Silodosin
As of the edition of 20 October 2026, Silodosin is a small molecule: marketed, first approved in 2008 (US); acts on ADRA1A; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Rapaflo
- First approved
- 8 October 2008 (US)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Apsen Farmaceutica; 3 holders in all
- Registered trials
- 31, 1 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Nervous system; Immune system; Infections
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Silodosin.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ADRA1A | Alpha-1A adrenergic receptor | P35348 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 7 | 6 | 1 | 0 |
| Phase 3 | 7 | 5 | 0 | 1 |
| Phase 4 | 11 | 9 | 2 | 0 |
| All trials | 31 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Actavis | Originator and Lead sponsor of trials | 2005 to now |
| Recordati | Applicant | 2010 to now |
| AbbVie | Acquired holder | 2024 to now |
| Apsen Farmaceutica | Applicant | 2025 to now |