NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1953
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
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. Approved for hypogonadism. First approved in 1953.
Drug data last refreshed 23h ago
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 (1)
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.