Benign Prostatic Hyperplasia Pipeline Insight 2025: Advancing Therapies Targeting Smooth Muscle Modulation, Hormonal Pathways, and Minimally Invasive Innovations | DelveInsight

DelveInsight's "Benign Prostatic Hyperplasia (BPH) - Pipeline Insight, 2025" provides a comprehensive review of the therapeutic development landscape for one of the most common non-malignant urological conditions in aging men-BPH. Characterized by progressive prostate gland enlargement, BPH results in lower urinary tract symptoms (LUTS), significantly impacting quality of life and healthcare utilization worldwide.

The current standard of care comprises alpha-blockers, 5-alpha-reductase inhibitors, PDE5 inhibitors, and combination regimens. While these offer symptomatic relief, many patients face issues such as incomplete response, adverse sexual side effects, and long-term adherence concerns. The unmet need has prompted robust R&D activity focused on next-generation medical therapies and non-surgical alternatives.

Emerging candidates in the BPH pipeline are targeting novel hormonal and neurogenic pathways, such as GnRH antagonists, androgen receptor modulators, and vasoactive peptides. Additionally, compounds that modulate prostate smooth muscle tone and fibrosis pathways are gaining traction in mid-phase trials. These aim to offer symptom control with fewer systemic effects.

Minimally invasive device-based interventions are also a key area of innovation. Technologies such as prostatic urethral lift systems, water vapor thermal therapy, and temporary implantable stents are being refined for improved durability and reduced invasiveness. These modalities are especially appealing for patients seeking alternatives to long-term pharmacotherapy or surgery.

Biopharmaceutical companies are also repurposing agents originally designed for urological and hormonal disorders to manage LUTS associated with BPH. Furthermore, digital therapeutics and remote monitoring tools are being explored in adjunct to therapies for better symptom tracking and adherence.

With a growing aging population and rising demand for personalized, non-invasive options, the BPH treatment paradigm is shifting. The pipeline is increasingly populated with promising drugs and devices that aim to redefine clinical management and deliver better outcomes with fewer trade-offs for patients.

Interested in learning more about the current treatment landscape and the key drivers shaping the Benign Prostatic Hyperplasia pipeline? Click here: https://www.delveinsight.com/report-store/benign-prostatic-hyperplasia-bph-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Benign Prostatic Hyperplasia Pipeline Report
• DelveInsight's Benign Prostatic Hyperplasia pipeline analysis depicts a strong 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 July 2025, a study published in Urology showed that patients with benign prostatic hyperplasia (BPH) treated with Rezūm Water Vapor Therapy had lower 5-year clinical progression rates and better initial symptom improvements compared to those receiving pharmaceutical treatments. The analysis compared data from 1,477 patients in the MTOPS trial (treated with doxazosin, finasteride, combination therapy, or placebo) to 130 patients from a Rezūm randomized controlled trial.
• In December 2024, the FDA approved GEMTESA (vibegron), a once-daily β3 adrenergic receptor agonist (75 mg), for treating overactive bladder (OAB) symptoms in men receiving pharmacologic therapy for benign prostatic hyperplasia (BPH). GEMTESA is now the first and only β3 agonist approved for this patient group and is available by prescription in the U.S.

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Benign Prostatic Hyperplasia Overview
Benign Prostatic Hyperplasia (BPH) is a common, non-cancerous enlargement of the prostate gland that typically affects aging men. As the prostate grows, it can press against the urethra and interfere with normal urine flow, leading to lower urinary tract symptoms (LUTS) such as increased frequency, urgency, weak stream, and nocturia (frequent urination at night). BPH is not linked to prostate cancer, but its symptoms can significantly impact quality of life.

The exact cause of BPH is not fully understood, but hormonal changes associated with aging-particularly involving testosterone and dihydrotestosterone (DHT)-are believed to play a central role. Diagnosis is often based on clinical symptoms, digital rectal exam (DRE), and other tests such as PSA (prostate-specific antigen) levels, ultrasound, or urinary flow studies. Treatment options range from lifestyle changes and medications (like alpha-blockers and 5-alpha-reductase inhibitors) to minimally invasive procedures and surgery in more severe cases.

Find out more about Benign Prostatic Hyperplasia medication at https://www.delveinsight.com/report-store/benign-prostatic-hyperplasia-bph-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Benign Prostatic Hyperplasia Treatment Analysis: Drug Profile
DKF-313: Dongkook Pharmaceutical
DKF-313 is an investigational combination therapy of dutasteride and tadalafil, currently in Phase III clinical development for the treatment of benign prostatic hyperplasia (BPH). This combination aims to deliver enhanced therapeutic benefits by both reducing prostate size and improving urinary symptoms more effectively than either drug alone. DKF-313 is designed to selectively target overexpressed antigens on affected cells, enabling more precise drug delivery and improved treatment outcomes.

Teverelix Trifluoroacetate: Antev
Teverelix trifluoroacetate (Teverelix TFA) is a gonadotrophin-releasing hormone (GnRH) antagonist being developed in a novel formulation. It works by rapidly inhibiting the production of sex hormones, which is beneficial for hormone-dependent conditions such as BPH, prostate cancer, and endometriosis. Unlike GnRH agonists, Teverelix TFA offers the potential for faster onset and fewer side effects. Currently in Phase II clinical trials for BPH, it holds promise as a next-generation therapy that could eventually replace traditional GnRH agonists.

Learn more about the novel and emerging Benign Prostatic Hyperplasia pipeline therapies at https://www.delveinsight.com/report-store/benign-prostatic-hyperplasia-bph-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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.

To dive deep into rich insights for drugs used for Benign Prostatic Hyperplasia treatment, visit: https://www.delveinsight.com/report-store/benign-prostatic-hyperplasia-bph-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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: Mid-Stage Products (Phase II)
8. Benign Prostatic Hyperplasia 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

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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This release was published on openPR.