NDAORALCAPSULE
Approved
Oct 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
4/8 — Partial
RAPAFLO (silodosin) by AbbVie is adrenergic alpha-antagonists [moa]. First approved in 2008.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RAPAFLO (silodosin) is an oral alpha-1A adrenergic antagonist approved in 2008 for benign prostatic hyperplasia and related lower urinary tract symptoms. It works by blocking alpha-1A receptors in the prostate and bladder neck to relax smooth muscle and improve urine flow. The drug is indicated for BPH, ureteral stone, neurogenic bladder, voiding dysfunction, nocturia, and urinary calculus.
$3MPart D
LOE ApproachingDeclining
Product is in decline phase with minimal Medicare spending ($3M, 5,473 claims in 2023), indicating reduced market presence and likely smaller commercial team with focus on managed decline or generic transition.
Mechanism of Action
Adrenergic alpha-Antagonists
Pharmacologic Class:
alpha-Adrenergic Blocker
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia
Started Jan 2014
135 enrolled
NocturiaBenign Prostatic Hyperplasia
Efficacy and Safety of Silodosin in the Treatment of Natural Expulsion in Patients With Ureteral Stones
Started Oct 2011
114 enrolled
Ureteral Stone
Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia
Started May 2011
1,036 enrolled
Benign Prostatic Hyperplasia
Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder
Started Apr 2011
95 enrolled
Neurogenic BladderVoiding Dysfunction
Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)
Started Dec 2010
100 enrolled
Benign Prostatic Hyperplasia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.