NDAINTRAMUSCULARSOLUTION
Approved
Jun 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
6/8 — Strong
AZMIRO (testosterone cypionate) by R-Pharm US is androgens, including testosterone and dihydrotestosterone (dht), are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Approved for klinefelter syndrome. First approved in 2022.
Drug data last refreshed 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AZMIRO is a testosterone cypionate intramuscular solution approved for treatment of Klinefelter Syndrome and male hypogonadism. It functions as an androgen replacement therapy, restoring testosterone levels to support normal development of male sex organs, secondary sex characteristics, and metabolic function. The drug works by replacing insufficient endogenous testosterone production caused by primary or secondary hypogonadism.
Peak12.9 years to LOE
Product is at peak commercial stage with no immediate LOE threat; core brand team focus on market penetration and indication expansion in endocrinology and urology.
Mechanism of Action
androgens, including testosterone and dihydrotestosterone (DHT), are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the…
Indications (1)
Clinical Trials (2)
Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)
Started Jun 2021
51 enrolled
Prostate Cancer
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
Started Jan 2019
74 enrolled
Hypogonadism
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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.