MedPath

Testosterone

Generic Name
Testosterone
Brand Names
Androderm, Androgel, Axiron, Fortesta, Natesto, Striant, Testim, Testopel, Vogelxo
Drug Type
Small Molecule
Chemical Formula
C19H28O2
CAS Number
58-22-0
Unique Ingredient Identifier
3XMK78S47O

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

Published: Jul 17, 2025

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]

Continue reading the full research report

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.

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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