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Disease

Benign prostatic hyperplasia

Late-stage therapeutic development
Also known as benign hyperplasia of prostate, benign hyperplasia of the prostate, benign prostate hyperplasia, benign prostatic Hypertrophy+7 more

benign hyperplasia of prostate, benign hyperplasia of the prostate, benign prostate hyperplasia, benign prostatic Hypertrophy, benign prostatic hyperplasia (disease), benign prostatic hyperplasia - BPH, benign prostatic hypertrophy, BPH, prostatic hyperplasia, benign, prostate hypertrophy, prostatic hypertrophy.

21
Clinical trials
12
Associated genes
12
Related proteins
Current focus
Alpha-1a adrenergic biologyAlpha-1d adrenergic biologyTherapeutic development

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 4 clinical trials expected to report results, the earliest in Q4 2026.
Upcoming Milestones
Clinical Milestones6View
Results expected 4
Recently completed 1
Other updates 1
Activity timeline6

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Silodosinapproved

Approval — Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men. (2019)

Tadalafilapproved

Approval — Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective,… (2017)

Clinical trials

17 sponsors · 5 new · 0 completed in the last 12 months (net +5)

The current development programme across all trial phases.

Clinical programme
21
All trials
6
Active
15
Late-stage
6
Completed
Late-stage studies

Tamsulosin With Versus Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Prospective Double-Blind Randomized Trial

Phase 4 · Recruiting · Beni-Suef University

The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Double-blind, Positive Controlled Study

Phase 4 · Recruiting · Xintian Pharmaceutical

Tamsulosin 0.4 mg Continuation Versus Dose Escalation to 0.8 mg Versus Switch to Silodosin 8 mg for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Randomized Controlled Trial

Phase 4 · Recruiting · Beni-Suef University

A Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate

Phase 4 · Recruiting · The Fourth Affiliated Hospital of Zhejiang University School of Medicine

The Efficacy and Safety of Qianweitai (Silodosin Capsule) Compared to Tamsulosin in the Treatment of Benign Prostaic Hyperplasia (BPH) -A Multicenter, Prospecive, Randomized, Investigator-Blind, Positive-Controlled Study

Phase 4 · Completed · Shanghai Huilun Pharmaceutical Co., Ltd.

Comparison of Magnesium Sulphate vs Tramadol as Adjuvants in Intrathecal Bupivacaine for Postoperative Pain in TURP Patients

Phase 4 · Completed · Armed Forces Institute of Urology, Rawalpindi
Recruiting

Tamsulosin With Versus Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Prospective Double-Blind Randomized Trial

Phase 4 · Recruiting · Beni-Suef University

The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Double-blind, Positive Controlled Study

Phase 4 · Recruiting · Xintian Pharmaceutical

A Phase 2b Randomized, Single-Center, Double Blind, Placebo Controlled, 2-Arm Study to Investigate Orally Administered Combination Therapies (5-alpha Reductase Inhibitor + Raloxifene) Compared With Monotherapy (5-alpha Reductase Inhibitor + Placebo) in Adult Patients With Benign Prostatic Hyperplasia (BPH)

Phase 2 · Recruiting · Beth Israel Deaconess Medical Center

Tamsulosin 0.4 mg Continuation Versus Dose Escalation to 0.8 mg Versus Switch to Silodosin 8 mg for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Randomized Controlled Trial

Phase 4 · Recruiting · Beni-Suef University

A Clinical Observation Study of a Chinese Patent Medicine Combined With Tamsulosin in Improving Sleep and Nocturia Symptoms After Enucleation of the Prostate

Phase 4 · Recruiting · The Fourth Affiliated Hospital of Zhejiang University School of Medicine

An Open-Label, Randomized, Fasting, Single-Dose, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of "AJU-G721" and "G721R" in Healthy Adult Male Subjects

Phase 1 · Recruiting · AJU Pharm Co., Ltd.
Recently completed

Comparison of Magnesium Sulphate vs Tramadol as Adjuvants in Intrathecal Bupivacaine for Postoperative Pain in TURP Patients

Phase 4 · Completed · Armed Forces Institute of Urology, Rawalpindi

The Efficacy and Safety of Qianweitai (Silodosin Capsule) Compared to Tamsulosin in the Treatment of Benign Prostaic Hyperplasia (BPH) -A Multicenter, Prospecive, Randomized, Investigator-Blind, Positive-Controlled Study

Phase 4 · Completed · Shanghai Huilun Pharmaceutical Co., Ltd.

National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia

Phase 3 · Completed · EMS

A Multi-center, Randomized, Double-blinded, Double-dummy, Parallel Group, 48-week, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

Phase 3 · Completed · Dongkook Pharmaceutical Co., Ltd.

PlacEbo-controlled, Randomized, Patient-Selected Outcomes N-of-1 triALs (PERSONAL-pilot): Alpha-blockers for Lower Urinary Tract Symptoms

Phase 4 · Completed · University of California, San Francisco

Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Phase 3 · Completed · Jeil Pharmaceutical Co., Ltd.

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2019emaApproval — Silodosin· Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men. source ↗
2017emaApproval — Tadalafil· Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Lilly is not indicated for use by women. Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. source ↗
2010emaApproval — Silodosin· Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). source ↗
2010emaApproval — Silodosin· Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

SRD5A20.63ADRA1A0.61ADRA1D0.61ADRA1B0.61PDE5A0.61SRD5A30.60SRD5A10.59RNASEH2B0.55BCL11A0.49CLPTM1L0.48E2F10.45GATA50.45

Disease biology

12 matches

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

3-oxo-5-alpha-steroid 4-dehydrogenase 2via SRD5A20.63Alpha-1A adrenergic receptorvia ADRA1A0.61Alpha-1D adrenergic receptorvia ADRA1D0.61Alpha-1B adrenergic receptorvia ADRA1B0.61cGMP-specific 3',5'-cyclic phosphodiesterasevia PDE5A0.61Polyprenal reductasevia SRD5A30.603-oxo-5-alpha-steroid 4-dehydrogenase 1via SRD5A10.59BCL11 transcription factor Avia BCL11A0.49Prostate-specific antigenvia KLK30.37DNA-directed RNA polymerase I subunit RPA1via POLR1A0.26Serine/threonine-protein kinase 3via STK30.25Somatoliberinvia GHRH0.07

Reference

Authoritative identity, definition & identifiers.

Synonyms

benign hyperplasia of prostate, benign hyperplasia of the prostate, benign prostate hyperplasia, benign prostatic Hypertrophy, benign prostatic hyperplasia (disease), benign prostatic hyperplasia - BPH, benign prostatic hypertrophy, BPH, prostatic hyperplasia, benign, prostate hypertrophy, prostatic hypertrophy

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.