NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1953
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
Priority Review
DELATESTRYL (testosterone enanthate) by Hikma is androgens, including testosterone and dihydrotestosterone (dht) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. First approved in 1953.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DELATESTRYL is a testosterone enanthate injection approved in 1953 for treating male hypogonadism, a condition caused by insufficient testosterone production. It works by replacing or supplementing testosterone to restore normal male sexual development, secondary sex characteristics, and metabolic function. The drug addresses both primary hypogonadism (gonadal defects) and secondary hypogonadism (hypothalamic/pituitary failure).
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), indicating a contracting team focused on generic transition and market defense rather than growth initiatives.
Mechanism of Action
androgens, including testosterone and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of the prostate, seminal vesicles, penis, and scrotum;…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism
Started Jun 2016
66 enrolled
Hypogonadism
Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
Started Jul 2015
133 enrolled
Hypogonadism
Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
Started Sep 2014
12 enrolled
Hypogonadism
Pharmacokinetic Study of Testosterone Enanthate
Started Sep 2013
39 enrolled
Hypogonadism
A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
80 enrolled
HIV InfectionsHIV Wasting Syndrome
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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.