TheraRadar
Data updated: May 26, 2026

RAPAFLO (silodosin)

Trial Activity: Mature 1 active trials
Urology Approved 2008-10-08
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

JW Pharmaceutical conducting 6 trials (35%)
18 indications explored (Broad Platform)
→ benign prostatic hyperplasia (5 trials)
→ ureteral stone (2 trials)
→ nocturia (2 trials)
1
Indication
--
Phase 3 Trials
17
Years on Market

Details

Status
Discontinued
First Approved
2008-10-08
Routes
ORAL
Dosage Forms
CAPSULE

Companies

AbbVie
Active Ingredient: SILODOSIN

RAPAFLO Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 2008 to 2020
Dec 2020 SUPPL
Label · Labeling
FDA Letter Label
Dec 2015 SUPPL
Mfg · Manufacturing (CMC)
Nov 2013 SUPPL
Mfg · Manufacturing (CMC)

What RAPAFLO Treats

1 FDA approvals

Originally approved for its first indication in 2008 .

  • Other (1)
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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NCT01560091 HN 4378 Ph 3 withdrawn Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

RAPAFLO FDA Label Details

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Data Sources

FDA Approval: NDA022206 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment