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 33
| 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 27 trials · 1 met primary | ||||||
| Phase 2 | NCT07822113 | Oct 2026 → Oct 2027 expected | urinary bladder disorder | Jaber Al Ahmad Al Sabah Hospital | Not yet recruiting | No outcome recorded |
| 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 | Met primary |
| Phase 2 | NCT01222650 | — | benign prostatic hyperplasia | Kissei Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01539265 | — | urolithiasis | 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 · 3 met primary | ||||||
| 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 Stop: Enrollment |
| Phase 3 | NCT00359905 | May 2006 → May 2007 | benign prostatic hyperplasia | RECORDATI GROUP | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00224120 | May 2005 → May 2006 | benign prostatic hyperplasia | Watson Pharmaceuticals | Completed | Met primary |
| 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 | Sep 2022 → Sep 2024 | benign prostatic hyperplasia | Xintian Pharmaceutical | Completed | 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 |
| Comparator or background therapy15 trials | ||||||
| Phase 1 | NCT07195097 Comparator | Sep → Nov 2025 overdue | — | Benha University | Not yet recruiting | No outcome recorded |
| 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 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 Stop: Enrollment |
| Phase 4 | NCT07467343 Comparator | Mar → Sep 2026 overdue | benign prostatic hyperplasia | Ain Shams University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07815379 Comparator | Oct 2025 → Oct 2026 expected | benign prostatic hyperplasia | Mansoura University | Active not 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 |
| — | NCT05094947 Background | Aug 2021 → Mar 2022 | benign prostatic hyperplasia | Moscow State University of Medicine and Dentistry | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2022-12-10 | Zydus Lifesciences Limited | Regulatory Zydus receives two final approvals from the USFDA for Silodosin capsules and Pregabalin capsules zyduslife.com ↗
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Silodosin Capsules, 4 mg and 8 mg (USRLD: Rapaflo ® capsules). |
| 2019-11-01 | Alembic Pharmaceuticals Ltd. | Regulatory 25th November, 2019, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Silodosin Capsules, 4 mg and 8 mg. |
| 2016-09-06 | Lupin Limited | Regulatory Lupin Receives Tentative Approval for Generic Rapaflo® Capsules lupin.com ↗
Mumbai, Baltimore: Pharma Major Lupin Limited (Lupin) announced today that it has received tentative approval for its Silodosin Capsules, 4 mg and 8 mg from the United States Food and Drug Administration (FDA) to market a generic version of Allergan Sales, LLC’s Rapaflo® Capsules, 4 mg and 8 mg. |
| 2008-10-09 | Kissei Pharmaceutical Co., Ltd. | Regulatory シロドシン（日本製品名：ユリーフ®）の米国での承認取得のお知らせ kissei.co.jp ↗
キッセイ薬品工業株式会社（代表取締役社長 神澤陸雄）は、当社が創製しワトソン社〔Watson Pharmaceuticals, Inc.（米国）〕に技術導出しました前立腺肥大症に伴う排尿障害改善薬シロドシン（一般名）、（日本製品名：「ユリーフ ® 」、 米国予定製品名：「RAPAFLO TM （ラパフロ）」）について、この度、ワトソン社が米国食品医薬品局（ＦＤＡ）より承認を取得しましたのでお知らせします。 |
| 2006-01-23 | Kissei Pharmaceutical Co., Ltd. | Regulatory 前立腺肥大症に伴う排尿障害改善薬 「ユリーフ®カプセル」 の製造販売承認取得のお知らせ kissei.co.jp ↗
キッセイ薬品工業株式会社（代表取締役社長 神澤陸雄）は、本日、前立腺肥大症に伴う排尿障害改善薬「ユリーフ ® カプセル２mg」及び「ユリーフ ® カプセル４mg」（一般名：シロドシン）の製造販売承認を取得しましたのでお知らせ致します。 |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-12-10 | Zydus Lifesciences Limited | Zydus receives two final approvals from the USFDA for Silodosin capsules and Pregabalin capsules zyduslife.com ↗ |
| 2019-11-01 | Alembic Pharmaceuticals Ltd. | 25th November, 2019, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2018-12-05 | Lupin Limited | Lupin launches generic Silodosin Capsules 4mg and 8mg lupin.com ↗ |
| 2016-09-06 | Lupin Limited | Lupin Receives Tentative Approval for Generic Rapaflo® Capsules lupin.com ↗ |
| 2008-10-09 | Kissei Pharmaceutical Co., Ltd. | シロドシン（日本製品名：ユリーフ®）の米国での承認取得のお知らせ kissei.co.jp ↗ |
| 2006-01-23 | Kissei Pharmaceutical Co., Ltd. | 前立腺肥大症に伴う排尿障害改善薬 「ユリーフ®カプセル」 の製造販売承認取得のお知らせ kissei.co.jp ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 49 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 ↗46“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 | 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 ↗ |