Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PD-0299685 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| PD 0299685 15mg | EXPERIMENTAL | - |
| PD 0299685 30mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PD 0299685 at 15mg BID | DRUG | 5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study |
| PD 0299685 at 30mg BID | DRUG | 10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID. |
| placebo for PD 0299685 | DRUG | Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study |
| PD-0299685 | DRUG | - |
Inclusion Criteria: * Men and women over 18 years of age with moderate to severe interstitial cystitis defined by pain score. * Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception. Exclusion Criteria: * Histor...
PD-0299685 was studied for two conditions: vasomotor symptoms (hot flashes or flushes) associated with menopause, and symptoms associated with interstitial cystitis, also called painful bladder syndrome. Both were Phase 2 programs. It is an investigational small molecule and is not described as an approved treatment for either indication.
PD-0299685 was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 2 studies of the compound in menopause-related hot flashes and in interstitial cystitis.
PD-0299685 reached Phase 2. Two Phase 2 trials were conducted, and both are now completed, with no active trials listed. The compound is investigational and is not described as approved for any indication.
PD-0299685 was evaluated in two completed Phase 2 trials. NCT00314964 studied it for vasomotor symptoms associated with menopause and enrolled 527 participants. NCT00739739 studied it for symptoms of interstitial cystitis and painful bladder syndrome and enrolled 161 participants across the United States, Canada, and several European countries.