silodosin
Trade name: rapaflo
Approved
Oct 8, 2008
Silodosin is a selective antagonsit of alpha-1a adrenergic receptor which was developed by Kissei Pharmaceutical. The drug was approved by FDA under the name Rapaflo for the treatment of signs and symptoms associated with benign prostatic hyperplasia. — NCATS
Clinical trial activity
39 trials · 43 clinical orgs · 21 marketing orgs
Earliest trial started May 1, 2005 (NCT00224107)
Timeline
2000s
- Jan 1, 2005
Watson Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2008
Watson Pharmaceuticals — Earliest Phase 2 Sponsor(trial)
- Oct 8, 2008
Watson Pharmaceuticals — Earliest FDA Approval
- Oct 8, 2008
Allergan — Marketing Organization
- Oct 8, 2008
Allergan — NDA Secondary Org
- Oct 8, 2008
Watson Pharmaceuticals — NDA Organization
- Oct 8, 2008
AbbVie — Marketing Organization
- Oct 8, 2008
GlaxoSmithKline — NDA Secondary Org
2010s
- Jan 1, 2013
Earliest Phase 1 Sponsor(trial)
- Mar 31, 2017
Sandoz — Marketing Organization
- Mar 31, 2017
Novartis — Marketing Organization
- Mar 31, 2017
Chartwell Pharmaceuticals — Marketing Organization
- Dec 3, 2018
Lupin — Marketing Organization
- Dec 3, 2018
Macleods Pharmaceuticals, Ltd — Marketing Organization
- Dec 3, 2018
MSN Laboratories — Marketing Organization
- Dec 3, 2018
Ajanta Pharma Ltd — Marketing Organization
- Dec 3, 2018
Amneal Pharmaceuticals — Marketing Organization
- Dec 3, 2018
Neogen — Marketing Organization
- Dec 10, 2018
Aurobindo Pharma — Marketing Organization
- Nov 22, 2019
Alembic — Marketing Organization
2020s
- Feb 14, 2020
Hetero Labs Ltd — Marketing Organization
- Jan 3, 2022
Upsher-Smith Laboratories — Marketing Organization
- Jan 3, 2022
CREEKWOOD PHARMS — Marketing Organization
- Jan 4, 2022
Prinston Inc — Marketing Organization
- Dec 8, 2022
Zydus Discovery DMCC — Marketing Organization
- Feb 10, 2025
Torrent Pharmaceuticals Limited — Marketing Organization
Indications
Approved for
Studied for
- Calculi · Phase 1
- Chronic Pain · Phase 2
- Kidney Calculi · Phase 3
- Lower Urinary Tract Symptoms · Phase 3
- Nocturia · Phase 4
- Premature Ejaculation · Phase 2
- Prostatic Neoplasms · Phase 4
- Ureteral Calculi · Phase 4
- Ureteral Diseases · Phase 4
- Ureterolithiasis · Phase 4
- Urinary Bladder, Neurogenic · Phase 4
- Urinary Calculi · Phase 3
- Urination Disorders · Phase 4
- Urolithiasis · Phase 3
Mechanism of action
- Alpha-1a adrenergic receptorANTAGONIST
ADRA1A antagonist
Approval history
- approvedOct 8, 2008
Chemistry & pharmacology
SMILES
C[C@H](CC1=CC2=C(N(CCCO)CC2)C(=C1)C(N)=O)NCCOC3=CC=CC=C3OCC(F)(F)F- Mol. weight
- 495.5345 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaSilodosin ↗
- NCATSCUZ39LUY82 ↗
- ChEMBLCHEMBL24778 ↗
Also known as
- 1-(3-hydroxypropyl)-5-(2-(2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethylamino)propyl)indoline-7-carboxamide
- kad 3213
- kad 3213
- kmd 3213
- kmd 3213
- kmd 3213
- kmd-3213
- kso-0400
- kso-0400
- rapaflo
- rapaflo
- rapaflo
- rapaflo
- rapaflo
- rapaflo
- silodoshin
- silodosin
- silodosin
- silodosin
- silodosin
- silodosin
- silodosin
- silodosin
- silodosin
- silodosin
- silodosin
- silodosin
- silodosin
- silodyx
- urief
- urief
- urief
- urorec
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07195097 | Phase 1 | Sep 30, 2025 | Benha University |
| NCT07146386 | Phase 3 | Aug 31, 2025 | Government of China |
| NCT07081659 | Phase 2/Phase 3 (Phase 3) | Mar 1, 2024 | Benha University |
| NCT06707181 | Phase 3 | Nov 1, 2023 | Beni Suef University |
| NCT06114979 | Phase 3 | Nov 1, 2023 | Mansoura University |
| NCT06999135 | N/A | Oct 1, 2023 | Fatima Jinnah Medical University |
| NCT05921370 | Phase 3 | Apr 4, 2023 | Ain Shams University |
| NCT06319469 | Phase 2 | Feb 1, 2023 | Beni Suef University |
| NCT06381206 | Phase 1/Phase 2 (Phase 2) | Oct 20, 2022 | Syrian Private University, Damascus, Syria |
| NCT05790902 | Phase 1 | Sep 1, 2022 | Government of Pakistan |
| NCT05551221 | Phase 4 | Jul 18, 2022 | University of Bern, Xintian Pharmaceutical |
| NCT07134907 | Phase 4 | Jul 18, 2022 | Capital Medical University, Government of China |
| NCT05570084 | Phase 3 | May 31, 2022 | City University of Hong Kong |
| NCT05789732 | N/A | Mar 30, 2022 | Benha University |
| NCT05823662 | N/A | Mar 2, 2022 | Benha University |
| NCT05798572 | N/A | Mar 1, 2022 | Benha University |
| NCT04590534 | Phase 2 | Aug 1, 2020 | Benha University |
| NCT04107896 | Phase 4 | Aug 31, 2017 | Bangladesh Medical University |
| NCT02220829 | Phase 3 | Sep 1, 2015 | McGill University |
| NCT02090439 | Phase 3 | Jul 1, 2014 | Centre Hospitalier Departemental Vendee |
Organizations
Research & Development (43)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Benha University | Academic/Hospital | 6 | 6 | 4 | 2020 |
| Watson Pharmaceuticals | For profit | 6 | 6 | 2 | 2005 |
| JW Pharmaceutical | For profit | 5 | 5 | 1 | 2010 |
| Beni Suef University | Academic/Hospital | 2 | 2 | 2 | 2023 |
| Government of China | Government | 2 | 2 | 2 | 2022 |
| Kissei Pharmaceuticals | For profit | 2 | 2 | 1 | 2010 |
| Recordati | For profit | 2 | 2 | 2 | 2006 |
| Seoul National University | Academic/Hospital | 2 | 0 | 1 | 2010 |
| Sheffield Hallam University | Academic/Hospital | 2 | 0 | 2 | 2006 |
| Sungkyunkwan University | Academic/Hospital | 2 | 0 | 1 | 2010 |
| University of Ulsan | Academic/Hospital | 2 | 0 | 1 | 2010 |
| Yeshiva University | Academic/Hospital | 2 | 2 | 2 | 2012 |
| Yeungnam University | Academic/Hospital | 2 | 0 | 1 | 2010 |
| Ain Shams University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Bangladesh Medical University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Capital Medical University | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Catholic University of Korea | Academic/Hospital | 1 | 0 | 1 | 2010 |
| Centre Hospitalier Departemental Vendee | Academic/Hospital | 1 | 1 | 1 | 2014 |
| Chonbuk National University | Academic/Hospital | 1 | 0 | 1 | 2010 |
| Chonnam National University | Academic/Hospital | 1 | 0 | 1 | 2010 |
Marketing (26)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | MKTG | Oct 8, 2008 |
| Ajanta Pharma Ltd | For profit | MKTG | Dec 3, 2018 |
| Alembic | For profit | SYN | Nov 22, 2019 |
| Alembic | For profit | MKTG | Nov 22, 2019 |
| Allergan | For profit | MKTG | Oct 8, 2008 |
| Allergan | For profit | NDA2 | Oct 8, 2008 |
| Amneal Pharmaceuticals | For profit | MKTG | Dec 3, 2018 |
| Aurobindo Pharma | For profit | MKTG | Dec 10, 2018 |
| CREEKWOOD PHARMS | For profit | MKTG | Jan 3, 2022 |
| Chartwell Pharmaceuticals | For profit | MKTG | Mar 31, 2017 |
| GlaxoSmithKline | For profit | NDA2 | Oct 8, 2008 |
| Hetero Labs Ltd | For profit | MKTG | Feb 14, 2020 |
| Lupin | For profit | MKTG | Dec 3, 2018 |
| Lupin | For profit | SYN | Dec 3, 2018 |
| MSN Laboratories | For profit | MKTG | Dec 3, 2018 |
| MSN Laboratories | For profit | SYN | Dec 3, 2018 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Dec 3, 2018 |
| Neogen | For profit | MKTG | Dec 3, 2018 |
| Novartis | For profit | MKTG | Mar 31, 2017 |
| Prinston Inc | For profit | MKTG | Jan 4, 2022 |
| Sandoz | For profit | MKTG | Mar 31, 2017 |
| Sandoz | For profit | SYN | Mar 31, 2017 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Feb 10, 2025 |
| Upsher-Smith Laboratories | For profit | MKTG | Jan 3, 2022 |
| Watson Pharmaceuticals | For profit | NDA | Oct 8, 2008 |
| Zydus Discovery DMCC | For profit | MKTG | Dec 8, 2022 |