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Drug

Silodosin

Approved · EMA
Emerging researchLate-stage development

Also known as Rapaflo, Silodosina.

2
Research papers
4
Active clinical trials
3
Regulatory events
Latest activity
beta

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

Approval: Silodyx (EMA)

Regulatory2010-01-29EMA

Approval: Urorec (EMA)

Regulatory2010-01-29EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Silodosin
Aliases & brands
RapafloSilodosina
RxNorm CUI
720825
ChEMBL ID
CHEMBL24778
UNII
CUZ39LUY82
Regulatory jurisdictions
ema

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2010-01-29
Latest approval
2019-01-07
Authorities
EMA
Total events
3
emaEuropean Medicines Agency· 3 events
2019-01-07Approval
Approval: Silodosin Recordati (EMA)

Indication: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.

Evidence ↗
2010-01-29Approval
Approval: Urorec (EMA)

Indication: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Evidence ↗
2010-01-29Approval
Approval: Silodyx (EMA)

Indication: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

35 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
35
registered trials across all phases
LATEST COMPLETION 2024
4
Active studies
4
Recruiting
25
Late-stage (III+)
25
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 35
Early Phase 11Phase 11Phase 1 / 21Phase 27Phase 39Phase 413Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

2 papers

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

Major research themes1
Adrenergic alpha-1 Receptor Antagonists1
Journals, researchers & institutions
Top journals
  • The Journal of urology1
  • Urology1
Leading researchers
  • Gittelman MC2
  • Hill LA2
  • Hoel G2
  • Marks LS2
  • Volinn W2
Leading institutions
free-text, unnormalised
  • University of California at Los Angeles and Urological Sciences Research Foundation1
  • Urological Sciences Research Foundation1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.