Last reviewed 2026-04-20 · How we verify

Ditrimin (HEXOBENDINE)

Phase 2 active Small molecule

Ditrimin (generic name: HEXOBENDINE) is a hexobendine drug. It is currently in Phase 2 development.

Ditrimin works by blocking sodium channels in the brain to modulate nerve impulses.

Ditrimin (HEXOBENDINE) is a small molecule hexobendine drug that targets sodium channel alpha subunits in the brain, specifically types I, II, and III. It is not FDA-approved for any indications, and its commercial status, generic availability, and patent status are unknown. As a hexobendine, Ditrimin works by modulating sodium channels, which are crucial for the transmission of nerve impulses. The exact indications and safety profile of Ditrimin are unclear due to its lack of FDA approval. Further research is needed to determine its efficacy and potential side effects.

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 name	HEXOBENDINE
Drug class	hexobendine
Target	Sodium channel alpha subunits; brain (Types I, II, III)
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your nerves are like electrical wires that send signals to different parts of your body. Sodium channels are like the switches that turn these signals on and off. Ditrimin blocks these switches to change the way your nerves send signals, which can affect how you feel and respond to stimuli.

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:

Ditrimin CI brief — competitive landscape report
Ditrimin updates RSS · CI watch RSS

Frequently asked questions about Ditrimin

What is Ditrimin?

Ditrimin (HEXOBENDINE) is a hexobendine drug.

How does Ditrimin work?

Ditrimin works by blocking sodium channels in the brain to modulate nerve impulses.

What is the generic name of Ditrimin?

HEXOBENDINE is the generic (nonproprietary) name of Ditrimin.

What drug class is Ditrimin in?

Ditrimin belongs to the hexobendine class. See all hexobendine drugs at /class/hexobendine.

What development phase is Ditrimin in?

Ditrimin is in Phase 2.

What does Ditrimin target?

Ditrimin targets Sodium channel alpha subunits; brain (Types I, II, III) and is a hexobendine.

Drug class: All hexobendine drugs
Target: All drugs targeting Sodium channel alpha subunits; brain (Types I, II, III)
Therapeutic area: All drugs in Neuroscience

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