Last reviewed 2026-04-20 · How we verify

Deparon (DEMEXIPTILINE)

Phase 2 active Small molecule

Deparon (generic name: DEMEXIPTILINE) is a drug. It is currently in Phase 2 development for Depressive disorder.

Deparon is thought to work by influencing neurotransmitter levels in the brain.

Deparon (DEMEXIPTILINE) is a small molecule drug with unknown drug class and target. It is used to treat depressive disorder, but its commercial status and key safety considerations are currently unknown. Further research is needed to determine its pharmacokinetic properties and potential side effects. Deparon's exact mechanism of action is also unclear, but it is likely to modulate neurotransmitter activity in the brain. As a result, its development and approval status are uncertain.

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	DEMEXIPTILINE
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a complex communication network. Neurotransmitters are like messengers that help different parts of the brain talk to each other. Deparon may help regulate the levels of these messengers to improve mood and reduce symptoms of depression.

Approved indications

Depressive disorder

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:

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

Frequently asked questions about Deparon

What is Deparon?

Deparon (DEMEXIPTILINE) is a Small molecule drug, indicated for Depressive disorder.

How does Deparon work?

Deparon is thought to work by influencing neurotransmitter levels in the brain.

What is Deparon used for?

Deparon is indicated for Depressive disorder.

What is the generic name of Deparon?

DEMEXIPTILINE is the generic (nonproprietary) name of Deparon.

What development phase is Deparon in?

Deparon is in Phase 2.

Therapeutic area: All drugs in Neuroscience
Indication: Drugs for Depressive disorder

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