NDAINTRAMUSCULARINJECTABLE
Approved
Mar 2014
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
10
Data completeness
6/8 — Strong
AVEED (testosterone undecanoate) by Verity Pharmaceuticals 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 male hypogonadism. First approved in 2014.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVEED (testosterone undecanoate) is an intramuscular injectable androgen replacement therapy approved in 2014 for male hypogonadism. It restores testosterone and DHT to normal physiological levels, supporting development and maintenance of male sex characteristics and secondary sexual function. The drug is also being investigated for indications including erectile dysfunction, obesity, prediabetes, and nonalcoholic steatohepatitis.
$1MPart D
LOE Approaching1.0 years to LOEWith only 757 Part D claims and LOE arriving May 2027, AVEED operates as a niche product with minimal team scale and declining commercial momentum.
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 prostate, seminal vesicles, penis, and scrotum; the…
Indications (1)
Clinical Trials (10)
Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism
Started Jan 2022
32 enrolled
Fatty LiverOverweight/ObesityPrediabetes/Type2 Diabetes Mellitus+1 more
Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations
Started Sep 2019
34 enrolled
Caloric RestrictionExerciseSleep
Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men
Started Sep 2018
155 enrolled
Hypogonadism, Male
Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
Started Jul 2017
314 enrolled
Hypogonadism, Male
Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
Started Nov 2016
25 enrolled
Male 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.