Hypogonadism Drug Development Pipeline: 2025 Analysis

DelveInsight's comprehensive "Hypogonadism Pipeline Insight, 2025" analysis delivers an in-depth examination of the therapeutic development landscape, highlighting more than 10 investigational pipeline assets designed to restore hormonal equilibrium through enhanced safety profiles, innovative delivery systems, and superior efficacy outcomes. The developmental pipeline encompasses oral testosterone replacement therapies (TRTs), selective estrogen receptor modulators (SERMs), kisspeptin analogs, gonadotropin-releasing hormone (GnRH) modulators, and gene-based treatments for uncommon genetic variants.

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Essential Highlights from the Hypogonadism Pipeline Analysis

In October 2025, Halozyme Therapeutics initiated a clinical investigation designed to assess the efficacy of XYOSTED as measured by the continuation or initiation of puberty, alongside evaluation of XYOSTED dosing, safety parameters and testosterone concentrations. This represents a 52-week open-label, single-arm trial examining the impact of XYOSTED as a testosterone replacement intervention for adolescent males diagnosed with either primary or secondary hypogonadism.

DelveInsight's hypogonadism pipeline assessment reveals a robust therapeutic arena with more than 10 active organizations advancing 10+ investigational compounds for hypogonadism management.

Prominent hypogonadism pharmaceutical developers include Chong Kun Dang Pharmaceutical, Mereo BioPharma, Merck & Co, Organon, Marius Pharmaceuticals, SOV Therapeutics, among others, all currently assessing their principal candidates to enhance the hypogonadism therapeutic environment.

Principal hypogonadism pipeline agents across different developmental phases include CKD-845, Leflutrozole, Corifollitropin alfa, SOV-2012-F1, among others.

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Understanding Hypogonadism

Hypogonadism represents a clinical condition distinguished by insufficient production of sex hormones—testosterone in males and estrogen in females—resulting from gonadal dysfunction (testes or ovaries) or disruption of their hormonal regulatory mechanisms. Classification includes primary hypogonadism (caused by direct gonadal impairment) or secondary hypogonadism (originating from hypothalamic or pituitary disorders). Clinical manifestations differ based on patient age and biological sex but typically encompass diminished libido, infertility, persistent fatigue, muscular weakness, and in males, reduction of facial and body hair growth. Among adolescent patients, delayed pubertal development may occur. Diagnosis relies on clinical assessment supplemented by serum hormone level measurements. Management generally involves personalized hormone replacement protocols designed to normalize hormone concentrations and ameliorate clinical symptoms.

Hypogonadism Treatment Pipeline: Drug Profiles

CKD-845: Chong Kun Dang Pharmaceutical CKD-845 represents an intramuscular testosterone preparation currently in development by Chong Kun Dang Pharmaceutical for hypogonadism management.

Leflutrozole: Mereo BioPharma Leflutrozole (BGS649) constitutes a novel, once-weekly oral aromatase inhibitor that has successfully completed Phase 2b clinical evaluation for obesity-related male hypogonadotropic hypogonadism (HH).

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Hypogonadism Pipeline Therapeutic Assessment

By Product Classification

• Monotherapy

• Combination therapy

• Monotherapy/Combination therapy

By Development Phase

• Advanced-stage candidates (Phase III)

• Intermediate-stage candidates (Phase II)

• Initial-stage candidates (Phase I) including details of

• Pre-clinical and Discovery phase programs

• Terminated & Inactive programs

By Administration Route

• Intra-articular

• Intraocular

• Intrathecal

• Intravenous

• Ophthalmic

• Oral

• Parenteral

• Subcutaneous

• Topical

• Transdermal

By Molecular Classification

• Oligonucleotide

• Peptide

• Small molecule

Hypogonadism Pipeline Report Parameters

Geographic Coverage: Global

Key Hypogonadism Pharmaceutical Companies: Chong Kun Dang Pharmaceutical, Mereo BioPharma, Merck & Co, Organon, Marius Pharmaceuticals, SOV Therapeutics, and others.

Key Hypogonadism Pipeline Assets: CKD-845, Leflutrozole, Corifollitropin alfa, SOV-2012-F1, and others.

Gain comprehensive insights into leading and emerging hypogonadism therapeutics !

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Report Contents

• Introduction

• Executive Summary

• Hypogonadism Pipeline: Overview

• Analytical Perspective In-depth Commercial Assessment

• Hypogonadism Pipeline Therapeutics

• Hypogonadism Pipeline: Advanced-Stage Assets (Phase III)

• Hypogonadism Pipeline: Intermediate-Stage Assets (Phase II)

• Hypogonadism Pipeline: Initial-Stage Assets (Phase I)

• Therapeutic Assessment

• Inactive Assets

• Company-University Collaborations (Licensing/Partnering) Analysis

• Key Companies

• Key Products

• Unmet Needs

• Market Drivers and Barriers

• Future Perspectives and Conclusion

• Analyst Views

• Appendix

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