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Dioloxol (MEPHENESIN)

Phase 2 active Small molecule ✓ Verified May 2026

Dioloxol (generic name: MEPHENESIN) is a mephenesin drug. It is currently in Phase 2 development.

Dioloxol works by modulating the central nervous system, although its exact target is unknown.

Dioloxol is a small molecule with the synonyms DECONTRACTYL, MEFENESINA, MEPHENESIN, and MEPHENESINE.

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 nameMEPHENESIN
Drug classmephenesin
ModalitySmall molecule
Therapeutic areaNeuroscience
PhasePhase 2

Mechanism of action

Think of Dioloxol like a volume control for your brain's signals. It helps to calm down overactive signals that can cause muscle spasms and other symptoms. By adjusting the volume, Dioloxol can help to reduce muscle tension and improve overall comfort.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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 Dioloxol

What is Dioloxol?

Dioloxol (MEPHENESIN) is a mephenesin drug.

How does Dioloxol work?

Dioloxol works by modulating the central nervous system, although its exact target is unknown.

What is the generic name of Dioloxol?

MEPHENESIN is the generic (nonproprietary) name of Dioloxol.

What drug class is Dioloxol in?

Dioloxol belongs to the mephenesin class. See all mephenesin drugs at /class/mephenesin.

What development phase is Dioloxol in?

Dioloxol is in Phase 2.

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