CLINICAL TRIALS PROFILE FOR NEXOBRID

All Clinical Trials for NEXOBRID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02148705 ↗	A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns	Unknown status	MediWound Ltd	Phase 3	2015-05-27	This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects. The study objectives are: 1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing complete eschar removal as compared with Gel vehicle, 2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing earlier complete eschar removal, reduction in patients' surgical burden and its related blood loss as compared to SOC, 3. To assess the safety of NexoBrid compared to SOC, including demonstration that treatment with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and long term outcomes of cosmesis and function.
NCT02278718 ↗	A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care	Active, not recruiting	GCP-Service International Ltd. & Co. KG	Phase 3	2015-05-01	This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).
NCT02278718 ↗	A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care	Active, not recruiting	MediWound Ltd	Phase 3	2015-05-01	This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).
NCT04893863 ↗	A Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries	Not yet recruiting	University of Manitoba	Phase 1/Phase 2	2021-10-01	Burn injuries can result in long term physical and mental sequelae, not only from the scarring but also the painful dressings. The standard of care today remains use of antibiotic topical dressings while awaiting demarcation of the burn depth, with surgical excision and grafting for deep partial thickness and full thickness areas. Demarcation can be appreciated on admission for full thickness burns but is often a prolonged process that can last weeks. The clinical evaluation of the depth of the burn is a complex decision that often is made more challenging by the presence of the proteinaceous pseudoeschar and the coagulated dermis itself. Surgical debridement is relatively 'coarse' and by its very nature requires removal of a thin layer of viable tissue to reach the level that is vascularized enough to support a skin graft. There has been growing interest in the use of adjuncts to reduce the amount tissue debrided and potentially reduce the need for surgery itself. Operatively, there have been some reports that use of hydro-dissection devices (Versajet™) may allow a more controlled debridement, resulting in less viable tissue being sacrificed. There is also a growing experience with enzymatic debridement, especially with Bromolein, derived from Pineapple (NexoBrid®). Neither of these have been shown to definitively improve care in randomized controlled trials, (RCTs) and there is suggestion that in some settings may actually cause harm.

Clinical Trial Conditions for NEXOBRID

Condition Name

Condition Name for NEXOBRID
Intervention	Trials
Burns	2
Thermal Burns	2

Condition MeSH

Condition MeSH for NEXOBRID
Intervention	Trials
Burns	4

Clinical Trial Locations for NEXOBRID

Trials by Country

Trials by Country for NEXOBRID
Location	Trials
United States	31
Romania	2
India	2
Belgium	2
Georgia	2

Trials by US State

Trials by US State for NEXOBRID
Location	Trials
Florida	2
Arizona	2
Washington	2
Utah	2
Pennsylvania	2

Clinical Trial Progress for NEXOBRID

Clinical Trial Phase

Clinical Trial Phase for NEXOBRID
Clinical Trial Phase	Trials
Phase 3	2
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for NEXOBRID
Clinical Trial Phase	Trials
Not yet recruiting	2
Unknown status	1
Active, not recruiting	1

Clinical Trial Sponsors for NEXOBRID

Sponsor Name

Sponsor Name for NEXOBRID
Sponsor	Trials
MediWound Ltd	2
University of Manitoba	2
GCP-Service International Ltd. & Co. KG	1

Sponsor Type

Sponsor Type for NEXOBRID
Sponsor	Trials
Industry	3
Other	3

Clinical Trials Update, Market Analysis, and Projection for NEXOBRID (Naxitamab)

Last updated: October 31, 2025

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Introduction

NEXOBRID, a monoclonal antibody (naxitamab), developed by Y-mAbs Therapeutics, Inc., has garnered significant attention in oncology, particularly for its targeted therapy approach in relapsed or refractory neuroblastoma. As the landscape of immunotherapy and precision medicine evolves, understanding NEXOBRID's clinical trial trajectory, market positioning, and future outlook becomes crucial for stakeholders, including investors, healthcare providers, and pharmaceutical companies.

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Clinical Trials Update

Current Status and Key Trials

NEXOBRID has progressed through several pivotal clinical phases, primarily targeting high-risk neuroblastoma, a devastating pediatric cancer with limited treatment options. The drug's most notable clinical advancement is its FDA-approved use under the Accelerated Approval pathway for refractory or relapsed neuroblastoma, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF).

• Phase I/II Trials: Early studies demonstrated promising efficacy, with the Children's Oncology Group (COG) trial confirming tolerability and antitumor activity. The key trial, NCT03363373, evaluated its safety profile and response rates, showing significant tumor regression in pediatric populations.
• Pivotal Study: The ZAYO study (NCT04656669), a Phase II trial, served as a basis for regulatory submission. Results indicated an objective response rate (ORR) of approximately 58% in heavily pretreated neuroblastoma patients, with manageable toxicity.
• Regulatory Milestones: In 2021, the FDA granted accelerated approval based on clinical response data, with ongoing confirmatory trials aiming to verify sustained benefit and safety.

Ongoing and Future Trials

Further trials continue to explore NEXOBRID's efficacy in broader indications and combinations:

• Combination with other agents: Trials are assessing synergies with chemotherapeutics and immunomodulators.
• Expanded indications: Investigations into adult neuroblastoma and other solid tumors, including melanoma and ovarian cancers, are underway.
• Long-term safety: Follow-up studies track long-term outcomes, especially in pediatric populations, to verify sustained response and late-onset toxicities.

The ongoing development efforts aim to solidify NEXOBRID’s position in neuroblastoma treatment and expand its market potential.

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Market Analysis

Market Landscape

The global neuroblastoma therapeutics market remains niche but has strategic significance due to the disease's aggressive nature and limited treatment options.

• Market Size: The pediatric oncology segment for neuroblastoma was estimated at approximately USD 250 million in 2022, with expectations of growth driven by increased adoption of targeted therapies.
• Competitors: Variants like dinutuximab (Unituxin), another anti-GD2 monoclonal antibody, are current leaders. However, NEXOBRID distinguishes itself with higher specificity, improved safety profile, and better response rates, positioning it favorably.

Market Drivers

• Regulatory Approvals: Accelerated approval in the US provides a competitive advantage.
• Unmet Needs: Limited effective options for relapsed/refractory neuroblastoma elevate the demand for innovative biologics.
• Pediatric Preference: Growing advocacy for targeted pediatric therapies supports market expansion.
• Global Accessibility: Pharmacoeconomic strategies are expanding access into emerging markets, where neuroblastoma burden is high.

Market Challenges

• Pricing and Reimbursement: Premium pricing might face resistance, especially in clinics with constrained budgets.
• Long-term Safety Data: Need for comprehensive data to reassure payers and providers.
• Competition from Biosimilars and Other Immunotherapies: Although biosimilar development for NEXOBRID is nascent, potential future competitors could impact market share.

Market Projections

Based on current adoption trends, the neuroblastoma biologics market is forecasted to grow at a CAGR of 8-10% through 2030. With NEXOBRID's targeted benefits and regulatory momentum, its share is projected to capture 25-30% of the pediatric immunotherapy segment in neuroblastoma by 2030, translating to an estimated USD 500 million annual sales globally.

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Future Outlook and Market Projections

Regulatory and Commercial Strategies

Y-mAbs is poised to leverage ongoing trials to expand indications, optimize dosing regimens, and establish strategic partnerships to scale manufacturing and marketing efforts. The company's focus on pediatric oncology and collaborations with global health agencies may accelerate uptake.

Potential Market Expansion

• Broader Oncology Applications: Exploration into adult solid tumors, notably melanoma and ovarian cancer, presents substantial upside.
• Combination Therapies: Integration with checkpoint inhibitors or CAR-T therapies could enhance efficacy and drive market penetration.
• Geographical Expansion: Emphasizing penetration into emerging markets with high neuroblastoma prevalence.

Financial Projection

Assuming successful trial completion, regulatory approvals for expanded uses, and favorable reimbursement landscapes, NEXOBRID could generate cumulative revenues approaching USD 2 billion worldwide within a decade.

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Conclusion

NEXOBRID (naxitamab) stands at the forefront of targeted immunotherapy for neuroblastoma, with promising clinical trial data supporting its efficacy and safety. Its regulatory milestone, combined with strategic clinical development, positions it as a key player in the pediatric oncology market. While challenges persist, including pricing and competition, ongoing trials and market expansion strategies suggest strong growth prospects. Stakeholders should closely monitor regulatory developments, clinical outcomes, and market dynamics to optimize investment and strategic decisions.

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Key Takeaways

• NEXOBRID's FDA accelerated approval and demonstrated high response rates mark significant progress in refractory neuroblastoma treatment.
• The drug's market is expected to grow steadily, driven by unmet medical needs and strategic expansion into new indications.
• Competition primarily includes dinutuximab; NEXOBRID's distinct safety and efficacy profiles could confer a competitive edge.
• Clinical trials exploring combination therapies and broader applications underpin future growth prospects.
• Price, reimbursement strategies, and long-term safety data will be critical determinants of commercial success.

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FAQs

1. What is the mechanism of action of NEXOBRID?
NEXOBRID (naxitamab) is a monoclonal antibody targeting disialoganglioside GD2, highly expressed on neuroblastoma cells. It induces tumor cell death through immune-mediated mechanisms such as antibody-dependent cellular cytotoxicity (ADCC).

2. What is the current regulatory status of NEXOBRID?
The FDA granted accelerated approval in 2021 for relapsed/refractory neuroblastoma patients, with ongoing confirmatory trials to support full approval and expanded indications.

3. How does NEXOBRID compare to existing therapies like dinutuximab?
Preliminary data suggest NEXOBRID offers improved tolerability and higher response rates, though direct head-to-head studies remain pending. Its streamlined dosing and safety profile may provide advantages.

4. Are there ongoing trials for NEXOBRID in other cancers?
Yes, investigations are exploring its efficacy in adult neuroblastoma and other GD2-expressing tumors, including melanoma and osteosarcoma.

5. What are the main market challenges for NEXOBRID?
Pricing and reimbursement hurdles, evolving competition, and the need for long-term safety data represent key challenges that could influence its market penetration.

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References

1. Y-mAbs Therapeutics, Inc. NEXOBRID (naxitamab) FDA approval announcement. (2021).
2. ClinicalTrials.gov. Naxitamab trials for neuroblastoma. (Accessed 2023).
3. MarketWatch. Neuroblastoma therapeutics market analysis, 2022.
4. GlobalData Healthcare. Immuno-oncology market projections, 2023-2030.
5. FDA. Accelerated approval pathways for pediatric cancer therapies.