Silodosin

Generic Name: Silodosin

Brand Names: Rapaflo, Silodyx, Urorec, Silodosin Recordati

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₃₂F_₃N_₃O_₄

CAS Number: 160970-54-7

Unique Ingredient Identifier: CUZ39LUY82

Background: Silodosin is a selective antagonist of alpha(α)-1 adrenergic receptors that binds to the α subtype with the highest affinity. α1-adrenergic receptors regulate smooth muscle tone in the bladder neck, prostate, and prostatic urethra: the α subtype accounts for approximately 75% of α1-adrenoceptors in the prostate.

Silodosin was first approved by the FDA in October 2008 and it is also approved in Europe and Canada. Silodosin is available as oral capsules with common trade names Rapaflo and Urorec. It is indicated for the symptomatic treatment of benign prostatic hyperplasia in adults. Most commonly affecting males over the age of 40 years, benign prostatic hyperplasia is the non-malignant enlargement of the prostate gland, associated with lower urinary tract symptoms that have a negative impact on the quality of life of patients. Silodosin works by binding to α-adrenoceptors with high affinity and relaxing the lower urinary tract, thereby improving urinary symptoms and alleviating bladder outlet obstruction.

Indication: Silodosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). It is not indicated for the treatment of hypertension.

Associated Conditions: Benign Prostatic Hyperplasia (BPH)

Clinical Trials

Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH

Phase 4

Completed

Conditions: Benign Prostatic Hypertrophy

Interventions: Drug: Silodosin

First Posted Date: 2010-12-15

Last Posted Date: 2012-03-30

Lead Sponsor: JW Pharmaceutical

Target Recruit Count: 424

Registration Number: NCT01260129

Locations: 🇰🇷
The Catholic Univ., Bucheon ST.Mary's Hospital, Bucheon, Korea, Republic of
🇰🇷
Chonnam Univ. Hospital, Hwasun, Korea, Republic of
🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

and more 11 locations

Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)

Phase 4

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: Silodosin

First Posted Date: 2010-12-14

Last Posted Date: 2012-03-30

Lead Sponsor: JW Pharmaceutical

Target Recruit Count: 100

Registration Number: NCT01259531

Locations: 🇰🇷
Seoul national university hospital, Seoul, Korea, Republic of

Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder

Phase 4

Completed

Conditions: Neurogenic Bladder
Voiding Dysfunction

Interventions: Drug: silodosin

First Posted Date: 2010-10-26

Last Posted Date: 2012-10-05

Lead Sponsor: JW Pharmaceutical

Target Recruit Count: 95

Registration Number: NCT01228370

Locations: 🇰🇷
Daegu Catholic Univ. Medical Center, Daegu, Daegu City, Korea, Republic of
🇰🇷
Daegu Fatima Hospital, Daegu, Daegu City, Korea, Republic of
🇰🇷
Yeungnam Univ. Medical Center, Daegu, Daegu City, Korea, Republic of

and more 3 locations

A Comparative Study of KSO-0400 in BPH Patients With LUTS

Phase 2

Completed

Conditions: Benign Prostatic Hyperplasia (BPH)

Interventions: Drug: KSO-0400
Drug: Silodosin
Drug: Placebo

First Posted Date: 2010-10-18

Last Posted Date: 2011-07-04

Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Target Recruit Count: 400

Registration Number: NCT01222650

Locations: 🇯🇵
Japan, Kanto region, Japan

Study of Silodosin to Facilitate Passage of Urinary Stones

Phase 2

Completed

Conditions: Urolithiasis
Kidney Stones
Ureteral Calculi

Interventions: Drug: silodosin
Drug: placebo

First Posted Date: 2010-06-16

Last Posted Date: 2014-08-11

Lead Sponsor: Watson Pharmaceuticals

Target Recruit Count: 239

Registration Number: NCT01144949

Locations: 🇺🇸
Watson Investigational Site, Virginia Beach, Virginia, United States
🇺🇸
Watson Investigative Site, North Kansas City, Missouri, United States