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bitopertin [RO4917838] level 2
bitopertin [RO4917838] level 2 is a Glycine receptor antagonist Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Schizophrenia.
Bitopertin is a glycine receptor antagonist.
Bitopertin is a glycine receptor antagonist. Used for Schizophrenia.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression). -
Big-pharma sponsor
+3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | bitopertin [RO4917838] level 2 |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | Glycine receptor antagonist |
| Target | Glycine receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
It works by blocking the action of glycine at its receptor in the central nervous system, which may help to reduce symptoms of schizophrenia and other psychiatric disorders.
Approved indications
- Schizophrenia
Common side effects
- Dizziness
- Headache
- Nausea
- Vomiting
- Somnolence
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- bitopertin [RO4917838] level 2 CI brief — competitive landscape report
- bitopertin [RO4917838] level 2 updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about bitopertin [RO4917838] level 2
What is bitopertin [RO4917838] level 2?
How does bitopertin [RO4917838] level 2 work?
What is bitopertin [RO4917838] level 2 used for?
Who makes bitopertin [RO4917838] level 2?
What drug class is bitopertin [RO4917838] level 2 in?
What development phase is bitopertin [RO4917838] level 2 in?
What are the side effects of bitopertin [RO4917838] level 2?
What does bitopertin [RO4917838] level 2 target?
Related
- Drug class: All Glycine receptor antagonist drugs
- Target: All drugs targeting Glycine receptor
- Manufacturer: Hoffmann-La Roche — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Schizophrenia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing