STRENSIQ — Supplemental Application (Alexion Pharmaceuticals, Inc.)
The FDA approved a supplemental application for STRENSIQ (ASFOTASE ALFA) from Alexion Pharmaceuticals, Inc. This action pertains to labeling…
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CLINICAL_TRIALS withdrawal · 2020-06-04Clinical Trial Update: Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease [Phase 4]
A Phase 4 clinical trial investigating relief of functional impairment in adults with hypophosphatasia has been withdrawn.
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CLINICAL_TRIALS trial_result · 2019-02-15Clinical Trial Update: Health Burden of Hypophosphatasia
This completed trial assesses the health burden of hypophosphatasia. It outlines outcomes related to disease impact and patient burden.
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CLINICAL_TRIALS trial_result · 2018-07-10Clinical Trial Update: Pharmacokinetic and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia (HPP) [Phase 2]
Phase 2 pharmacokinetic and dose–response study of asfotase alfa in adults with pediatric-onset hypophosphatasia completed; results posted i…
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CLINICAL_TRIALS trial_result · 2018-02-26Clinical Trial Update: Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP) [Phase 2, Phase 3]
Open-label study of asfotase alfa in infants and children ≤5 years with hypophosphatasia completed with results posted in 2018.
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FDA approval · 2018-01-26FDA Approved: STRENSIQ — Supplemental Application (Alexion Pharmaceuticals, Inc.)
The FDA approved a supplemental application for STRENSIQ (asfotase alfa) from Alexion Pharmaceuticals, Inc.