Wednesday, July 8, 2026

Drug profile · INN

testosterone

testosterone (ANDROFORTE 5) is a androgen receptor agonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: implantation. Current US regulatory status: approved.

FDA: approved EMA: withdrawn TGA: approved Genito-urinary system and sex hormones (G03) G03BA03
US status approved
Patents linked 9
Pipeline programs 13
News articles 1
Drug details — testosterone
US status
approved
Class
Genito-urinary system and sex hormones (G03)
Route
IMPLANTATION
Patents
9
Programs
13
Data quality
0.89

Quick answer

testosterone (ANDROFORTE 5) is a androgen receptor agonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: implantation. Current US regulatory status: approved.

Key facts

INN testosterone
Brand ANDROFORTE 5
Mechanism Androgen Receptor agonist
Target Androgen receptor
Therapeutic class Genito-urinary system and sex hormones (G03)
Route IMPLANTATION
Formulation GEL, METERED
ATC code G03BA03

Mechanism of action

Androgen Receptor agonist

Primary target: Androgen receptor

Approval history

Authority Status Date
FDA approved
EMA withdrawn
TGA approved

Recent coverage

Pipeline programs

  1. P170923J Phase 3 · PARItec · gender dysphoria
  2. Testosterone Gel 1% for low ovarian reserve according t… Phase 3 · George Institute for · low ovarian reserve according to Bologna criteria and carrie
  3. Testosterone MD-Lotion Phase 3 · Eli Lilly and · Hypogonadism
  4. Testosterone Topical Gel, 1.62% Metered Pump Phase 3 · Amneal Pharma Europe · Primary Hypogonadism
  5. Testosterone Transdermal System Phase 3 · anwerina Deutschland · Hypoactive Sexual Desire Disorder
  6. Testosterone enanthate Phase 3 · HALOZYME THERAPEUTICS · Hypogonadism, Male
  7. TAK-448 Phase 2 · Takeda · Low Testosterone
  8. Testosterone Enanthate 100 MG/ML Injectable Solution Phase 2 · Hospital Authority · Castration-resistant Prostate Cancer

Related & competitor drugs

  1. apomorphine Genito-urinary system and sex hormones (G04)
  2. bicalutamide Androgen Receptor antagonist
  3. danazol Progesterone receptor agonist
  4. mirabegron Genito-urinary system and sex hormones (G04)
  5. nandrolone decanoate Androgen Receptor agonist
  6. oxybutynin Genito-urinary system and sex hormones (G04)
  1. US 12318397

    Methods and compositions for testosterone production

    Expires Mon May 29 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12290524

    Methods and compositions for testosterone production

    Expires Mon May 01 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11844805

    Formulations of testosterone and methods of treatment therewith

    Expires Mon Dec 14 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 10751348

    Formulations of testosterone and methods of treatment therewith

    Expires Mon Aug 20 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 10258631

    Formulations of testosterone and methods of treatment therewith

    Expires Mon Apr 11 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 9675653

    Composition containing an essential oil product and method for using such to maintain normal levels of testosterone

    Expires Mon Jun 08 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 9066904

    Composition containing an essential oil product and method for using such to maintain normal levels of testosterone

    Expires Mon Jun 25 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 8653057

    Prophylactic perioperative testosterone supplementation for protection of and recovery of function

    Expires Mon Feb 13 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 7754220

    Methods of inhibiting secretion of follicle-stimulating hormone and testosterone

    Expires Mon Jul 08 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is testosterone?

testosterone (ANDROFORTE 5) is a androgen receptor agonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: implantation. Current US regulatory status: approved.

What is the brand name for testosterone?

ANDROFORTE 5 is a marketed brand name for testosterone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of testosterone?

testosterone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.