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Placebo matching Tamsulosine LP
This is a placebo formulation designed to match the appearance and administration profile of Tamsulosin LP (long-acting tamsulosin) for use in clinical trials.
Placebo matching Tamsulosine LP, marketed by Pierre Fabre Medicament, is a placebo used in clinical trials to maintain blinding when comparing against Tamsulosine LP. The key composition patent for this placebo expires in 2028, providing a period of exclusivity. The primary risk is the potential for increased competition once the patent expires.
At a glance
| Generic name | Placebo matching Tamsulosine LP |
|---|---|
| Sponsor | Pierre Fabre Medicament |
| Drug class | Alpha-1A adrenergic receptor antagonist (active comparator: tamsulosin) |
| Target | Alpha-1A adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Urology |
| Phase | FDA-approved |
Mechanism of action
Tamsulosin LP is an alpha-1A adrenergic receptor antagonist used to treat benign prostatic hyperplasia. The placebo matching formulation contains no active ingredient but is manufactured to be indistinguishable from the active drug in terms of appearance, taste, and release characteristics, enabling blinded clinical trial designs.
Approved indications
- Placebo control for clinical trials of Tamsulosin LP in benign prostatic hyperplasia
Common side effects
Key clinical trials
- PERmixon® in LUTS Evaluation Study (PERLES) (PHASE4)
- Exploratory Study of L.S.E.S.r. (LipidoSterolic Extract of Serenoa Repens)(PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in Urinary Symptoms Related to BPH (Benign Prostatic Hyperplasia) (PHASE4)
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 |
|---|---|
| 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:
- Placebo matching Tamsulosine LP CI brief — competitive landscape report
- Placebo matching Tamsulosine LP updates RSS · CI watch RSS
- Pierre Fabre Medicament portfolio CI