Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO4917523 · 5 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| RO4917523 Dose A | EXPERIMENTAL | - |
| RO4917523 Dose B | EXPERIMENTAL | - |
| RO4917523 0.5 mg | EXPERIMENTAL | - |
| RO4917523 1.5 mg | EXPERIMENTAL | - |
| Placebo (for RO4917523 ascending doses) | PLACEBO_COMPARATOR | - |
| Placebo (for RO4917523 fixed dose) | PLACEBO_COMPARATOR | - |
| RO4917523 ascending doses | EXPERIMENTAL | - |
| RO4917523 fixed dose | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | orally daily, 12 weeks |
| RO4917523 | DRUG | Dose A orally daily, 12 weeks |
| RO4917523 0.5 mg | DRUG | 0.5 mg orally once a day for 12 weeks |
| RO4917523 1.5 mg | DRUG | 1.5 mg orally once a day for 12 weeks |
| Placebo (for RO4917523 ascending doses) | DRUG | Placebo daily po |
| Placebo (for RO4917523 fixed dose) | DRUG | Placebo daily po |
Inclusion Criteria: * Children and adolescents, 5 to 13 years of age * Diagnosis of fragile X syndrome based on prior DNA testing confirming Fragile X Mental Retardation 1 (FMR1) full mutation and qualifying scores on the ABC and CGI-S Exclusion Criteria: * Previous treatment with another mGlu5 r...
RO4917523 is an investigational small molecule developed by Roche Holding AG for psychiatric conditions. It has been studied in Phase 2 clinical trials for Fragile X Syndrome and for Major Depressive Disorder, including as adjunctive therapy in patients with an inadequate response to ongoing antidepressant treatment. It is not an approved medicine.
RO4917523 has been studied in clinical trials for Fragile X Syndrome and Major Depressive Disorder. The Fragile X Syndrome studies enrolled pediatric, adolescent, and adult patients, while the Major Depressive Disorder study evaluated it as adjunctive therapy in adults with an inadequate response to ongoing antidepressant therapy. All of these programs were Phase 2.
RO4917523 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the Phase 2 clinical program evaluating the compound in Fragile X Syndrome and Major Depressive Disorder.
RO4917523 is in Phase 2 development. Three Phase 2 trials have been completed, and no active trials are currently listed. The studies were randomized, double-blind, and placebo-controlled, with a combined enrollment of 319 patients across the completed studies.
Completed Phase 2 trials include NCT01750957 in pediatric Fragile X Syndrome patients, NCT01517698 in Fragile X Syndrome patients aged 14 and older, NCT01015430 in adult Fragile X Syndrome patients, and NCT01437657, the MARIGOLD study, in adults with Major Depressive Disorder and an inadequate response to ongoing antidepressant therapy.