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Dexbenzetimide (DEXETIMIDE)

Phase 2 active Small molecule

Dexbenzetimide (generic name: DEXETIMIDE) is a dexetimide drug. It is currently in Phase 2 development for Neuroleptic-induced Parkinsonism.

Dexbenzetimide works by blocking the M2 muscarinic acetylcholine receptor, which helps to regulate muscle contractions and other bodily functions.

Dexbenzetimide, also known as DEXETIMIDE, is a small molecule drug that targets the muscarinic acetylcholine receptor M2. It is classified as a dexetimide and is used to treat neuroleptic-induced Parkinsonism. The commercial status of Dexbenzetimide is currently unknown, and it is not clear if it is patented or available as a generic medication. Dexbenzetimide's safety considerations are also unclear due to a lack of available information. Further research is needed to fully understand its pharmacological properties and clinical applications.

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 nameDEXETIMIDE
Drug classdexetimide
TargetMuscarinic acetylcholine receptor M2
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Imagine your body's muscles are like a car's engine, and the M2 receptor is like the accelerator pedal. When the M2 receptor is blocked, it's like taking your foot off the pedal, which can help to reduce muscle contractions and alleviate symptoms of neuroleptic-induced Parkinsonism.

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 Dexbenzetimide

What is Dexbenzetimide?

Dexbenzetimide (DEXETIMIDE) is a dexetimide drug, indicated for Neuroleptic-induced Parkinsonism.

How does Dexbenzetimide work?

Dexbenzetimide works by blocking the M2 muscarinic acetylcholine receptor, which helps to regulate muscle contractions and other bodily functions.

What is Dexbenzetimide used for?

Dexbenzetimide is indicated for Neuroleptic-induced Parkinsonism.

What is the generic name of Dexbenzetimide?

DEXETIMIDE is the generic (nonproprietary) name of Dexbenzetimide.

What drug class is Dexbenzetimide in?

Dexbenzetimide belongs to the dexetimide class. See all dexetimide drugs at /class/dexetimide.

What development phase is Dexbenzetimide in?

Dexbenzetimide is in Phase 2.

What does Dexbenzetimide target?

Dexbenzetimide targets Muscarinic acetylcholine receptor M2 and is a dexetimide.

Related

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