Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OMS201 · 2 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Drug |
| 2 | PLACEBO_COMPARATOR | Vehicle |
| Name | Type | Description |
|---|---|---|
| OMS201 | DRUG | Stage 1: OMS201 irrigation solution at 3X the base concentration during surgery Stage 2: OMS201 irrigation solution up to 10X the base concentration during surgery |
| Vehicle | DRUG | Stages 1-2: Vehicle irrigation solution during surgery |
Inclusion Criteria: * 18 - 65 years of age. * Subject is undergoing retrograde ureteroscopic removal of renal-collecting system or ureteral stones for which general anesthesia will be used. Exclusion Criteria: * No allergies to any of the individual ingredients in OMS201. * Subject taking a prohi...
OMS201 is an investigational small molecule being developed for use in urinary calculi, which are urinary tract stones. It is intended for patients undergoing ureteroscopic procedures to remove stones located in the urinary tract, including the upper urinary tract and kidneys.
OMS201 is being developed by Omeros Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol OMER. The company is conducting clinical research on this investigational drug for the treatment of urinary stones.
OMS201 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, and the drug is no longer in active clinical testing according to the available trial data.
OMS201 has been studied in two completed Phase 1 clinical trials. The first, NCT00599664, enrolled 11 subjects undergoing ureteroscopic treatment for urinary tract stones. The second, NCT00857090, enrolled 18 subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones. Both trials were conducted in the United States.
OMS201 is a unique investigational drug candidate developed by Omeros Corporation. No alternative names for OMS201 have been reported in the clinical trial data, and it is not known to be the same as any other marketed or investigational medication.