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antipsychotic dose increase
antipsychotic dose increase is a Small molecule drug developed by Prague Psychiatric Center. It is currently in Phase 1 development. Also known as: All antipsychotics approved for clinical use in Czech and Slovak Republic:.
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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).
| 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 | antipsychotic dose increase |
|---|---|
| Also known as | All antipsychotics approved for clinical use in Czech and Slovak Republic: |
| Sponsor | Prague Psychiatric Center |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Evaluation of a Brief Intervention to Improve Engagement in Early Intervention Services for Psychosis (NA)
- Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure (PHASE3)
- Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia (PHASE4)
- Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD) (PHASE3)
- Evaluating the Effect of the STEP@STAH Semaglutide Protocol on the Physical Health Measures of Atypical Antipsychotic-Treated Patients (PHASE4)
- A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform (PHASE3)
- Switching Antipsychotics: Abrupt Discontinuation Versus Overlap (PHASE4)
- Study to Compare Clozapine vs Treatment as Usual in People With Intellectual Disability & Treatment-resistant Psychosis (PHASE2)
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:
- antipsychotic dose increase CI brief — competitive landscape report
- antipsychotic dose increase updates RSS · CI watch RSS
- Prague Psychiatric Center portfolio CI
Frequently asked questions about antipsychotic dose increase
What is antipsychotic dose increase?
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Is antipsychotic dose increase also known as anything else?
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Related
- Manufacturer: Prague Psychiatric Center — full pipeline
- Also known as: All antipsychotics approved for clinical use in Czech and Slovak Republic:
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing