DEPO-TESTOSTERONE (testosterone cypionate)
DEPO-TESTOSTERONE is indicated for the treatment of Hypogonadism; Cryptorchidism; Orchitis; Vanishing Testis Syndrome; Gonadotropin Deficiency; LHRH Deficiency; Hypothalamic Injury.
Details
- Status
- Prescription
- First Approved
- 1979-07-25
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DEPO-TESTOSTERONE Approval History
What DEPO-TESTOSTERONE Treats
7 indicationsDEPO-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
DEPO-TESTOSTERONE 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 DEPO-TESTOSTERONE
3 of 15FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
22 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06305598 | I-3298823 NCI-2024-01390, I-3298823 | Ph 1 | recruiting | Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer |
| NCT04895306 | 2021P001447 | Ph 2 | completed | Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial) |
| NCT04363164 | J2060sIRB IRB00312725 | Ph 2 | recruiting | Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression |
| NCT07142551 | J2564 IRB00509292 | Ph 2 | recruiting | Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response |
| NCT07278362 | 20250346 | Ph 4 | not yet recruiting | Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance |
| NCT04558866 ExBAT | LACOG 0620 | Ph 2 | active not recruiting | Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial) |
| NCT04731376 | STUDY00001062 NCI-2020-06998, EU5097-20 | Ph 1 | active not recruiting | Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone |
| NCT06059118 | J2326 IRB00371517 | Ph 2 | recruiting | Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer |
| NCT06039371 | RG1123642 NCI-2023-05597, FHIRB0020106 | Ph 2 | recruiting | Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study |
| NCT06100705 | 2000035188 | Ph 2 | recruiting | Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC |
| NCT03516812 results posted | 9984 NCI-2018-00542, 9984 | Ph 2 | completed | Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer |
| NCT06922318 | J2513 IRB00480365, P50CA272391 | Ph 2 | recruiting | The COSMYC Trial (COmbined Suppression of MYC) |
| NCT06111209 | 2023P002632 R01DK136904 | Ph 2 | recruiting | The Anabolic Effect of Testosterone on Pelvic Floor Muscles |
| NCT03554317 COMBAT-CRPC results posted | J1812 IRB00164973 | Ph 2 | completed | COMbination of Bipolar Androgen Therapy and Nivolumab |
| NCT02995330 results posted | J1608 IRB00086105 | Ph 1 | terminated | Sex-Mismatched Allogeneic Bone Marrow Transplantation for Men With Metastatic Castration-Resistant Prostate Cancer |
| NCT04424654 PSMA-BAT | HSL-1820 | Ph 2 | completed | Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Bipolar Androgen Therapy |
| NCT02090114 Restore results posted | J1416 NA_00093344, 1R01CA184012-01 | Ph 2 | completed | RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study) |
| NCT04345666 | Orthopedicinstitutesf | Ph 2, Ph 3 | withdrawn | Can Testosterone Accelerate Injury Recovery After Arthroscopic Rotator Cuff Repair |
| NCT00853502 | 2008P-001902 | Ph 2 | withdrawn | The Effect of Testosterone Replacement on Bone Mineral Density in Boys and Men With Anorexia Nervosa |
| 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 |
| NCT01378299 results posted | SPLC-001-10S | Ph 1 | completed | CYP19A1 (Cytochrome P450 Family 19 Subfamily A Member 1) Gene and Pharmacogenetics of Response to Testosterone Therapy |
| NCT01750398 BAT results posted | J1298 NA_00077460 | Ph 2 | completed | Bipolar Androgen-based Therapy for Prostate Cancer (BAT) |
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.
DEPO-TESTOSTERONE FDA Label Details
Indications & Usage
FDA Label (PDF)DEPO-TESTOSTERONE is indicated for the treatment of Hypogonadism; Cryptorchidism; Orchitis; Vanishing Testis Syndrome; Gonadotropin Deficiency; LHRH Deficiency; Hypothalamic Injury.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.