Last reviewed 2026-05-14 · How we verify

Duloxetine (DLX)

Eli Lilly and Company · Phase 3 active Small molecule

Duloxetine (DLX) is a Serotonin-norepinephrine reuptake inhibitor (SNRI) Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 3 development for Major depressive disorder, Generalized anxiety disorder, Diabetic peripheral neuropathic pain. Also known as: LY248686, Cymbalta.

Duloxetine inhibits the reuptake of serotonin and norepinephrine in the central nervous system, increasing their availability at synaptic sites.

Duloxetine inhibits the reuptake of serotonin and norepinephrine in the central nervous system, increasing their availability at synaptic sites. Used for Major depressive disorder, Generalized anxiety disorder, Diabetic peripheral neuropathic pain.

Likelihood of approval

58.3% 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).
Big-pharma sponsor +3.0pp
Eli Lilly and Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	Duloxetine (DLX)
Also known as	LY248686, Cymbalta
Sponsor	Eli Lilly and Company
Drug class	Serotonin-norepinephrine reuptake inhibitor (SNRI)
Target	Serotonin transporter (SERT); Norepinephrine transporter (NET)
Modality	Small molecule
Therapeutic area	Psychiatry; Pain Management
Phase	Phase 3

Mechanism of action

Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) that blocks the presynaptic reuptake transporters for both serotonin and norepinephrine, leading to increased neurotransmitter concentrations in the synaptic cleft. This dual mechanism is thought to enhance mood regulation and pain modulation, making it effective for both psychiatric and pain-related conditions. The norepinephrine component particularly contributes to analgesic effects.

Approved indications

Major depressive disorder
Generalized anxiety disorder
Diabetic peripheral neuropathic pain
Fibromyalgia
Chronic musculoskeletal pain
Stress urinary incontinence

Common side effects

Nausea
Dizziness
Somnolence
Dry mouth
Fatigue
Constipation
Decreased appetite
Sweating
Sexual dysfunction

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:

Duloxetine (DLX) CI brief — competitive landscape report
Duloxetine (DLX) updates RSS · CI watch RSS
Eli Lilly and Company portfolio CI

Frequently asked questions about Duloxetine (DLX)

What is Duloxetine (DLX)?

Duloxetine (DLX) is a Serotonin-norepinephrine reuptake inhibitor (SNRI) drug developed by Eli Lilly and Company, indicated for Major depressive disorder, Generalized anxiety disorder, Diabetic peripheral neuropathic pain.

How does Duloxetine (DLX) work?

Duloxetine inhibits the reuptake of serotonin and norepinephrine in the central nervous system, increasing their availability at synaptic sites.

What is Duloxetine (DLX) used for?

Duloxetine (DLX) is indicated for Major depressive disorder, Generalized anxiety disorder, Diabetic peripheral neuropathic pain, Fibromyalgia, Chronic musculoskeletal pain.

Who makes Duloxetine (DLX)?

Duloxetine (DLX) is developed by Eli Lilly and Company (see full Eli Lilly and Company pipeline at /company/eli-lilly).

Is Duloxetine (DLX) also known as anything else?

Duloxetine (DLX) is also known as LY248686, Cymbalta.

What drug class is Duloxetine (DLX) in?

Duloxetine (DLX) belongs to the Serotonin-norepinephrine reuptake inhibitor (SNRI) class. See all Serotonin-norepinephrine reuptake inhibitor (SNRI) drugs at /class/serotonin-norepinephrine-reuptake-inhibitor-snri.

What development phase is Duloxetine (DLX) in?

Duloxetine (DLX) is in Phase 3.

What are the side effects of Duloxetine (DLX)?

Common side effects of Duloxetine (DLX) include Nausea, Dizziness, Somnolence, Dry mouth, Fatigue, Constipation.

What does Duloxetine (DLX) target?

Duloxetine (DLX) targets Serotonin transporter (SERT); Norepinephrine transporter (NET) and is a Serotonin-norepinephrine reuptake inhibitor (SNRI).

Drug class: All Serotonin-norepinephrine reuptake inhibitor (SNRI) drugs
Target: All drugs targeting Serotonin transporter (SERT); Norepinephrine transporter (NET)
Manufacturer: Eli Lilly and Company — full pipeline
Therapeutic area: All drugs in Psychiatry; Pain Management
Indication: Drugs for Major depressive disorder
Indication: Drugs for Generalized anxiety disorder
Indication: Drugs for Diabetic peripheral neuropathic pain
Also known as: LY248686, Cymbalta

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