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Drug

Silodosin

Established medicine
ResearchOngoing clinical research

Also known as Rapaflo, Silodosina.

RxNorm720825ChEMBLCHEMBL24778ATCG04CA04UNIICUZ39LUY82
2
Research papers
3
Active clinical trials
3
Regulatory events
Latest activity
beta

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

: Efficacy of Silodosin Versus Tamsulosin in Patients With Moderate to Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: A Randomized Crossover Clinical Trial

Clinical trial2026-09-22Primary completion · ClinicalTrials.gov

The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Investigator-blind, Active Controlled Study

Clinical trial2026-09-09Status changed to Completed · ClinicalTrials.gov

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

Clinical trial2026-06-16Results expected Q2 2027 · ClinicalTrials.gov

Is Silodosin Effective for Treating Lower Urinary Tract Symptoms in Female Patients With Multiple Sclerosis? A Randomized Controlled Trial

Clinical trial2026-05-29Results expected Q1 2028 · ClinicalTrials.gov

Silodosin vs Placebo in the Treatment of Female Lower Urinary Tract Symptoms: A Randomized Controlled Trial

Clinical trial2024-10-30Primary completion · ClinicalTrials.gov

Comparison of Silodosin and Tamsulosin for Medical Expulsive Therapy in Patients With Ureteral Stones

Clinical trial2024-08-15Completed · ClinicalTrials.gov

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

Clinical trial2024-07-09Completed · ClinicalTrials.gov

Generic medicine authorisation: Silodosin Recordati (EMA)

Regulatory2019-01-07EMA

Marketing authorisation: Silodyx (EMA)

Regulatory2010-01-29EMA

Marketing authorisation: Urorec (EMA)

Regulatory2010-01-29EMA

Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study.

Research2009-10-07Urology

Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies.

Research2009-04-16The Journal of urology

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
ATC codes
G04CA04
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
2019-01-07Generic approvalMarket
Generic medicine authorisation: Silodosin Recordati (EMA)

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

Evidence ↗
2010-01-29Original application approval
Marketing authorisation: Urorec (EMA)

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

Evidence ↗
2010-01-29Original application approval
Marketing authorisation: 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
3
Active studies
3
Recruiting
25
Late-stage (III+)
26
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.

Is Silodosin Effective for Treating Lower Urinary Tract Symptoms in Female Patients With Multiple Sclerosis? A Randomized Controlled Trial

RecruitingPH IVAtlantic Health Systemn=602028

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

RecruitingPH IVBeni-Suef Universityn=3782027

: Efficacy of Silodosin Versus Tamsulosin in Patients With Moderate to Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: A Randomized Crossover Clinical Trial

Not yet recruitingPH IVAin Shams Universityn=1402026

The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Investigator-blind, Active Controlled Study

CompletedPH IVXintian Pharmaceuticaln=1102024

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

CompletedPH IVShanghai Huilun Pharmaceutical Co., Ltd.n=1102024

Recent completions

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

The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Investigator-blind, Active Controlled Study

CompletedPH IVXintian Pharmaceuticaln=1102024

Comparison of Silodosin and Tamsulosin for Medical Expulsive Therapy in Patients With Ureteral Stones

CompletedN/AFatima Jinnah Medical Universityn=2002024

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

CompletedPH IVShanghai Huilun Pharmaceutical Co., Ltd.n=1102024

The Additive Value of Pyridostigmine to Silodosin in the Management of Acute Urinary Retention Secondary to Benign Prostatic Hyperplasia

CompletedPH IIBeni-Suef Universityn=1402024

The Use of Selective Alpha Blockers (Silodosin) in Management of Lower Ureteral Stones Larger Than 6 mm in Diameter

CompletedPH I/IISyrian Private Universityn=1002023

Effect of Perioperative Silodosin on Ureteric Dilatation in Retrograde Intrarenal Surgery

CompletedPH IIIAin Shams Universityn=602023

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.