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Also known as MCS-2
MCS-2/day · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| MCS-2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Drug Name: MCS-2 placebo Dosage: 2 soft-gel capsules Frequency: Qd per day after dinner Duration: 12 weeks |
| MCS-2 15 mg/day | ACTIVE_COMPARATOR | For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 15 mg/day is selected as the optimal dosage. |
| MCS-2 30 mg/day | ACTIVE_COMPARATOR | For the phase 2b part of the study. It can also be used in the phase 3 part of the study if MCS-2 30 mg/day is selected as the optimal dosage. |
| Name | Type | Description |
|---|---|---|
| MCS-2 | DRUG | 15 or 30 mg/day of MCS-2 soft-gel capsules Qd for 24 weeks, depending on which dose level is selected after the phase 2b part of the protocol MCS-2-US-a. |
| Placebo | DRUG | 2 soft-gel placebo capsules Qd for 12 weeks |
| MCS-2 15 mg/day | DRUG | One MCS-2 15 mg soft-gel capsule plus one matching placebo capsule, oral daily for 12 weeks. |
| MCS-2 30 mg/day | DRUG | Two MCS-2 soft-gel capsules, oral daily for 12 weeks. |
Inclusion Criteria: * Subject has completed 12 weeks of treatment under the protocol MCS-2-US-a. * Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form for participation in this extension study. Exclusion Criteria: * Subject has sev...
MCS-2/day is an investigational small molecule being studied for the treatment of lower urinary tract symptoms, including symptoms associated with benign prostatic hyperplasia. It is being developed by Jyong Biotech Ltd. and has been evaluated in Phase 3 clinical trials in male patients aged 40 years and older.
MCS-2/day is being developed by Jyong Biotech Ltd., which trades under the ticker MENS. The company has sponsored four completed clinical trials of the drug in lower urinary tract symptoms, conducted in both Taiwan and the United States.
MCS-2/day has completed Phase 3 clinical development. Four trials have been completed, including three Phase 3 studies and one Phase 2 study, with no active trials currently ongoing. It is an investigational drug and is not approved for commercial use.
MCS-2/day has been evaluated in four completed trials: NCT01002664, a Phase 3 study in Taiwan; NCT01002417, a Phase 2 study in the United States; NCT01002274, a Phase 3 open-label extension in Taiwan; and NCT01002222, a Phase 3 open-label extension in the United States.
Across four completed clinical trials, MCS-2/day has enrolled a total of 926 patients. The studies were randomized, double-blind, and placebo-controlled, and enrolled male participants aged 40 years and older with lower urinary tract symptoms and benign prostatic hyperplasia.