Andriol

(Testosterone)

ApprovedSmall molecule

Testosterone is used to treat low testosterone levels in men, helping to restore energy, muscle strength, and sexual function. It can also be used in hormone therapy for transgender individuals.[2] Andriol is currently approved and in use across 50 indications[4].[1]

Andriol is one of 811 small molecule programs targeting Growth delay. It is currently in Approved.

Indications

184

Total Trials

Active Trials

810

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Growth DelayApproved

Stress Urinary IncontinenceActive, not recruiting

Male Breast CarcinomaActive, not recruiting

HIV InfectionActive, not recruiting

TestosteroneWithdrawn

Muscle WeaknessApproved

Testicular CarcinomaApproved

AIDSApproved

Klinefelter's SyndromeActive, not recruiting

BurnActive, not recruiting

Growth DelayApproved

Approved

Stress Urinary IncontinencePreclinical

Active, not recruiting

Male Breast CarcinomaPreclinical

Active, not recruiting

HIV InfectionPreclinical

Active, not recruiting

TestosteroneApproved

Withdrawn

Muscle WeaknessApproved

Approved

Testicular CarcinomaApproved

Approved

AIDSApproved

Approved

Klinefelter's SyndromeApproved

Active, not recruiting

BurnPreclinical

Active, not recruiting

Showing 10 of 49 indications

Competition

Competitive Landscape

268 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

25 2

Wellcovorin

EEastern Cooperative Oncology Group

Phase 3

58 3

Andriol

AAuxilium

Approved

1 4

Tyvyt

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

8 5

XL092

Roche

Phase 3

1 6

PD-1 Monoclonal Antibody

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

2 7

Cadonilimab

SShanghai Pharmaceuticals Holding Co., Ltd

Phase 3

2 8

Cytokine-Induced Killer Cells

TThe First People's Hospital of Changzhou

Phase 3

2 9

Biological Check-up

UUniversity Hospital, Bordeaux

Phase 3

1 10

IBI363

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Recruiting

Testosterone

NCT06670053

Q1 2027

Phase 2Not yet recruiting

Testosterone

NCT01894308

Q3 2027

ApprovedRecruiting

Musculoskeletal Injury

NCT06455969

Q4 2027

N/ANot yet recruiting

Testosterone

NCT07212712

Clinical

Trials by Indication[1]

Testosterone63 trials

Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT00009555·86 enrolled

Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00018356·88 enrolled

The Role of Estrogen and Testosterone in Determining Brain Blood Flow and Metabolic Regulation in Humans

Not yet recruiting·UUniversity of British Columbia·N/A·NCT07212712·50 enrolled

Show 60 more trials

Comparison Between Testosterone and Estradiol Over the Homogenization of Follicular Cohort

Unknown status·HHospital de Clinicas de Porto Alegre·Phase 3·NCT03238092·26 enrolled

A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

Completed· Endo Pharmaceuticals logo

Endo Pharmaceuticals·Phase 3·NCT00522431·149 enrolled

A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator

Completed· Ferring logo

Ferring·Phase 2·NCT01464879·20 enrolled

Lifestyle Intervention and Testosterone Replacement in Obese Seniors

Completed·VVA Office of Research and Development·Phase 3·NCT02367105·83 enrolled

Generation of Biological Samples Positive to Testosterone for Anti-doping Control

Completed·PParc de Salut Mar·Phase 1·NCT04207684·4 enrolled

Testosterone and Alendronate in Hypogonadal Men

Terminated·MMassachusetts General Hospital·Phase 2·NCT01460654·44 enrolled

Influence of Administration Route of Testosterone on Male Fertility

Withdrawn·AAcerus Pharmaceuticals Corporation·Phase 1·NCT00705796

Puberty, Testosterone, and Brain Development

Recruiting·UUniversity of Colorado, Denver··NCT06670053·100 enrolled

AIDS Wasting in Women: Anabolic Effects of Testosterone

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00006158

Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents

Terminated·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT02679274·3 enrolled

NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers

Completed·AAcerus Pharmaceuticals Corporation·Phase 1·NCT00647868·32 enrolled

Does Testosterone Improve Function in Hypogonadal Older Men

Withdrawn·NNorth Florida Foundation for Research and Education·Phase 4·NCT00304213

Study on the Effects of Exogenous Testosterone on Threat Perception and Behavioral Avoidance

Completed·UUniversity of Texas at Austin·N/A·NCT01408498·120 enrolled

Subcutaneous vs. Intramuscular Testosterone

Completed·MMen's Health Boston·Phase 4·NCT03091348·4 enrolled

Intranasal Delivery of Testosterone and Its Effect on Doping Markers

Completed·UUniversity of Utah·Phase 4·NCT02611154·5 enrolled

Testosterone Therapy in Hypogonadal Men Treated With Opioids

Completed·MMarianne Andersen·Phase 4·NCT02433730·40 enrolled

Testosterone Antidepressant Augmentation in Women

Completed·MMassachusetts General Hospital·N/A·NCT01783574·101 enrolled

Testosterone Regulation of the Natriuretic Peptide System

Withdrawn·MMassachusetts General Hospital·N/A·NCT02269072

Effects of Testosterone in Women With Depression

Completed·MMassachusetts General Hospital·N/A·NCT00676676·9 enrolled

Co-Administering Testosterone With PDE5 Inhibitors in ED Patients Non Responders to PDE5 Inhibitors Alone

Completed·SSELARL du Dr Jacques BUVAT·Phase 3·NCT00244023·173 enrolled

A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01725451·30 enrolled

Cycled Testosterone Replacement Study

Completed·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT00957528·26 enrolled

Pharmacokinetic Evaluation of Testosterone Gel (1%)

Completed·SSolvay Pharmaceuticals·Phase 1·NCT00193700

Evaluation of Testosterone Nasal Gel in Hypogonadal Boys

Terminated·AAcerus Biopharma Inc.·Phase 1·NCT03345797·8 enrolled

Transdermal Testosterone Pretreatment in Poor Responders Undergoing IVF

Completed·—·Phase 3·NCT01961336·50 enrolled

Transdermal Testosterone Nanoemulsion in Women Libido

Unknown status·UUniversity Potiguar·Phase 2·NCT02445716·70 enrolled

Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men

Completed·CClarus Therapeutics, Inc.·Phase 3·NCT01699178·182 enrolled

A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00969163·30 enrolled

Effect of Testosterone Treatment on Embryo Quality

Unknown status·CCenter for Human Reproduction·Phase 1/2·NCT01662466·180 enrolled

Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.

Completed·UUniversity of Florence··NCT04336891·81 enrolled

Testosterone and Pain Sensitivity

Withdrawn·JJohns Hopkins University·Phase 4·NCT01689896

Testosterone TRANSdermal Gel for Poor Ovarian Responders Trial

Terminated·FFundacion Dexeus·Phase 3·NCT02418572·290 enrolled

Study of The Effects of Testosterone in Frail Elderly Men

Completed·MManchester University NHS Foundation Trust·Phase 4·NCT00190060·262 enrolled

Effects of Testosterone and Fat Utilization

Completed·UUniversity of Colorado, Denver·N/A·NCT03289559·13 enrolled

Testosterone Treatment in a Patient With 17β-hydroxysteroid Dehydrogenase Type 3 Deficiency: an N-of-1 Study

Unknown status·EErasmus Medical Center·Phase 3·NCT04831099·1 enrolled

The Effects of Testosterone on Prostate Tissue (ACYP-1)

Completed·UUniversity of Washington·Phase 1·NCT00161486·13 enrolled

Effect of Testosterone Gel Replacement on Fat Mass in Males With Low Testosterone Levels and Diabetes

Withdrawn·DDiabetes Center of the Southwest·Phase 4·NCT00440440

A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01816295·715 enrolled

Efficacy, Pharmacokinetics and Safety of Testosterone

Completed· Ferring logo

Ferring·Phase 2·NCT01370369·20 enrolled

Effect of Testosterone Pretreatment in POR

Completed·HHanoi Medical University·N/A·NCT04602143·165 enrolled

Testosterone Gel Applied to Women With Pituitary Gland Problems

Completed·—·Phase 4·NCT00144391·20 enrolled

The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01893281·78 enrolled

Testosterone and Neurovascular Control in Humans

Unknown status·WWestern University, Canada·N/A·NCT04819204·20 enrolled

Testosterone in Female Hypoactive Sexual Desire Disorder

Completed·—·Phase 3·NCT00140153·20 enrolled

A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel

Completed· Ferring logo

Ferring·Phase 3·NCT01703741·145 enrolled

NES Gel-1, To Evaluate Nestorone Gel in Combination With Testosterone Gel

Completed·UUniversity of Washington·Phase 1·NCT00229593·140 enrolled

Subcutaneous Testosterone Project

Completed·UUniversity of British Columbia·Phase 1/2·NCT02229617·14 enrolled

Testosterone Gel in Poor Responders Undergoing IVF

Withdrawn·VVietnam National University·N/A·NCT02549690

Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

Completed·WWashington University School of Medicine·Phase 3·NCT00345969·25 enrolled

Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration

Completed·SSports Medicine Research and Testing Laboratory·Phase 1·NCT06393634·14 enrolled

Steroid Profile: Differentiating Testosterone Administration From (Simultaneous) Ethanol Consumption

Completed·PParc de Salut Mar·Phase 1·NCT04166786·4 enrolled

Sexual Effects of Transdermal or Vaginal Testosterone

Active, not recruiting·UUniversity of Sao Paulo General Hospital·Phase 2·NCT06794346·132 enrolled

Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone

Completed·UUniversity of Washington·Phase 2·NCT00161421·18 enrolled

Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents

Completed·OOregon Health and Science University·Phase 1·NCT03864913·26 enrolled

HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone

Completed·UUniversity of Washington·Phase 1/2·NCT00839319·59 enrolled

Testosterone Effects on Bone and Frailty

Completed·NNational Institute on Aging (NIA)·Phase 4·NCT00182871·140 enrolled

Bioequivalence of Testosterone Reduced-size Patch Relative to the Testosterone Reference Patch

Completed·WWarner Chilcott·Phase 1·NCT00791856·110 enrolled

Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (HOP 5) Testicular Aspiration Addendum

Completed·UUniversity of Washington·Phase 1/2·NCT00156650·23 enrolled

A Dose Ranging Study to Examine TDS-Testosterone 5%

Not yet recruiting·TTransdermal Delivery Solutions Corp·Phase 2·NCT01894308·48 enrolled

Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors

Terminated·UUniversity of Zurich·Phase 3·NCT02419105·91 enrolled

Hypogonadism6 trials

The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

Completed·RRepros Therapeutics Inc.·Phase 2·NCT01386606·60 enrolled

Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism

Completed·AAcerus Pharmaceuticals Corporation·Phase 3·NCT01446042·306 enrolled

Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism

Terminated·—·Phase 4·NCT01084369·22 enrolled

Show 3 more trials

Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.

Completed·UUniversity Medical Centre Ljubljana·Phase 4·NCT03619330·30 enrolled

Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

Completed·RRepros Therapeutics Inc.·Phase 2·NCT01270841·83 enrolled

Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism

Completed·SSolvay Pharmaceuticals·Phase 2·NCT00193661

Prostate Cancer5 trials

Testosterone in Castration-Resistant Prostate Cancer

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT00577980

Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00586898·36 enrolled

Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00587431·102 enrolled

Show 2 more trials

Testosterone Therapy in Castration Resistant Prostate Cancer

Completed·UUniversity of Colorado, Denver·Phase 1·NCT03734653·30 enrolled

A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·N/A·NCT01084759·16 enrolled

Metabolic Syndrome4 trials

Insulin Sensitivity in Men With the Metabolic Syndrome

Suspended·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·N/A·NCT00433173·72 enrolled

Testosterone Replacement in Metabolic Syndrome and Inflammation

Completed·UUniversity of Roma La Sapienza·Phase 4·NCT01123278·82 enrolled

Testosterone Effects on Men With the Metabolic Syndrome

Withdrawn·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT00382057·72 enrolled

Show 1 more trial

Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome

Terminated·MMassachusetts General Hospital·Phase 1·NCT00438321·66 enrolled

Breast Cancer4 trials

Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy

Completed·—·Phase 1·NCT01697345·12 enrolled

Testosterone Implants and the Incidence of Breast Cancer

Completed· Takeda logo

Takeda··NCT03768258·1,268 enrolled

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients

Completed·UUniversity of California, San Francisco·Phase 2·NCT00698035·76 enrolled

Show 1 more trial

Androgen Therapy for Breast Cancer Patients With Aromatase Inhibitor Induced Side-Effects

Unknown status·UUnknown Sponsor·Phase 2·NCT00497458·90 enrolled

76 more indications

Growth3 trials

Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment

Completed·HHelsinki University Central Hospital·Phase 2/3·NCT01797718·35 enrolled

Testosterone and Growth Hormone for Bone Loss in Men

Completed·UUniversity of Pennsylvania·Phase 2·NCT00080483·35 enrolled

Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men

Completed·MMayo Clinic·Phase 1·NCT00309855·80 enrolled

Menopausal Women3 trials

TDSM- Testosterone Dose Response in Surgically Menopausal Women

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·N/A·NCT00494208·270 enrolled

Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido

Completed·WWarner Chilcott·Phase 3·NCT00131495·814 enrolled

Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen

Completed·WWarner Chilcott·Phase 3·NCT00384046·272 enrolled

Steroid3 trials

Metabolic Effects of Steroids in Obese Men

Unknown status·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·N/A·NCT00983554·57 enrolled

Effects of Sex Steroids on the Serotonin System

Unknown status·MMedical University of Vienna·Phase 4·NCT02715232·92 enrolled

Dose-Response of Gonadal Steroids and Bone Turnover in Older Men

Completed·MMassachusetts General Hospital·N/A·NCT00114114·177 enrolled

Hypogonadotropic Hypogonadism3 trials

Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment

Completed·GGulhane School of Medicine·Phase 4·NCT02111434·150 enrolled

The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism

Completed·GGulhane School of Medicine·Phase 4·NCT02111473·49 enrolled

Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH)

Terminated·MMassachusetts General Hospital·Phase 1·NCT03118479·7 enrolled

Klinefelter Syndrome3 trials

Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

Recruiting·GGeorgios Papadakis·Phase 3·NCT05586802·150 enrolled

Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome

Completed·UUniversity of Colorado, Denver·N/A·NCT01585831·48 enrolled

Klinefelter Syndrome and Testosterone Treatment in Puberty

Recruiting·LLise Aksglæde·Phase 4·NCT06294990·32 enrolled

Safety and Efficacy3 trials

Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

Completed·BBioSante Pharmaceuticals·Phase 3·NCT00657501·575 enrolled

Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

Completed·BBioSante Pharmaceuticals·Phase 3·NCT00613002·597 enrolled

Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Completed·CClarus Therapeutics, Inc.·Phase 3·NCT01403116·325 enrolled

Postmenopausal Women2 trials

Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems

Completed·EEmotional Brain NY Inc.·Phase 2·NCT01743235·207 enrolled

Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Completed·BBioSante Pharmaceuticals·Phase 3·NCT00612742·3,656 enrolled

Type 2 Diabetes2 trials

Testosterone for Men With Insulin Treated Type 2 Diabetes

Completed·—·Phase 4·NCT00349362·40 enrolled

Hypogonadism in Young Men With Type 2 Diabetes

Terminated·SState University of New York at Buffalo·Phase 2·NCT01155518·5 enrolled

Function2 trials

Sex Steroids, Sleep, and Metabolic Dysfunction in Women

Completed·WWashington University School of Medicine·N/A·NCT00805207·61 enrolled

Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults

Completed·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT02203656·113 enrolled

ESS2 trials

Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men

Completed·PPremier Research·Phase 1·NCT00891228·99 enrolled

Hormone and Information Processing Study

Completed·UUniversity of Washington·Phase 3·NCT00539305·22 enrolled

Anorexia Nervosa2 trials

Hormonal Factors in the Treatment of Anorexia Nervosa

Completed·MMassachusetts General Hospital·Phase 2·NCT01121211·90 enrolled

Bone Loss in Women With Anorexia Nervosa

Completed·MMassachusetts General Hospital·Phase 2/3·NCT00089843·77 enrolled

Oral2 trials

A Multinomial Process Model of Moral Judgment

Completed·UUniversity of Texas at Austin·Phase 4·NCT02799277·220 enrolled

ORAL T-6: Oral Androgens in Man-6

Completed·UUniversity of Washington·Phase 1·NCT00663793·16 enrolled

Injury2 trials

Randomized Study of Testosterone and Progressive Resistance Exercise in Men With Burn Injury

Unknown status·NNational Center for Research Resources (NCRR)·N/A·NCT00006129·60 enrolled

Starting a Testosterone and Exercise Program After Hip Injury

Completed·WWashington University School of Medicine·Phase 3·NCT02938923·129 enrolled

Heart Failure2 trials

The VO2 Increase With Testosterone Addition - Heart Failure (VITA-HF) Trial

Terminated·UUniversity of Alberta·Phase 2·NCT01469988·318 enrolled

Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure

Terminated·WWarner Chilcott·Phase 2·NCT00957034·17 enrolled

Sexual Dysfunction2 trials

ANDRO 2002: Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction

Completed·QQueen's University·Phase 2·NCT00202163·120 enrolled

Lybrido for Female Sexual Dysfunction

Completed·EEmotional Brain NY Inc.·Phase 2·NCT01432665·196 enrolled

Efficacy and Safety2 trials

A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males

Completed· Ferring logo

Ferring·Phase 3·NCT02149264·160 enrolled

A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel

Completed· Ferring logo

Ferring·Phase 3·NCT01665599·180 enrolled

Endothelial Dysfunction2 trials

The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism

Completed·GGulhane School of Medicine·Phase 4·NCT01533129·106 enrolled

Endothelial Dysfunction, Inflammation and Insulin Resistance in Congenital Hypogonadism and Effect of Testosteron Replacement Therapy

Completed·GGulhane School of Medicine·Phase 4·NCT02171390·130 enrolled

Menopause1 trial

COMPASS - COpenhagen MenoPAuSe Study

Recruiting·MMartin Blomberg Jensen·Phase 2·NCT07254429·192 enrolled

Weight loss1 trial

Testosterone and Weight Loss

Completed·AAustin Health·Phase 2·NCT01616732·100 enrolled

Fat Metabolism1 trial

Influence of Male Hormones on Regional Fat Metabolism

Completed·MMayo Clinic·Phase 1·NCT01160328·39 enrolled

Drug1 trial

Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening

Completed·IIndiana University·Phase 4·NCT04675788·73 enrolled

Insulin resistance1 trial

Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure

Terminated·IIRCCS San Raffaele··NCT00512408

Torsades de Pointes1 trial

Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes

Completed·IIndiana University·Phase 4·NCT02513940·14 enrolled

Multiple Sclerosis1 trial

A Trial to Investigate the Effectiveness of Testosterone Treatment in Men With Multiple Sclerosis

Withdrawn·UUniversity of California, Los Angeles·Phase 2·NCT02317263

ACL Reconstruction1 trial

Testosterone Administration and ACL Reconstruction in Men

Completed·UUniversity of Southern California·Phase 3·NCT01595581·14 enrolled

AIN1 trial

Effect of PROGRESSive Training and Teststerone in Older Frail Men

Completed·UUniversity Hospital, Gentofte, Copenhagen·Phase 2/3·NCT02873559·192 enrolled

Intracytoplasmic Sperm Injection1 trial

Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders

Completed·IInstituto de Investigacion Sanitaria La Fe·Phase 2·NCT01310647·66 enrolled

Precocious Puberty1 trial

Purification of Testis-Stimulating Factor in Precocious Puberty

Completed·NNational Center for Research Resources (NCRR)··NCT00004344·4 enrolled

Vascular Disease1 trial

Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

Completed·—·Phase 4·NCT00355537·19 enrolled

Obesity1 trial

Testosterone Replacement in Men With Diabetes and Obesity

Completed·UUniversity at Buffalo·Phase 4·NCT01127659·137 enrolled

Cognition1 trial

The Effects of Sex Hormones on Cognition and Mood in Older Adults

Terminated·NNational Institute on Aging (NIA)·N/A·NCT00000175

Testicular Cancer1 trial

Study of Testosterone vs Placebo in Testicular Cancer Survivors

Completed·MMikkel Bandak·Phase 2/3·NCT02991209·69 enrolled

Arthralgia1 trial

Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT01573442·227 enrolled

Vaginal Delivery1 trial

Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA)

Completed·LLaboratorios Andromaco S.A.·Phase 1·NCT03967964·46 enrolled

Colorectal Cancer1 trial

Perioperative Testosterone Replacement Therapy in Sarcopenic Male Colorectal Cancer Patients

Unknown status·LLondon North West Healthcare NHS Trust··NCT05367284·30 enrolled

Geriatric Patients1 trial

Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients

Completed·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT02990533·80 enrolled

Renal Failure1 trial

Testosterone Replacement in Renal Failure

Terminated·TTexas Tech University Health Sciences Center·Phase 1·NCT02712944·21 enrolled

Aging1 trial

Metabolic Effects of Androgenicity in Aging Men and Women

Completed·VVA Office of Research and Development·N/A·NCT00680797·33 enrolled

Hypogonadal Males1 trial

Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

Completed·AAcrux DDS Pty Ltd·Phase 2·NCT00372008·40 enrolled

Premenopausal1 trial

Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women

Completed·—·Phase 2·NCT00004400·56 enrolled

MPA1 trial

Impact of Estradiol Addback

Completed·MMayo Clinic·Phase 1·NCT01862835·43 enrolled

Pain Perception1 trial

The Influence of Testosterone on Experimental Pain Perception

Completed·UUniversity of New Mexico·Phase 1·NCT05781685·20 enrolled

Insulin Sensitivity1 trial

Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man

Completed·UUniversity Hospital, Caen·Phase 3·NCT02847806·6 enrolled

Motor Neuron Disease1 trial

Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004771·40 enrolled

Dialysis Patients1 trial

Multimodal Therapeutic Approach in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

Unknown status·UUniversity Hospital, Clermont-Ferrand·Phase 3·NCT02418065·120 enrolled

Sleep Restriction1 trial

Hormonal Mechanisms of Sleep Restriction

Completed·LLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center·Phase 1·NCT02256865·40 enrolled

Complete Response1 trial

AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment

Completed·MMclean Hospital·Phase 4·NCT00304746·100 enrolled

Functional Outcomes1 trial

Impact of Peri-operative tEstosterone Levels on oNcological and Functional Outcomes in RadiCal prostatEctomy

Recruiting·—·Phase 3·NCT04833426·140 enrolled

Metabolism1 trial

HORMA: Hormonal Regulators of Muscle and Metabolism in Aging

Completed·NNational Institute on Aging (NIA)·Phase 2·NCT00183040·108 enrolled

Cardiovascular1 trial

Cardiovascular Outcomes of Low Testosterone

Completed·UUniversity of Colorado, Denver·N/A·NCT02758431·232 enrolled

Treatment1 trial

Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

Completed·BBioSante Pharmaceuticals·Phase 3·NCT01235754·626 enrolled

Meibomian Gland Dysfunction1 trial

Safety and Efficacy Study of a Testosterone Eye Drop for the Treatment of Meibomian Gland Dysfunction

Completed·OORA, Inc.·Phase 2·NCT00755183·60 enrolled

Hip Fracture1 trial

Testosterone Therapy After Hip Fracture in Elderly Women

Completed·WWashington University School of Medicine·Phase 2·NCT00280267·15 enrolled

Sex Differences1 trial

Brain Blood Flow Responses to Stress: Sex Differences

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT06253702·22 enrolled

Type 2 Diabetes Mellitus1 trial

Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)

Completed·MMarianne Andersen·Phase 4·NCT01560546·43 enrolled

Chronic pain1 trial

Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.

Withdrawn·JJames J. Peters Veterans Affairs Medical Center·Phase 2·NCT00398034

Erectile Dysfunction1 trial

Effect of Testosterone in Men With Erectile Dysfunction

Completed·—·Phase 4·NCT00512707·140 enrolled

Contraception1 trial

ORAL T-8 Oral Testosterone for Male Hormonal Contraception

Completed·UUniversity of Washington·Phase 1·NCT01167829·14 enrolled

Randomized1 trial

Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

Recruiting·VVA Office of Research and Development·Phase 2·NCT06084338·60 enrolled

Controlled Ovarian Stimulation1 trial

Transdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF

Unknown status·WWolfson Medical Center·Phase 4·NCT03078569·30 enrolled

Quality of Life1 trial

The Effect of Testosterone on Mood and Quality of Life

Completed·SSeattle Institute for Biomedical and Clinical Research·N/A·NCT00202462·33 enrolled

Prostate1 trial

PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue

Completed·UUniversity of Washington·Phase 2/3·NCT00490555·32 enrolled

Stress urinary incontinence1 trial

Testosterone Replacement in Postmenopausal Women With Stress Urinary Incontinence

Completed·—·N/A·NCT03116087·60 enrolled

Atherosclerosis1 trial

Testosterone Replacement in Older Men and Atherosclerosis Progression

Completed·—·Phase 4·NCT00287586·308 enrolled

Cardiovascular Risk Factor1 trial

Association Between the Prevalence of Cardiovascular Risk Factors and New Use of Testosterone

Completed· Bayer logo

Bayer··NCT03484260·27,778 enrolled

In Vitro Fertilization1 trial

Androgens for Poor Responders in In Vitro Fertilization

Completed·HHospital Clinic of Barcelona·Phase 3·NCT00693108

Inflammatory Response1 trial

Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men

Completed·TThe University of Texas Medical Branch, Galveston·Phase 4·NCT00957801·29 enrolled

Anxiety1 trial

Effects of Fast Acting Testosterone Nasal Spray on Anxiety

Completed·UUniversity of Texas at Austin·N/A·NCT02361190·96 enrolled

Peripheral Vascular Disease1 trial

Testosterone for Peripheral Vascular Disease

Completed·—·Phase 4·NCT00504712·24 enrolled

Effectiveness1 trial

TRADE-Testosterone Replacement and Dutasteride Effectiveness

Completed·UUniversity of Washington·Phase 4·NCT00194675·53 enrolled

Fatigue1 trial

Testosterone Replacement for Fatigue in Male Hypogonadic Advanced Cancer Patients

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00965341·53 enrolled

Myocardial Infarction1 trial

Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After a Recent Myocardial Infarction

Withdrawn·TTexas Tech University Health Sciences Center·Phase 2/3·NCT02803073

Acne1 trial

Factors Associated With the Acne Severity Among Transmen Population: a Cross-sectional Study

Completed·MMahidol University··NCT06149065·247 enrolled

Metabolic Disease1 trial

Exploring the Relationship Between Androgen Metabolism, Metabolic Disease and Skeletal Muscle Energy Balance in Men

Unknown status·RRoyal College of Surgeons, Ireland··NCT05773183·60 enrolled

Musculoskeletal Injury1 trial

Musculoskeletal Resiliency and Adaptation to Sex Steroid Suppression and Replacement During Multi-Stressor Training

Recruiting·BBradley Nindl·Approved·NCT06455969·120 enrolled

Unspecified4 trials

ITT4 Intratesticular Hormonal Milieu in Man (ITT4)

Completed·UUniversity of Washington·Phase 1/2·NCT01215292·46 enrolled

Human Cerebral Blood Flow Regulation

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT04265053·110 enrolled

Periodontal Profile of Hypogonadic Men

Withdrawn·UUniversidade Federal do Paraná·Phase 4·NCT03176537

Show 1 more trial

Male Hormonal Contraceptive Development-ACY-5

Completed·UUniversity of Washington·Phase 1/2·NCT00161447·43 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 12, 1993

TESTODERM

NDA NDA019762

Dec 18, 1997

TESTODERM TTS

NDA NDA020791

Oct 31, 2002

TESTIM

NDA NDA021454

Jun 19, 2003

STRIANT

NDA NDA021543

Sep 26, 2003

ANDROGEL

NDA NDA021015

Nov 23, 2010

AXIRON

NDA NDA022504

Dec 29, 2010

FORTESTA

NDA NDA021463

Apr 29, 2011

ANDROGEL

NDA NDA022309

Oct 20, 2011

ANDRODERM

NDA NDA020489

Feb 14, 2012

TESTOSTERONE

NDA NDA202763

Jan 31, 2013

TESTOSTERONE

NDA NDA203098

May 28, 2014

NATESTO

NDA NDA205488

Jun 4, 2014

VOGELXO

NDA NDA204399

Sources

References

[1]
ClinicalTrials.gov — 184 trial records for Testosterone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Andriol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Testosterone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Testosterone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204399). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Andriol. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Auxilium company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Androgen Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAuxilium

Patent Landscape[6]

Patent Cliff

Oct 12, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9180194Jun 2, 2026

8993520Jun 2, 2026

8486925Oct 12, 2026

8466138Oct 12, 2026

8741881Oct 12, 2026

14 more patents

8754070Oct 12, 2026

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