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Rapaflo (SILODOSIN)
Silodosin blocks alpha-1 adrenoreceptors in the prostate and bladder, causing smooth muscle relaxation and improving urine flow.
Silodosin (Rapaflo), marketed by AbbVie, is an alpha-1 adrenergic receptor antagonist indicated for the treatment of benign prostatic hyperplasia (BPH) with a key composition patent expiring in 2028. Its selective mechanism of action on the prostate and bladder smooth muscles provides a distinct advantage over broader-acting competitors, potentially reducing side effects. The primary risk to Silodosin's market position is the presence of multiple off-patent generics, including alfuzosin, tamsulosin, and finasteride, which may erode market share and revenue.
At a glance
| Generic name | SILODOSIN |
|---|---|
| Sponsor | AbbVie |
| Drug class | alpha-Adrenergic Blocker [EPC] |
| Target | alpha-1 adrenoreceptors |
| Modality | Small molecule |
| Therapeutic area | Urology |
| Phase | FDA-approved |
| First approval | 2008 |
Mechanism of action
Silodosin works by blocking specific receptors called alpha-1 adrenoreceptors found in the prostate and bladder. This blockage leads to the relaxation of smooth muscles in these areas, which helps improve urine flow and reduce symptoms of benign prostatic hyperplasia (BPH).
Approved indications
- Treatment of BPH
Common side effects
- Retrograde Ejaculation
- Dizziness
- Diarrhea
- Orthostatic Hypotension
- Headache
- Nasopharyngitis
- Nasal Congestion
Drug interactions
- Strong P-glycoprotein inhibitors (e.g., cyclosporine)
- Alpha-blockers
- PDE5 inhibitors
- Moderate and Strong CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, ritonavir)
- Digoxin
Key clinical trials
- Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial (PHASE4)
- Effect of Preoperative Alpha-blockers on Successful Insertion Ureteral Access Sheath and Reduce Ureteral Injury in Non-prestented Patients During RIRS. Assessment of Factors for Successful Ureteral Access Sheath Insertion.
- Sildosin as a Male Contraceptive Non Hormonal (PHASE1)
- A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia (PHASE3)
- The Efficacy and Safety of Qianweitai (Silodosin Capsule) Versus Tamsulosin in the Treatment of BPH (PHASE4)
- Medical Stone Expulsive Therapy for Acutely Obstructed Ureteric Calculi (PHASE4)
- Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation (PHASE4)
- On-demand Silodosin 4mg vs Dapoxetine 60mg in Treatment of Primary Premature Ejaculation (PHASE2,PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rapaflo CI brief — competitive landscape report
- Rapaflo updates RSS · CI watch RSS
- AbbVie portfolio CI