Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
UK369, 003 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| 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 | 100 mg MR tablet once daily for 2 weeks |
| 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 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13. * Clinical diagnosis of BPH * Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml * Urodynamically defined bladder outlet obstruction Exclusion Criteria: * p...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Boston Scientific Corporation | BSX | 2 | - | Undisclosed |
| PROCEPT BioRobotics Corp. | PRCT | 2 | N/A | Undisclosed |
| EDAP TMS SA Sponsored ADR | EDAP | 1 | N/A | Undisclosed |
| Profound Medical Corp | PROF | 1 | - | Undisclosed |
UK-369,003 is an investigational small molecule being studied for male urogenital and pulmonary conditions, including erectile dysfunction (impotence), chronic obstructive pulmonary disease, benign prostatic hyperplasia, and overactive bladder. It is not approved and remains in clinical development.
UK-369,003 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored clinical trials of the drug across multiple countries.
UK-369,003 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, along with a Phase 1 drug interaction study.
UK-369,003 has been studied in several completed trials, including NCT00141349 in male erectile dysfunction, NCT00408954 in men with lower urinary tract symptoms, NCT00479505 in overactive bladder, and NCT00814736, a Phase 1 study with sildenafil.
No, UK-369,003 is a distinct investigational compound. A completed Phase 1 trial (NCT00814736) studied the safety and toleration of single-dose sildenafil in subjects receiving chronic UK-369,003, indicating they are separate drugs that may be used together.