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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/31 | Not Applicable | Completed | Fatima Jinnah Medical University | ||
2024/04/24 | Phase 1 | Completed | Syrian Private University | ||
2024/03/27 | N/A | Recruiting | |||
2024/03/20 | Phase 2 | Completed | |||
2024/02/28 | Early Phase 1 | Completed | |||
2023/11/02 | Phase 3 | Not yet recruiting | |||
2023/06/27 | Phase 3 | Completed | |||
2023/04/21 | Not Applicable | Completed | |||
2023/03/30 | Phase 1 | Completed | Armed Forces Institute of Urology, Rawalpindi | ||
2023/03/29 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
AvKARE | 42291-778 | ORAL | 8 mg in 1 1 | 1/10/2024 | |
Alembic Pharmaceuticals Limited | 46708-405 | ORAL | 4 mg in 1 1 | 1/30/2023 | |
MSN LABORATORIES PRIVATE LIMITED | 69539-053 | ORAL | 8 mg in 1 1 | 12/29/2020 | |
Alembic Pharmaceuticals Inc. | 62332-406 | ORAL | 8 mg in 1 1 | 7/15/2021 | |
Novadoz Pharmaceuticals LLC | 72205-009 | ORAL | 4 mg in 1 1 | 1/1/2021 | |
PD-Rx Pharmaceuticals, Inc. | 72789-351 | ORAL | 4 mg in 1 1 | 9/22/2023 | |
Amneal Pharmaceuticals NY LLC | 69238-1421 | ORAL | 4 mg in 1 1 | 12/30/2023 | |
Alembic Pharmaceuticals Inc. | 62332-405 | ORAL | 4 mg in 1 1 | 7/15/2021 | |
Novadoz Pharmaceuticals LLC | 72205-010 | ORAL | 8 mg in 1 1 | 1/1/2021 | |
Camber Pharmaceuticals, Inc. | 31722-635 | ORAL | 4 mg in 1 1 | 2/25/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 1/7/2019 | ||
Authorised | 1/29/2010 | ||
Authorised | 1/29/2010 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Silodosin Capsules | 国药准字H20244076 | 化学药品 | 胶囊剂 | 6/18/2024 | |
Silodosin Capsules | 国药准字H20234393 | 化学药品 | 胶囊剂 | 10/27/2023 | |
Silodosin Capsules | 国药准字H20249444 | 化学药品 | 胶囊剂 | 11/22/2024 | |
Silodosin Capsules | 国药准字H20244313 | 化学药品 | 胶囊剂 | 6/28/2024 | |
Silodosin Capsules | 国药准字H20233954 | 化学药品 | 胶囊剂 | 7/25/2023 | |
Silodosin Capsules | 国药准字H20234269 | 化学药品 | 胶囊剂 | 10/12/2023 | |
Silodosin Capsules | 国药准字H20223105 | 化学药品 | 胶囊剂 | 3/1/2022 | |
Silodosin Capsules | 国药准字H20233605 | 化学药品 | 胶囊剂 | 5/26/2023 | |
Silodosin Capsules | 国药准字H20213612 | 化学药品 | 胶囊剂 | 7/28/2021 | |
Silodosin Capsules | 国药准字H20110100 | 化学药品 | 胶囊剂 | 8/11/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
UROREC silodosin 8 mg hard capsule blister pack | 275265 | Medicine | A | 5/23/2017 | |
UROREC silodosin 4 mg hard capsule blister pack | 275256 | Medicine | A | 5/23/2017 |
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