TESTOSTERONE ENANTHATE
TESTOSTERONE ENANTHATE is indicated for the treatment of Primary Hypogonadism; Hypogonadotropic Hypogonadism; Delayed Puberty.
Details
- Status
- Discontinued
- First Approved
- 1980-12-10
- Routes
- INJECTION, Injection
- Dosage Forms
- INJECTABLE, Injectable
TESTOSTERONE ENANTHATE Approval History
What TESTOSTERONE ENANTHATE Treats
3 indicationsTESTOSTERONE 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
TESTOSTERONE ENANTHATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TESTOSTERONE ENANTHATE
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06594926 WOMBAT | ANZUP 2201 | Ph 2 | recruiting | Working Out M0 Bipolar Androgen Therapy |
| NCT04363164 | J2060sIRB IRB00312725 | Ph 2 | recruiting | Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression |
| NCT03516812 results posted | 9984 NCI-2018-00542, 9984 | Ph 2 | completed | Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer |
| NCT04460872 | 649726 | Ph 2 | recruiting | Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury |
| NCT02248701 results posted | B1449-R 1I01RX001449-01A1 | Ph 2 | terminated | Testosterone Plus Finasteride Treatment After Spinal Cord Injury |
| NCT03123913 STARFISH results posted | 1R01NS095813-01 | Ph 1 | completed | Study of Testosterone and rHGH in FSHD |
| NCT04026880 TPELVIC | 2018P000248 | Ph 3 | withdrawn | Testosterone Effects on Pelvic Floor Muscles |
| NCT02090114 Restore results posted | J1416 NA_00093344, 1R01CA184012-01 | Ph 2 | completed | RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study) |
| NCT03674320 | 18-0202 | Ph 2, Ph 3 | withdrawn | Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD |
| NCT01275365 OPTIMen results posted | 2012P001321 7R01AG037547 | Ph 3 | completed | Optimizing Protein Intake in Older Americans With Mobility Limitations |
| NCT02286921 Transformer results posted | J14146 IRB00046414, W81XWH-14-2-0189 | Ph 2 | completed | Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance |
| NCT02734238 OPS results posted | PBRC 2015-063 | Ph 4 | completed | Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery |
| NCT01962454 | 200030 | Ph 1 | completed | A Study to Evaluate a Skeletal-muscle Microbiopsy Technique With Dynamic Proteomic Measurement in Healthy Male Volunteers |
| NCT01417364 | 11-132 | Ph 4 | withdrawn | The Effects of Long Term Cyclic Testosterone Administration on Muscle Function and Bone in Older Men |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
TESTOSTERONE ENANTHATE is indicated for the treatment of Primary Hypogonadism; Hypogonadotropic Hypogonadism; Delayed Puberty.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.