Hunter Syndrome Pipeline Drugs Report 2025: Drug Development, Clinical Progress, and Industry Trends | DelveInsight

DelveInsight's, "Hunter Syndrome Pipeline Insight 2025" report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Hunter Syndrome pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Hunter Syndrome pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Hunter Syndrome Pipeline Report

* On 10 September 2025, JCR Pharmaceuticals Co. ltd announced a Phase III randomized, assessor-blinded, active-controlled designed to evaluate safety and efficacy of study drug for the treatment of the MPS II.
* DelveInsight's Hunter Syndrome Pipeline report depicts a robust space with 10+ active players working to develop 10+ pipeline therapies for Hunter Syndrome treatment.
* The leading Hunter Syndrome Companies such as AVROBIO, Capsida Biotherapeutics, GENERIUM Pharmaceuticals, Denali Therapeutics, REGENXBIO, ArmaGen Technologies, Homology Medicines and others.
* Promising Hunter Syndrome Pipeline Therapies such as Elaprase, Idursulfase-IT, RGX-121, Hunterase, JR-141 and others.

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The Hunter Syndrome Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Hunter Syndrome Pipeline Report also highlights the unmet needs with respect to the Hunter Syndrome.

Hunter Syndrome Overview

Hunter syndrome is a mucopolysaccharide disease caused by the enzymatic deficiency of iduronate-2-sulfatase (I2S). This is also called as mucopolysaccharoidosis Type II. Hunter syndrome is a hereditary disease in which the breakdown of a mucopolysaccharide (a chemical that is widely distributed in the body outside of cells) is defective. This chemical builds up and causes a characteristic facial appearance, abnormal function of multiple organs, and in severe cases, early death. In the neuronopathic form of this disorder, physical and mental development reaches a peak at 2-4 years of age with subsequent deterioration.

Hunter Syndrome Emerging Drugs Profile

* DNL310: Denali Therapeutics Inc

DNL310, or ETV:IDS, is a recombinant form of the iduronate 2-sulfatase ("IDS") enzyme engineered to cross the blood-brain barrier using Denali's proprietary ETV technology. DNL310 is intravenously administered and intended to improve overall clinical manifestations of Hunter Syndrome, including neurological symptoms, which are not adequately addressed by currently approved therapies. The FDA has granted orphan drug status and a rare pediatric disease designation to Denali Therapeutics pipeline candidate, DNL310. The drug is being evaluated in Phase I/II clinical trial to treat Hunter Syndrome.

* RGX-121: Regenxbio Inc.

RGX-121 is a product candidate for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome. RGX-121 is designed to use the AAV9 vector to deliver the human iduronate-2-sulfatase gene (IDS) which encodes the iduronate-2-sulfatase (I2S) enzyme to the central nervous system (CNS). Delivery of the IDS gene within cells in the CNS could provide a permanent source of secreted I2S beyond the blood-brain barrier, allowing for long-term cross correction of cells throughout the CNS. RGX-121 has received orphan drug product, rare pediatric disease and Fast Track designations from the U.S. Food and Drug Administration.

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The Hunter Syndrome Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Hunter Syndrome 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 Hunter Syndrome Treatment.
* Hunter Syndrome Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Hunter Syndrome 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 Hunter Syndrome market

Hunter Syndrome Companies

AVROBIO, Capsida Biotherapeutics, GENERIUM Pharmaceuticals, Denali Therapeutics, REGENXBIO, ArmaGen Technologies, Homology Medicines and others.

Hunter Syndrome 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

Hunter Syndrome Products have been categorized under various Molecule types such as

* Monoclonal Antibody
* Peptides
* Polymer
* Small molecule
* Gene therapy

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Scope of the Hunter Syndrome Pipeline Report

* Coverage- Global
* Hunter Syndrome Companies- AVROBIO, Capsida Biotherapeutics, GENERIUM Pharmaceuticals, Denali Therapeutics, REGENXBIO, ArmaGen Technologies, Homology Medicines and others.
* Hunter Syndrome Pipeline Therapies- Elaprase, Idursulfase-IT, RGX-121, Hunterase, JR-141 and others.
* Hunter Syndrome Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Hunter Syndrome Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

* Introduction
* Executive Summary
* Hunter Syndrome: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Mid Stage Products (Phase II)
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I/II)
* DNL310: Denali Therapeutics Inc
* Drug profiles in the detailed report.....
* Preclinical stage products
* AVR RD 05: AVROBIO
* Drug profiles in the detailed report.....
* Inactive Products
* Hunter Syndrome Key Companies
* Hunter Syndrome Key Products
* Hunter Syndrome- Unmet Needs
* Hunter Syndrome- Market Drivers and Barriers
* Hunter Syndrome- Future Perspectives and Conclusion
* Hunter Syndrome Analyst Views
* Hunter Syndrome Key Companies
* Appendix

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