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Sordinol (CLOPENTHIXOL)

Phase 2 active Small molecule

Sordinol (generic name: CLOPENTHIXOL) is a clopenthixol drug. It is currently in Phase 2 development for Psychotic disorder.

Sordinol works by blocking the 5-hydroxytryptamine receptor 6, which helps to regulate mood and behavior.

Sordinol (Clopenthixol) is a small molecule drug belonging to the clopenthixol class, targeting the 5-hydroxytryptamine receptor 6. It is used to treat psychotic disorders. The commercial status of Sordinol is unclear, and it may be patented or have generic manufacturers. Key safety considerations are not well-documented. As a result, its use should be approached with caution.

Likelihood of approval
12.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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).
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameCLOPENTHIXOL
Drug classclopenthixol
Target5-hydroxytryptamine receptor 6
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Think of it like a volume control on a radio. The 5-hydroxytryptamine receptor 6 is like a dial that helps control how much of a certain signal is sent to the brain. By blocking this dial, Sordinol helps to reduce the amount of signal sent, which can help to calm the brain and reduce symptoms of psychosis.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Sordinol

What is Sordinol?

Sordinol (CLOPENTHIXOL) is a clopenthixol drug, indicated for Psychotic disorder.

How does Sordinol work?

Sordinol works by blocking the 5-hydroxytryptamine receptor 6, which helps to regulate mood and behavior.

What is Sordinol used for?

Sordinol is indicated for Psychotic disorder.

What is the generic name of Sordinol?

CLOPENTHIXOL is the generic (nonproprietary) name of Sordinol.

What drug class is Sordinol in?

Sordinol belongs to the clopenthixol class. See all clopenthixol drugs at /class/clopenthixol.

What development phase is Sordinol in?

Sordinol is in Phase 2.

What does Sordinol target?

Sordinol targets 5-hydroxytryptamine receptor 6 and is a clopenthixol.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing