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.
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
Research Report
A Comprehensive Monograph on Testosterone (DB00624): From Molecular Structure to Clinical and Regulatory Realities
Executive Summary
Testosterone, the principal endogenous androgenic steroid hormone, is fundamental to the development, maturation, and physiological maintenance of male reproductive tissues and secondary sexual characteristics. In its capacity as a pharmaceutical agent (DrugBank ID: DB00624), testosterone serves as a cornerstone therapy for male hypogonadism, a clinical syndrome characterized by deficient hormone production. Its mechanism of action is centered on its function as an agonist of the nuclear androgen receptor (AR). This interaction occurs either directly or, more potently, through its primary active metabolite, 5α-dihydrotestosterone (DHT), which is synthesized in target tissues. Activation of the AR initiates a cascade of gene transcription events that orchestrate the hormone's broad physiological effects.[1]
The primary and most rigorously defined therapeutic indication for testosterone is as replacement therapy for male hypogonadism. This encompasses both primary hypogonadism, which originates from testicular failure, and secondary (or hypogonadotropic) hypogonadism, which results from dysfunction of the hypothalamic-pituitary axis.[1] Regulatory bodies, including the U.S. Food and Drug Administration (FDA), mandate that a diagnosis be unequivocally confirmed through at least two separate, low serum testosterone measurements taken in the morning, in conjunction with clinical symptoms, before initiating therapy.[5]
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 | Terminated | |||
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 |
---|---|---|---|---|---|
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 |
---|---|---|---|---|---|
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ANDROGEL | BGP Pharma ULC | 02249499 | Gel - Transdermal | 12.5 MG / ACT | 9/20/2004 |
ANDROGEL | BGP Pharma ULC | 02245345 | Gel - Transdermal | 1 % | 5/6/2002 |
TARO-TESTOSTERONE GEL | 02463792 | Gel - Transdermal | 1 % | 10/31/2017 | |
MALOGEN AQUEOUS 100 SUS 100MG/ML | 02027046 | Suspension - Intramuscular | 100 MG / ML | 12/31/1994 | |
ANDRODERM | 02239653 | Patch - Transdermal | 2.5 MG / 24 HOUR | 12/19/2000 | |
ANDROGEL | BGP Pharma ULC | 02245346 | Gel - Transdermal | 1 % | 5/6/2002 |
NATESTO | 02450550 | Gel - Nasal | 4.5 % / W/W | 5/6/2016 | |
TARO-TESTOSTERONE GEL | 02463806 | Gel - Transdermal | 1 % | 10/31/2017 | |
AXIRON | eli lilly canada inc | 02382369 | Solution - Transdermal | 30 MG / ACT | 5/8/2013 |
ANDRODERM | 02245972 | Patch - Transdermal | 5 MG / 24 HOUR | 9/24/2002 |
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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