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Also known as UK-369,003
UK369, 003 · 6 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Comparator | ACTIVE_COMPARATOR | Tamsulosin 0.4 mg prolonged release |
| Treatment Arm | EXPERIMENTAL | There are 5 possible UK-369,003 arms as follows: UK-369,003 MR (10mg, 25mg, 50mg \& 100mg), UK-369,003 IR (40mg), |
| UK-369,003 | ACTIVE_COMPARATOR | - |
| UK369,003 + Placebo or sildenafil | EXPERIMENTAL | All subjects will receive 17 days daily dosing of UK-369,003 100 mg MR Subjects will receive single oral doses of the following interactant treatments in a randomized order On Day 14, a single dose of sildenafil-matching placebo or 100 mg sildenafil and on Day 17 a single dose of 100 mg sildenafil or a sildenafil matching placebo |
| Name | Type | Description |
|---|---|---|
| UK-369,003 | DRUG | UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo. |
| Placebo | DRUG | Placebo |
| Tamsulosin | DRUG | Tamsulosin hydrochloride capsules, 0.4 mg. Tamsulosin hydrochloride is an antagonist of alpha1A adrenoceptors in the prostate |
| UK369,003 | DRUG | oral tablet, once a day |
| sildenafil | DRUG | single oral dose on day 14 or day 17 |
| sildenafil matching placebo | DRUG | single oral dose on day 14 or day 17 |
Inclusion Criteria: * Male subjects aged 18 years and above * documented clinical diagnosis of overactive bladder with urinary frequency \>= 8 times / 24 hours and number of urgency episodes \> 1 episode / 24 hours. Exclusion Criteria: * Neurological diseases known to affect bladder function. * U...
UK369,003 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) that has been studied in Phase 2 clinical trials. Research has focused on male urologic and related conditions, including overactive bladder, prostatic hyperplasia, erectile dysfunction, and chronic obstructive pulmonary disease. It has not been approved and remains an investigational agent.
UK369,003 has been studied for overactive bladder, prostatic hyperplasia, and lower urinary tract symptoms in men, as well as erectile dysfunction and chronic obstructive pulmonary disease. All clinical work to date has been in Phase 1 and Phase 2 trials, so UK369,003 is not an approved treatment for any indication.
Pfizer, Inc., which trades under the ticker PFE, is the developer of UK369,003. Pfizer sponsored the Phase 1 and Phase 2 studies of the compound in men with overactive bladder, prostatic hyperplasia, and lower urinary tract symptoms.
UK369,003 reached Phase 2 clinical development. Three completed Phase 2 trials and one completed Phase 1 trial have been recorded, with no active trials ongoing. UK369,003 is investigational and has not been approved for any indication.
Completed studies of UK369,003 include NCT00479505 in men with overactive bladder, NCT00457457 and NCT00408954 in men with lower urinary tract symptoms and prostatic hyperplasia, and NCT00814736, a Phase 1 drug interaction study with sildenafil. These trials enrolled a combined total of 658 participants.
Yes, UK369,003 and UK-369,003 refer to the same investigational compound from Pfizer. The hyphenated form UK-369,003 appears in the registered clinical trial titles, while UK369,003 is the unhyphenated spelling of the same drug name.