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

• In May 2025, Denali Therapeutics Inc. announced a Phase 2/3 study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II).
• In May 2025, JCR Pharmaceuticals Co., Ltd. conducted a phase III study multicenter, 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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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.

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

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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

Unveil the future of Hunter Syndrome Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Hunter Syndrome Market Drivers and Barriers

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

Get the latest on Hunter Syndrome Therapies and clinical trials. Download DelveInsight’s in-depth pipeline report today! @ Hunter Syndrome Companies, Key Products and Unmet Needs

Table of Contents

1. Introduction
2. Executive Summary
3. Hunter Syndrome: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Mid Stage Products (Phase II)
7. Drug Name: Company Name
8. Drug profiles in the detailed report…..
9. Early Stage Products (Phase I/II)
10. DNL310: Denali Therapeutics Inc
11. Drug profiles in the detailed report…..
12. Preclinical stage products
13. AVR RD 05: AVROBIO
14. Drug profiles in the detailed report…..
15. Inactive Products
16. Hunter Syndrome Key Companies
17. Hunter Syndrome Key Products
18. Hunter Syndrome- Unmet Needs
19. Hunter Syndrome- Market Drivers and Barriers
20. Hunter Syndrome- Future Perspectives and Conclusion
21. Hunter Syndrome Analyst Views
22. Hunter Syndrome Key Companies
23. Appendix

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