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Disease

Hyperplasia

Late-stage therapeutic developmentEmerging research
MeSHHyperplasia
1
Publications
24
Clinical trials
2002
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

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

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 2 clinical trials expected to report results, the earliest in Q4 2027.
  • 2 industry developments reported.
Upcoming Milestones
Clinical Milestones11View all 11
Results posted 1
Results expected 2
Recently completed 4
Other updates 4
+3 more in the activity timeline below
Industry & Market2View
Activity timeline13

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
Hydrocortisoneapproved

Original application approval — Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over a… (2021)

Silodosinapproved

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

Tadalafilapproved

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

Clinical trials

18 sponsors · 4 new · 3 completed in the last 12 months (net +2)

The current development programme across all trial phases.

Clinical programme
24
All trials
6
Active
18
Late-stage
6
Completed
Late-stage studies

Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma

Phase 2/3 · Recruiting · West China Second University Hospital

A Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants With Congenital Adrenal Hyperplasia Including a Long-Term Extension

Phase 2/3 · Recruiting · Crinetics Pharmaceuticals Inc.

Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment

Phase 4 · Recruiting · Federico II University

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

Randomized Placebo-controlled Phase III Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up

Phase 3 · Active, not recruiting · Andrea DeCensi

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

Phase 3 · Active, not recruiting · Neurocrine Biosciences
Recruiting

Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma

Phase 2/3 · Recruiting · West China Second University Hospital

A Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants With Congenital Adrenal Hyperplasia Including a Long-Term Extension

Phase 2/3 · Recruiting · Crinetics Pharmaceuticals Inc.

Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment

Phase 4 · Recruiting · Federico II University

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
Recently completed

Investigating the Effect of Topical Imiquimod on Sebaceous Hyperplasia

Phase 4 · Completed · University of Michigan

A Phase 3 Open-Label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia

Phase 3 · Completed · Immedica Pharma AB

A Randomized Controlled Pilot Study of Polyethylene Glycol Loxenatide Plus LNG-IUS in Women With Endometrial Atypical Hyperplasia

Phase 2/3 · Completed · Fudan University

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

Regulatory timeline

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

Product approvals and authorisations
2021emaOriginal application approval — Hydrocortisone· Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. source ↗
2019emaGeneric approval — Silodosin· Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men. source ↗
2017emaOriginal application approval — 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 ↗
2010emaOriginal application approval — Silodosin· Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). source ↗
2010emaOriginal application approval — 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.

Research activity

1 paper

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Most influential

A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.

The New England journal of medicine · 2002 · 2,660 cites
Recent publications

A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.

The New England journal of medicine · 2002 · 2,660 cites
Major themes1
  • Stents1
Leading journals1
  • The New England journal of medicine1
Leading researchers8
  • Ban Hayashi E1
  • Barragan P1
  • Colombo A1
  • Fajadet J1
  • Falotico R1
  • Guagliumi G1
  • Molnàr F1
  • Morice MC1
Affiliations (unnormalised)1
  • Institut Cardiovasculaire Paris Sud1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

An increase in the number of cells in a tissue or organ without tumor formation. It differs from HYPERTROPHY, which is an increase in bulk without an increase in the number of cells.

Identifiers
MeSHHyperplasia
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.