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)

Associated Therapies: -

Clinical Trials

Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia

Phase 4

Completed

Conditions: Nocturia
Benign Prostatic Hyperplasia

Interventions: Drug: Silodosin
Other: Laboratory tests
Other: 3-days voiding diary
Other: 12 weeks

First Posted Date: 2014-04-08

Last Posted Date: 2017-03-10

Lead Sponsor: JW Pharmaceutical

Target Recruit Count: 135

Registration Number: NCT02106182

Locations: 🇰🇷
Bucheon St.Mary's Hospital, Bucheon, Gyeonggi-do, Korea, Republic of
🇰🇷
Hanyang University Hospital, Seoul, Korea, Republic of
🇰🇷
Soon Chun Hyang University Hospital, Seoul, Korea, Republic of

and more 3 locations

Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.

Phase 3

Terminated

Conditions: Expulsive Medical Therapy
Kidney Stone

Interventions: Drug: Silodosin

First Posted Date: 2014-03-18

Last Posted Date: 2016-02-11

Lead Sponsor: Centre Hospitalier Departemental Vendee

Target Recruit Count: 8

Registration Number: NCT02090439

Locations: 🇫🇷
CH Loire Vendée Océan, Challans, France
🇫🇷
Centre hospitalier départemental Vendée, La Roche sur Yon, France

Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia

Phase 4

Completed

Conditions: Benign Prostatic Hyperplasia

Interventions: Drug: Silodosin

First Posted Date: 2012-12-31

Last Posted Date: 2014-04-29

Lead Sponsor: RECORDATI GROUP

Target Recruit Count: 1036

Registration Number: NCT01757769

Locations: 🇮🇹
Vita e Salute University, Department of Urology, Istituto Scientifico Ospedale San Raffaele, Milan, Italy

Differential Effect of Silodosin Versus Tamsulosin on Stone Clearance After Extra-corporeal Shock Wave Lithotripsy

Phase 3

Withdrawn

Conditions: Kidney Stones

Interventions: Procedure: Extra-corporeal shock wave lithotripsy
Drug: silodosin
Drug: Tamsulosin

First Posted Date: 2012-03-22

Last Posted Date: 2017-02-17

Lead Sponsor: Albert Einstein Healthcare Network

Registration Number: NCT01560091

Locations: 🇺🇸
Albert Einstein Healthcare Network, Philadelphia, Pennsylvania, United States

A Dose-finding Study of Silodosin in Patients With Urinary Calculi

Phase 2

Completed

Conditions: Urinary Calculus

Interventions: Drug: placebo
Drug: silodosin

First Posted Date: 2012-02-27

Last Posted Date: 2013-10-30

Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Target Recruit Count: 300

Registration Number: NCT01539265

Locations: 🇯🇵
Japan, Tokyo and Other Japanese City, Japan

Efficacy and Safety of Silodosin in the Treatment of Natural Expulsion in Patients With Ureteral Stones

Phase 4

Completed

Conditions: Ureteral Stone

Interventions: Drug: Placebo
Drug: Silodosin

First Posted Date: 2012-02-15

Last Posted Date: 2013-11-20

Lead Sponsor: JW Pharmaceutical

Target Recruit Count: 114

Registration Number: NCT01533389

Locations: 🇰🇷
Kangbuk Samsung Medical Center, Seoul, Korea, Republic of
🇰🇷
Eulji General Hospital, Seoul, Korea, Republic of
🇰🇷
NHIC Ilsan Hospital, Goyang-Si, Gyonggi-Do, Korea, Republic of

and more 2 locations

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

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy