Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SMP-986 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | Placebo run-in phase. 2 week duration. |
| 2 | PLACEBO_COMPARATOR | To be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986). |
| 3 | EXPERIMENTAL | 20mg dose of SMP-986 to be taken once daily for 8 week duration. |
| 4 | EXPERIMENTAL | 40mg dose of SMP-986 to be taken for 8 week duration. |
| 5 | EXPERIMENTAL | 80mg dose of SMP-986 to be taken for 8 week duration. |
| 6 | EXPERIMENTAL | 120mg dose of SMP-986 to be taken for 8 week duration. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo, 2 week duration. |
| SMP-986 | DRUG | Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks |
Inclusion Criteria: Main Inclusion Criteria: * Males, or females who are not of child-bearing potential * Aged 20-80 years (inclusive) with a diagnosis of OABS based on symptomatic reporting over a period of 6 months (micturition frequency, and urgency with or without incontinence) prior to screen...
SMP-986 is an investigational small molecule being developed for the treatment of Overactive Bladder Syndrome (OABS). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied to evaluate its potential efficacy and safety in patients with this condition.
SMP-986 is being developed by Icon Plc, a company listed on the stock exchange under the ticker ICLR. The drug is currently in Phase 2 clinical development for Overactive Bladder Syndrome (OABS). As an investigational agent, it has not yet received regulatory approval.
SMP-986 is in Phase 2 clinical development. It is an investigational small molecule being studied for the treatment of Overactive Bladder Syndrome (OABS). The drug has not been approved by regulatory authorities and remains in clinical testing to assess its safety and efficacy.
SMP-986 has one completed Phase 2 clinical trial, identified as NCT00409539, titled "SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)." The trial enrolled 550 participants and was conducted in the United States, Estonia, France, Germany, Latvia, Lithuania, Poland, Spain, and the United Kingdom.
SMP-986 is not FDA approved. It is an investigational small molecule currently in Phase 2 clinical development for Overactive Bladder Syndrome (OABS). The drug has completed one Phase 2 proof-of-concept trial, but it has not yet received regulatory approval from the FDA or other health authorities.