SILODOSIN
Silodosin is an alpha-adrenergic blocker that helps patients with the signs and symptoms of benign prostatic hyperplasia (BPH). It is used to improve urinary issues associated with an enlarged prostate by targeting specific receptors in the lower urinary tract. Although it belongs to a class of drugs often associated with cardiovascular care, it is not used to manage hypertension.
How SILODOSIN Works
Silodosin works by binding with high affinity to alpha-1A adrenoreceptors located in the prostate, bladder, and urethra. Blocking these receptors causes the smooth muscle in these tissues to relax. This relaxation improves urine flow and reduces the physical symptoms associated with BPH.
Details
- Status
- Discontinued
- First Approved
- 2017-03-31
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
SILODOSIN Approval History
What SILODOSIN Treats
1 indicationsSILODOSIN is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Benign Prostatic Hyperplasia
SILODOSIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SILODOSIN
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07467343 | FMASU MS 151/2026 | Ph 4 | not yet recruiting | Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial |
| NCT07134907 | NM-22-A-001-YJ-001 | Ph 4 | completed | The Efficacy and Safety of Qianweitai (Silodosin Capsule) Versus Tamsulosin in the Treatment of BPH |
| NCT06381206 | No 475 | Ph 1, Ph 2 | completed | Silodosin in Management of Lower Ureteral Stones |
| NCT05790902 | AFIU-2022-02 | Ph 1 | completed | COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI |
| NCT02369744 results posted | HN 4441 | Ph 4 | terminated | Silodosin Versus Tamsulosin for Treatment of Ureteral Stones |
| NCT04107896 | No BSMMU/2017/9066 | Ph 4 | completed | Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH) |
| NCT02106182 BPH | JW-SDS-406 | Ph 4 | completed | Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia |
| NCT01560091 | HN 4378 | Ph 3 | withdrawn | Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy |
| NCT02090439 SiloMET | CHD 062-13 | Ph 3 | terminated | Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm. |
| NCT01144949 results posted | SIL1001 | Ph 2 | completed | Study of Silodosin to Facilitate Passage of Urinary Stones |
| NCT01757769 SiRE | KMD 3213 IT-CL 0376 2011-000045-20 | Ph 4 | completed | Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia |
| NCT01533389 STONE | CWP-SDS-404 | Ph 4 | completed | Efficacy and Safety of Silodosin in the Treatment of Natural Expulsion in Patients With Ureteral Stones |
| NCT01228370 | CWP-SDS-402 | Ph 4 | completed | Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder |
| NCT01260129 | CWP-SDS-401 | Ph 4 | completed | Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH |
| NCT01259531 STRONG | CWP-SDS-403 | Ph 4 | completed | Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH) |
| NCT00793819 results posted | SI08005 | Ph 2 | completed | A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SILODOSIN FDA Label Details
Indications & Usage
SILODOSIN is indicated for the treatment of Benign Prostatic Hyperplasia.
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RAPAFLO
Full clinical data, patents, trials, and competitive landscape for silodosin.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.