Last reviewed 2026-06-02 · How we verify

Esketamine DPI - low dose

Celon Pharma SA · Phase 2 active Small molecule

Esketamine DPI - low dose is a NMDA receptor antagonist Small molecule drug developed by Celon Pharma SA. It is currently in Phase 2 development for Treatment-resistant depression (Phase 2 investigation), Major depressive disorder with suicidal ideation (potential indication).

Esketamine is an NMDA receptor antagonist that blocks glutamate signaling in the brain, with rapid-acting antidepressant effects.

Esketamine is an NMDA receptor antagonist that blocks glutamate signaling in the brain, with rapid-acting antidepressant effects. Used for Treatment-resistant depression (Phase 2 investigation), Major depressive disorder with suicidal ideation (potential indication).

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	Esketamine DPI - low dose
Sponsor	Celon Pharma SA
Drug class	NMDA receptor antagonist
Target	NMDA receptor
Modality	Small molecule
Therapeutic area	Psychiatry / Neurology
Phase	Phase 2

Mechanism of action

Esketamine is the S-enantiomer of ketamine, which acts as a non-competitive antagonist at the N-methyl-D-aspartate (NMDA) receptor. The dry powder inhaled (DPI) formulation allows for rapid systemic absorption and CNS penetration. This mechanism is thought to promote synaptic plasticity and neuronal growth, leading to faster antidepressant effects compared to traditional monoamine-based antidepressants.

Approved indications

Treatment-resistant depression (Phase 2 investigation)
Major depressive disorder with suicidal ideation (potential indication)

Common side effects

Dissociation
Dizziness
Nausea
Sedation
Headache

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:

Esketamine DPI - low dose CI brief — competitive landscape report
Esketamine DPI - low dose updates RSS · CI watch RSS
Celon Pharma SA portfolio CI

Frequently asked questions about Esketamine DPI - low dose

What is Esketamine DPI - low dose?

Esketamine DPI - low dose is a NMDA receptor antagonist drug developed by Celon Pharma SA, indicated for Treatment-resistant depression (Phase 2 investigation), Major depressive disorder with suicidal ideation (potential indication).

How does Esketamine DPI - low dose work?

Esketamine is an NMDA receptor antagonist that blocks glutamate signaling in the brain, with rapid-acting antidepressant effects.

What is Esketamine DPI - low dose used for?

Esketamine DPI - low dose is indicated for Treatment-resistant depression (Phase 2 investigation), Major depressive disorder with suicidal ideation (potential indication).

Who makes Esketamine DPI - low dose?

Esketamine DPI - low dose is developed by Celon Pharma SA (see full Celon Pharma SA pipeline at /company/celon-pharma-sa).

What drug class is Esketamine DPI - low dose in?

Esketamine DPI - low dose belongs to the NMDA receptor antagonist class. See all NMDA receptor antagonist drugs at /class/nmda-receptor-antagonist.

What development phase is Esketamine DPI - low dose in?

Esketamine DPI - low dose is in Phase 2.

What are the side effects of Esketamine DPI - low dose?

Common side effects of Esketamine DPI - low dose include Dissociation, Dizziness, Nausea, Sedation, Headache.

What does Esketamine DPI - low dose target?

Esketamine DPI - low dose targets NMDA receptor and is a NMDA receptor antagonist.

Drug class: All NMDA receptor antagonist drugs
Target: All drugs targeting NMDA receptor
Manufacturer: Celon Pharma SA — full pipeline
Therapeutic area: All drugs in Psychiatry / Neurology
Indication: Drugs for Treatment-resistant depression (Phase 2 investigation)
Indication: Drugs for Major depressive disorder with suicidal ideation (potential indication)

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