Spinal Stenosis

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

Spine BioPharmaNY - New York

6 programs

Epidural steroid with local anesthetic injectionPhase 4

DecompressionN/A

Implantation of coflex™ after surgical decompressionN/A

Instrumented posterolateral spine fusion.N/A1 trial

coflex® Interlaminar TechnologyN/A

+1 more programs

Active Trials

NCT04166981Completed104Est. Dec 2021

MedtronicNJ - Phillipsburg

2 programs

Aperius® Percutaneous Interspinous SpacerPhase 41 trial

Aperius™ PercLID™ SystemPhase 41 trial

Active Trials

NCT00887744Completed162Est. Mar 2010

NCT00905359Completed163Est. Apr 2015

Colorado TherapeuticsCO - Louisville

1 program

Epidural steroid with local anesthetic injectionPhase 41 trial

Active Trials

NCT01238536Completed400Est. Sep 2015

Oregon TherapeuticsFrance - Paris

1 program

Epidural steroid with local anesthetic injectionPhase 4

Paradigm TherapeuticsSC - Mount Pleasant

3 programs

DecompressionN/A1 trial

Implantation of coflex™ after surgical decompressionN/A1 trial

coflex® Interlaminar TechnologyN/A1 trial

Active Trials

NCT00534235Completed322Est. Dec 2015

NCT01316211Completed246Est. Aug 2014

NCT03041896Completed5,050Est. Aug 2018

CerapedicsCO - Westminster

2 programs

i-FACTORN/A1 trial

i-FACTORPHASE_31 trial

Active Trials

NCT02895555Completed102Est. Sep 2020

NCT01618435Unknown108Est. May 2018

PfizerNEW YORK, NY

1 program

Dexmedetomidine groupN/A1 trial

Active Trials

NCT01377623Terminated66Est. Jan 2012

Physical SciencesMA - Andover

1 program

Endoscopic Spinal Canal DecompressionN/A1 trial

Active Trials

NCT07232836Not Yet Recruiting100Est. Dec 2030

UNION therapeuticsDenmark - Hellerup

1 program

Wound topically irrigated with 500mg TXAN/A1 trial

Active Trials

NCT03011866Unknown176

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

Colorado TherapeuticsEpidural steroid with local anesthetic injection

MedtronicAperius™ PercLID™ System

MedtronicAperius® Percutaneous Interspinous Spacer

Cerapedicsi-FACTOR

Physical SciencesEndoscopic Spinal Canal Decompression

UNION therapeuticsWound topically irrigated with 500mg TXA

Spine BioPharmaInstrumented posterolateral spine fusion.

Paradigm Therapeuticscoflex® Interlaminar Technology

Paradigm TherapeuticsDecompression

Cerapedicsi-FACTOR

PfizerDexmedetomidine group

Paradigm TherapeuticsImplantation of coflex™ after surgical decompression

Clinical Trials (12)

Total enrollment: 6,999 patients across 12 trials

NCT01238536 Colorado TherapeuticsEpidural steroid with local anesthetic injection

Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)

Start: Apr 2011Est. completion: Sep 2015400 patients

Phase 4Completed

NCT00905359 MedtronicAperius™ PercLID™ System

Neurogenic Intermittent Claudication Evaluation Study

Start: Jan 2010Est. completion: Apr 2015163 patients

Phase 4Completed

NCT00887744 MedtronicAperius® Percutaneous Interspinous Spacer

Intermittent Neurogenic Claudication Treatment With APERIUS®

Start: Nov 2006Est. completion: Mar 2010162 patients

Phase 4Completed

NCT01618435 Cerapedicsi-FACTOR

The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation in the Elderly With Spinal Stenosis Due to Degenerative Spondylolisthesis

Start: Mar 2012Est. completion: May 2018108 patients

Phase 3Unknown

NCT07232836 Physical SciencesEndoscopic Spinal Canal Decompression

Cytokines, Neuroplasticity Modulators, and Biomarkers in Spinal Canal Stenosis and Endoscopic Decompression

Start: Nov 2025Est. completion: Dec 2030100 patients

N/ANot Yet Recruiting

NCT03011866 UNION therapeuticsWound topically irrigated with 500mg TXA

Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

Start: Feb 2017176 patients

N/AUnknown

NCT04166981 Spine BioPharmaInstrumented posterolateral spine fusion.

Instr. vs. Non-instr. Posterolateral Spinal Fusion in Patients With Spinal Stenosis and Degenerative Listhesis

Start: Jan 2017Est. completion: Dec 2021104 patients

N/ACompleted

NCT03041896 Paradigm Therapeuticscoflex® Interlaminar Technology

Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion

Start: Jul 2016Est. completion: Aug 20185,050 patients

N/ACompleted

NCT00534235 Paradigm TherapeuticsDecompression

Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis

Start: Oct 2012Est. completion: Dec 2015322 patients

N/ACompleted

NCT02895555 Cerapedicsi-FACTOR

The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Fusion The IVANOS-study

Start: Mar 2012Est. completion: Sep 2020102 patients

N/ACompleted

NCT01377623 PfizerDexmedetomidine group

Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion

Start: Sep 2010Est. completion: Jan 201266 patients

N/ATerminated

NCT01316211 Paradigm TherapeuticsImplantation of coflex™ after surgical decompression

Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis

Start: Jan 2008Est. completion: Aug 2014246 patients

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

9 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.