NDASUBCUTANEOUSSOLUTION
Approved
Sep 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
4/8 — Partial
XYOSTED (AUTOINJECTOR) (testosterone enanthate) by Antares Therapeutics is clinical pharmacology endogenous androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. First approved in 2018.
Drug data last refreshed 7h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XYOSTED is a subcutaneous autoinjector formulation of testosterone enanthate approved in 2018 for testosterone replacement therapy in men with hypogonadism. The drug works by replacing deficient endogenous androgens to restore secondary sex characteristics, muscle mass, bone density, and red blood cell production. Testosterone enanthate is slowly absorbed from the subcutaneous depot, allowing dosing intervals of 2-4 weeks with sustained therapeutic levels.
Peak12.2 years to LOE
Product is in peak commercial phase with moderate team investment; growth trajectory dependent on HCP adoption and market penetration in the testosterone replacement segment.
Mechanism of Action
CLINICAL PHARMACOLOGY Endogenous androgens are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of prostate, seminal vesicles, penis, and scrotum; development of male hair…
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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.