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Data updated: May 26, 2026

TESTOPEL (testosterone)

Androgen Receptor Agonists
Endocrine Approved 1972-07-13

TESTOPEL is indicated for the treatment of Hypogonadism; Delayed Puberty.

Source: FDA Label • ENDO OPERATIONS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
53
Years on Market

Details

Status
Prescription
First Approved
1972-07-13
Routes
IMPLANTATION
Dosage Forms
PELLET

Companies

ENDO OPERATIONS
Active Ingredient: TESTOSTERONE

TESTOPEL Approval History

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Original
New Indication
New Form
Label Update
15 FDA actions from 1972 to 2025
Jul 2025 SUPPL
Label · Labeling
Oct 2016 SUPPL
Label · Labeling
Oct 2016 SUPPL
Label · Labeling

What TESTOPEL Treats

2 indications

TESTOPEL is approved for 2 conditions since its original approval in 1972. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypogonadism
  • Delayed Puberty
Source: FDA Label

TESTOPEL Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

KYZATREX
MARIUS
2022 1 indic.
AZMIRO
AZURITY
2022 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to TESTOPEL

3 of 15

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

NATESTO
TESTOSTERONE
2 shared
ACERUS
Shared indications:
HypogonadismDelayed Puberty
XYOSTED (AUTOINJECTOR)
TESTOSTERONE ENANTHATE
2 shared
ANTARES PHARMA INC
Shared indications:
HypogonadismDelayed Puberty
ANDROGEL
TESTOSTERONE
1 shared
BESINS HLTHCARE
Shared indications:
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📋

Clinical Trial Registry

47 trials
Trial Sponsor ID Phase Status Title
NCT04675788 2005890134 1R01HL153114-01 Ph 4 completed Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening
NCT07254429 COMPASS 2025-522558-37-00 2025-522558-37-00 Ph 2 recruiting COMPASS - COpenhagen MenoPAuSe Study
NCT01894308 PARC-T-D PARC-Testosterone-D1/09/13 2013-001766-42, IRAS project ID: 146877 Ph 2 not yet recruiting A Dose Ranging Study to Examine TDS-Testosterone 5%
NCT02938923 STEP-HI results posted R01AG051647 201609077 Ph 3 completed Starting a Testosterone and Exercise Program After Hip Injury
NCT01573442 results posted A221102 CDR0000730083, NCI-2012-00719 Ph 3 completed Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
NCT02990533 GRAMS 16-0146 Ph 1 completed Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients
NCT02873559 PROGRESS Ethical protocol H-16020521 Ph 2, Ph 3 completed Effect of PROGRESSive Training and Teststerone in Older Frail Men
NCT01460654 results posted MGH-988 Ph 2 terminated Testosterone and Alendronate in Hypogonadal Men
NCT01127659 results posted NIH testosterone grant R01DK075877 Ph 4 completed Testosterone Replacement in Men With Diabetes and Obesity
NCT02367105 LITROS results posted ENDA-034-12F CX000906 Ph 3 completed Lifestyle Intervention and Testosterone Replacement in Obese Seniors
NCT01595581 TACL results posted HS-11-00649 Ph 3 completed Testosterone Administration and ACL Reconstruction in Men
NCT02433730 22102014 Ph 4 completed Testosterone Therapy in Hypogonadal Men Treated With Opioids
NCT01121211 results posted 2009P-001845/1 5R01MH083657-05A2 Ph 2 completed Hormonal Factors in the Treatment of Anorexia Nervosa
NCT02419105 T&D T&D Study 32003B_135192, SNCTP: 000001224 Ph 3 terminated Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors
NCT02991209 Einstein 010815Testis Ph 2, Ph 3 completed Study of Testosterone vs Placebo in Testicular Cancer Survivors
NCT02611154 Intranasal results posted 84225 Ph 4 completed Intranasal Delivery of Testosterone and Its Effect on Doping Markers
NCT02803073 L16-116 Ph 2, Ph 3 withdrawn Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After a Recent Myocardial Infarction
NCT03091348 results posted MHB023 Ph 4 completed Subcutaneous vs. Intramuscular Testosterone
NCT01155518 results posted 1-10-JF-13 Ph 2 terminated Hypogonadism in Young Men With Type 2 Diabetes
NCT02513940 results posted 1507526854 Ph 4 completed Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes
NCT01862835 13-000047 Ph 1 completed Impact of Estradiol Addback
NCT03967964 PKAVD+T EC1503 Ph 1 completed Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA)
NCT02712944 L16-079 Ph 1 terminated Testosterone Replacement in Renal Failure
NCT01084369 Testosterone version1 Ph 4 terminated Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism
NCT02203656 PACE 13-038 1229 Ph 1 completed Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults
NCT02799277 PSY 2014-12-0010 Ph 4 completed A Multinomial Process Model of Moral Judgment
NCT03619330 TESTOSTERON Ph 4 completed Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.
NCT01446042 results posted TBS-1-2011-03 Ph 3 completed Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
NCT00891228 CCN007 results posted CCN007 Ph 1 completed Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men
NCT00647868 Nasobol 01/2008 Ph 1 completed NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers
NCT01797718 CDGP EudraCT:2012-002477-59 Ph 2, Ph 3 completed Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment
NCT01469988 VITA-HF 82-VH-01 Ph 2 terminated The VO2 Increase With Testosterone Addition - Heart Failure (VITA-HF) Trial
NCT03118479 2009 - P - 001874 Ph 1 terminated Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)
NCT00965341 results posted 2008-0262 Ph 3 completed Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients
NCT01961336 UHR-9 Ph 3 completed Transdermal Testosterone Pretreatment in Poor Responders Undergoing IVF
NCT01616732 04495 Ph 2 completed Testosterone and Weight Loss
NCT01386606 results posted ZA-204 Ph 2 completed The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
NCT01725451 results posted 15083 I5E-MC-TSBD Ph 1 completed A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants
NCT01160328 09-000309 R01DK045343 Ph 1 completed Influence of Male Hormones on Regional Fat Metabolism
NCT02111434 GSM-022014 Ph 4 completed Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment
NCT02111473 GSM-032014 Ph 4 completed The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism
NCT01743235 EB90 EB90 Ph 2 completed Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems
NCT01310647 FOLLPRIM 2009-018009-26 2009-018009-26 Ph 2 completed Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders
NCT01560546 2011-002102-73 Ph 4 completed Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
NCT01432665 EB82 Ph 2 completed Lybrido for Female Sexual Dysfunction
NCT00957034 CORDELIA results posted 2009015 Ph 2 terminated Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
NCT00663793 ORAL-T-6 results posted 33738-B U54HD42456-06, K23HD045386 Ph 1 completed ORAL T-6: Oral Androgens in Man-6
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TESTOPEL FDA Label Details

Indications & Usage

TESTOPEL is indicated for the treatment of Hypogonadism; Delayed Puberty.

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Data Sources

FDA Approval: ANDA080911 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.