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Spasticity Pipeline Insight

DelveInsight’s “Spasticity – Pipeline Insight, 2025” explores a dynamic portfolio of emerging therapies poised to redefine management. Next-generation botulinum toxins with extended duration of action are under development to reduce the frequency of injections and improve patient compliance. Regenerative approaches, including stem cell therapies and gene-modifying treatments, are being investigated to restore neural pathways and address the root causes of motor dysfunction. Novel oral and injectable small molecules—such as selective GABA modulators and ion channel regulators—promise improved efficacy with reduced adverse effects compared to existing options.

Beyond pharmacology, the pipeline also features innovative non-invasive neuromodulation devices and digital health platforms designed to integrate physiotherapy with real-time patient monitoring. These advances aim to deliver personalized, outcome-driven care while reducing the burden on patients and caregivers.

With increasing research investments, expanding clinical trials, and a growing emphasis on holistic rehabilitation strategies, the 2025 spasticity pipeline reflects a paradigm shift—moving from temporary symptom control toward transformative, long-term functional recovery.

Interested in learning more about the current treatment landscape and the key drivers shaping the Spasticity pipeline? Click here

Key Takeaways from the Spasticity Pipeline Report

• DelveInsight’s spasticity pipeline analysis depicts a strong space with 10+ active players working to develop 12+ pipeline drugs for spasticity treatment.

• The leading spasticity companies include RVL Pharmaceuticals, Huons, Bionorica SE, Supernus Pharmaceuticals, Saol Therapeutics, Revance Therapeutics, Flex Pharma, Canbex Therapeutics, Ipsen, Lundbeck A/S, CKD Bio Corporation, Sentynl Therapeutics, Shionogi, Lexicon Pharmaceuticals, Incannex, Delpor, Ethicann Pharmaceuticals, and others are evaluating their lead assets to improve the Spasticity treatment landscape.

• Key spasticity pipeline therapies in various stages of development include Arbaclofen extended release, HU-014, BX-1, Myobloc, SL-1002, DAXI, FLX 787, VSN-16R, IPN10200, IPN59011, Lu AG06466, CKDB-501A, STI-103, S-109802, LX9211, Medchew Rx, DLP-208, and others.

• In July 2025, an international clinical trial began testing that same oral therapy in MS spasticity, designed to enhance naturally produced molecules (endocannabinoids) by inhibiting the MAGL and FAAH enzymes. The study includes a placebo period followed by open-label or dose comparison among active arms.

• In July 2025, a Phase II international trial was initiated for a novel oral drug (sponsored in part by Bristol Myers Squibb) in MS patients to treat muscle spasticity. The drug inhibits two enzymes — MAGL (monoacylglycerol lipase) and FAAH (fatty acid amide hydrolase) — thereby boosting endocannabinoid levels to help muscles relax. Approximately 200 participants will be randomized across multiple doses and placebo, with a 6-week treatment period, followed by additional evaluation.

• In May 2025, the FDA approved a Phase 1/2 clinical trial (IND cleared) for BlackfinBio Limited’s novel AAV (adenovirus-associated virus) gene therapy BFB-101, targeting Hereditary Spastic Paraplegia (HSP) Type 47 (SPG47). This trial will assess safety, tolerability, and preliminary efficacy in patients with SPG47.

Spasticity Overview

Spasticity is a condition characterized by abnormal muscle tightness due to prolonged muscle contraction, typically resulting from damage to the brain or spinal cord. It is commonly associated with neurological disorders such as multiple sclerosis (MS), cerebral palsy, stroke, spinal cord injury, and traumatic brain injury. Symptoms can include stiffness, involuntary muscle spasms, pain, and difficulty with movement or speech.

Spasticity can significantly impact quality of life, limiting mobility and daily functioning. Treatment typically involves a combination of physical therapy, oral medications (such as baclofen or tizanidine), injectable therapies (like botulinum toxin), and in severe cases, surgical interventions. Advances in drug development and neuromodulation are contributing to more targeted and effective spasticity management strategies.

Find out more about Spasticity medication at https://www.delveinsight.com/report-store/spasticity-pipeline-insight

Spasticity Treatment Analysis: Drug Profile

MTR-601: Motric Bio

MTR-601 is a potential first-in-class oral antispastic therapy that uniquely targets myosin 2, a contractile protein in fast-twitch skeletal muscles. Designed to treat cervical dystonia, it selectively relaxes fast-twitch muscle fibers, aiming to reduce stiffness and enhance physical function. Supported by strong preclinical data, MTR-601 has shown promising results in improving gait in spastic cerebral palsy models. The drug is currently in Phase II clinical trials for spasticity treatment.

IPN10200: Ipsen

IPN10200 is a long-acting botulinum neurotoxin candidate from Ipsen, developed to treat upper limb spasticity. Engineered for prolonged effects, it works by inhibiting acetylcholine release at neuromuscular junctions to provide sustained muscle relaxation. This targeted neurotoxin aims to maintain consistent muscle tone reduction, potentially lowering injection frequency and enhancing patient convenience. IPN10200 is currently in Phase I/II clinical development for spasticity management.

Learn more about the novel and emerging Spasticity pipeline therapies.

Spasticity Therapeutics Assessment

By Product Type

• Mono

• Combination

• Mono/Combination.

By Stage

• Late-stage products (Phase III)

• Mid-stage products (Phase II)

• Early-stage product (Phase I) along with the details of

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

By Route of Administration

• Oral

• Intravenous

• Subcutaneous

• Parenteral

• Topical

By Molecule Type

• Recombinant fusion proteins

• Small molecule

• Monoclonal antibody

• Peptide

• Polymer

• Gene therapy

Scope of the Spasticity Pipeline Report

• Coverage: Global

• Key Spasticity Companies: RVL Pharmaceuticals, Huons, Bionorica SE, Supernus Pharmaceuticals, Saol Therapeutics, Revance Therapeutics, Flex Pharma, Canbex Therapeutics, Ipsen, Lundbeck A/S, CKD Bio Corporation, Sentynl Therapeutics, Shionogi, Lexicon Pharmaceuticals, Incannex, Delpor, Ethicann Pharmaceuticals, and others.

• Key Spasticity Pipeline Therapies: Arbaclofen extended release, HU-014, BX-1, Myobloc, SL-1002, DAXI, FLX 787, VSN-16R, IPN10200, IPN59011, Lu AG06466, CKDB-501A, STI-103, S-109802, LX9211, Medchew Rx, DLP-208, and others.

Explore detailed insights on drugs used in the treatment of Spasticity here.

Table of Contents

1. Introduction

2. Executive Summary

3. Spasticity Pipeline: Overview

4. Analytical Perspective In-depth Commercial Assessment

5. Spasticity Pipeline Therapeutics

6. Spasticity Pipeline: Late-Stage Products (Phase III)

7. Spasticity Pipeline: Mid-Stage Products (Phase II)

8. Spasticity Pipeline: Early Stage Products (Phase I)

9. Therapeutic Assessment

10. Inactive Products

11. Company-University Collaborations (Licensing/Partnering) Analysis

12. Key Companies

13. Key Products

14. Unmet Needs

15. Market Drivers and Barriers

16. Future Perspectives and Conclusion

17. Analyst Views

18. Appendix

About DelveInsight

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