Overview
Testosterone enanthate is an esterified variant of testosterone that comes as an injectable compound with a slow-release rate. This slow release is achieved by the presence of the enanthate ester functional group attached to the testosterone molecule. This testosterone derivative was first approved on December 24, 1953. In 2017, about 6.5 million retail prescriptions for testosterone therapy were filled . The majority of the prescriptions written were for injectable (66%) and topical (32%) testosterone products. As recent as 1 October 2018, the US FDA approved Antares Pharma Inc.'s Xyosted - a subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable autoinjector . As the first subcutaneous autoinjector product designed for testosterone replacement therapy, this innovative formulation removes transfer concerns commonly associated with testosterone gels and potentially reduces the need for in-office/in-clinic injection procedures that may inconvenience patients with frequent visits to the clinic .
Background
Testosterone enanthate is an esterified variant of testosterone that comes as an injectable compound with a slow-release rate. This slow release is achieved by the presence of the enanthate ester functional group attached to the testosterone molecule. This testosterone derivative was first approved on December 24, 1953. In 2017, about 6.5 million retail prescriptions for testosterone therapy were filled . The majority of the prescriptions written were for injectable (66%) and topical (32%) testosterone products. As recent as 1 October 2018, the US FDA approved Antares Pharma Inc.'s Xyosted - a subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable autoinjector . As the first subcutaneous autoinjector product designed for testosterone replacement therapy, this innovative formulation removes transfer concerns commonly associated with testosterone gels and potentially reduces the need for in-office/in-clinic injection procedures that may inconvenience patients with frequent visits to the clinic .
Indication
⑴男性性功能低减替代疗法；⑵绝经后女性晚期乳腺癌姑息性治疗；⑶男性青春期发育迟缓。⑷再生障碍性贫血。
Associated Conditions
- Congenital Hypogonadotropic Hypogonadism
- Hypergonadotropic Hypogonadism
- Idiopathic Hypogonadotropic Hypogonadism
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/19 | Phase 2 | Recruiting | Australian and New Zealand Urogenital and Prostate Cancer Trials Group | ||
2020/10/23 | Phase 4 | Not yet recruiting | |||
2020/07/08 | Phase 2 | Recruiting | |||
2020/04/27 | Phase 2 | Recruiting | |||
2019/07/19 | Phase 3 | Withdrawn | |||
2018/09/17 | Phase 2 | Withdrawn | |||
2018/05/04 | Phase 2 | Completed | |||
2017/04/21 | Phase 1 | Completed | |||
2016/04/12 | Phase 4 | Completed | |||
2016/03/03 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 0143-9750 | INTRAMUSCULAR | 200 mg in 1 mL | 11/12/2021 | |
| Antares Pharma, Inc. | 54436-250 | SUBCUTANEOUS | 50 mg in 0.5 mL | 8/1/2023 | |
| Eugia US LLC | 55150-336 | INTRAMUSCULAR | 200 mg in 1 mL | 9/19/2018 | |
| Antares Pharma, Inc. | 54436-200 | SUBCUTANEOUS | 100 mg in 0.5 mL | 8/1/2023 | |
| Antares Pharma, Inc. | 54436-275 | SUBCUTANEOUS | 75 mg in 0.5 mL | 8/1/2023 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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. | |||||