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Clozaril
Clozaril is a Small molecule drug developed by Dong Wha Pharmaceutical Co. Ltd.. It is currently in Phase 1 development for Suicidal Behavior in Schizoaffective Disorder, Suicidal Behavior in Schizophrenia, Treatment-Resistant Schizophrenia. Also known as: Clozaril Tablet 100mg.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Clozaril |
|---|---|
| Also known as | Clozaril Tablet 100mg |
| Sponsor | Dong Wha Pharmaceutical Co. Ltd. |
| Target | Aldehyde oxidase, UDP-glucuronosyltransferase 1-4, 5-hydroxytryptamine receptor 1E |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 1 |
Approved indications
- Suicidal Behavior in Schizoaffective Disorder
- Suicidal Behavior in Schizophrenia
- Treatment-Resistant Schizophrenia
Common side effects
Key clinical trials
- Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism (Phase 4)
- Cross-Sectional Study of the Association Between Multiple Genetic Polymorphisms and the Metabolic Side Effects in Patients With Schizophrenia Taking Clozapine More Than 1 Year (N/A)
- National Pregnancy Registry for Psychiatric Medications (N/A)
- Clinical Trials to Compare the Pharmacokinetics Profile of DWCZP Tablet 100mg and Clozaril® Tablet 100mg After a Multi-dose Oral Administration in Schizophrenia Patients (Phase 1)
- Observation of Clozapine Treatment Safety in Bipolar Disorder. (N/A)
- Neural Biomarkers of Clozapine Response (N/A)
- A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and (N/A)
- Treatment Strategy for Refractory Schizophrenia: Drug Interaction Between Clozapine and Fluvoxamine (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Clozaril CI brief — competitive landscape report
- Clozaril updates RSS · CI watch RSS
- Dong Wha Pharmaceutical Co. Ltd. portfolio CI
Frequently asked questions about Clozaril
What is Clozaril?
What is Clozaril used for?
Who makes Clozaril?
Is Clozaril also known as anything else?
What development phase is Clozaril in?
What does Clozaril target?
Related
- Target: All drugs targeting Aldehyde oxidase, UDP-glucuronosyltransferase 1-4, 5-hydroxytryptamine receptor 1E
- Manufacturer: Dong Wha Pharmaceutical Co. Ltd. — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Suicidal Behavior in Schizoaffective Disorder
- Indication: Drugs for Suicidal Behavior in Schizophrenia
- Indication: Drugs for Treatment-Resistant Schizophrenia
- Also known as: Clozaril Tablet 100mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing