TheraRadar
Data updated: May 26, 2026

TESTOSTERONE CYPIONATE

Endocrine Approved 1978-06-23

TESTOSTERONE CYPIONATE is indicated for the treatment of Hypogonadism.

Source: FDA Label • AM REGENT
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
13
Indications
--
Phase 3 Trials
47
Years on Market

Details

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

Companies

AM REGENT EUGIA PHARMA Hikma WATSON LABS Sun Pharma CAPLIN ONE LABS PADAGIS US XIROMED WATSON PHARMS INC Cipla QUAD PHARMS WILSHIRE PHARMS INC RISING
Active Ingredient: TESTOSTERONE CYPIONATE

TESTOSTERONE CYPIONATE Approval History

1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
120 FDA actions from 1978 to 2025
Jul 2025 SUPPL
Label · Labeling
Jul 2025 SUPPL
Label · Labeling
Jul 2025 SUPPL
Label · Labeling

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

TESTOSTERONE CYPIONATE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

KYZATREX
MARIUS
2022 1 indic.
TLANDO
VERITY
2022 6 indic.
Unlock 8 more competitors across all three rings.
Upgrade to Pro

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 CYPIONATE

3 of 14

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ANDROGEL
TESTOSTERONE
1 shared
BESINS HLTHCARE
Shared indications:
Hypogonadism
AVEED
TESTOSTERONE UNDECANOATE
1 shared
ENDO OPERATIONS
Shared indications:
Hypogonadism
AZMIRO
TESTOSTERONE CYPIONATE
1 shared
AZURITY
Shared indications:
Hypogonadism
View all 14 similar drugs Pro
📋

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

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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

Indications & Usage

TESTOSTERONE CYPIONATE is indicated for the treatment of Hypogonadism.

Looking for the branded version?

AZMIRO

Full clinical data, patents, trials, and competitive landscape for testosterone cypionate.

See AZMIRO

Data Sources

FDA Approval: ANDA207742 → Label: DailyMed → Trials: ClinicalTrials.gov →

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