NDASUBCUTANEOUSSOLUTION
Approved
Sep 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6
Data completeness
5/8 — 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. Approved for hypogonadism. First approved in 2018.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XYOSTED is a subcutaneous autoinjector formulation of testosterone enanthate approved in 2018 for the treatment of male hypogonadism. It delivers testosterone via self-injection every 1-2 weeks, enabling patients to maintain physiologic androgen levels for development and maintenance of male sex characteristics. The drug works by binding androgen receptors to restore normal testosterone-dependent functions including sexual development, muscle growth, and nitrogen retention.
Peak12.3 years to LOE
XYOSTED is in peak commercial phase with strong patent protection through 2038; team expansion likely modest given competitive market saturation and approaching LOE for legacy topical competitors.
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.