Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as bitopertin [RO4917838] level 1
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 ...
Top 15 of 16 competitors
Bitopertin is an investigational small molecule developed by Roche for schizophrenia, specifically studied in patients with sub-optimally controlled symptoms. It was evaluated in a Phase 3 trial as an adjunctive treatment for persistent symptoms despite standard antipsychotic therapy. It is not approved for schizophrenia or any other indication.
Bitopertin targets SLC6A9, also known as glycine transporter 1 (GlyT1). It acts as an inhibitor of this transporter. By inhibiting SLC6A9, bitopertin is designed to modulate glycine levels in the brain, which may influence NMDA receptor function, a mechanism explored for treating schizophrenia symptoms.
Bitopertin is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical trial program for bitopertin, including the Phase 3 study in schizophrenia. The company holds the rights to the compound.
Bitopertin is in Phase 3 development for schizophrenia. One Phase 3 trial has been completed, and there are currently no active trials listed. The drug remains investigational and has not been approved by the FDA or any regulatory agency for any indication.
Bitopertin has been studied in a Phase 3 clinical trial, NCT01235559, titled "A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)." This completed trial enrolled 604 patients across multiple countries, including the United States, Bulgaria, China, Czechia, Italy, Japan, and Russia.
Yes, bitopertin is also known as RO4917838. RO4917838 is the internal development code used by Roche for bitopertin. Both names refer to the same investigational small molecule targeting SLC6A9 for schizophrenia.