Hypogonadism Clinical Trial Pipeline Gains Momentum: 10+ Companies Lead the Charge in Pioneering New Treatments | DelveInsight

DelveInsight's "Hypogonadism Pipeline Insight, 2026" report provides a detailed overview of the therapeutic landscape, spotlighting over 10 emerging pipeline candidates aimed at restoring hormonal balance with improved safety, delivery mechanisms, and efficacy profiles. The pipeline includes oral TRTs, selective estrogen receptor modulators (SERMs), kisspeptin analogs, gonadotropin-releasing hormone (GnRH) modulators, and gene therapies for rare genetic subtypes. Key industry players such as Antares Pharma (Halozyme), Clarus Therapeutics, Lipocine, Marius Pharmaceuticals, and Kissei Pharmaceutical are at the forefront of this innovation. Notable candidates include JATENZO (testosterone undecanoate), the first FDA-approved oral TRT, and TLANDO, LPCN 1021, a novel prodrug formulation designed for steady testosterone levels without injections or gels. Additionally, investigational therapies like kisspeptin analogs are targeting central hypogonadism by stimulating endogenous hormone production, offering potential disease-modifying approaches. Advanced candidates are also focused on non-testosterone-based therapies that preserve fertility and address the metabolic and psychological aspects of hypogonadism, marking a paradigm shift from symptomatic testosterone replacement to holistic hormonal restoration.

Interested in learning more about the current treatment landscape and the key drivers shaping the hypogonadism pipeline? Dive in now! @ https://www.delveinsight.com/sample-request/hypogonadism-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Key Takeaways from the Hypogonadism Pipeline Report
• On February 18, 2026- Halozyme Therapeutics conducted a Phase 3/4, open-label, multicenter study in approximately 100 males 12 to < 18 years of age with primary or secondary hypogonadism (congenital or acquired). Each participant will be screened for eligibility within 28 days before receiving his first dose of study drug on Day 1. During the Screening period, each participant will have a full clinical examination with pubertal staging, including 2 separate serum total testosterone (TT) measurements obtained in the early morning, where the average (Cavg) will be considered baseline value. Each participant will be categorized as having primary or secondary hypogonadism prior to dosing on Day 1.
• DelveInsight's hypogonadism pipeline analysis depicts a strong space with 10+ active players working to develop 10+ pipeline drugs for hypogonadism treatment.
• The leading hypogonadism Companies such as Chong Kun Dang Pharmaceutical, Mereo BioPharma, Merck & Co, Organon, Marius Pharmaceuticals, SOV Therapeutics, and others.
• Promising hypogonadism Pipeline Therapies such as CKD-845, Leflutrozole, Corifollitropin alfa, SOV-2012-F1, and others.

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Hypogonadism Overview
Hypogonadism is a medical condition characterized by the body's inability to produce adequate levels of sex hormones, testosterone in males and estrogen in females, due to dysfunction of the gonads (testes or ovaries) or their regulatory hormonal pathways. It can be classified as primary (due to intrinsic gonadal failure) or secondary (due to hypothalamic or pituitary dysfunction). Symptoms vary by age and sex but commonly include reduced, infertility, fatigue, muscle weakness, and, in men, decreased facial and body hair. In adolescents, it may cause delayed puberty. Diagnosis is based on clinical evaluation and confirmed by measuring serum hormone levels. Treatment typically involves hormone replacement therapy tailored to the patient's needs, aiming to restore normal hormone levels and alleviate symptoms. Hypogonadism is a hormonal disorder caused by reduced sex hormone production due to dysfunction in the hypothalamic-pituitary-gonadal axis. It may be congenital or acquired, leading to symptoms like infertility, fatigue, low, and reduced muscle or bone mass. While testosterone replacement therapy (TRT) remains the standard for men, concerns over risks and long-term safety are driving the development of safer, more physiological treatments.

Hypogonadism Treatment Analysis: Drug Profile
• CKD-845: Chong Kun Dang Pharmaceutical
CKD-845 is an intramuscular testosterone formulation under development by Chong Kun Dang Pharmaceutical for the treatment of hypogonadism.

• Leflutrozole: Mereo BioPharma
Leflutrozole (BGS649) is a novel, once-weekly oral aromatase inhibitor that has completed a Phase 2b clinical trial targeting obesity-associated male hypogonadotropic hypogonadism (HH).

Discover the emerging therapies transforming hypogonadism treatment here @ https://www.delveinsight.com/sample-request/hypogonadism-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Hypogonadism Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule

Scope of the Hypogonadism Pipeline Report
• Coverage: Global
• Key Hypogonadism Companies: Chong Kun Dang Pharmaceutical, Mereo BioPharma, Merck & Co, Organon, Marius Pharmaceuticals, SOV Therapeutics, and others.
• Key Hypogonadism Pipeline Therapies: CKD-845, Leflutrozole, Corifollitropin alfa, SOV-2012-F1, and others.

Take a deep dive into key insights on leading and emerging therapies for hypogonadism @ https://www.delveinsight.com/sample-request/hypogonadism-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Table of Contents
1. Introduction
2. Executive Summary
3. Hypogonadism Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Hypogonadism Pipeline Therapeutics
6. Hypogonadism Pipeline: Late-Stage Products (Phase III)
7. Hypogonadism Pipeline: Mid-Stage Products (Phase II)
8. Hypogonadism Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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