NDAORALCAPSULE
Approved
Mar 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
5/8 — Partial
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
JATENZO (testosterone undecanoate) is an oral androgen replacement therapy approved in 2019 for male hypogonadism, a condition caused by insufficient testosterone production. The drug mimics natural testosterone and DHT to restore secondary sex characteristics and normal male development. It is also being evaluated for metabolic and neurological indications including Type 2 Diabetes, obesity, and multiple sclerosis.
$5MPart D
Peak12.9 years to LOEJATENZO is in peak commercial lifecycle with minimal Medicare Part D penetration, suggesting significant upside opportunity and an active field-based commercial team.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months
Started May 2024
110 enrolled
Hypogonadism
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
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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.