Last reviewed 2026-04-19 · How we verify

FEMOXETINE

Phase 2 active Small molecule

FEMOXETINE is a femoxetine drug. It is currently in Phase 2 development.

Femoxetine works by blocking the reuptake of serotonin, allowing more of this neurotransmitter to be available in the brain.

Femoxetine is a small molecule drug that targets the sodium-dependent serotonin transporter. It is classified as a femoxetine, a type of antidepressant. However, its commercial status and approved indications are unknown. Femoxetine works by inhibiting the reuptake of serotonin, allowing more of this neurotransmitter to be available in the brain. Further information on its safety and efficacy is needed.

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	FEMOXETINE
Drug class	femoxetine
Target	5-hydroxytryptamine receptor 1A, D(2) dopamine receptor, Histamine H1 receptor
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of serotonin like a messenger in your brain. When serotonin is released, it helps to regulate mood, appetite, and sleep. By blocking the reuptake of serotonin, femoxetine allows these messengers to stay in the brain longer, which can help improve mood and reduce symptoms of depression.

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:

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

Frequently asked questions about FEMOXETINE

What is FEMOXETINE?

FEMOXETINE is a femoxetine drug.

How does FEMOXETINE work?

Femoxetine works by blocking the reuptake of serotonin, allowing more of this neurotransmitter to be available in the brain.

What drug class is FEMOXETINE in?

FEMOXETINE belongs to the femoxetine class. See all femoxetine drugs at /class/femoxetine.

What development phase is FEMOXETINE in?

FEMOXETINE is in Phase 2.

What does FEMOXETINE target?

FEMOXETINE targets 5-hydroxytryptamine receptor 1A, D(2) dopamine receptor, Histamine H1 receptor and is a femoxetine.

Drug class: All femoxetine drugs
Target: All drugs targeting 5-hydroxytryptamine receptor 1A, D(2) dopamine receptor, Histamine H1 receptor
Therapeutic area: All drugs in Neuroscience

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