Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed for the treatment of Lower Urinary Tract Symptoms (LUTS), including those associated with Benign Prostatic Hyperplasia (BPH). It is administered once daily and is currently in Phase 3 clinical development.
MCS-2/day is being developed by Jyong Biotech Ltd., a company listed under the ticker MENS. The drug is in Phase 3 clinical trials for Lower Urinary Tract Symptoms.
MCS-2/day is in Phase 3 clinical development. It has completed four clinical trials, including Phase 2 and Phase 3 studies, with a total enrollment of 926 participants. The drug is not yet approved and remains investigational.
MCS-2/day has been studied in four completed trials: NCT01002222 (Phase 3, open-label extension, US, 200 patients), NCT01002274 (Phase 3, open-label extension, Taiwan, 180 patients), NCT01002417 (Phase 2, US, 274 patients), and NCT01002664 (Phase 3, Taiwan, 272 patients). All trials enrolled males aged 40 and older.
MCS-2/day is the once-daily formulation of the drug MCS-2. Clinical trials for Lower Urinary Tract Symptoms have used both names, with MCS-2/day indicating the daily dosing regimen.