Drugs / Silodosin
Silodosin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Urorec | — | 2010-01-29 | europa.eu ↗ |
| Approved | US (FDA) | RAPAFLO | — | 2008-10-08 | fda.gov ↗ |
Trials 32 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06282731 | May 2013 → Sep 2016 | benign prostatic hyperplasia | En Chu Kong Hospital | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT05790902 | Sep 2022 → Feb 2023 | urolithiasis | Armed Forces Institute of Urology, Rawalpindi | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06381206 | Oct 2022 → Oct 2023 | urolithiasis | Syrian Private University | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07393334 | Dec 2025 → Mar 2026 overdue | — | Next Life Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT06319469 | Feb 2023 → Jan 2024 | benign prostatic hyperplasia | Beni-Suef University | Completed | No outcome recorded |
| Phase 2 | NCT00793819 | Jan → Oct 2009 | benign prostatic hyperplasia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00740779 | Sep 2008 → Oct 2009 | chronic prostatitis | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01539265 | — | urolithiasis | Kissei Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01222650 | — | benign prostatic hyperplasia | Kissei Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07081659 | Mar 2024 | premature ejaculation | Benha University | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT05921370 | Apr → Jul 2023 | urolithiasis | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT05570084 | May 2022 → Jun 2023 | urolithiasis | Princess Margaret Hospital, Hong Kong | Unknown | No outcome recorded |
| Phase 3 | NCT02090439 | Jul 2014 → Dec 2015 | ureterolithiasis | Centre Hospitalier Departemental Vendee | Terminated | No outcome recorded |
| Phase 3 | NCT00359905 | May 2006 → May 2007 | benign prostatic hyperplasia | RECORDATI GROUP | Completed | No outcome recorded |
| Phase 3 | NCT00224133 | Sep 2005 → Apr 2007 | benign prostatic hyperplasia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00224107 | May 2005 → Aug 2006 | benign prostatic hyperplasia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00224120 | May 2005 → May 2006 | benign prostatic hyperplasia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT07650968 | Jun 2026 → May 2027 expected | benign prostatic hyperplasia, urinary tract obstruction | Beni-Suef University | Recruiting | No outcome recorded |
| Phase 4 | NCT07614321 | Apr 2026 → Mar 2028 expected | multiple sclerosis | Atlantic Health System | Recruiting | No outcome recorded |
| Phase 4 | NCT05551221 | Jul 2022 → Dec 2023 overdue | benign prostatic hyperplasia | Xintian Pharmaceutical | Recruiting | No outcome recorded |
| Phase 4 | NCT07134907 | Jul 2022 → Jul 2024 | benign prostatic hyperplasia | Shanghai Huilun Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT04107896 | Aug 2017 → Aug 2018 | benign prostatic hyperplasia | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT02106182 | Jan 2014 → Mar 2016 | benign prostatic hyperplasia | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT01533389 | Oct 2011 → Mar 2012 | ureterolithiasis | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT01757769 | May 2011 → Mar 2013 | benign prostatic hyperplasia | RECORDATI GROUP | Completed | No outcome recorded |
| Phase 4 | NCT01228370 | Apr 2011 → Jan 2012 | urinary bladder disorder | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT01259531 | Dec 2010 → Sep 2011 | benign prostatic hyperplasia | JW Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT01260129 | Oct → Nov 2010 | benign prostatic hyperplasia | JW Pharmaceutical | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT06999135 | Oct 2023 → Apr 2024 | — | Fatima Jinnah Medical University | Completed | No outcome recorded |
| — | NCT05789732 | Mar → Aug 2022 | ureterolithiasis | Benha University | Completed | No outcome recorded |
| — | NCT05823662 | Mar 2022 → Mar 2023 | ureterolithiasis, urolithiasis | Benha University | Completed | No outcome recorded |
| — | NCT05798572 | Mar 2022 → Mar 2023 | — | Benha University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 14 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07195097 Comparator | Sep → Nov 2025 overdue | — | Benha University | Not yet recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04590534 Comparator | Aug 2020 → Feb 2023 | benign prostatic hyperplasia | Benha University | Unknown | No outcome recorded |
| Phase 2 | NCT02581826 Comparator | Oct 2013 → Dec 2016 | premature ejaculation | Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | Unknown | No outcome recorded |
| Phase 2 | NCT01144949 Comparator | Jun 2010 → Jul 2012 | nephrolithiasis, ureterolithiasis | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07146386 Comparator | Aug 2025 → Jan 2027 expected | benign prostatic hyperplasia | Shanghai Huilun Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06707181 Comparator | Nov 2023 → May 2024 | ureterolithiasis | Beni-Suef University | Completed | No outcome recorded |
| Phase 3 | NCT06114979 Comparator | Nov 2023 → Oct 2024 | — | Mansoura University | Unknown | No outcome recorded |
| Phase 3 | NCT02220829 Comparator | Jun 2016 → Apr 2023 | prostate cancer | Sir Mortimer B. Davis - Jewish General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01560091 Comparator | Mar 2012 → Feb 2013 | nephrolithiasis | Albert Einstein Healthcare Network | Withdrawn | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07467343 Comparator | Mar → Sep 2026 expected | benign prostatic hyperplasia | Ain Shams University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05977647 Comparator | Sep 2024 → May 2025 | ureterolithiasis | Getz Pharma | Completed | No outcome recorded |
| Phase 4 | NCT07113145 Comparator | Jun 2024 → Jan 2025 | premature ejaculation | Beni-Suef University | Completed | No outcome recorded |
| Phase 4 | NCT02369744 Comparator | Mar → Oct 2013 | ureterolithiasis | Albert Einstein Healthcare Network | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05094947 Background | Aug 2021 → Mar 2022 | benign prostatic hyperplasia | Moscow State University of Medicine and Dentistry | Unknown | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 47 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Silodosin | “Secondary outcomes include time to ejaculation by dose and orgasm quality scores using the Derogatis questionnaire and other questions as well as serum silodosin and guanfacine...” NCT07393334 ↗44“Patients with lower ureteric stone will be randomized through permuted block randomization equally into two group. 120 patients will be on Silodosin 8 mg once daily. Therapy...” NCT05977647 ↗ “A Prospective Study to Evaluate the Efficacy of Silodosin 8 mg as an on-Demand, Reversible, Nonhormonal Oral Contraceptive for Males:” NCT07195097 ↗ “Patients in this group had flexible ureteroscopy (F-URS) with preoperative daily uptake of 8 mg silodosin for one week.” NCT05798572 ↗ “However, Silodosin 4 mg, an α1-adrenoceptor antagonist, has emerged as a promising alternative” NCT07081659 ↗ “Group A (33 patients) received Silodosin, 8 mg, once daily.” PMID 40209997 ↗ Apr 2025 “Received Silodosin 4mg, administered orally once daily.” NCT07113145 ↗ “tamsulosin, alfuzosin, doxazosin, silodosin” NCT05094947 ↗ |
| Known as | Qianweitai | “The instruction of Silodosin Capsule (Qianweitai®) is 4mg/capsule，1 capsule/time, bid, after breakfast and dinner.” NCT05551221 ↗ |
| Known as | Rapaflo | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02220829 ↗ |
| Known as | THRUPAS Capsule 4mg | “The drug to be used in this clinical trial, silodosin, was registered under the proprietary name of 'THRUPAS® Capsule 4mg' and is being marketed after being authorized by Korea...” NCT01533389 ↗ |
| Action | Inhibit | “highly selective alpha1A-adrenoceptor antagonist silodosin” PMID 19371887 ↗ Apr 2009 |
| Route | Oral | “one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks” NCT01144949 ↗ |