TheraRadar

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Data updated: Mar 10, 2026

TESTOSTERONE CYPIONATE

TESTOSTERONE CYPIONATE
Oncology Approved 1978-06-23
13
Indications
--
Phase 3 Trials
47
Years on Market

Details

Status
Prescription
First Approved
1978-06-23
Routes
INJECTION, Injection
Dosage Forms
INJECTABLE, Injectable

TESTOSTERONE CYPIONATE Approval History

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What TESTOSTERONE CYPIONATE Treats

1 indications

TESTOSTERONE CYPIONATE is approved for 1 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypogonadism
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 CYPIONATE FDA Label Details

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Indications & Usage

Testosterone cypionate 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 testosterone cypionate injection in men with β€œageΒ­-related hypogonadism” (also r...

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Data Sources

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