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Serdolect
Serdolect is a Small molecule drug developed by University of Aarhus. It is currently in Phase 1 development for Schizophrenia. Also known as: sertindole.
Sertindole, sold under the brand name Serdolect, is an antipsychotic medication used in the treatment of schizophrenia. It works as a dopamine D2 receptor antagonist, a small molecule that blocks the action of dopamine at these receptors in the brain.
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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 | Serdolect |
|---|---|
| Also known as | sertindole |
| Sponsor | University of Aarhus |
| Target | 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 6, D(4) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 1 |
Approved indications
- Schizophrenia
Common side effects
Key clinical trials
- An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)
- Antipsychotic Induced Structural and Functional Brain Changes (PHASE4)
- The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia (PHASE4)
- Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients (PHASE4)
- Pharmacovigilance in Gerontopsychiatric Patients (PHASE3)
- Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia (PHASE4)
- Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis (PHASE3)
- Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia (PHASE3)
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:
- Serdolect CI brief — competitive landscape report
- Serdolect updates RSS · CI watch RSS
- University of Aarhus portfolio CI
Frequently asked questions about Serdolect
What is Serdolect?
What is Serdolect used for?
Who makes Serdolect?
Is Serdolect also known as anything else?
What development phase is Serdolect in?
What does Serdolect target?
Related
- Target: All drugs targeting 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 6, D(4) dopamine receptor
- Manufacturer: University of Aarhus — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Schizophrenia
- Also known as: sertindole
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing