Diabetic Neuropathies

Neurology
16
Pipeline Programs
10
Companies
15
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
4
0
7
5
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Eli Lilly and Company
CYMBALTAApproved
duloxetine hydrochloride
Eli Lilly and Company
oral2004
U
DULOXETINE HYDROCHLORIDEApproved
duloxetine hydrochloride
Unknown Company
oral2013

Competitive Landscape

10 companies ranked by most advanced pipeline stage

Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
3 programs
1
2
DuloxetinePhase 41 trial
Duloxetine 60 mg QDPhase 41 trial
Duloxetine HydrochloridePhase 31 trial
Active Trials
NCT00408993Completed215Est. Feb 2008
NCT00322621Completed216Est. Oct 2007
NCT00844194Completed108
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
2 programs
1
1
DuloxetinePhase 4
Duloxetine HydrochloridePhase 3
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
2 programs
1
1
tramadol, acetaminophenPhase 31 trial
TopiramatePhase 21 trial
Active Trials
NCT00231673Completed72Est. Jan 2003
NCT00210847Completed313Est. May 2005
Pfizer
PfizerNEW YORK, NY
1 program
1
DVS SRPhase 32 trials
Active Trials
NCT01371708Completed283Est. Apr 2016
NCT00283842TerminatedEst. Jun 2008
M&
Merck & Co.RAHWAY, NJ
1 program
1
F0434Phase 31 trial
Active Trials
NCT01263132CompletedEst. Feb 2010
UP
UCB PharmaBelgium - Brussels
1 program
1
SPM 927Phase 31 trial
Active Trials
NCT00135109Completed654Est. Dec 2005
OD
1 program
1
tramadol, acetaminophenPhase 3
Astellas
AstellasChina - Shenyang
1 program
1
ASP8825Phase 24 trials
Active Trials
NCT02632331Completed18Est. Feb 2009
NCT02629224Completed18Est. Oct 2008
NCT02658188Completed182Est. Apr 2009
+1 more trials
SK Life Science
SK Life ScienceNJ - Paramus
1 program
1
Pregabalin 300 mg/dPhase 21 trial
Active Trials
NCT00870454CompletedEst. Dec 2010
Takeda
TakedaTOKYO, Japan
1 program
1
TAK-128Phase 21 trial
Active Trials
NCT00756041Terminated221Est. Sep 2006

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Boehringer IngelheimDuloxetine 60 mg QD
Boehringer IngelheimDuloxetine
PfizerDVS SR
Merck & Co.F0434
AstellasASP8825
Boehringer IngelheimDuloxetine Hydrochloride
PfizerDVS SR
UCB PharmaSPM 927
Johnson & Johnsontramadol, acetaminophen
SK Life SciencePregabalin 300 mg/d
AstellasASP8825
TakedaTAK-128
Johnson & JohnsonTopiramate
AstellasASP8825
AstellasASP8825

Clinical Trials (15)

Total enrollment: 2,499 patients across 15 trials

NCT00844194Boehringer IngelheimDuloxetine 60 mg QD

Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder

Start: Feb 2009108 patients
Phase 4Completed
NCT00322621Boehringer IngelheimDuloxetine

Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Start: Apr 2006Est. completion: Oct 2007216 patients
Phase 4Completed
NCT01371708PfizerDVS SR

A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD

Start: Feb 2012Est. completion: Apr 2016283 patients
Phase 3Completed
NCT01263132Merck & Co.F0434

Neuropathic Pain Management

Start: Feb 2008Est. completion: Feb 2010
Phase 3Completed
NCT02658188AstellasASP8825

Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Start: Dec 2007Est. completion: Apr 2009182 patients
Phase 3Completed
NCT00408993Boehringer IngelheimDuloxetine Hydrochloride

Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China

Start: Dec 2006Est. completion: Feb 2008215 patients
Phase 3Completed
NCT00283842PfizerDVS SR

Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy

Start: Mar 2006Est. completion: Jun 2008
Phase 3Terminated
NCT00135109UCB PharmaSPM 927

Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy

Start: Oct 2004Est. completion: Dec 2005654 patients
Phase 3Completed
NCT00210847Johnson & Johnsontramadol, acetaminophen

A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients

Start: Dec 2003Est. completion: May 2005313 patients
Phase 3Completed
NCT00870454SK Life SciencePregabalin 300 mg/d

An Efficacy and Safety Study of Carisbamate in the Treatment of Nerve Pain in Diabetics

Start: May 2009Est. completion: Dec 2010
Phase 2Completed
NCT00508430AstellasASP8825

ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

Start: Jul 2007Est. completion: Nov 2008199 patients
Phase 2Terminated
NCT00756041TakedaTAK-128

Safety Study of TAK-128 in Subjects With Diabetic Peripheral Neuropathy

Start: Sep 2005Est. completion: Sep 2006221 patients
Phase 2Terminated
NCT00231673Johnson & JohnsonTopiramate

A Study To Evaluate The Effect Of Topiramate On Clinical And Electrophysiological Parameters In Subjects With Diabetic Peripheral Polyneuropathy

Start: Jul 2001Est. completion: Jan 200372 patients
Phase 2Completed
NCT02632331AstellasASP8825

ASP8825 - A Study to Investigate the Food Effect on the Pharmacokinetics of ASP8825

Start: Jan 2009Est. completion: Feb 200918 patients
Phase 1Completed
NCT02629224AstellasASP8825

ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis

Start: Feb 2008Est. completion: Oct 200818 patients
Phase 1Completed

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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

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

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