TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

TESTOSTERONE ENANTHATE

TESTOSTERONE ENANTHATE
Oncology Approved 1980-12-10
5
Indications
--
Phase 3 Trials
45
Years on Market

Details

Status
Prescription
First Approved
1980-12-10
Routes
INJECTION, Injection
Dosage Forms
INJECTABLE, Injectable

TESTOSTERONE ENANTHATE Approval History

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What TESTOSTERONE ENANTHATE Treats

3 indications

TESTOSTERONE ENANTHATE is approved for 3 conditions since its original approval in 1980. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Primary Hypogonadism
  • Hypogonadotropic Hypogonadism
  • Delayed Puberty
Source: FDA Label
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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TESTOSTERONE ENANTHATE FDA Label Details

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Indications & Usage

Males Testosterone enanthate injection is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) โ€“ Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) โ€“ Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still n...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.