FLOMAX (tamsulosin hydrochloride)
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1997-04-15
- Routes
- ORAL
- Dosage Forms
- CAPSULE
FLOMAX Approval History
What FLOMAX Treats
2 FDA approvalsOriginally approved for its first indication in 1997 . Covers 2 distinct patient populations.
- Other (2)
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02757768 PLUS results posted | 178-MA-1008 2015-004036-36 | Ph 4 | completed | A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) |
| NCT04994431 POUR results posted | H00018178 | Ph 4 | terminated | Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin |
| NCT06262048 PrePOURTS | PrePOURTS | Ph 2 | recruiting | Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial |
| NCT01568918 results posted | 11-006704 | Ph 3 | terminated | Use of Tamsulosin to Reduce the Incidence and Duration of Postoperative Urinary Retention Following Spine Surgery |
| NCT05890235 | NMT18016S | Ph 4 | completed | Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome |
| NCT02573311 results posted | 527.85 | Ph 3 | completed | Actual Use Study of Tamsulosin in Men |
| NCT00796614 results posted | 527.51 | Ph 2, Ph 3 | completed | Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder |
| NCT00771394 | 905-JC-001 | Ph 4 | completed | Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FLOMAX FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment