Last reviewed 2026-05-27 · How we verify

Etifoxin (ETIFOXINE)

Phase 3 active Small molecule Under review Quality 0/100

Etifoxin (generic name: ETIFOXINE) is a etifoxine drug. It is currently in Phase 3 development.

Etifoxine works by modulating the activity of GABA, a neurotransmitter that helps calm the brain.

Etifoxine is a small molecule that acts as an antagonist of the GABA-A receptor and anion channel. It has been studied in clinical trials for conditions such as multiple sclerosis and as a potential neuroimmunodulator.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	ETIFOXINE
Drug class	etifoxine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 3

Mechanism of action

Think of GABA like a brake pedal in a car. When GABA is active, it helps slow down the activity of brain cells, which can help reduce feelings of anxiety. Etifoxine helps GABA work more effectively, which can lead to a calming effect on the brain.

Approved indications

No approved indications tracked.

Common side effects

Altered state of consciousness
Cutaneous T-cell lymphoma

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.

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:

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

Frequently asked questions about Etifoxin

What is Etifoxin?

Etifoxin (ETIFOXINE) is a etifoxine drug.

How does Etifoxin work?

Etifoxine works by modulating the activity of GABA, a neurotransmitter that helps calm the brain.

What is the generic name of Etifoxin?

ETIFOXINE is the generic (nonproprietary) name of Etifoxin.

What drug class is Etifoxin in?

Etifoxin belongs to the etifoxine class. See all etifoxine drugs at /class/etifoxine.

What development phase is Etifoxin in?

Etifoxin is in Phase 3.

What are the side effects of Etifoxin?

Common side effects of Etifoxin include Altered state of consciousness, Cutaneous T-cell lymphoma.

Drug class: All etifoxine drugs
Therapeutic area: All drugs in Neuroscience

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