Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bitopertin level 1 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| bitopertin [RO4917838] 1 | EXPERIMENTAL | - |
| bitopertin [RO4917838] 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Oral doses, once a day for 52 weeks |
| bitopertin [RO4917838] level 1 | DRUG | Oral dose level 1, once a day for 52 weeks |
| bitopertin [RO4917838] level 2 | DRUG | Oral dose level 2, once a day for 52 weeks |
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Diagnosis of schizophrenia * Clinical stability for 16 weeks (4 months) prior to randomization * Antipsychotic treatment stability for the past 12 weeks prior to randomization * With the exception of clozapine, patients are on any of the ...
Bitopertin is an investigational small molecule being developed for the treatment of schizophrenia. It is intended for patients with sub-optimally controlled symptoms of the condition. The drug is currently in Phase 3 clinical development, though the specific trial has been completed.
Bitopertin is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational therapy for schizophrenia.
Bitopertin is in Phase 3 clinical development. A Phase 3 study has been completed, but the drug remains investigational and has not been approved by regulatory authorities. It is still in clinical development for schizophrenia.
Bitopertin has one completed Phase 3 clinical trial, identified as NCT01235559. This study, titled 'A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)', enrolled 604 participants across multiple countries including the United States, Bulgaria, China, Czechia, Italy, Japan, and Russia.
Yes, bitopertin is also known as RO4917838. The clinical trial for bitopertin, NCT01235559, uses the name RO4917838 in its official title, confirming that these names refer to the same investigational drug.