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Flupenthixol
Flupenthixol is a Small molecule drug developed by National Institute on Drug Abuse (NIDA). It is currently in Phase 2 development for Schizophrenia.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Flupenthixol |
|---|---|
| Sponsor | National Institute on Drug Abuse (NIDA) |
| Target | D(1B) dopamine receptor, D(4) dopamine receptor, Solute carrier family 22 member 1 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 2 |
Approved indications
- Schizophrenia
Common side effects
Key clinical trials
- Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum
- Efficacy of Gut-Brain Neuromodulators in the Treatment of Gastroesophageal Reflux Disease (NA)
- Assessment of SSD in Outpatients Using SSS-CN
- Effects of Cognitive Behavioral Therapy Through a Mobile App on Patients With Refractory Functional Dyspepsia (NA)
- Efficacy of Gut-Brain Neuromodulators for Functional Dyspepsia (NA)
- A Study on the Combined Use of Tocilizumab and Flupentixol-Melitracen in the Treatment of Thyroid-Associated Ophthalmopathy (PHASE4)
- Bioequivalence Study to Compare Two Formulations of Deanxit® (PHASE1)
- The Role of Neuromodulators in Refractory Functional Dyspepsia (NA)
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:
- Flupenthixol CI brief — competitive landscape report
- Flupenthixol updates RSS · CI watch RSS
- National Institute on Drug Abuse (NIDA) portfolio CI
Frequently asked questions about Flupenthixol
What is Flupenthixol?
What is Flupenthixol used for?
Who makes Flupenthixol?
What development phase is Flupenthixol in?
What does Flupenthixol target?
Related
- Target: All drugs targeting D(1B) dopamine receptor, D(4) dopamine receptor, Solute carrier family 22 member 1
- Manufacturer: National Institute on Drug Abuse (NIDA) — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Schizophrenia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing