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Aveed (TESTOSTERONE UNDECANOATE)
Aveed works by binding to androgen receptors in the body, mimicking the effects of natural testosterone.
Aveed (testosterone undecanoate) is a small molecule androgen medication developed by Endo Pharms Inc and currently owned by Marius. It targets the androgen receptor to treat conditions associated with low testosterone levels, including deficiency or absence of endogenous testosterone, hypogonadotropic hypogonadism, and primary hypogonadism. Aveed was FDA-approved in 2014 for these indications. As a patented medication with no generic manufacturers, its commercial status is proprietary. Key safety considerations include the potential for cardiovascular events and prostate issues.
At a glance
| Generic name | TESTOSTERONE UNDECANOATE |
|---|---|
| Sponsor | Marius |
| Drug class | Androgen |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2014 |
Mechanism of action
Endogenous 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 development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement; vocal cord thickening; alterations in body musculature; and fat distribution.Male hypogonadism, clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter syndrome or Leydig cell aplasia, whereas secondary hypogonadism (also known as hypogonadotropic hypogonadism) is the failure of the hypothalamus (or pituitary gland) to produce sufficient gonadotropins (FSH, LH).
Approved indications
- Deficiency or absence of endogenous testosterone
- Hypogonadotropic hypogonadism
- Primary hypogonadism
Common side effects
- Acne
- Injection site pain
- Prostatic specific antigen increased
- Hypogonadism
- Estradiol increased
- Fatigue
- Irritability
- Hemoglobin increased
- Insomnia
- Mood swings
- Aggression
- Ejaculation disorder
Key clinical trials
- Body Composition Assessment in Transgender Population.
- Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism (PHASE2)
- Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? (PHASE2,PHASE3)
- Cardiovascular Health of Transgender Individuals During the Gender-affirming Pathway
- Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer (PHASE2)
- Multimodality Intervention for Function and Metabolism in SCI (PHASE2)
- TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis (PHASE2)
- Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8492369 | 2030-12-20 | Formulation |
| 8241664 | 2029-03-29 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Aveed CI brief — competitive landscape report
- Aveed updates RSS · CI watch RSS
- Marius portfolio CI