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Disease

Hypogonadism

Late-stage therapeutic developmentEmerging researchSteady momentum
MeSHHypogonadism
4
Publications
23
Clinical trials
1
Related treatments
2025
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 3 clinical trials expected to report results, the earliest in Q3 2027.
Upcoming Milestones
Major developments
Major trial resultsHigh impact
Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism
Results posted2026-04-29
Upcoming trial readoutImportant
Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease
Results expected Q2 20282026-04-30
Clinical Milestones6View
Results posted 1
Results expected 3
Recently completed 2
Activity timeline6

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Follitropin alfaapproved

Approval — In adult women: anovulation (including polycystic ovarian disease, PCOD) in women who ha… (2014)

Corifollitropin alfaapproved

Approval — Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the develo… (2010)

Follitropin betaapproved

Approval — In the female: Puregon is indicated for the treatment of female infertility in the follow… (1996)

Research-associated treatments
Luteinizing Hormone2

Clinical trials

18 sponsors · 0 new · 1 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Clinical programme
23
All trials
6
Active
14
Late-stage
6
Completed
Late-stage studies

52 Week RCT to Investigate the Effect of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Obese/Overweight Men With T2DM/Prediabetes and Hypogonadism and Subsequent 108 Week Open Label Phase to Investigate Effects on Cardiometabolic Parameters

Phase 4 · Recruiting · Alexandra Kautzky-Willer

A Phase 4, Open-Label Study to Evaluate Primary Adrenal Function (Glucocorticoid Axis) in Hypogonadal Men Treated With JATENZO® for 12 Months

Phase 4 · Active, not recruiting · Tolmar Inc.

A Phase III, Multi-Center, Open Label, Single-Group Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) for Initiation or Restoration of Puberty as Assessed by Increased Testicular Volume in Adolescent Males 14 to <18 Years Old With Hypogonadotropic Hypogonadism (MK-8962-043)

Phase 3 · Completed · Organon and Co

Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism

Phase 4 · Completed · VA Office of Research and Development

Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism

Phase 4 · Completed · Baylor College of Medicine

The Effects of Intranasal Testosterone (NatestoTM) for Treatment of Hypogonadism on Maintenance of Spermatogenesis

Phase 4 · Completed · University of Florida
Recruiting

52 Week RCT to Investigate the Effect of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Obese/Overweight Men With T2DM/Prediabetes and Hypogonadism and Subsequent 108 Week Open Label Phase to Investigate Effects on Cardiometabolic Parameters

Phase 4 · Recruiting · Alexandra Kautzky-Willer

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Phase 2 · Recruiting · Stephanie B. Seminara, MD

Androgen Replacement to Improve Patient-Important Outcomes in Men With Opioid-Induced Hypogonadism

Phase 2 · Recruiting · Brigham and Women's Hospital

Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease

Phase 2 · Recruiting · St. Louis University

An Open-labeled Prospective Randomized Controlled Trial on the Effect of Different Regimens for Luteal Phase Support on Pregnancy Outcomes in Patients With Idiopathic Hypogonadotropic Hypogonadism

N/A · Recruiting · Fudan University
Recently completed

Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism

Phase 4 · Completed · VA Office of Research and Development

Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism

Phase 4 · Completed · Baylor College of Medicine

The Effects of Intranasal Testosterone (NatestoTM) for Treatment of Hypogonadism on Maintenance of Spermatogenesis

Phase 4 · Completed · University of Florida

A Phase 4, Open-Label, Single-Arm Study to Evaluate the Effects of Vogelxo(R) on 24-hour Ambulatory Blood Pressure Monitoring in Hypogonadal Men Using Therapeutic Testosterone Replacement Therapy

Phase 4 · Completed · Upsher-Smith Laboratories

The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity

Phase 3 · Completed · University Medical Centre Ljubljana

A Phase III, Multi-Center, Open Label, Single-Group Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) for Initiation or Restoration of Puberty as Assessed by Increased Testicular Volume in Adolescent Males 14 to <18 Years Old With Hypogonadotropic Hypogonadism (MK-8962-043)

Phase 3 · Completed · Organon and Co

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2014emaApproval — Follitropin alfa· In adult women: anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate; stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT); follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level &lt; 1.2 IU/l. In adult men: follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy. source ↗
2013emaApproval — Follitropin alfa· In adult women Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate; Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer; Ovaleap in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level &lt; 1.2 IU/L. In adult men Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy. source ↗
2010emaApproval — Corifollitropin alfa· Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. Elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG). source ↗
1996emaApproval — Follitropin beta· In the female: Puregon is indicated for the treatment of female infertility in the following clinical situations: anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate; controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in-vitro fertilisation / embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism. source ↗
1995emaApproval — Follitropin alfa· Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate. Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in-vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT). GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level &lt;1.2 IU/l. GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

4 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20202025
Major themes7
  • Hypogonadism2
  • Endocrinology1
  • Infertility, Male1
  • Klinefelter Syndrome1
  • Luteinizing Hormone1
  • Puberty, Delayed1
  • Spermatogenesis1
Leading journals4
  • Andrology1
  • Clinical endocrinology1
  • International journal of molecular sciences1
  • Reproductive biology and endocrinology : RB&E1
Leading researchers8
  • Anderson RA1
  • Barber K1
  • Comninos AN1
  • Conway GS1
  • Corona G1
  • Crown A1
  • Davies MC1
  • Devine K1
Affiliations (unnormalised)6
  • Andrology and Human Reproduction Clinic1
  • Department of Clinical Medicine1
  • Department of Experimental and Clinical Biomedical Sciences1
  • Hammersmith Hospital1
  • Imperial College Healthcare NHS Trust1
  • Imperial College London1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Condition resulting from deficient gonadal functions, such as GAMETOGENESIS and the production of GONADAL STEROID HORMONES. It is characterized by delay in GROWTH, germ cell maturation, and development of secondary sex characteristics. Hypogonadism can be due to a deficiency of GONADOTROPINS (hypogonadotropic hypogonadism) or due to primary gonadal failure (hypergonadotropic hypogonadism).

Identifiers
MeSHHypogonadism
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.