Benign Prostatic Hyperplasia
Urology 1 original drugsUrology indication. Benign Prostatic Hyperplasia has 1 FDA-approved novel treatment, led by SUMITOMO PHARMA AM, with 33 active industry clinical trials across 14 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.
Benign Prostatic Hyperplasia Market Leaders
Companies with the most FDA-approved novel Benign Prostatic Hyperplasia drugs.
Phase 3 Readouts Pro
1 active Phase 3 trial with confidence-graded completion dates.
Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.
Benign Prostatic Hyperplasia Treatments by Mechanism
Top 6 mechanisms across 17 industry trials with a known mechanism of action.
MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.
Benign Prostatic Hyperplasia Clinical Pipeline by Phase
61 industry-sponsored trials across 28 sponsors
Novel Benign Prostatic Hyperplasia Drugs by Company (New molecular entities)
1 company has an FDA-approved novel drug for Benign Prostatic Hyperplasia.
Reformulations (7 drugs) Click to expand
Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.
Benign Prostatic Hyperplasia Drug Targets
Molecular targets of approved and investigational Benign Prostatic Hyperplasia drugs — 14 targets tracked.
Generic Drugs (5 ANDA approved) Click to expand
Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).
Drug Categories:
- Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
- Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
- Biosimilars: BLA-approved biologics highly similar to reference products
- Generics: ANDA-approved copies of small molecule drugs