Rapaflo

(silodosin)

ApprovedSmall molecule

Rapaflo is a small molecule that works as Alpha-1a Adrenergic Receptor Antagonist.[2] It is being used across 8 indications, with its most advanced program in Approved.[1]

Rapaflo is one of 87 small molecule programs targeting Nephrolithiasis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

NephrolithiasisApproved

UrolithiasisApproved

ProstatitisApproved

Prostate CancerApproved

Double J StentCompleted

Lower Urinary Tract SymptomCompleted

Benign Prostatic HyperplasiaCompleted

Neurogenic BladderCompleted

NephrolithiasisApproved

Approved

UrolithiasisApproved

Approved

ProstatitisApproved

Approved

Prostate CancerApproved

Approved

Double J StentPreclinical

Completed

Lower Urinary Tract SymptomApproved

Completed

Benign Prostatic HyperplasiaApproved

Completed

Neurogenic BladderApproved

Completed

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Rapaflo

AbbVie

Approved

37 2

Yervoy

Bristol-Myers Squibb

Phase 3

20 3

Zejula

GGlaxo Dba Glaxosmithkline

Phase 3

10 4

AAA617

Novartis

Phase 3

2 5

Piflufolastat

Novartis

Phase 3

2 6

Gnrh Agonist/antagonist

NNorthwestern University

Phase 3

2 7

Piflufolastat F 18

Novartis

Phase 3

1 8

Trexall

Jazz Pharmaceuticals

Preclinical

—9

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

1 10

Duragesic

CCephalon

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Randomized

NCT07467343

Q2 2027

ApprovedNot yet recruiting

Benign Prostatic Hyperplasia

NCT07743060

ApprovedNot yet recruiting

Benign Prostatic Hyperplasia

NCT07743034

Q4 2027

Phase 2Not yet recruiting

Voiding Dysfunction

NCT07822113

Clinical

Trials by Indication[1]

Benign Prostatic Hyperplasia10 trials

Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

Completed·—·Phase 4·NCT04107896·141 enrolled

Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia

Completed·RRECORDATI GROUP·Phase 4·NCT01757769·1,036 enrolled

A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

Completed·WWatson Pharmaceuticals·Phase 3·NCT00224120·462 enrolled

Show 7 more trials

Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia

Completed·JJW Pharmaceutical·Phase 4·NCT02106182·135 enrolled

Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)

Completed·JJW Pharmaceutical·Phase 4·NCT01259531·100 enrolled

A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Completed·WWatson Pharmaceuticals·Phase 2·NCT00793819·215 enrolled

The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months

Completed·WWatson Pharmaceuticals·Phase 3·NCT00224133·661 enrolled

A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

Completed·WWatson Pharmaceuticals·Phase 3·NCT00224107·461 enrolled

Comparison of Tamsulosin and Silodosin on Pupil Size and Choroidal Thickness in Patients With Benign Prostatic Hyperplasia

Not yet recruiting·MMohsen Pourazizi·Approved·NCT07743060·40 enrolled

Comparison of the Efficacy of Tamsulosin and Silodosin on Anatomical Iris Changes in Patients With Benign Prostatic Hyperplasia: A Single-blind Randomized Clinical Trial

Not yet recruiting·MMohsen Pourazizi·Approved·NCT07743034·40 enrolled

Efficacy and Safety3 trials

Efficacy and Safety of Silodosin in the Treatment of Natural Expulsion in Patients With Ureteral Stones

Completed·JJW Pharmaceutical·Phase 4·NCT01533389·114 enrolled

Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH

Completed·RRECORDATI GROUP·Phase 3·NCT00359905·1,228 enrolled

The Efficacy and Safety of Qianweitai (Silodosin Capsule) Versus Tamsulosin in the Treatment of BPH

Completed·SShanghai Huilun Pharmaceutical Co., Ltd.·Phase 4·NCT07134907·110 enrolled

Treatment2 trials

Silodosin vs Placebo in the Treatment of Female LUTS

Unknown status·MMansoura University·Phase 3·NCT06114979·278 enrolled

Silodosin Versus Tamsulosin for Treatment of Ureteral Stones

Terminated·AAlbert Einstein Healthcare Network·Phase 4·NCT02369744·1 enrolled

MPA2 trials

Comparison of Silodosin and Tamsulosin for Medical Expulsive Therapy in Patients With Ureteral Stones

Completed·FFatima Jinnah Medical University·N/A·NCT06999135·200 enrolled

COMPARISON OF SILODOSIN AND TAMSULOSIN IN MEDICAL EXPULSIVE THERAPY OF DISTAL URETERIC CALCULI

Completed·—·Phase 1·NCT05790902·142 enrolled

Age2 trials

Silodosin in Management of Lower Ureteral Stones

Completed·SSyrian Private University·Phase 1/2·NCT06381206·100 enrolled

Study of Silodosin to Facilitate Passage of Urinary Stones

Completed·WWatson Pharmaceuticals·Phase 2·NCT01144949·239 enrolled

15 more indications

Lower Urinary Tract Symptom2 trials

Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH

Completed·JJW Pharmaceutical·Phase 4·NCT01260129·424 enrolled

Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population.

Unknown status·KKaohsiung Medical University Chung-Ho Memorial Hospital··NCT06332235·70 enrolled

BPH1 trial

A Comparative Study of KSO-0400 in BPH Patients With LUTS

Completed·KKissei Pharmaceutical Co., Ltd.·Phase 2·NCT01222650·400 enrolled

Completed·JJW Pharmaceutical·Phase 4·NCT01228370·95 enrolled

Double J Stent1 trial

Double J Stenting and Sildosin After URSL for Lower Ureteric Stones

Completed·—·N/A·NCT05823662·70 enrolled

Growth1 trial

The Changes of Urine Growth Factors Level

Completed·EEn Chu Kong Hospital·Phase 1·NCT06282731·74 enrolled

Effectiveness1 trial

Effectiveness of Silodosin in Medical Expulsive Therapy for Ureteral Pelvic Stone From 4 to 10 mm.

Terminated·—·Phase 3·NCT02090439·8 enrolled

Randomized1 trial

Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial

Not yet recruiting·—·Phase 4·NCT07467343·140 enrolled

Chronic Prostatitis1 trial

Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

Completed·WWatson Pharmaceuticals·Phase 2·NCT00740779·153 enrolled

Retrograde Intrarenal Surgery1 trial

Silodosin in Retrograde Intrarenal Surgery

Completed·—·Phase 3·NCT05921370·60 enrolled

Urinary retention1 trial

The Additive Value of Pyridostigmine to Silodosin in Acute Urinary Retention

Completed·—·Phase 2·NCT06319469·140 enrolled

Voiding Dysfunction1 trial

A Multicenter Randomized Cross-Over Study Evaluating the Efficacy and Safety of Silodosin in Adult Women With Voiding Dysfunction

Not yet recruiting·JJaber Al Ahmad Al Sabah Hospital·Phase 2·NCT07822113·150 enrolled

Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms1 trial

The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Investigator-blind, Active Controlled Study

Completed·XXintian Pharmaceutical·Approved·NCT05551221·110 enrolled

Unspecified3 trials

Silodosin vs Tamsulosin as MET

Unknown status·—·Phase 3·NCT05570084·80 enrolled

A Dose-finding Study of Silodosin in Patients With Urinary Calculi

Completed·KKissei Pharmaceutical Co., Ltd.·Phase 2·NCT01539265·300 enrolled

Silodosin, Tadalafil Alone vs. Silodosin Plus Tadalafil as MET for Lower Ureteric Stones

Completed·—·N/A·NCT05789732·168 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 8, 2008

RAPAFLO

NDA NDA022206

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for silodosin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — silodosin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for silodosin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022206). U.S. Food & Drug Administration.
[5]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Alpha-1a Adrenergic Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AbbVie

Rapaflo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Trials by Indication[1]

Benign Prostatic Hyperplasia10 trials

Efficacy and Safety3 trials

Treatment2 trials

MPA2 trials

Age2 trials

Lower Urinary Tract Symptom2 trials

BPH1 trial

Shock1 trial

Premature Ejaculation1 trial

Neurogenic bladder1 trial

Double J Stent1 trial

Growth1 trial

Effectiveness1 trial

Randomized1 trial

Chronic Prostatitis1 trial

Retrograde Intrarenal Surgery1 trial

Urinary retention1 trial

Voiding Dysfunction1 trial

Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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