Diabetic Neuropathy, Painful

Neurology
8
Pipeline Programs
6
Companies
7
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
1
0
4
3
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Eli Lilly and Company
CYMBALTAApproved
duloxetine hydrochloride
Eli Lilly and Company
oral2004
U
PREGABALINApproved
pregabalin
Unknown Company
oral2021

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
2 programs
1
1
duloxetine hydrochloridePhase 41 trial
DuloxetinePhase 31 trial
Active Trials
NCT01089556Completed811Est. Nov 2011
NCT00385671Completed407Est. Nov 2009
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
1
1
DuloxetinePhase 31 trial
Active Trials
NCT01179672Completed405Est. Aug 2013
Pfizer
PfizerNEW YORK, NY
2 programs
2
PregabalinPhase 31 trial
pregabalinPhase 31 trial
Active Trials
NCT00150423Completed384Est. Jul 2005
NCT01057693Completed633Est. Jan 2012
M&
Merck & Co.RAHWAY, NJ
1 program
1
MK-6096Phase 21 trial
Active Trials
NCT01564459Completed170Est. Apr 2013
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
Sooma OyN/A1 trial
Active Trials
NCT06152887Unknown40Est. Dec 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Boehringer Ingelheimduloxetine hydrochloride
Eli Lilly and CompanyDuloxetine
Pfizerpregabalin
Boehringer IngelheimDuloxetine
PfizerPregabalin
Merck & Co.MK-6096
Novo NordiskSooma Oy

Clinical Trials (7)

Total enrollment: 2,850 patients across 7 trials

NCT00385671Boehringer Ingelheimduloxetine hydrochloride

An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain

Start: Sep 2006Est. completion: Nov 2009407 patients
Phase 4Completed
NCT01179672Eli Lilly and CompanyDuloxetine

A Study in Participants With Diabetic Peripheral Neuropathic Pain in China

Start: Apr 2011Est. completion: Aug 2013405 patients
Phase 3Completed
NCT01057693Pfizerpregabalin

Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

Start: Mar 2010Est. completion: Jan 2012633 patients
Phase 3Completed
NCT01089556Boehringer IngelheimDuloxetine

A Study in Painful Diabetic Neuropathy

Start: Mar 2010Est. completion: Nov 2011811 patients
Phase 3Completed
NCT00150423PfizerPregabalin

To Evaluate the Safety and Efficacy of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy.

Start: Jan 2001Est. completion: Jul 2005384 patients
Phase 3Completed
NCT01564459Merck & Co.MK-6096

Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021)

Start: Mar 2012Est. completion: Apr 2013170 patients
Phase 2Completed
NCT06152887Novo NordiskSooma Oy

Noninvasive Cortical Neurostimulation For Diabetic Neuropathic Pain

Start: Aug 2023Est. completion: Dec 202540 patients
N/AUnknown

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

4 late-stage (Phase 3) programs — potential near-term approvals
6 companies competing in this space

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