Overview
Testosterone is a steroid sex hormone indicated to treat primary hypogonadism and hypogonadotropic hypogonadism. Testosterone antagonizes the androgen receptor to induce gene expression that causes the growth and development of masculine sex organs and secondary sexual characteristics. Testosterone was isolated from samples and also synthesized in 1935.
Background
Testosterone is a steroid sex hormone indicated to treat primary hypogonadism and hypogonadotropic hypogonadism. Testosterone antagonizes the androgen receptor to induce gene expression that causes the growth and development of masculine sex organs and secondary sexual characteristics. Testosterone was isolated from samples and also synthesized in 1935.
Indication
Testosterone is indicated to treat primary hypogonadism and hypogonadotropic hypogonadism.
Associated Conditions
- Hypergonadotropic Hypogonadism
- Hypogonadotrophic Hypogonadism
- Idiopathic Hypogonadotropic Hypogonadism
- Puberty, Delayed
- Inoperable, metastatic Breast cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/27 | Phase 2 | Active, not recruiting | |||
2024/12/13 | Phase 4 | Recruiting | |||
2024/12/06 | Not Applicable | Not yet recruiting | |||
2024/11/01 | N/A | Recruiting | |||
2024/09/19 | Phase 4 | Active, not recruiting | Leticia Maria Defendi Barboza Marson | ||
2024/06/13 | Phase 4 | Recruiting | Bradley Nindl | ||
2024/06/10 | Phase 4 | Recruiting | |||
2024/05/01 | Early Phase 1 | Completed | |||
2024/04/03 | Phase 3 | Not yet recruiting | |||
2024/03/15 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Padagis Israel Pharmaceuticals Ltd | 45802-754 | TOPICAL | 16.2 mg in 1 g | 8/27/2019 | |
| TWi Pharmaceuticals, Inc. | 24979-078 | TRANSDERMAL | 16.2 mg in 1 g | 10/1/2019 | |
| Physicians Total Care, Inc. | 54868-5814 | TRANSDERMAL | 10 mg in 1 g | 12/15/2011 | |
| Advanced Pharmaceutical Technology, Inc. | 57377-060 | SUBCUTANEOUS | 60 mg in 1 1 | 5/27/2022 | |
| Dr. Donna Restivo DC | 62185-0050 | ORAL | 8 [hp_X] in 1 mL | 5/23/2025 | |
| Stat Rx USA | 16590-853 | TOPICAL | 50 mg in 5 g | 3/15/2010 | |
| Actavis Pharma, Inc. | 0591-3216 | TOPICAL | 10 mg in 1 g | 5/20/2019 | |
| Rebel Distributors Corp. | 21695-112 | TRANSDERMAL | 10 mg in 1 g | 1/14/2010 | |
| Alembic Pharmaceuticals Inc. | 62332-488 | TOPICAL | 30 mg in 1.5 mL | 12/8/2023 | |
| REMEDYREPACK INC. | 70518-1171 | TOPICAL | 12.5 mg in 1.25 g | 5/14/2018 |
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 |
|---|---|---|---|---|---|
| ANDROGEL GEL 16.2MG/G | SIN16857P | GEL | 1.62g/100g | 9/7/2023 | |
| Androgel 50mg | SIN13162P | GEL | 0.05g | 12/22/2005 | |
| Androgel 25mg | SIN13161P | GEL | 0.025g | 12/22/2005 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Testosterone Propionate Injection | 国药准字H12020532 | 化学药品 | 注射剂 | 7/27/2020 | |
| Testosterone Propionate Injection | 国药准字H44022012 | 化学药品 | 注射剂 | 4/9/2024 | |
| Testosterone Propionate Injection | 国药准字H44022011 | 化学药品 | 注射剂 | 4/9/2024 | |
| Testosterone Propionate Injection | 国药准字H44023823 | 化学药品 | 注射剂 | 4/1/2020 | |
| Testosterone Propionate Injection | 国药准字H42022037 | 化学药品 | 注射剂 | 7/6/2022 | |
| Testosterone Propionate Injection | 国药准字H41023555 | 化学药品 | 注射剂 | 8/14/2020 | |
| Testosterone Propionate Injection | 国药准字H12020531 | 化学药品 | 注射剂 | 7/20/2020 | |
| Testosterone Propionate Injection | 国药准字H44022010 | 化学药品 | 注射剂 | 4/1/2020 | |
| Testosterone Propionate Injection | 国药准字H31021263 | 化学药品 | 注射剂 | 5/14/2020 | |
| Testosterone Propionate Injection | 国药准字H42022038 | 化学药品 | 注射剂 | 7/6/2022 |
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 |
|---|---|---|---|---|---|
| ANDRODERM testosterone 24.3 mg per patch transdermal drug delivery system sachet | 82398 | Medicine | A | 4/10/2002 | |
| TESTOGEL testosterone 1% 2.5g sachets | 96129 | Medicine | A | 1/7/2005 | |
| TESTOGEL testosterone 1% gel bottle | 227563 | Medicine | A | 11/7/2014 | |
| TESTAVAN testosterone 2% w/w gel in a metered-dose dispenser with a cap applicator | 277958 | Medicine | A | 5/26/2017 | |
| ANDROGEL testosterone 1% 2.5g sachets | 96122 | Medicine | A | 1/7/2005 | |
| TESTOGEL testosterone 1% 5g sachets | 96131 | Medicine | A | 1/7/2005 | |
| ANDROGEL testosterone 1% 5g sachets | 96130 | Medicine | A | 1/7/2005 | |
| ANDROFORTE 5 testosterone 5% w/v (50 mg/mL) cream tube | 123764 | Medicine | A | 7/11/2014 | |
| ANDROFEME 1 testosterone 1% w/v (10 mg/mL) cream tube | 324274 | Medicine | A | 11/23/2020 |