Benign Prostatic Hyperplasia Pipeline: Over 10 Leading Companies Driving Innovation with Next-Generation Therapies | DelveInsight

The benign prostatic hyperplasia market is rapidly advancing and is fueled by groundbreaking research and innovative therapies from companies such as GemVax & Kael, Antev, Dongkook Pharmaceutical, and Chong Kun Dang Pharmaceutical. These industry pioneers are transforming treatment strategies and redefining the future of Benign prostatic hyperplasia, bringing new hope to patients worldwide.

DelveInsight's "Benign prostatic hyperplasia Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Benign prostatic hyperplasia market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.

For emerging Benign prostatic hyperplasia drugs, the Benign prostatic hyperplasia pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Benign Prostatic Hyperplasia Pipeline Report
• DelveInsight's Benign prostatic hyperplasia Pipeline analysis depicts a robust space with 10+ active players working to develop 10+ pipeline drugs for Benign prostatic hyperplasia treatment.
• The leading Benign prostatic hyperplasia companies include GemVax & Kael, Antev, Dongkook Pharmaceutical, Chong Kun Dang Pharmaceutical, Resurge Therapeutics Inc., DMK Pharmaceuticals, and others are evaluating their lead assets to improve the Benign prostatic hyperplasia treatment landscape.
• Key benign prostatic hyperplasia pipeline therapies in various stages of development include GV1001, Teverelix, DKF-313, CKD-846, RT-310, DPI 221, and others.
• In Dec 2024, Sumitomo Pharma America, Inc. (SMPA) announced that the FDA has approved GEMTESA® (vibegron), a once-daily 75 mg beta-3 (β3) adrenergic receptor agonist, for the treatment of individuals with overactive bladder (OAB) symptoms-such as urgency, urinary frequency, and urge incontinence-who are also receiving treatment for benign prostatic hyperplasia (BPH). This makes GEMTESA the first and only β3 agonist approved for this patient population in the U.S.

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Benign Prostatic Hyperplasia Overview
Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the prostate that becomes increasingly common with age, affecting up to 60% of men in their 60s and nearly 90% of those over 70. This gradual tissue growth in the prostate can lead to lower urinary tract symptoms (LUTS), such as difficulty starting urination, weak stream, or frequent urges. These issues arise from the compression of the urethra due to the overgrowth in the prostate's transition zone. If not managed, BPH can result in further complications like urinary retention or infections. Risk factors include both genetic and modifiable elements-men with a family history are more likely to develop BPH, while obesity, metabolic conditions like diabetes, and lifestyle habits such as excessive alcohol or caffeine intake may increase the risk. Protective dietary factors, such as adequate intake of beta-carotene and vitamin A, may offer some benefit. Inflammation and conditions like metabolic syndrome have also been linked to the progression of BPH.

Diagnosis typically involves a combination of medical history, physical examination, and urine tests, with further evaluations like urine flow measurement and post-void residual checks used to assess severity. Management options range from lifestyle changes and monitoring to medications and surgical procedures. Common treatments include alpha-blockers that relax muscle tissue to ease urine flow and 5-alpha reductase inhibitors that reduce prostate size over time. In cases where medications are ineffective, minimally invasive or surgical interventions such as transurethral resection may be necessary. Treatment plans are tailored to symptom severity and overall health status, aiming to relieve discomfort and prevent complications.

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Benign Prostatic Hyperplasia Treatment Analysis: Drug Profile
DKF-313 - Dongkook Pharmaceutical
DKF-313 is a combination therapy comprising dutasteride and tadalafil, designed to more effectively reduce prostate size and relieve urinary symptoms associated with benign prostatic hyperplasia (BPH) compared to monotherapies. This formulation targets antigens that are overexpressed on affected cells, enabling precise drug delivery and potentially improving treatment efficacy. DKF-313 is currently in Phase III clinical trials for BPH.

Teverelix Trifluoroacetate - Antev
Teverelix trifluoroacetate (Teverelix TFA) is a novel gonadotrophin-releasing hormone (GnRH) antagonist. It works by rapidly suppressing the production of sex hormones, offering therapeutic benefits for hormone-dependent conditions such as prostate cancer, endometriosis, and benign prostatic hyperplasia. Compared to GnRH agonists, GnRH antagonists like Teverelix TFA may provide superior outcomes. The drug is currently being evaluated in Phase II clinical trials for BPH.

Key Benign Prostatic Hyperplasia Therapies and Companies
• DKF-313: Dongkook Pharmaceutical
• Teverelix trifluoroacetate: Antev
• DPI-221: DMK Pharmaceuticals

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Benign Prostatic Hyperplasia 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
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

Scope of the Benign Prostatic Hyperplasia Pipeline Report
• Coverage: Global
• Key Benign prostatic hyperplasia Companies: GemVax & Kael, Antev, Dongkook Pharmaceutical, Chong Kun Dang Pharmaceutical, Resurge Therapeutics Inc., DMK Pharmaceuticals, and others.
• Key Benign prostatic hyperplasia Pipeline Therapies: GV1001, Teverelix, DKF-313, CKD-846, RT-310, DPI 221, and others.

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

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This release was published on openPR.