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bitopertin · 7 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | PLACEBO_COMPARATOR | - |
| Bitopertin oral dose level 1 | EXPERIMENTAL | - |
| Bitopertin oral dose level 2 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Bitopertin 10 mg + Antipsychotics | EXPERIMENTAL | Treatment Period 1: Participants will receive bitopertin 10 milligrams (mg) tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin 10 mg tablet orally once daily for 28 weeks (up to Study Week 52). After Week 52 there will be a 4-week washout period for at least 50 percent (%) of participants (up to Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and continue to receive bitopertin 10 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study. |
| Bitopertin 20 mg + Antipsychotics | EXPERIMENTAL | Treatment Period 1: Participants will receive bitopertin 20 mg tablet orally once daily for 24 weeks. Treatment Period 2: Participants will receive bitopertin 20 mg tablet orally once daily for 28 weeks (up to Study Week 52). After Week 52 there will be a 4-week washout period for at least 50% of participants (up to Week 56). Long-Term Extension: After Week 56, participants will enter the long term extension period and continue to receive bitopertin 20 mg tablet orally once daily up to 3 years. In addition, throughout the study, participants will continue their same stable antipsychotic treatment as they were receiving prior to entry in the study. |
| Bitopertin | EXPERIMENTAL | Part 1 - The main study - 16 weeks in total: Participants will undergo a 6-week dose-escalation period followed by 10 weeks of treatment at the attained target dose of bitopertin. Part 2 - Open Label Extension (OLE) - up to an additional 12 months: Participants will be given the option to enroll into the OLE once the 16-week treatment of Part 1 has been completed. Participants who decide not to enroll in the OLE, at the end of Part 1 will enter a 6-week follow-up period. |
| Bitopertin 30 mg | EXPERIMENTAL | Participants in Stratum 1 will receive bitopertin 30 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 30 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI. |
| Bitopertin 10 mg | EXPERIMENTAL | Participants in Stratum 1 will receive bitopertin 10 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 10 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI. |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | ACTIVE_COMPARATOR | - |
| D | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Oral doses, once a day for 52 weeks |
| bitopertin [RO4917838] | DRUG | Oral dose level 1, once a day for 52 weeks |
| Bitopertin | DRUG | Participants will receive 10 mg or 20 mg of bitopertin. |
| Antipsychotics | DRUG | Participants will continue to receive their stable antipsychotic regiment throughout the study. Study protocol does not specify any particular antipsychotic drug and regimen. |
| SSRI | DRUG | Participants will continue their background SSRI treatment as per standard of care at the same dose taken during the 8 weeks prior to Day 1. Protocol does not enforce any particular SSRI drug or regimen. |
| olanzapine | DRUG | 15 mg orally daily, 4 weeks |
Inclusion Criteria: * Adult patients, aged 18 years and above * Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype * Predominant negative symptoms * With the exception of clozapine, patients are on any of the available marketed atypical or typical ...
Bitopertin is an investigational small molecule being studied for several conditions, including schizophrenia, obsessive-compulsive disorder, and beta-thalassemia. It has also been evaluated in healthy volunteers. All completed trials were in Phase 1 or Phase 2, and Bitopertin is not approved for any indication.
Bitopertin is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored clinical trials of the drug across multiple countries, including the United States, Canada, and several European and Asian nations.
Bitopertin has completed Phase 1 and Phase 2 clinical trials. It is not approved and remains investigational. The most advanced studies were Phase 2 trials in schizophrenia, obsessive-compulsive disorder, and beta-thalassemia, all of which have been completed.
Bitopertin has been studied in four completed trials: NCT01234779 in schizophrenia (Phase 2, 301 participants), NCT01636492 in healthy volunteers (Phase 1, 71 participants), NCT01674361 in obsessive-compulsive disorder (Phase 2, 99 participants), and NCT03271541 in beta-thalassemia (Phase 2, 12 participants).
Yes, Bitopertin is also known as RO4917838. Clinical trial records use both names interchangeably, with RO4917838 appearing in study titles and Bitopertin as the common name.