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testosterone undecanoate

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

testosterone undecanoate: sourced relationships with 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 · 0 study sponsors

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (2)
CompanyDated record stage
Endo LP (NDOI)
Reported 2014-03-05 · Current development: unknownSource
Approved
Endo LP (NDOI)
Reported 2014-03-05 · Current development: unknownSource
Approved
Clinical Trial Registry Records (2)

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

NCT05081193Registry updated 2025-09-22·Phase 2
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

A Phase 1, Randomised, Open-label, 2-cohort, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Native Oral Testosterone Formulation (DITEST) in the Fed and Fasted State and Compared to Testosterone Undecanoate in Adult Men With Primary or Secondary Hypogonadism

NCT02966652Registry updated 2026-09-14·Phase 1
Completed

Primary endpoint: Testosterone serum concentrations - Peak Plasma Concentration (Cmax)

InterventionalRandomizedopen25 enrolledStarted 2016-11Completion 2018-101 site · United KingdomNeurocrine UK Limited
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

Which companies have sourced relationships with testosterone undecanoate?

testosterone undecanoate has dated SEC/FDA relationship records for 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.