Hypogonadism

Endocrinology
27
Pipeline Programs
10
Companies
21
Clinical Trials
11
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
1
3
0
6
13
Early DiscoveryClinical DevelopmentMarket

On Market (11)

Approved therapies currently available

AbbVie
ANDRODERMApproved
testosterone
AbbVie
transdermal1995
Besins Healthcare
ANDROGELApproved
testosterone
Besins Healthcare
Androgen [EPC]transdermal2000
U
AVEEDApproved
testosterone undecanoate
Unknown Company
intramuscular2014
U
FORTESTAApproved
testosterone
Unknown Company
transdermal2010
U
NATESTOApproved
testosterone
Unknown Company
Androgen [EPC]nasal2014
U
TESTIMApproved
testosterone
Unknown Company
Androgen [EPC]transdermal2002
U
TESTODERMApproved
testosterone
Unknown Company
transdermal1993
U
TESTODERM TTSApproved
testosterone
Unknown Company
transdermal1997
U
TESTOPELApproved
testosterone
Unknown Company
Androgen [EPC]implantation1972
U
TESTOSTERONEApproved
testosterone
Unknown Company
Androgen [EPC]transdermal2017
U
VOGELXOApproved
testosterone
Unknown Company
Androgen [EPC]transdermal2014

Competitive Landscape

10 companies ranked by most advanced pipeline stage

AbbVie
AbbVieNORTH CHICAGO, IL
3 programs
1
1
1
AndroGel 1.62%Phase 41 trial
ABT-SLV176Phase 31 trial
Testosterone Gel 1.62%Phase 11 trial
Active Trials
NCT01133548Completed62Est. Jul 2010
NCT02082197Withdrawn0Est. Jun 2015
NCT04274894Completed246Est. Jan 2022
Besins Healthcare
Besins HealthcareMonaco - Monaco
2 programs
1
1
1
TestosteronePhase 31 trial
AndroGelPhase 21 trial
Active Trials
NCT04492553CompletedEst. Nov 2022
NCT02419105TerminatedEst. Jun 2020
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
1
Topical Testosterone SolutionPhase 41 trial
Active Trials
NCT01893281Completed78Est. Jan 2014
Antares Therapeutics
5 programs
1
1
1
2
Testosterone enanthate auto-injectorPhase 31 trial
Testosterone enanthate auto-injectorPhase 31 trial
Testosterone enanthate auto-injectorPhase 21 trial
QuickShot™ - 50 mg Treatment BPhase 1/21 trial
Testosterone enanthate auto-injectorPhase 11 trial
Active Trials
NCT02233751CompletedEst. Oct 2014
NCT01887418CompletedEst. Jan 2014
NCT02777242CompletedEst. Aug 2016
+2 more trials
Bayer
BayerLEVERKUSEN, Germany
4 programs
1
Testosterone undecanoatePhase 31 trial
Testosterone ProductN/A1 trial
Testosterone UndeconateN/A1 trial
Testosterone UndeconateN/A1 trial
Active Trials
NCT03484260Completed27,778Est. May 2018
NCT00847314Completed30Est. Oct 2008
NCT00838838Completed26Est. May 2009
+1 more trials
M&
Merck & Co.RAHWAY, NJ
2 programs
1
1
Recombinant human luteinizing hormonePhase 31 trial
Test: Follitropin alfaPhase 11 trial
Active Trials
NCT07097259CompletedEst. Dec 2025
NCT01084265CompletedEst. Dec 2005
AT
1 program
1
DihydrotestosteronePhase 21 trial
Active Trials
NCT00163566CompletedEst. Sep 2006
Pfizer
PfizerNEW YORK, NY
1 program
1
Test formulationPhase 11 trial
Active Trials
NCT03792477Completed74Est. Apr 2020
Abbott
AbbottABBOTT PARK, IL
1 program
AndroGelN/A1 trial
Active Trials
NCT01143818Completed1,053Est. Aug 2010
Ferring Pharmaceuticals
Ferring PharmaceuticalsArgentina - Buenos Aires
1 program
Quality of Life With TESTIM®N/A1 trial
Active Trials
NCT01148433Completed157Est. Jul 2011

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AbbVieAndroGel 1.62%
Eli Lilly and CompanyTopical Testosterone Solution
Besins HealthcareTestosterone
Antares TherapeuticsTestosterone enanthate auto-injector
Antares TherapeuticsTestosterone enanthate auto-injector
AbbVieABT-SLV176
Merck & Co.Recombinant human luteinizing hormone
BayerTestosterone undecanoate
Besins HealthcareAndroGel
Antares TherapeuticsTestosterone enanthate auto-injector
Ascend TherapeuticsDihydrotestosterone
Antares TherapeuticsQuickShot™ - 50 mg Treatment B
Merck & Co.Test: Follitropin alfa
PfizerTest formulation
Antares TherapeuticsTestosterone enanthate auto-injector

Showing 15 of 21 trials with date data

Clinical Trials (21)

Total enrollment: 29,600 patients across 21 trials

NCT04274894AbbVieAndroGel 1.62%

A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism

Start: May 2020Est. completion: Jan 2022246 patients
Phase 4Completed
NCT01893281Eli Lilly and CompanyTopical Testosterone Solution

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

Start: Jul 2013Est. completion: Jan 201478 patients
Phase 4Completed
NCT02419105Besins HealthcareTestosterone

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

Start: Sep 2015Est. completion: Jun 2020
Phase 3Terminated
NCT02504541Antares TherapeuticsTestosterone enanthate auto-injector

Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism

Start: Jul 2015Est. completion: Jun 2016
Phase 3Completed
NCT02159469Antares TherapeuticsTestosterone enanthate auto-injector

Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism

Start: Jul 2014Est. completion: Nov 2015
Phase 3Completed
NCT02082197AbbVieABT-SLV176

An Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men

Start: Mar 2014Est. completion: Jun 20150
Phase 3Withdrawn
NCT01084265Merck & Co.Recombinant human luteinizing hormone

A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism

Start: Feb 2004Est. completion: Dec 2005
Phase 3Completed
NCT00220298BayerTestosterone undecanoate

Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism

Start: Feb 2003Est. completion: Oct 200796 patients
Phase 3Completed
NCT04492553Besins HealthcareAndroGel

Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality

Start: Apr 2021Est. completion: Nov 2022
Phase 2Completed
NCT02777242Antares TherapeuticsTestosterone enanthate auto-injector

Safety of Subcutaneous Testosterone Enanthate in Adult Male Hypogonadism

Start: Jun 2016Est. completion: Aug 2016
Phase 2Completed
NCT00163566Ascend TherapeuticsDihydrotestosterone

Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80

Start: Oct 2004Est. completion: Sep 2006
Phase 2Completed
NCT01887418Antares TherapeuticsQuickShot™ - 50 mg Treatment B

Pharmacokinetic Study of Testosterone Enanthate

Start: Sep 2013Est. completion: Jan 2014
Phase 1/2Completed
NCT07097259Merck & Co.Test: Follitropin alfa

A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants

Start: Jul 2025Est. completion: Dec 2025
Phase 1Completed
NCT03792477PfizerTest formulation

A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males

Start: Jan 2019Est. completion: Apr 202074 patients
Phase 1Completed
NCT02233751Antares TherapeuticsTestosterone enanthate auto-injector

Pharmacokinetic Study of Subcutaneous Testosterone Enanthate

Start: Sep 2014Est. completion: Oct 2014
Phase 1Completed
NCT01133548AbbVieTestosterone Gel 1.62%

Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males

Start: May 2010Est. completion: Jul 201062 patients
Phase 1Completed
NCT03484260BayerTestosterone Product

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

Start: Apr 2018Est. completion: May 201827,778 patients
N/ACompleted
NCT01148433Ferring PharmaceuticalsQuality of Life With TESTIM®

Quality of Life With TESTIM®

Start: May 2010Est. completion: Jul 2011157 patients
N/ACompleted
NCT01143818AbbottAndroGel

ESPRIT Study in Hypogonadal Men

Start: Dec 2007Est. completion: Aug 20101,053 patients
N/ACompleted
NCT00847314BayerTestosterone Undeconate

Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients

Start: Jun 2007Est. completion: Oct 200830 patients
N/ACompleted
NCT00838838BayerTestosterone Undeconate

Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis

Start: Sep 2005Est. completion: May 200926 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

6 late-stage (Phase 3) programs — potential near-term approvals
10 companies competing in this space

Related Indications

Acromegaly(67)Growth Hormone Deficiency(39)Growth Hormone Disorder(37)Secondary Hyperparathyroidism(13)Hypoparathyroidism(12)Thyroid Eye Disease(11)Adult Growth Hormone Deficiency(10)Hypothyroidism(9)Cushing's Syndrome(9)Growth Hormone Deficiency in Children(5)