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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
  • 4 clinical trials expected to report results, the earliest in Q4 2026.
Upcoming Milestones
Clinical Milestones10View all 10
Results expected 4
Recently completed 3
Other updates 3
+2 more in the activity timeline below
Activity timeline10

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

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

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

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.

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

Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment

Phase 4 · Recruiting · Federico II University

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients With Conservative Treatment

Phase 2/3 · Active, not recruiting · Xiaojun Chen

A Multi-center, Open Label, Randomized Parallel Group Study Evaluating the Proportion of Women With Complete Resolution of Nonatypical Endometrial Hyperplasia Treated With Mirena or Oral Medroxyprogesterone Acetate for 6 Months

Phase 3 · Recruiting · Bayer
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.

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

Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment

Phase 4 · Recruiting · Federico II University

A Multi-center, Open Label, Randomized Parallel Group Study Evaluating the Proportion of Women With Complete Resolution of Nonatypical Endometrial Hyperplasia Treated With Mirena or Oral Medroxyprogesterone Acetate for 6 Months

Phase 3 · Recruiting · Bayer
Recently completed

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.

An Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children With Congenital Adrenal Hyperplasia

Phase 3 · Completed · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

First approvals
2021emaApproval — Hydrocortisone· Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. source ↗
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.

Research activity

1 papers

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.