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testosterone undecanoate

Generic: TESTOSTERONE UNDECANOATE·Brand: AVEED, JATENZO, KYZATREX, TLANDO

testosterone undecanoate: developed by 1 company · 2 clinical trials tracked · 1 FDA decision.

testosterone undecanoate evidence translation

What we can confirm

1 FDA record · 2 tracked trials

What it means

Source-backed records connect testosterone undecanoate to NDOI; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could testosterone undecanoate → NDOI affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 1 study sponsors
Development Pipeline (2)
CompanyPhase
Endo LP (NDOI)Approved
Endo LP (NDOI)Approved
Clinical Trials (2)

A Phase 4, Open-Label Study to Evaluate Primary Adrenal Function (Glucocorticoid Axis) in Hypogonadal Men Treated With JATENZO® for 12 Months

NCT06385509·Phase 4
Active, not recruiting

Primary endpoint: CST Test

Interventionalopen110 enrolledStarted 2024-05Completion 2026-0327 sites · United StatesTolmar Inc.

A Phase II Study Assessing the Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer

NCT05081193·Phase 2·KYNB
Completed

Primary endpoint: Objective Response Rate of Oral Testosterone Undecanoate (CT Scan)

Interventionalopen15 enrolledStarted 2022-03Completion 2025-082 sites · United StatesSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE AVEED is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins ((NDOI)FDA ↗
NDA022219Type 3 - New Dosage FormStandardSubcutaneousInjectable

Frequently asked questions

Who is developing testosterone undecanoate?

testosterone undecanoate is being developed by Endo LP.

How many clinical trials involve testosterone undecanoate?

BioSniper tracks 2 clinical trials involving testosterone undecanoate.

What is testosterone undecanoate's latest FDA decision?

The most recent tracked FDA decision for testosterone undecanoate is Approval for 1 INDICATIONS AND USAGE AVEED is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (, dated March 5, 2014.