Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as hMaxi-K
URO-902 · 3 trials · 3 indications
Physical examination of the penis included inspection and palpation.
Clinical significance was determined by the Investigator using central laboratory values.
Clinical significance was determined by the Investigator using central laboratory values.
Average daily number of urgency episodes was calculated as the total number of urgency episodes recorded on a completed diary day within the visit window divided by the number of days the Bladder Diary was filled out. An urgency episode was defined as when a participant answered "Yes" to the question "Need to urinate immediately" on the bladder diary electronic case report form (eCRF). If a participant had more than 1 bladder diary filled out on the same day, then all the urgency episodes were summed together. The denominator used for calculating the average number only counted the days in which there was at least 1 completed bladder diary day within the visit window. Baseline was defined as the last non-missing measurement prior to the study treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
| Arm | Type | Description |
|---|---|---|
| hMaxi-K | ACTIVE_COMPARATOR | Single Treatment/ two escalating dose levels (8000 µg and 16,000 µg injection). In each dose level, 11 participants will receive hMaxi-K and 6 will receive placebo (only one injection per each participant) |
| Placebo (PBS-20% sucrose) | PLACEBO_COMPARATOR | PBS-20% sucrose administered during two single treatment dose levels (8000 µg and 16000 µg) by injection (only one injection per each participant) |
| Cohort 1: URO-902 24 mg; Placebo | EXPERIMENTAL | Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo. |
| Cohort 2: URO-902 48 mg; Placebo | EXPERIMENTAL | Participants will receive either a single treatment of URO-902 48 mg or matching placebo. |
| hMaxi-K 16000 µg | EXPERIMENTAL | Single treatment (16000 µg by 20 intramuscular injections). A total of 6 participants will receive hMaxi-K, and 3 will receive placebo. |
| hMaxi-K 24000 µg | EXPERIMENTAL | Single treatment (24000 µg by 30 intramuscular injections). A total of 6 participants will receive hMaxi-K, and 3 will receive placebo. |
| Name | Type | Description |
|---|---|---|
| hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection) | DRUG | - |
| Placebo (PBS-20% sucrose) | DRUG | - |
| URO-902 | DRUG | intradetrusor injection |
| Placebo | DRUG | intradetrusor injection |
| hMaxi-K | DRUG | Single treatment/2 escalating dose levels (16000 µg and 24000 µg by intramuscular injection) |
Inclusion Criteria: * Eligible participants must meet the following inclusion criteria: 1. Signed Informed Consent 2. Be adult males over 18 years of age diagnosed with erectile dysfunction and whose ED is attributable to an underlying, stable medical condition such as hypertension and atheros...
URO-902 is an investigational small molecule being developed for the treatment of overactive bladder with urge urinary incontinence. It is intended for female patients with this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.
URO-902 is a small molecule designed to treat overactive bladder with urge urinary incontinence. Its specific molecular target has not been disclosed in available information. The drug is being studied for its ability to address symptoms associated with this condition in affected patients.
URO-902 is being developed by Roivant Sciences Ltd., a biopharmaceutical company traded on the stock exchange under the ticker symbol ROIV. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for overactive bladder with urge urinary incontinence.
URO-902 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 2 trial has been completed, and the drug remains under evaluation for its potential use in treating overactive bladder with urge urinary incontinence.
URO-902 has one completed clinical trial registered under NCT04211831, titled "URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence." This Phase 2 study enrolled 80 female participants in the United States, with a minimum age of 40 years, and was a randomized, double-blind, controlled trial.
URO-902 is not known to have alternative names. It is a distinct investigational small molecule being developed by Roivant Sciences Ltd. for overactive bladder with urge urinary incontinence. No other names for this drug have been identified in available information.