Overview
Testosterone undecanoate is the ester prodrug of testosterone and has a mid-chain fatty acid at the carbon 17β position. It was developed via fatty acid esterification of testosterone in order to achieve orally administer testosterone. There are oral and intramuscular formulations available for testosterone undecanoate: both formulations are indicated for testosterone replacement therapy in adult males with hypogonadism. Testosterone is a critical male hormone that is responsible for the normal growth and development of the male sex organs and for the maintenance of secondary sex characteristics. Male hypogonadism, resulting from insufficient testosterone secretion, can result symptoms and signs of testosterone deficiency, such as decreased libido, erectile dysfunction, and loss of muscle and bone mass. Testosterone replacement therapy aims to restore the levels of testosterone, thereby improving symptoms and signs of testosterone deficiency.
Indication
Testosterone undecanoate is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. These conditions include: Testosterone undecanoate is not used to treat age-related hypogonadism.
Associated Conditions
- Testosterone Deficiency
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/07/08 | Phase 3 | Completed | |||
2024/04/26 | Phase 4 | Active, not recruiting | |||
2024/01/03 | Not Applicable | Recruiting | Morten Hostrup, PhD | ||
2023/07/28 | Phase 2 | Recruiting | Norwegian School of Sport Sciences | ||
2022/09/15 | N/A | Recruiting | Hospital de Niños R. Gutierrez de Buenos Aires | ||
2022/02/21 | Phase 2 | Recruiting | |||
2021/10/18 | Phase 2 | Active, not recruiting | |||
2021/07/30 | Phase 4 | Completed | |||
2020/09/11 | Phase 3 | Completed | Unita Complessa di Ostetricia e Ginecologia | ||
2020/07/02 | Phase 4 | Completed | Endo Pharmaceuticals |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Endo Pharmaceuticals Inc. | 67979-511 | INTRAMUSCULAR | 250 mg in 1 mL | 1/10/2023 | |
| Marius Pharmaceuticals | 80603-101 | ORAL | 100 mg in 1 1 | 10/26/2023 | |
| TOLMAR Inc. | 69087-237 | ORAL | 237 mg in 1 1 | 8/16/2023 | |
| Marius Pharmaceuticals | 80603-103 | ORAL | 150 mg in 1 1 | 10/26/2023 | |
| Antares Pharma, Inc. | 54436-112 | ORAL | 112.5 mg in 1 1 | 3/31/2022 | |
| TOLMAR Inc. | 69087-158 | ORAL | 158 mg in 1 1 | 8/16/2023 | |
| TOLMAR Inc. | 69087-198 | ORAL | 198 mg in 1 1 | 8/16/2023 | |
| Verity Pharmaceuticals Inc. | 74676-0112 | ORAL | 112.5 mg in 1 1 | 2/1/2024 | |
| Marius Pharmaceuticals | 80603-105 | ORAL | 200 mg in 1 1 | 10/26/2023 |
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 |
|---|---|---|---|---|---|
| NEBIDO Solution | SIN13281P | SOLUTION, STERILE | 1000.0 mg/4 ml | 5/21/2007 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Testosterone Undecanoate Soft Capsules | 国药准字H10970240 | 化学药品 | 胶囊剂 | 1/9/2020 | |
| Testosterone Undecanoate Injection | 国药准字H10900063 | 化学药品 | 注射剂 | 4/26/2020 |
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 |
|---|---|---|---|---|---|
| TESTOSTERONE RBX testosterone undecanoate 1000 mg/4 mL oily solution for injection vial | 414399 | Medicine | A | 5/6/2024 | |
| TESTOSTERONE SUN testosterone undecanoate 1000 mg/4 mL oily solution for injection vial | 414397 | Medicine | A | 5/6/2024 | |
| REJUNON 1000 testosterone undecanoate 1000 mg in 4 mL oily solution for injection vial | 407004 | Medicine | A | 1/24/2024 | |
| REANDRON 1000 testosterone undecanoate 1000 mg/4 mL injection ampoule | 106946 | Medicine | A | 10/26/2005 | |
| TESTOSTERONE ADVZ 1000 testosterone undecanoate 1000 mg/4 mL oily solution for injection vial | 405893 | Medicine | A | 12/13/2023 | |
| LEVANE 1000 testosterone undecanoate 1000 mg/4 mL injection vial | 420890 | Medicine | A | 1/12/2024 | |
| REANDRON 1000 testosterone undecanoate 1000 mg/4 mL injection vial | 213942 | Medicine | A | 1/7/2014 | |
| GONADRON testosterone undecanoate 1000 mg/4 mL oily solution for injection vial | 414398 | Medicine | A | 5/6/2024 |
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