STRENSIQ (asfotase alfa)
STRENSIQ is indicated for the treatment of Hypophosphatasia.
How STRENSIQ Works
Hypophosphatasia is caused by a deficiency in TNSALP enzyme activity, which leads to the accumulation of inorganic pyrophosphate (PPi), a substance that blocks bone mineralization. STRENSIQ replaces the missing TNSALP enzyme, which catalyzes the hydrolysis of phosphomonoesters into inorganic phosphate and alcohol. By reducing elevated extracellular levels of PPi, the treatment promotes hydroxyapatite crystal growth and prevents the accumulation of unmineralized bone matrix.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-10-23
- Patent Cliff
- 2022
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
STRENSIQ Approval History
What STRENSIQ Treats
1 indicationsSTRENSIQ is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypophosphatasia
STRENSIQ Boxed Warning
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate STRENSIQ under the supervision of a healthcare provider with appropriate medical monitoring and support measures. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discont...
WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate STRENSIQ under the supervision of a healthcare provider with appropriate medical monitoring and support measures. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue STRENSIQ and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1) ] . WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. ( 5.1 ) Initiate STRENSIQ under the supervision of a healthcare provider with appropriate medical monitoring and support measures. ( 5.1 ) If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue STRENSIQ and immediately initiate appropriate medical treatment, including use of epinephrine. ( 5.1 )
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06079372 CHESTNUT | D8590C00004 ALXN1850-HPP-303 | Ph 3 | active not recruiting | Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa |
| NCT04189315 REBUILD | AA-HPP-406 | Ph 4 | withdrawn | Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease |
| NCT02797821 results posted | AA-HPP-208 | Ph 2 | completed | Pharmacokinetic and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia (HPP) |
| NCT00952484 results posted | ENB-006-09 | Ph 2 | completed | Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP) |
| NCT00744042 results posted | ENB-002-08 | Ph 1, Ph 2 | completed | Safety and Efficacy Study of Asfotase Alfa in Severely Affected Infants With Hypophosphatasia (HPP) |
| NCT00739505 | ENB-001-08 | Ph 1 | completed | Safety Study of Human Recombinant Tissue Non-Specific Alkaline Phosphatase Fusion Protein Asfotase Alfa in Adults With Hypophosphatasia (HPP) |
| NCT01205152 results posted | ENB-003-08 FD-R-003745-03 | Ph 2 | completed | Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP) |
| NCT01176266 results posted | ENB-010-10 | Ph 2, Ph 3 | completed | Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP) |
| NCT01163149 results posted | ENB-009-10 | Ph 2 | completed | Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP) |
| NCT01203826 results posted | ENB-008-10 | Ph 2 | completed | Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP) |
| NCT02531867 results posted | AA-HPP-409 | Ph 4 | completed | Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
STRENSIQ FDA Label Details
Indications & Usage
FDA Label (PDF)STRENSIQ is indicated for the treatment of Hypophosphatasia.
WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment