Male Hypogonadism - Pipeline Insight, 2025

This “Male-Hypogonadism- Pipeline Insight, 2025” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Male-Hypogonadism pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Male-Hypogonadism: Understanding

Male-Hypogonadism: Overview

Male hypogonadism is a condition in which the body does not produce enough of the testosterone hormone; the hormone that plays a key role in masculine growth and development during puberty. There is a clear need to increase the awareness of hypogonadism throughout the medical profession, especially in primary care physicians who are usually the first port of call for the patient. Hypogonadism is a medical term for decreased functional activity of the gonads. The gonads (ovaries or testes) produce hormones (testosterone, estradiol, antimullerian hormone, progesterone, inhibin B, activin) and gametes (eggs or sperm). Male hypogonadism is characterized by a deficiency in testosterone - a critical hormone for sexual, cognitive, and body function and development. Clinically low testosterone levels can lead to the absence of secondary sex characteristics, infertility, muscle wasting, and other abnormalities. Low testosterone levels may be due to testicular, hypothalamic, or pituitary abnormalities. Male hypogonadism, acquired or congenital, can be caused by defects that interfere with the hypothalamic-pituitary-testicular axis. It is essential to distinguish between primary hypogonadism (which originates in the testes) and secondary hypogonadism (which originates in the hypothalamus or pituitary gland). There are two basic types of hypogonadism that exist: Primary: This type of hypogonadism - also known as primary testicular failure - originates from a problem in the testicles. Secondary: This type of hypogonadism indicates a problem in the hypothalamus or the pituitary gland - parts of the brain that signal the testicles to produce testosterone. The hypothalamus produces the gonadotropin releasing hormone, which signals the pituitary gland to make the follicle-stimulating hormone (FSH) and luteinizing hormone. The luteinizing hormone then signals the testes to produce testosterone. Either type of hypogonadism may be caused by an inherited (congenital) trait or something that happens later in life (acquired), such as an injury or an infection. Early diagnosis and treatment can reduce risks associated with hypogonadism. Early detection in young boys can help to prevent problems due to delayed puberty. Early diagnosis in men helps protect against the development of osteoporosis and other conditions. The diagnosis of hypogonadism is based on symptoms and blood work, particularly on testosterone levels. Once the treatment starts, the patient may continue to have testosterone levels drawn to determine if the medication is helping to produce adequate testosterone levels. Testosterone replacement therapy is the primary treatment option for hypogonadism. Hypogonadism affects men of all ages, either through congenital or acquired causes. For patients who have clinical symptoms associated with their low testosterone levels, treatment is essential for the prevention of sexual, cognitive, and bodily changes.

'Male-Hypogonadism- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Male-Hypogonadism pipeline landscape is provided which includes the disease overview and Male-Hypogonadism treatment guidelines. The assessment part of the report embraces, in depth Male-Hypogonadism commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Male-Hypogonadism collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Male-Hypogonadism R&D. The therapies under development are focused on novel approaches to treat/improve Male-Hypogonadism.

Male-Hypogonadism Emerging Drugs Chapters

This segment of the Male-Hypogonadism report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Male-Hypogonadism Emerging Drugs

Leflutrozole: Mereo BioPharma

Leflutrozole, is an investigational drug being developed by Mereo BioPharma. It is a novel once weekly oral aromatase inhibitor that has completed a Phase IIb study in obesity-associated male hypogonadotropic hypogonadism (HH).

Corifollitropin alfa: Merck & Co

Corifollitropin alfa (MK-8962; formerly Org 36286/SCH 900962) is a recombinant gonadotropin consisting of the α-subunit of human FSH and a hybrid subunit composed of the sequence of the β-subunit of human FSH and the carboxy-terminal peptide part of the β-subunit of hCG. In women seeking infertility care, treatment with corifollitropin alfa produced a similar therapeutic response compared with that of recFSH. Corifollitropin alfa has the same pharmacodynamic (PD) profile as recFSH, but an approximately two-fold longer elimination half-life (t1/2) and an almost four-fold extended time interval to peak serum levels relative to that of recFSH. Currently, the drug is in Phase III stage of Clinical trial evaluation for the treatment of males with Hypogonadotropic Hypogonadism (HH).

Male-Hypogonadism: Therapeutic Assessment

This segment of the report provides insights about the different Male-Hypogonadism drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Male-Hypogonadism

There are approx. 5+ key companies which are developing the therapies for Male-Hypogonadism. The companies which have their Male-Hypogonadism drug candidates in the most advanced stage, i.e. phase III include, Merck & Co.

Phases

The report covers around 5+ products under different phases of clinical development like

• 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

Route of Administration

Male-Hypogonadism pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Male-Hypogonadism: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Male-Hypogonadism therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Male-Hypogonadism drugs.

Male-Hypogonadism Report Insights

• Male-Hypogonadism Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Male-Hypogonadism Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Male-Hypogonadism drugs?
• How many Male-Hypogonadism drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Male-Hypogonadism?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Male-Hypogonadism therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Male-Hypogonadism and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Mereo BioPharma
• Merck & Co
• Marius Pharmaceuticals

Key Products

• Leflutrozole
• Corifollitropin alfa
• KYZATREX