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RO6889450 · 2 trials · 2 indications
The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
| Arm | Type | Description |
|---|---|---|
| 150 mg Once Daily (QD) RO6889450 | EXPERIMENTAL | Participants will receive 150 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks. |
| 45 mg QD RO6889450 | EXPERIMENTAL | Participants will receive 45 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive oral placebo QD for 4 weeks. Participants from this arm that continue to the extension period will be randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks or additional 44 weeks (optional 36-Week Safety Extension Phase). |
| 4 mg QD Risperidone | ACTIVE_COMPARATOR | Participants will receive 4 mg of risperidone QD for 4 weeks or 12 weeks or 48 weeks. |
| RO6889450: Part 1 Single Ascending Dose (SAD) | EXPERIMENTAL | Participants will undergo a series of screening visits prior to treatment and 4 weeks follow-up. Healthy volunteers will be enrolled in up to 7 dose groups (5 milligram \[mg\] to 450 mg) and will receive single oral dose of RO6889450 in the morning of the Day 1. |
| RO6889450: Part 2 Multiple Ascending Dose (MAD) | EXPERIMENTAL | The starting dose for Part 2 MAD will be determined by analysis of safety and pharmacokinetic data of Part 1 SAD. All participants will receive RO6889450 orally for 14 days. |
| Name | Type | Description |
|---|---|---|
| RO6889450 | DRUG | Participants will receive oral RO6889450 QD. |
| Placebo | DRUG | Participants will receive oral placebo QD. |
| Risperidone | DRUG | Participants will receive oral risperidone QD. |
Inclusion criteria * Participant must be 18 to 45 years of age inclusive * Participants with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)...
RO6889450 is an investigational small molecule being studied for the treatment of schizophrenia and schizoaffective disorder. It has been evaluated in healthy volunteers to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is not approved and remains in clinical development.
RO6889450 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored clinical trials of the drug in healthy volunteers and in patients with schizophrenia or schizoaffective disorder.
RO6889450 has completed a Phase 1 trial in healthy volunteers and a Phase 2 trial in patients with an acute exacerbation of schizophrenia or schizoaffective disorder. Both trials are completed, and the drug remains investigational and not FDA approved.
RO6889450 has been studied in two completed trials. NCT02699372 was a Phase 1 study in 164 healthy volunteers in the Netherlands. NCT04512066 was a Phase 2 efficacy and safety trial in 287 patients with schizophrenia or schizoaffective disorder across the United States, Japan, Russia, and Ukraine.
Yes, RO6889450 is also known as Ralmitaront. The Phase 2 trial NCT04512066 refers to the drug as RO6889450 (Ralmitaront) in its title, confirming that both names refer to the same investigational compound.