Lumbar Spinal Stenosis

Pipeline Programs

Companies

Clinical Trials

2 recruiting

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide

1100%

+ 33 programs with unclassified modality

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

Spine BioPharmaNY - New York

10 programs

Liposomal bupivacainePhase 41 trial

X-STOP PEEKPhase 4

X-STOP®Phase 4

Standard analgesia use [Oxygen]Phase 11 trial

Stabilimax NZ® Dynamic Spine Stabilization SystemN/A1 trial

+5 more programs

Active Trials

NCT00529997Terminated480Est. Dec 2010

NCT04079894Completed206Est. Feb 2023

NCT01933607Unknown10Est. Dec 2016

+4 more trials

Vertos MedicalCA - Aliso Viejo

6 programs

Interlaminar DecompressionPhase 41 trial

MILD®Phase 41 trial

lumbar decompressionPhase 41 trial

Minimally Invasive Lumbar DecompressionN/A1 trial

+1 more programs

Active Trials

NCT00749073Completed10Est. Jul 2009

NCT01076244Completed46Est. Jan 2012

NCT01315145Completed138Est. May 2014

+3 more trials

MedtronicNJ - Phillipsburg

3 programs

X-STOP PEEKPhase 41 trial

X-STOP®Phase 41 trial

X STOP® Interspinous Process Decompression SystemN/A1 trial

Active Trials

NCT00534092Completed69Est. Jun 2010

NCT00517751Terminated176Est. Apr 2015

NCT00558129Withdrawn0Est. Nov 2011

PfizerNEW YORK, NY

1 program

PregabalinPhase 41 trial

Active Trials

NCT00638443Completed29Est. Sep 2010

Colorado TherapeuticsCO - Louisville

2 programs

Liposomal bupivacainePhase 21 trial

Epidural steroid injection plus physical therapyN/A1 trial

Active Trials

NCT00786981Completed54Est. Dec 2018

NCT04066296Recruiting100Est. Jan 2025

AttralusFL - Naples

1 program

124I-evuzamitidePhase 2Peptide1 trial

Active Trials

NCT06907849Enrolling By Invitation40Est. May 2027

Boston ScientificCA - Valencia

4 programs

Superion® Indirect Decompression SystemN/A1 trial

Superion™ IDSN/A1 trial

Superion™ IDS deviceN/A1 trial

Superion™ Interspinous SpacerN/A1 trial

Active Trials

NCT04087811Completed1,674Est. Mar 2021

NCT04563793Completed129Est. Mar 2023

NCT04192591Active Not Recruiting166Est. Feb 2041

+1 more trials

Globus MedicalAUDUBON, PA

2 programs

FLEXUSN/A1 trial

Non-randomized ACADIA® Facet Replacement SystemN/A1 trial

Active Trials

NCT01156675Terminated215Est. Jul 2015

NCT00401518Completed390Est. Oct 2017

Medical MetricsTX - Houston

2 programs

Flexion-extension radiographsN/A1 trial

Sagittal plane shear indexN/A1 trial

Active Trials

NCT05633550Active Not Recruiting45Est. Jul 2026

NCT03754972Completed100Est. Mar 2025

StrykerCA - San Jose

1 program

MILDN/A1 trial

Active Trials

NCT03072927Recruiting8,000Est. Dec 2026

Relief TherapeuticsSwitzerland - Geneva

1 program

Minimally Invasive Lumbar DecompressionN/A

Spinal SimplicityKS - Overland Park

1 program

Minuteman Fusion ImplantN/A1 trial

Active Trials

NCT01455805Completed48Est. Mar 2024

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

2028

2029

2030

2031

Spine BioPharmaLiposomal bupivacaine

Vertos Medicallumbar decompression

Vertos MedicalMILD®

Vertos MedicalInterlaminar Decompression

PfizerPregabalin

MedtronicX-STOP®

MedtronicX-STOP PEEK

Attralus124I-evuzamitide

Colorado TherapeuticsLiposomal bupivacaine

Spine BioPharmaStandard analgesia use [Oxygen]

Medical MetricsFlexion-extension radiographs

Boston ScientificSuperion™ IDS

Boston ScientificSuperion™ IDS device

Spine BioPharmaStandard Movement Protocol

Medical MetricsSagittal plane shear index

Showing 15 of 30 trials with date data

Clinical Trials (30)

Total enrollment: 13,111 patients across 30 trials

NCT03745040 Spine BioPharmaLiposomal bupivacaine

Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

Start: Jan 2019Est. completion: Aug 202860 patients

Phase 4Suspended

NCT01082159 Vertos Medicallumbar decompression

MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

Start: Feb 2010Est. completion: Jan 201355 patients

Phase 4Completed

NCT00995371 Vertos MedicalMILD®

Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis

Start: Aug 2009Est. completion: May 201338 patients

Phase 4Completed

NCT00956631 Vertos MedicalInterlaminar Decompression

MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

Start: Jul 2008Est. completion: Apr 201278 patients

Phase 4Completed

NCT00638443 PfizerPregabalin

Lumbar Stenosis Outcomes Research (LUSTOR)

Start: Mar 2008Est. completion: Sep 201029 patients

Phase 4Completed

NCT00558129 MedtronicX-STOP®

Effects of X-STOP® Versus Laminectomy Study

Start: Nov 2007Est. completion: Nov 20110

Phase 4Withdrawn

NCT00517751 MedtronicX-STOP PEEK

Condition of Approval Study

Start: Aug 2007Est. completion: Apr 2015176 patients

Phase 4Terminated

NCT06907849 Attralus124I-evuzamitide

124I-Evuzamitide PET/CT Imaging In Patients With Lumbar Spinal Stenosis and Carpal Tunnel Syndrome

Start: May 2025Est. completion: May 202740 patients

Phase 2Enrolling By Invitation

NCT04066296 Colorado TherapeuticsLiposomal bupivacaine

Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

Start: Sep 2019Est. completion: Jan 2025100 patients

Phase 2Recruiting

NCT03088306 Spine BioPharmaStandard analgesia use [Oxygen]

Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients

Start: Jul 2017Est. completion: Aug 201849 patients

Phase 1Completed

NCT05633550 Medical MetricsFlexion-extension radiographs

Flexion-Extension Radiograph Imaging Protocol Reliability Study

Start: Nov 2024Est. completion: Jul 202645 patients

N/AActive Not Recruiting

NCT04563793 Boston ScientificSuperion™ IDS

Postmarket Outcomes Study for Evaluation of the Superion™ Spacer

Start: Oct 2020Est. completion: Mar 2023129 patients

N/ACompleted

NCT04192591 Boston ScientificSuperion™ IDS device

A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

Start: Jan 2020Est. completion: Feb 2041166 patients

N/AActive Not Recruiting

NCT04079894 Spine BioPharmaStandard Movement Protocol

Physical Activity in the Elderly Spine Patient

Start: Jun 2019Est. completion: Feb 2023206 patients

N/ACompleted

NCT03754972 Medical MetricsSagittal plane shear index

Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery

Start: Feb 2019Est. completion: Mar 2025100 patients

N/ACompleted

NCT03012776 Spine BioPharmaTotal Posterior Spine System

A Pivotal Study of the Premia Spine TOPS™ System

Start: Jul 2017Est. completion: Jun 2023305 patients

N/ACompleted

NCT03072927 StrykerMILD

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

Start: Mar 2017Est. completion: Dec 20268,000 patients

N/ARecruiting

NCT04087811 Boston ScientificSuperion® Indirect Decompression System

Postmarket Registry for Evaluation of the Superion® Spacer

Start: Nov 2016Est. completion: Mar 20211,674 patients

N/ACompleted

NCT02234154 Spine BioPharmaTOPS System

Post-market Study of the TOPS™ System

Start: Dec 2014Est. completion: May 201710 patients

N/AUnknown

NCT01933607 Spine BioPharmaTOPS System

Post-market Study of the TOPS™ System

Start: May 2014Est. completion: Dec 201610 patients

N/AUnknown

NCT01455805 Spinal SimplicityMinuteman Fusion Implant

Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis

Start: Jun 2012Est. completion: Mar 202448 patients

N/ACompleted

NCT01315145 Vertos MedicalPercutaneous Lumbar Decompression

MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

Start: Mar 2011Est. completion: May 2014138 patients

N/ACompleted

NCT01076244 Vertos MedicalMinimally Invasive Lumbar Decompression

Vertos Mild - Post Market Patient Outcomes

Start: Feb 2010Est. completion: Jan 201246 patients

N/ACompleted

NCT00786981 Colorado TherapeuticsEpidural steroid injection plus physical therapy

Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis

Start: Apr 2009Est. completion: Dec 201854 patients

N/ACompleted

NCT00749073 Vertos MedicalMinimally Invasive Lumbar Decompression

The Vertos MILD™ Preliminary Patient Evaluation Study

Start: Sep 2008Est. completion: Jul 200910 patients

N/ACompleted

NCT01156675 Globus MedicalFLEXUS

Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer

Start: Jun 2008Est. completion: Jul 2015215 patients

N/ATerminated

NCT00692276 Boston ScientificSuperion™ Interspinous Spacer

Investigating Superion™ In Spinal Stenosis

Start: Jun 2008Est. completion: Feb 2017391 patients

N/ACompleted

NCT00529997 Spine BioPharmaStabilimax NZ® Dynamic Spine Stabilization System

Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System

Start: Feb 2007Est. completion: Dec 2010480 patients

N/ATerminated

NCT00534092 MedtronicX STOP® Interspinous Process Decompression System

Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®

Start: Dec 2006Est. completion: Jun 201069 patients

N/ACompleted

NCT00401518 Globus MedicalNon-randomized ACADIA® Facet Replacement System

A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis

Start: Oct 2006Est. completion: Oct 2017390 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

2 actively recruiting trials targeting 13,111 patients

13 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.