Low Back Pain

15
Pipeline Programs
22
Companies
24
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
0
1
10
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
1100%
+ 23 programs with unclassified modality

On Market (2)

Approved therapies currently available

Ipsen
DYSPORTApproved
botulinum toxin type a
Ipsen
Acetylcholine Release Inhibitor [EPC]injection2009
U
TAPENTADOLApproved
tapentadol
Unknown Company
oral

Competitive Landscape

20 companies ranked by most advanced pipeline stage

Ipsen
IpsenChina - Tianjin
1 program
1
1
Botulinum toxin type APhase 31 trial
Active Trials
NCT00246155Completed35Est. Jul 2005
Mainstay Medical
Mainstay MedicalIreland - Dublin
1 program
1
Multifidus stimulatorPhase 41 trial
Active Trials
NCT04327817CompletedEst. Mar 2025
RS Medical
RS MedicalWA - Vancouver
1 program
1
Vertis Percutaneous Neuromodulation TherapyPhase 41 trial
Active Trials
NCT00290238Terminated122Est. Sep 2008
Teva
TevaIsrael - Petach Tikva
3 programs
3
Hydrocodone ERPhase 31 trial
Hydrocodone ERPhase 31 trial
OraVescent FentanylPhase 31 trial
Active Trials
NCT01789970Completed625Est. Feb 2014
NCT01922739Completed182Est. Aug 2014
NCT00228605Completed500Est. May 2007
Nektar Therapeutics
Nektar TherapeuticsSAN FRANCISCO, CA
2 programs
2
NKTR-181 BID tabletsPhase 31 trial
NKTR-181 BID tabletsPhase 31 trial
Active Trials
NCT02367820CompletedEst. Jan 2018
NCT02362672CompletedEst. Feb 2017
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
2 programs
2
tapentadolPhase 31 trial
tapentadolPhase 31 trial
Active Trials
NCT00449176Completed981Est. May 2008
NCT00594516Completed117Est. May 2008
Sanofi
SanofiPARIS, France
1 program
1
ITP FIRTECHPhase 31 trial
Active Trials
NCT05137041Completed221Est. Nov 2022
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
1
nonivamide + nicoboxilPhase 31 trial
Active Trials
NCT02300311Completed138Est. May 2015
Regeneron
RegeneronTARRYTOWN, NY
1 program
1
FasinumabPhase 2/3Monoclonal Antibody1 trial
Active Trials
NCT02620020Completed563Est. Sep 2017
Vivex Biologics
Vivex BiologicsGA - Atlanta
1 program
AlloGen-LIN/A1 trial
Active Trials
NCT02932020WithdrawnEst. Sep 2017
Design Therapeutics
1 program
Intervention TechnologyN/A1 trial
Active Trials
NCT03478007CompletedEst. Dec 2021
Nimbus Therapeutics
1 program
Lumbar MB RFNN/A1 trial
Active Trials
NCT02120625CompletedEst. Dec 2015
Aspen Medical products
1 program
Lumbar corsetN/A1 trial
Active Trials
NCT02251106Completed54Est. Jan 2014
AT
Agile TherapeuticsNJ - Princeton
1 program
Manual TherapyN/A1 trial
Active Trials
NCT05780593Completed44Est. Jun 2023
Genesis Therapeutics
Genesis TherapeuticsCA - Burlingame
1 program
Medical CareN/A1 trial
Active Trials
NCT01312233CompletedEst. Mar 2013
AM-Pharma
AM-PharmaNetherlands - Utrecht
1 program
Osteopathic Manipulative TreatmentN/A1 trial
Active Trials
NCT00426244CompletedEst. Sep 2011
M&
Merck & Co.RAHWAY, NJ
1 program
Pain Quality StudyN/A1 trial
Active Trials
NCT01321190Completed307Est. Apr 2013
Mission Therapeutics
Mission TherapeuticsUK - Cambridge
1 program
Rehabilitation exercisesN/A1 trial
Active Trials
NCT02864732Completed30Est. Feb 2015
United Therapeutics
United TherapeuticsMD - Silver Spring
1 program
SPRINT Peripheral Nerve StimulationN/A1 trial
Active Trials
NCT04246281Active Not Recruiting230Est. Apr 2027
Pfizer
PfizerNEW YORK, NY
1 program
painPREMIER cohortN/A1 trial
Active Trials
NCT01838057Terminated103Est. Jul 2014

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Mainstay MedicalMultifidus stimulator
RS MedicalVertis Percutaneous Neuromodulation Therapy
SanofiITP FIRTECH
Nektar TherapeuticsNKTR-181 BID tablets
Nektar TherapeuticsNKTR-181 BID tablets
Boehringer Ingelheimnonivamide + nicoboxil
TevaHydrocodone ER
TevaHydrocodone ER
Johnson & Johnsontapentadol
Johnson & Johnsontapentadol
TevaOraVescent Fentanyl
IpsenBotulinum toxin type A
RegeneronFasinumab
Agile TherapeuticsManual Therapy
United TherapeuticsSPRINT Peripheral Nerve Stimulation

Showing 15 of 24 trials with date data

Clinical Trials (24)

Total enrollment: 4,252 patients across 24 trials

NCT04327817Mainstay MedicalMultifidus stimulator

Multifidus PET Scan Study

Start: Aug 2021Est. completion: Mar 2025
Phase 4Completed
NCT00290238RS MedicalVertis Percutaneous Neuromodulation Therapy

Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients

Start: Dec 2005Est. completion: Sep 2008122 patients
Phase 4Terminated
NCT05137041SanofiITP FIRTECH

Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain

Start: Nov 2021Est. completion: Nov 2022221 patients
Phase 3Completed
NCT02367820Nektar TherapeuticsNKTR-181 BID tablets

Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain

Start: Apr 2015Est. completion: Jan 2018
Phase 3Completed
NCT02362672Nektar TherapeuticsNKTR-181 BID tablets

Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain

Start: Mar 2015Est. completion: Feb 2017
Phase 3Completed
NCT02300311Boehringer Ingelheimnonivamide + nicoboxil

Efficacy and Safety of Finalgon® Cream Multiple Doses in Acute Low Back Pain

Start: Jan 2015Est. completion: May 2015138 patients
Phase 3Completed
NCT01922739TevaHydrocodone ER

Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets

Start: Jul 2013Est. completion: Aug 2014182 patients
Phase 3Completed
NCT01789970TevaHydrocodone ER

Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

Start: Mar 2013Est. completion: Feb 2014625 patients
Phase 3Completed
NCT00594516Johnson & Johnsontapentadol

Study on the Safety and Effectiveness of Switching Between Two Forms of Tapentadol in Patients With Chronic Low Back Pain

Start: Dec 2007Est. completion: May 2008117 patients
Phase 3Completed
NCT00449176Johnson & Johnsontapentadol

A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain

Start: Feb 2007Est. completion: May 2008981 patients
Phase 3Completed
NCT00228605TevaOraVescent Fentanyl

Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain

Start: Mar 2005Est. completion: May 2007500 patients
Phase 3Completed
NCT00246155IpsenBotulinum toxin type A

Study on the Effects of Botulinum Toxin Type A on Back Muscle in Chronic Low Back Pain

Start: Jan 2005Est. completion: Jul 200535 patients
Phase 3Completed
NCT02620020RegeneronFasinumab

A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain

Start: Jan 2016Est. completion: Sep 2017563 patients
Phase 2/3Completed
NCT05780593Agile TherapeuticsManual Therapy

Effects of Manual Therapy and Inclined Board Standing on Low Back Pain

Start: Mar 2023Est. completion: Jun 202344 patients
N/ACompleted
NCT04246281United TherapeuticsSPRINT Peripheral Nerve Stimulation

The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain

Start: Jun 2020Est. completion: Apr 2027230 patients
N/AActive Not Recruiting
NCT03478007Design TherapeuticsIntervention Technology

Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients

Start: Aug 2019Est. completion: Dec 2021
N/ACompleted
NCT02932020Vivex BiologicsAlloGen-LI

AlloGen-LI Treatment of Spinal Stenosis

Start: Oct 2016Est. completion: Sep 2017
N/AWithdrawn
NCT02864732Mission TherapeuticsRehabilitation exercises

Stabilization Exercises Alone vs Stabilization Exercises Plus Neuromuscular Electrical Stimulation in People With Chronic Low Back Pain

Start: Jan 2014Est. completion: Feb 201530 patients
N/ACompleted
NCT02120625Nimbus TherapeuticsLumbar MB RFN

Technical Efficacy of a Direction Specific Radiofrequency Device in the Performance of Lumbar Medial Branch Neurotomies

Start: Dec 2013Est. completion: Dec 2015
N/ACompleted
NCT01838057PfizerpainPREMIER cohort

Evaluation of the Clinical and Economic Impact of painPRIMER in the Treatment of Low Back Pain in a Primary Care Setting

Start: Jun 2013Est. completion: Jul 2014103 patients
N/ATerminated
NCT02251106Aspen Medical productsLumbar corset

Effect of Lumbar Bracing on Spinal Function

Start: May 2012Est. completion: Jan 201454 patients
N/ACompleted
NCT01321190Merck & Co.Pain Quality Study

Pain Quality Study

Start: Jun 2011Est. completion: Apr 2013307 patients
N/ACompleted
NCT01312233Genesis TherapeuticsMedical Care

Collaborative Care for Older Adults With Back Pain (COCOA)

Start: Mar 2011Est. completion: Mar 2013
N/ACompleted
NCT00426244AM-PharmaOsteopathic Manipulative Treatment

Osteopathic Manipulative Medicine in Pregnancy: Physiologic and Clinical Effects

Start: Apr 2006Est. completion: Sep 2011
N/ACompleted

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

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