Painful Diabetic Neuropathy

Neurology
14
Pipeline Programs
5
Companies
10
Clinical Trials
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
6
0
4
4
Early DiscoveryClinical DevelopmentMarket

On Market (4)

Approved therapies currently available

U
ESLICARBAZEPINE ACETATEApproved
eslicarbazepine acetate
Unknown Company
oral2023
U
LACOSAMIDEApproved
lacosamide
Unknown Company
oral2022
U
MOTPOLY XRApproved
lacosamide
Unknown Company
oral2023
UP
VIMPATApproved
lacosamide
UCB Pharma
oral2008

Competitive Landscape

5 companies ranked by most advanced pipeline stage

UP
UCB PharmaBelgium - Brussels
5 programs
2
3
1
LacosamidePhase 31 trial
LacosamidePhase 31 trial
SPM 929Phase 31 trial
SPM927/LacosamidePhase 21 trial
SPM927/LacosamidePhase 21 trial
Active Trials
NCT00861042Completed69Est. Mar 2005
NCT00861445Completed119Est. Feb 2003
NCT00220337Completed371Est. Oct 2007
+2 more trials
Bial
BialPortugal - Coronado
2 programs
1
1
Eslicarbazepine acetatePhase 31 trial
Eslicarbazepine acetatePhase 21 trial
Active Trials
NCT00980746CompletedEst. Nov 2008
NCT01129960TerminatedEst. Apr 2012
WinSanTor
WinSanTorCA - San Diego
1 program
1
Active: WST-057 4mLPhase 21 trial
Active Trials
NCT04786340CompletedEst. Dec 2022
M&
Merck & Co.RAHWAY, NJ
1 program
1
Comparator: A: PregabalinPhase 21 trial
Active Trials
NCT00837941Withdrawn0Est. Sep 2009
SK Life Science
SK Life ScienceNJ - Paramus
1 program
1
SKL11197Phase 21 trial
Active Trials
NCT01521598CompletedEst. Jun 2013

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
BialEslicarbazepine acetate
UCB PharmaSPM 929
UCB PharmaLacosamide
UCB PharmaLacosamide
WinSanTorActive: WST-057 4mL
SK Life ScienceSKL11197
Merck & Co.Comparator: A: Pregabalin
BialEslicarbazepine acetate
UCB PharmaSPM927/Lacosamide
UCB PharmaSPM927/Lacosamide

Clinical Trials (10)

Total enrollment: 1,731 patients across 10 trials

NCT01129960BialEslicarbazepine acetate

Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain

Start: Nov 2010Est. completion: Apr 2012
Phase 3Terminated

A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy

Start: Jun 2006Est. completion: Jun 2007551 patients
Phase 3Completed

A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

Start: Dec 2004Est. completion: Oct 2007371 patients
Phase 3Completed

Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

Start: May 2004Est. completion: Jan 2011621 patients
Phase 3Completed
NCT04786340WinSanTorActive: WST-057 4mL

A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy

Start: Nov 2020Est. completion: Dec 2022
Phase 2Completed

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy

Start: Jan 2012Est. completion: Jun 2013
Phase 2Completed
NCT00837941Merck & Co.Comparator: A: Pregabalin

A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)

Start: Apr 2009Est. completion: Sep 20090
Phase 2Withdrawn
NCT00980746BialEslicarbazepine acetate

Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy

Start: Nov 2007Est. completion: Nov 2008
Phase 2Completed
NCT00861042UCB PharmaSPM927/Lacosamide

An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy

Start: Apr 2002Est. completion: Mar 200569 patients
Phase 2Completed
NCT00861445UCB PharmaSPM927/Lacosamide

A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

Start: Jun 2001Est. completion: Feb 2003119 patients
Phase 2Completed

Related Jobs in Neurology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

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