Benign Prostatic Hyperplasia - Pipeline Insight, 2025

This “Benign prostatic hyperplasia - Pipeline Insight, 2025” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Benign prostatic hyperplasia 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.

Benign prostatic hyperplasia: Understanding

Benign prostatic hyperplasia: Overview

Benign prostatic hyperplasia (BPH) is a common condition among older men, marked by nonmalignant growth of prostate tissue leading to lower urinary tract symptoms (LUTS). Its prevalence increases with age, affecting up to 50-60% of males in their 60s and 80-90% of those over 70. BPH is characterized by histological changes, benign prostatic enlargement (BPE), and bladder outlet obstruction, resulting in urinary flow blockage. LUTS encompass the urinary abnormalities associated with BPH, replacing older terms like 'prostatism.' BPH development involves stromal and epithelial cell proliferation in the prostate transition zone, causing urethral compression and obstruction, potentially leading to urinary retention and infections. Untreated BPH can lead to chronic high-pressure retention and bladder detrusor muscle changes. Treatment options vary from watchful waiting to medical and surgical interventions, with risk factors including age, genetics, geographical location, and obesity, both non-modifiable and modifiable.

Non-modifiable risk factors for BPH include genetic predisposition, with first-degree relatives showing a four-fold increase in risk. Modifiable risk factors such as diabetes and obesity contribute to BPH development, with diabetes and insulin use linked to increased BPH risk. Dietary factors like excessive alcohol and caffeine intake elevate BPH risk, while protective effects are seen with beta-carotene and vitamin A. Localized inflammation, possibly triggered by chronic prostatitis or autoimmune disorders, and metabolic syndrome, characterized by hypertension and insulin resistance, are also associated with BPH development.

Diagnosing BPH involves a comprehensive evaluation, including a detailed medical history assessment, physical examination (including digital rectal examination), and urinalysis. Further tests such as uroflowmetry and measuring post-void residual (PVR) volume aid in confirming the presence of obstructive symptoms attributable to BPH.Treatment options for BPH encompass a spectrum ranging from lifestyle modifications to medical and surgical interventions, depending on the severity of symptoms and individual patient factors. Lifestyle changes such as dietary modifications and fluid management may provide relief for some individuals. Medications play a pivotal role, with the two major classes being alpha-adrenergic blockers, which relax muscles around the prostate and bladder neck to enhance urine flow, and 5-alpha reductase inhibitors, which reduce the size of the prostate gland over time. In cases where medications fail to adequately control symptoms, surgical procedures such as transurethral resection of the prostate (TURP) or minimally invasive therapies may be considered to alleviate symptoms and improve urinary function.

Overall, the management of BPH is tailored to each patient's specific needs and preferences, with the ultimate goal of improving symptoms, preserving urinary function, and enhancing quality of life.

'Benign prostatic hyperplasia- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the benign prostatic hyperplasia pipeline landscape is provided which includes the disease overview and benign prostatic hyperplasia treatment guidelines. The assessment part of the report embraces, in depth benign prostatic hyperplasia 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, Benign prostatic hyperplasia 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 benign prostatic hyperplasia R&D. The therapies under development are focused on novel approaches to treat/improve benign prostatic hyperplasia.

Benign prostatic hyperplasia Emerging Drugs Chapters

This segment of the benign prostatic hyperplasia 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.

Benign prostatic hyperplasia Emerging Drugs

DKF-313: Dongkook Pharmaceutical

DKF-313, a combination of dutasteride and tadalafil, is expected to reduce prostate size and improve dysuria symptoms caused by BPH more effectively than single drugs. This combination targets specific antigens overexpressed on cancer cells, allowing for selective targeting. By binding to these target antigens, DKF-313 can deliver the drugs directly to the affected cells, enhancing treatment outcomes. Currently, the drug is in Phase III stage of its clinical trial for the treatment of benign prostatic hyperplasia.

Teverelix trifluoroacetate: Antev

Teverelix trifluoroacetate (Teverelix TFA) is a gonadotrophin-releasing hormone (GnRH) antagonist with a novel formulation. GnRH antagonists rapidly suppress the effects of sex hormones by limiting their production. This is therapeutically valuable for conditions that are controlled by sex hormone secretion, including prostate cancer, benign prostatic hyperplasia, and endometriosis. Recent data suggest that GnRH antagonists may have multiple therapeutic advantages over the traditionally used GnRH agonists, and therefore have the potential to supersede GnRH agonists as the gold-standard treatment. Currently, the drug is in Phase II stage of its clinical trial for the treatment of benign prostatic hyperplasia.

DPI-221: DMK Pharmaceuticals

DPI-221 by DMK Pharmaceuticals is a drug that acts as a highly selective agonist for the δ-opioid receptor, known for producing fewer convulsions compared to other drugs in the same family. This drug is a novel nonpeptide delta receptor agonist that has shown effects such as increased micturition interval in normal rats. Currently, the drug is in Phase I stage of its clinical trial for the treatment of benign prostatic hyperplasia.

Benign prostatic hyperplasia: Therapeutic Assessment

This segment of the report provides insights about the different benign prostatic hyperplasia drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Benign prostatic hyperplasia

• There are approx. 10+ key companies which are developing the therapies for benign prostatic hyperplasia. The companies which have their benign prostatic hyperplasia drug candidates in the most advanced stage, i.e. Phase III include, Dongkook Pharmaceutical.

Phases

The report covers around 10+ 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

Benign prostatic hyperplasia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

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

Benign prostatic hyperplasia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses benign prostatic hyperplasia 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 benign prostatic hyperplasia drugs.

Benign prostatic hyperplasia Report Insights

• Benign prostatic hyperplasia Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Benign prostatic hyperplasia 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 benign prostatic hyperplasia drugs?
• How many benign prostatic hyperplasia drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of benign prostatic hyperplasia?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the benign prostatic hyperplasia 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 benign prostatic hyperplasia and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

GemVax & Kael

Antev

Dongkook Pharmaceutical

Chong Kun Dang Pharmaceutical

Resurge Therapeutics Inc.

DMK Pharmaceuticals

Key Products

GV1001

Teverelix

DKF-313

CKD-846

RT-310

DPI 221

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