TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

DEPO-TESTOSTERONE

TESTOSTERONE CYPIONATE
Oncology Approved 1979-07-25
1
Indication
--
Phase 3 Trials
46
Years on Market

Details

Status
Prescription
First Approved
1979-07-25
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: TESTOSTERONE CYPIONATE

DEPO-TESTOSTERONE Approval History

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What DEPO-TESTOSTERONE Treats

7 indications

DEPO-TESTOSTERONE is approved for 7 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypogonadism
  • Cryptorchidism
  • Orchitis
  • Vanishing Testis Syndrome
  • Gonadotropin Deficiency
  • LHRH Deficiency
  • Hypothalamic Injury
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.

DEPO-TESTOSTERONE FDA Label Details

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Indications & Usage

FDA Label (PDF)

DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of DEPO-Testosterone (testosterone cypionate) in men with β€œage-related hypogonadism” (...

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Data Sources

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