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Silodosin

Generic Name
Silodosin
Brand Names
Rapaflo, Silodyx, Urorec, Silodosin Recordati
Drug Type
Small Molecule
Chemical Formula
C25H32F3N3O4
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)

The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia

Phase 4
Recruiting
Conditions
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Interventions
First Posted Date
2022-09-22
Last Posted Date
2022-09-23
Lead Sponsor
Xintian Pharmaceutical
Target Recruit Count
312
Registration Number
NCT05551221
Locations
🇨🇳

Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China

🇨🇳

Peking University Shenzhen Hospital, Shenzhen, Guangdong, China

🇨🇳

Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing, China

and more 5 locations

Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

Phase 4
Completed
Conditions
Benign Prostatic Hyperplasia
Interventions
First Posted Date
2019-09-27
Last Posted Date
2019-09-27
Lead Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Target Recruit Count
141
Registration Number
NCT04107896
Locations
🇧🇩

Maidul islam, Dhaka, Bangladesh

Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation

Phase 2
Conditions
Premature Ejaculation
Interventions
Drug: Placebo
First Posted Date
2015-10-21
Last Posted Date
2016-01-05
Lead Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Target Recruit Count
40
Registration Number
NCT02581826
Locations
🇨🇳

Cheng-Hsing Hsieh, Taipei, Xindian, Taiwan

Silodosin Versus Tamsulosin for Treatment of Ureteral Stones

Phase 4
Terminated
Conditions
Ureteral Stone
Ureteral Calculus
Ureterolithiasis
Interventions
First Posted Date
2015-02-24
Last Posted Date
2020-06-23
Lead Sponsor
Albert Einstein Healthcare Network
Target Recruit Count
1
Registration Number
NCT02369744
Locations
🇺🇸

Einstein Medical Center Philadelphia, Philadelphia, Pennsylvania, United States

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

Phase 4
Completed
Conditions
Nocturia
Benign Prostatic Hyperplasia
Interventions
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
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
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
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
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
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
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