BLAINJECTIONSOLUTIONPriority Review
Approved
Oct 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
18
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STRENSIQ (asfotase alfa) is a recombinant tissue-nonspecific alkaline phosphatase (TNSALP) enzyme replacement therapy administered by injection. It treats hypophosphatasia (HPP), a rare genetic disorder characterized by deficient alkaline phosphatase activity and impaired bone mineralization. The drug works by replacing the deficient enzyme to restore normal bone metabolism and improve skeletal health.
$259MPart D
PeakStable
>90% of HPP market
Peak commercial performance with strong market penetration suggests stable team size and focused execution; commercial talent should expect mature portfolio management and maximization strategies.
Mechanism of Action
Pharmacologic Class:
Tissue-nonspecific Alkaline Phosphatase
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia
Started Jul 2026
0Hypophosphatasia
Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa
Started Apr 2024
43 enrolled
Hypophosphatasia
Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa
Started Jan 2024
124 enrolled
Hypophosphatasia
A Prospective Sub-Study of the Global Hypophosphatasia Registry
Started Aug 2022
30 enrolled
Hypophosphatasia
Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease
Started Apr 2020
0Hypophosphatasia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
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.