Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO4917523 · 11 trials · 4 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 | - |
| Fast release MR capsule | EXPERIMENTAL | - |
| Slow release MR capsule | EXPERIMENTAL | - |
| Target release MR capsule | EXPERIMENTAL | - |
| Dosing Period 1 | EXPERIMENTAL | - |
| Dosing Period 2 | EXPERIMENTAL | - |
| [14C]-labeled RO4917523 | EXPERIMENTAL | - |
| Concept Proof | ACTIVE_COMPARATOR | - |
| Receptor Occupancy | EXPERIMENTAL | - |
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| 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 |
| Carbamazepine | DRUG | Multiple doses of carbamazepine |
| RO5011232 | DRUG | \[11C\]-RO5011232 intravenously |
| escitalopram | DRUG | Oral single dose |
| methylphenidate | DRUG | Oral single dose |
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 being studied for Fragile X Syndrome and Major Depressive Disorder. It has been evaluated in Phase 2 clinical trials as an adjunctive therapy in patients with Major Depressive Disorder who had an inadequate response to ongoing antidepressant therapy, and in patients with Fragile X Syndrome.
RO4917523 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored multiple clinical trials of this investigational drug in Fragile X Syndrome and Major Depressive Disorder.
RO4917523 is in Phase 2 clinical development. All six trials listed for this drug are Phase 2 studies, and all have been completed. The drug is investigational and has not been approved by regulatory authorities.
RO4917523 has been studied in several completed Phase 2 trials, including NCT01015430 and NCT01517698 in Fragile X Syndrome, NCT01750957 in pediatric Fragile X Syndrome, and NCT01437657, the MARIGOLD study, in Major Depressive Disorder. These trials enrolled a total of 319 participants.
RO4917523 is also known as basimglurant. It is an investigational small molecule developed by Roche. The drug has been evaluated in clinical trials for Fragile X Syndrome and Major Depressive Disorder, but it is not approved for any indication.