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(Albany, US) On November 05, 2026, DelveInsight’s “Spasticity Market Insights, Epidemiology and Market Forecast – 2036” report provides comprehensive insights into the Spasticity market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type, and examines the market drivers and barriers shaping the space.

Discover the latest drugs and treatment options in the Spasticity Market @ https://www.delveinsight.com/report-store/spasticity-market

Key Takeaways from the Spasticity Report

• In May 2026, Ipsen reported results from the Phase IV DIRECTION trial, the only prospective head-to-head study of abobotulinumtoxinA (DYSPORT) versus Botox in adults with upper limb spasticity. DYSPORT showed a non-inferior safety profile and longer-lasting symptom control, presented at the ISPRM World Congress 2026.

• In April 2026, Bristol Myers Squibb said it expects data from the Phase II BALANCE-MSS-1 trial of BMS-986368, a FAAH/MAGL inhibitor, in multiple sclerosis-associated spasticity in 2027.

• In October 2024, Saol Therapeutics announced positive topline results from the SL-1002 (RAISE) trial, showing a favorable safety profile in adults with limb spasticity.

• In April 2025, BlackfinBio received FDA IND clearance for a Phase I/II trial of its AAV gene therapy BFB-101 in children with hereditary spastic paraplegia type 47 (SPG47).

• Spasticity affects about 35% of stroke patients, more than 90% of people with cerebral palsy, about 50% of traumatic brain injury patients, about 40% of spinal cord injury patients, and 37 to 78% of people with multiple sclerosis.

• DelveInsight’s report depicts a space with little recent oral drug innovation, now shifting toward endocannabinoid modulators, longer-acting neurotoxins, injectables, and gene therapy.

• Leading Spasticity companies include Azurity, Merz Pharma, Ipsen Pharmaceuticals, Amneal Pharmaceuticals, Metacel Pharmaceuticals, Bristol-Myers Squibb, Saol Therapeutics, BlackfinBio, Sania Therapeutics, Pacira Pharmaceuticals, and others.

• Promising therapies include baclofen (LIORESAL/FLEQSUVY/OZOBAX), incobotulinumtoxinA (XEOMIN), abobotulinumtoxinA (DYSPORT), BMS-986368, SL-1002, IPN10200, BFB-101, SRx-T001, IOVERA, and others.

Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Spasticity Treatment Drugs

Spasticity Overview

Spasticity is a neurological disorder of increased muscle tone, stiffness, and involuntary spasms caused by damage to the brain or spinal cord. It commonly occurs in multiple sclerosis, cerebral palsy, stroke, traumatic brain injury, and spinal cord injury, and leads to impaired mobility, pain, and reduced quality of life. Diagnosis is clinical, using the Modified Ashworth Scale and Tardieu Scale, with MRI or CT when needed. Management is multidisciplinary. Physical and occupational therapy are first-line, oral agents such as baclofen, tizanidine, and diazepam treat widespread spasticity (with drowsiness limiting use), botulinum toxin injections treat focal spasticity, and intrathecal baclofen is used in severe cases. Surgery is considered when conservative measures fail.

Common features include:

• Increased muscle tone and stiffness

• Involuntary muscle spasms

• Impaired mobility

• Pain

• Reduced quality of life

Spasticity Emerging Drugs Profile

BMS-986368: Bristol-Myers Squibb BMS-986368 is an investigational oral small-molecule dual inhibitor of FAAH and MAGL that raises endogenous endocannabinoid levels (anandamide and 2-AG) to enhance cannabinoid receptor signaling and reduce neuronal hyperexcitability. It is being studied in the randomized, placebo-controlled Phase II BALANCE-MSS-1 trial in about 200 patients with MS-related spasticity, with data expected in 2027. Currently, the drug is in Phase II.

SL-1002: Saol Therapeutics SL-1002 is an investigational perineural chemoneurolytic injection built on Saol’s proprietary CYCLOPHLE technology, being developed for adult limb spasticity. Positive topline results from the RAISE trial in October 2024 showed a favorable safety profile. Currently, the drug is in Phase II.

BFB-101: BlackfinBio BFB-101 is an AAV gene therapy given by intra-cisterna magna injection for hereditary spastic paraplegia type 47 in children. It received FDA IND clearance in April 2025. Currently, the therapy is in Phase I/II.

Explore groundbreaking therapies and clinical trials in the Spasticity Pipeline @ Spasticity Treatment Drugs

Spasticity Market Drivers

• Rising neurological disease burden: Growing stroke, multiple sclerosis, cerebral palsy, brain injury, and spinal cord injury populations are expanding the pool of patients with spasticity.

• Better diagnosis and rehabilitation: Improved diagnosis, treatment rates, and integration of drugs with physical therapy support broader use of therapies.

• Large unmet need: Current treatments give symptomatic relief but often fail to deliver sustained functional improvement, and little oral innovation has occurred in two to three decades.

• Novel mechanisms: Endocannabinoid modulators, perineural injections, and gene therapy aim for longer-lasting control.

• Long-acting options: Head-to-head data for DYSPORT and new formulations may reduce treatment burden.

• Lifecycle innovation: New baclofen formulations such as OZOBAX and FLEQSUVY improve convenience.

• Multidisciplinary care: Wider access to specialized rehabilitation supports treatment uptake.

Learn about new drugs, pipeline developments, and key players with DelveInsight’s expert analysis @ Spasticity Market Drivers and Barriers

Spasticity Market Barriers

• Entrenched generics: Generic baclofen and tizanidine are widely used and inexpensive.

• Side effects of oral drugs: Drowsiness and weakness limit daytime use and utility.

• Short duration and repeat dosing: Botulinum toxin effects wear off, creating a repeated treatment burden.

• Early-stage pipeline: Most candidates are in Phase II or earlier, with data not due until 2027.

• Delayed referral and access: Limited access to multidisciplinary rehabilitation slows treatment.

• Heterogeneous patient population: Varied causes and treatment responses complicate trials and personalization.

• Reimbursement pressure: Payers may scrutinize high-cost injectables and gene therapies against inexpensive generics.

Scope of the Spasticity Report

• Coverage: 7MM (US, EU4, UK, Japan)

• Companies: As listed above

• Therapies: Baclofen (LIORESAL/FLEQSUVY/OZOBAX), incobotulinumtoxinA (XEOMIN), abobotulinumtoxinA (DYSPORT), BMS-986368, SL-1002, IPN10200, BFB-101, SRx-T001, IOVERA, and others

• Assessment by Product Type: Mono, Combination, Mono/Combination

• Assessment by Clinical Stage: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Download DelveInsight’s in-depth Spasticity report today! @ Spasticity Companies

Table of Contents

1. Introduction

2. Executive Summary

3. Spasticity: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III): None currently

8. Mid Stage Products (Phase II): BMS-986368 (Bristol-Myers Squibb), SL-1002 (Saol Therapeutics)

9. Early Stage Products (Phase I): BFB-101 (BlackfinBio), Phase I/II

10. Preclinical and Discovery Stage Products

11. Inactive Products

12. Key Companies

13. Key Products

14. Unmet Needs

15. Market Drivers and Barriers

16. Future Perspectives and Conclusion

17. Analyst Views

18. Appendix

19. About Us

About DelveInsight DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.

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