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.
Background
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 |
|---|---|---|---|---|---|
2025/04/10 | Phase 2 | Not yet recruiting | |||
2024/03/12 | Phase 1 | Recruiting | |||
2023/11/01 | Phase 2 | Recruiting | |||
2023/10/25 | Phase 2 | Recruiting | |||
2023/09/28 | Phase 2 | Recruiting | |||
2023/09/15 | Phase 2 | Recruiting | |||
2021/05/20 | Phase 2 | Recruiting | |||
2021/02/17 | Phase 1 | Completed | Parc de Salut Mar | ||
2021/02/01 | Phase 1 | Recruiting | |||
2020/09/22 | Phase 2 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-4921 | INTRAMUSCULAR | 200 mg in 1 mL | 3/26/2019 | |
| Physicians Total Care, Inc. | 54868-0216 | INTRAMUSCULAR | 200 mg in 1 mL | 1/12/2011 | |
| Eugia US LLC | 55150-277 | INTRAMUSCULAR | 200 mg in 1 mL | 10/21/2023 | |
| Asclemed USA, Inc. | 76420-645 | INTRAMUSCULAR | 200 mg in 1 mL | 11/20/2023 | |
| A-S Medication Solutions | 50090-4446 | INTRAMUSCULAR | 200 mg in 1 mL | 11/3/2020 | |
| Eugia US LLC | 55150-278 | INTRAMUSCULAR | 2000 mg in 10 mL | 10/21/2023 | |
| Cipla USA Inc. | 69097-802 | INTRAMUSCULAR | 200 mg in 1 mL | 8/11/2021 | |
| Cipla USA Inc. | 69097-537 | INTRAMUSCULAR | 200 mg in 1 mL | 8/30/2023 | |
| Physicians Total Care, Inc. | 54868-3669 | INTRAMUSCULAR | 100 mg in 1 mL | 2/2/2012 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9726 | INTRAMUSCULAR | 200 mg in 1 mL | 3/14/2022 |
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 | 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. | |||||