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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

Overview

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

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Title
Posted
Study ID
Phase
Status
Sponsor
2012/02/15
Phase 4
Completed
JW Pharmaceutical
2010/12/15
Phase 4
Completed
JW Pharmaceutical
2010/12/14
Phase 4
Completed
JW Pharmaceutical
2010/10/26
Phase 4
Completed
JW Pharmaceutical
2010/10/18
Phase 2
Completed
2010/06/16
Phase 2
Completed
Watson Pharmaceuticals
2008/11/19
Phase 2
Completed
Watson Pharmaceuticals
2008/08/25
Phase 2
Completed
Watson Pharmaceuticals
2006/08/03
Phase 3
Completed
2005/09/22
Phase 3
Completed
Watson Pharmaceuticals

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Macleods Pharmaceuticals Limited
33342-385
ORAL
8 mg in 1 1
6/28/2022
Aurobindo Pharma Limited
59651-096
ORAL
8 mg in 1 1
7/23/2021
Amneal Pharmaceuticals NY LLC
60219-1420
ORAL
8 mg in 1 1
12/28/2023
Amneal Pharmaceuticals NY LLC
60219-1421
ORAL
4 mg in 1 1
12/28/2023
Amneal Pharmaceuticals NY LLC
69238-1420
ORAL
8 mg in 1 1
12/30/2023
Allergan, Inc.
0023-6147
ORAL
4 mg in 1 1
11/12/2021
Aurobindo Pharma Limited
59651-095
ORAL
4 mg in 1 1
7/23/2021
Lupin Pharmaceuticals, Inc.
68180-740
ORAL
4 mg in 1 1
12/14/2023
Alembic Pharmaceuticals Limited
46708-406
ORAL
8 mg in 1 1
1/30/2023

EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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