Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ralmitaront · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sequence 1: Ralmitaront then Placebo | EXPERIMENTAL | Participants were given a daily dose of Ralmitaront during the treatment period of 14 days, followed by a 7 day washout period, and then a daily dose for 14 days with the placebo. |
| Sequence 2: Placebo then Ralmitaront | EXPERIMENTAL | Participants were given a daily dose of the placebo during the 14 day period, followed by a 7 day washout, and then a daily dose of Ralmitaront for 14 days. |
| Name | Type | Description |
|---|---|---|
| Ralmitaront | DRUG | Participants were given a once 150 mg daily dose of Ralmitaront orally during the 14 day treatment period. |
| Radiolabeled PET tracer [18F]-DOPA | OTHER | \[18 F\]-DOPA solution for injection is manufactured by the PET imaging centers according to specifications established for the tracer at the site. The injection will happen prior to the scan being done and will last for approximately 30 seconds. |
| Placebo | DRUG | Participants were given a daily dose of the placebo during the 14 day treatment period. |
Inclusion Criteria: * Male patients with non-acute schizophrenia defined by DSM-5 diagnosis of schizophrenia as established by the mini-international neuropsychiatric interview (MINI) * Medically stable over 1 month and psychiatrically stable for at least 3 months prior to the screening visit * Pat...
Ralmitaront is an investigational small molecule being studied for the treatment of schizophrenia. It is currently in Phase 1 clinical development and is not approved by the FDA. A completed Phase 1 trial evaluated its effects on dopamine synthesis capacity in the striatum of participants with schizophrenia.
Ralmitaront is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule for schizophrenia, with the drug currently in Phase 1 development.
Ralmitaront is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and the drug remains under investigation for the treatment of schizophrenia.
Ralmitaront has one completed Phase 1 clinical trial, identified as NCT06880328. This study was a randomized, double-blind, controlled trial that enrolled 35 male participants with schizophrenia in the United States. It used 18F-DOPA PET imaging to explore dopamine synthesis capacity in the striatum after two weeks of treatment.
Ralmitaront is a small molecule being studied for schizophrenia. The completed Phase 1 trial examined its effect on dopamine synthesis capacity in the whole striatum, suggesting the drug may influence dopaminergic activity. However, its specific molecular target has not been disclosed in available information.