Spasticity Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Spasticity pipeline constitutes 10+ key companies continuously working towards developing 12+ Spasticity treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Spasticity Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Spasticity Market.

The Spasticity Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Spasticity Pipeline Report: https://www.delveinsight.com/sample-request/spasticity-pipeline-insight?utm_source=openpr&utm_medium=promotion&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Spasticity treatment therapies with a considerable amount of success over the years.
• Spasticity companies working in the treatment market are Lundbeck, Revance Therapeutics, Ipsen, Saol Therapeutics, Huons, Supernus Pharma, Sun Pharma, Acorda Therapeutics, Merz Pharmaceuticals GmbH, Medy-Tox, XenoPort, Inc., Medtronic Neuro, Daewoong Pharma, and others, are developing therapies for the Spasticity treatment
• Emerging Spasticity therapies in the different phases of clinical trials are- Lu AG06466, DAXXIFY, IPN10200, SIL 1002, HU-014, MYOBLOC, SPARC1103, Tizanidine, CORETOX®, XP19986 SR1, intrathecal baclofen, Botulinum toxin type A, and others are expected to have a significant impact on the Spasticity market in the coming years.
• In July 2025, A global Phase 2 clinical trial, BALANCE-MSS-1 (NCT06782490), has been initiated to assess the oral therapy candidate BMS-986368 for the treatment of spasticity - characterized by muscle stiffness and spasms - in individuals with multiple sclerosis (MS). The study aims to enroll around 200 adult MS patients who have been experiencing spasticity for at least six months. Trial sites are located in the U.S., Australia, Canada, Puerto Rico, and several European countries, with some already open for recruitment. The trial is sponsored by Celgene and conducted by Bristol Myers Squibb, which acquired Celgene in 2019.
• In April 2025, The US FDA has approved BlackfinBio's IND application to initiate a Phase I/II trial of BFB-101, an adeno-associated virus gene therapy for hereditary spastic paraplegia type 47 (SPG47). The therapy has also received orphan drug and rare pediatric disease designations for SPG47, a rare disorder caused by AP4B1 gene mutations, leading to progressive lower-limb spasticity and developmental delays in children.
• In March 2025, BlackfinBio Limited announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its innovative adeno-associated virus (AAV) gene therapy designed to treat Hereditary Spastic Paraplegia Type 47 (SPG47).
• In January 2024, Neurotech International obtained clearance from both the Human Research Ethics Committee (HREC) and the Therapeutic Goods Administration (TGA) to initiate a Phase I/II clinical trial for NTI164 in treating cerebral palsy (CP). This trial will focus on assessing the effectiveness and safety of NTI164 specifically in pediatric patients diagnosed with spastic CP, the most common form of this condition.

Spasticity Overview
Spasticity is a condition characterized by an abnormal increase in muscle tone or stiffness, which can interfere with movement, speech, and gait. It is caused by damage to or a disruption in the pathways that control muscle movement, typically within the brain or spinal cord.

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Emerging Spasticity Drugs Under Different Phases of Clinical Development Include:
• Lu AG06466: Lundbeck
• DAXXIFY: Revance Therapeutics
• IPN10200: Ipsen
• HU-014: Huons
• SL-1002: Saol Therapeutics Inc
• MYOBLOC: Supernus Pharma
• SPARC1103: Sun Pharma
• Tizanidine: Acorda Therapeutics
• botulinum A toxin: Merz Pharmaceuticals GmbH
• CORETOX®: Medy-Tox
• XP19986 SR1: XenoPort, Inc.
• intrathecal baclofen: MedtronicNeuro

Spasticity Route of Administration
Spasticity pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Spasticity Molecule Type
Spasticity Products have been categorized under various Molecule types, such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Spasticity Pipeline Therapeutics Assessment
• Spasticity Assessment by Product Type
• Spasticity By Stage and Product Type
• Spasticity Assessment by Route of Administration
• Spasticity By Stage and Route of Administration
• Spasticity Assessment by Molecule Type
• Spasticity by Stage and Molecule Type

DelveInsight's Spasticity Report covers around 12+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Spasticity product details are provided in the report. Download the Spasticity pipeline report to learn more about the emerging Spasticity therapies
https://www.delveinsight.com/sample-request/spasticity-pipeline-insight?utm_source=openpr&utm_medium=promotion&utm_campaign=gpr

Spasticity Pipeline Analysis:
The Spasticity pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Spasticity with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Spasticity Treatment.
• Spasticity key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Spasticity Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Spasticity market.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Spasticity drugs and therapies
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Spasticity Pipeline Market Drivers
• Increasing prevalence of stroke, multiple sclerosis, and brain injury drive the market, increasing R&D for developing effective therapies are some of the important factors that are fueling the Spasticity Market.

Spasticity Pipeline Market Barriers
• However, high cost of the treatment, lack of disease awareness in emerging economies and other factors are creating obstacles in the Spasticity Market growth.

Scope of Spasticity Pipeline Drug Insight
• Coverage: Global
• Key Spasticity Companies: Lundbeck, Revance Therapeutics, Ipsen, Saol Therapeutics, Huons, Supernus Pharma, Sun Pharma, Acorda Therapeutics, Merz Pharmaceuticals GmbH, Medy-Tox, XenoPort, Inc., Medtronic Neuro, Daewoong Pharma, and others
• Key Spasticity Therapies: Lu AG06466, DAXXIFY, IPN10200, SIL 1002, HU-014, MYOBLOC, SPARC1103, Tizanidine, CORETOX®, XP19986 SR1, intrathecal baclofen, Botulinum toxin type A, and others
• Spasticity Therapeutic Assessment: Spasticity current marketed and Spasticity emerging therapies
• Spasticity Market Dynamics: Spasticity market drivers and Spasticity market barriers

Request for Sample PDF Report for Spasticity Pipeline Assessment and clinical trials
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Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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