Testosterone cypionate

Overview

Testosterone cypionate is a synthetic derivative of testosterone in the form of an oil-soluble 17 (beta)-cyclopentylpropionate ester. Its benefit compared to other testosterone derivatives is the slow rate of release after injection and longer half-life. It was developed by the company Pharmacia and Upjohn and FDA approved on July 25, 1979.

Indication

Testosterone cypionate is used in males that present conditions derived from a deficiency or absence of endogenous testosterone. These conditions are 1) primary hypogonadism, defined as the testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome or orchidectomy; and 2) hypogonadotropic hypogonadism characterized by idiopathic gonadotropin, LHRH deficiency or pituitary-hypothalamic injury from tumors, trauma or radiation.

Associated Conditions

Hypergonadotropic Hypogonadism
Hypogonadotrophic Hypogonadism

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response	2025/08/26	NCT07142551	Not Applicable	Not yet recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
The COSMYC Trial (COmbined Suppression of MYC)	2025/04/10	NCT06922318	Phase 2	Recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer	2024/03/12	NCT06305598	Phase 1	Recruiting	Roswell Park Cancer Institute
The Anabolic Effect of Testosterone on Pelvic Floor Muscles	2023/11/01	NCT06111209	Phase 2	Recruiting	Brigham and Women's Hospital
Sipuleucel-T Combined with Bipolar Androgen Therapy in Men with MCRPC	2023/10/25	NCT06100705	Phase 2	Recruiting	Yale University
Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer	2023/09/28	NCT06059118	Phase 2	Recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study	2023/09/15	NCT06039371	Phase 2	Recruiting	University of Washington
Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)	2021/05/20	NCT04895306	Phase 2	Recruiting	Brigham and Women's Hospital
Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.	2021/02/17	NCT04757532	Phase 1	Completed	Parc de Salut Mar
Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone	2021/02/01	NCT04731376	Phase 1	Recruiting	Emory University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Depo-Testosterone	Asclemed USA, Inc.	76420-425	INTRAMUSCULAR	100 mg in 1 mL	8/27/2025
Testosterone Cypionate	A-S Medication Solutions	50090-4921	INTRAMUSCULAR	200 mg in 1 mL	3/26/2019
Depo-Testosterone	Physicians Total Care, Inc.	54868-0216	INTRAMUSCULAR	200 mg in 1 mL	1/12/2011
Testosterone Cypionate	Eugia US LLC	55150-277	INTRAMUSCULAR	200 mg in 1 mL	10/21/2023
Testosterone Cypionate	Asclemed USA, Inc.	76420-645	INTRAMUSCULAR	200 mg in 1 mL	11/20/2023
Testosterone Cypionate	A-S Medication Solutions	50090-4446	INTRAMUSCULAR	200 mg in 1 mL	11/3/2020
Testosterone Cypionate	Eugia US LLC	55150-278	INTRAMUSCULAR	2000 mg in 10 mL	10/21/2023
Testosterone Cypionate	Cipla USA Inc.	69097-802	INTRAMUSCULAR	200 mg in 1 mL	8/11/2021
TESTOSTERONE CYPIONATE	Cipla USA Inc.	69097-537	INTRAMUSCULAR	200 mg in 1 mL	8/30/2023
Testosterone Cypionate	Physicians Total Care, Inc.	54868-3669	INTRAMUSCULAR	100 mg in 1 mL	2/2/2012

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DEPO-TESTOSTERONE STERILE SOLUTION 100 mg/ml	PHARMACIA AND UPJOHN COMPANY LLC	SIN04518P	INJECTION	100 mg/ml	5/23/1990

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TARO-TESTOSTERONE CYPIONATE INJECTION	Taro Pharmaceuticals Inc	02496003	Solution - Intramuscular	100 MG / ML	10/20/2020
TESTOSTERONE CYPIONATE INJECTION, USP	Sterimax Inc	01977601	Liquid - Intramuscular	100 MG / ML	12/31/1992
DEPO-TESTOSTERONE INJ 100MG/ML	Pfizer Canada Ulc	00030783	Solution - Intramuscular	100 MG / ML	12/31/1953
SCHEINPHARM TESTONE-CYP INJECT.- IM 100MG/ML	schein pharmaceutical canada inc.	02220318	Liquid - Intramuscular	100 MG / ML	12/12/1996
TESTOSTERONE CYPIONATE INJECTION USP	Sandoz Canada, Inc.	02246063	Liquid - Intramuscular	100 MG / ML	8/1/2002

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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