Neuroblastoma Clinical Pipeline | 20+ Companies Advancing the Future of Treatment

The Neuroblastoma market is rapidly evolving with cutting-edge research and breakthrough therapies driven by leading companies like United Therapeutics, EUSA Pharma, Y-mAbs Therapeutics, and Clarity Pharmaceuticals. These innovators are revolutionizing treatment approaches and shaping the future of Neuroblastoma care, offering new hope for patients worldwide.

DelveInsight's 'Neuroblastoma Pipeline Insight 2025' report provides comprehensive global coverage of pipeline Neuroblastoma therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Neuroblastoma pipeline domain.

For emerging Neuroblastoma drugs, the Neuroblastoma pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

Key Takeaways from the Neuroblastoma Pipeline Report
• DelveInsight's Neuroblastoma Pipeline analysis depicts a robust space with 20+ active players working to develop 25+ pipeline drugs for Neuroblastoma treatment.
• The leading Neuroblastoma companies include United Therapeutics, EUSA Pharma, Y-mAbs Therapeutics, Clarity Pharmaceuticals, Eli Lilly, Novartis, Roche, Aptorum Group, and others are evaluating their lead assets to improve the Neuroblastoma treatment landscape.
• Key Neuroblastoma pipeline therapies in various stages of development include Hu14.18, 67-Cu-SARTATE, Alrizomadlin, Omburtamab, SARTATE, Eflornithine, and others.
• In January 2025, Norgine announced it completed its marketing authorisation application for eflornithine in high-risk neuroblastoma (HRNB) to the European Medicines Agency (EMA), following submissions in April 2024 through Project Orbis in Australia, Switzerland, and the UK.
• In September 2024, Senhwa Biosciences announced that its drug Silmitasertib (CX-4945) received Rare Pediatric Disease Designation (RPDD) from the US FDA for treating neuroblastoma.
• In August 2024, Invenra Inc. revealed that its bispecific antibody, INV724, for neuroblastoma treatment, was granted both Rare Pediatric Disease (RPDD) and Orphan Drug (ODD) Designations by the US FDA.

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Neuroblastoma Overview
Neuroblastoma is a rare cancer that primarily affects infants and young children, originating from immature nerve cells called neuroblasts. It most commonly develops in the adrenal glands, located above the kidneys, but can also arise in nerve tissue along the spine, neck, chest, abdomen, or pelvis. The disease can spread to the bone marrow, bones, lymph nodes, liver, and skin. Symptoms vary based on tumor location and progression but often include a lump or mass in the abdomen, neck, or chest, accompanied by pain, swelling, fatigue, loss of appetite, and fever. Advanced cases may present with bone pain, breathing difficulties, or neurological symptoms like abnormal eye movements and dark circles under the eyes. Genetic factors, such as MYCN oncogene amplification and chromosomal abnormalities, are linked to aggressive forms of the disease, influencing its progression and prognosis.

Diagnosing neuroblastoma involves clinical evaluation, imaging techniques such as MRI, CT scans, and MIBG scans to assess tumor size and spread, and laboratory tests to detect elevated catecholamine levels. Treatment varies based on risk classification, ranging from low to high. Low-risk cases are often treated successfully with surgery alone, while intermediate-risk cases require a combination of surgery and chemotherapy. High-risk neuroblastoma involves aggressive treatments, including high-dose chemotherapy, surgery, radiation, stem cell transplantation, and immunotherapy, such as anti-GD2 antibodies. Targeted therapies, such as ALK inhibitors for tumors with specific mutations, are also being explored to improve outcomes. Treatment approaches aim to manage tumor growth, prevent recurrence, and address metastasis, offering hope for improved survival rates in affected children.

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Neuroblastoma Treatment Analysis: Drug Profile
Hu14.18: Essential Pharma
Hu14.18K322A, commonly referred to as Hu14.18, is a humanized anti-GD2 monoclonal antibody developed by Renaissance Pharma for the treatment of high-risk neuroblastoma (HRNB). In April 2025, Essential Pharma announced that it had completed the acquisition of Renaissance Pharma Ltd., with its lead asset being Hu14.18K322A (Hu14.18). Currently, the drug is in the Phase II stage of its clinical trial for the treatment of neuroblastoma.

67-Cu-SARTATE: Clarity Pharmaceuticals
67Cu-SARTATE is an emerging theranostic radiopharmaceutical specifically designed for the diagnosis and treatment of high-risk neuroblastoma, a particularly aggressive childhood cancer. This compound utilizes copper-67 (67Cu) as a therapeutic agent, complementing its diagnostic counterpart, copper-64 (64Cu), which is used for imaging. The drug has been granted Rare Pediatric Disease Designation and Orphan Drug Designation for the clinical management of neuroblastoma. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of neuroblastoma.

Key Neuroblastoma Therapies and Companies
• Hu14.18: Essential Pharma
• 67-Cu-SARTATE: Clarity Pharmaceuticals
• Alrizomadlin (APG-115): Ascentage Pharma
• Omburtamab: Y-mabs therapeutics
• SARTATE: Clarity Pharmaceuticals
• Eflornithine: K C Pharmaceuticals

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Neuroblastoma 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 Neuroblastoma Pipeline Report
• Coverage: Global
• Key Neuroblastoma Companies: United Therapeutics, EUSA Pharma, Y-mAbs Therapeutics, Clarity Pharmaceuticals, Eli Lilly, Novartis, Roche, Aptorum Group, and others.
• Key Neuroblastoma Pipeline Therapies: Hu14.18, 67-Cu-SARTATE, Alrizomadlin, Omburtamab, SARTATE, Eflornithine, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Neuroblastoma Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Neuroblastoma Pipeline Therapeutics
6. Neuroblastoma Pipeline: Late-Stage Products (Phase III)
7. Neuroblastoma Pipeline: Late-Stage Products (Phase III)
8. Neuroblastoma Pipeline: Mid-Stage Products (Phase II)
9. Neuroblastoma Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Jatin Vimal
jvimal@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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

This release was published on openPR.