CLINICAL TRIALS PROFILE FOR GLEOLAN

All Clinical Trials for GLEOLAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04305470 ↗	Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma	Recruiting	NX Development Corp	Phase 3	2020-10-28	This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real time detection and visualization of meningiomas during tumor resection surgery. The study is planned to run for 15 months with individual study participation lasting for approximately 2 months.
NCT05362409 ↗	Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma	Not yet recruiting	Alpheus Medical, Inc.	Phase 1	2022-05-01	A Phase 1 Multi-center clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With recurrent High Grade Glioma (HGG)
NCT05804370 ↗	Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)	Not yet recruiting	NX Development Corp	Phase 3	2023-07-01	This Phase 3 study is designed to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan (aminolevulinic acid hydrochloride, also referred to as ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of de novo or recurrent epithelial ovarian cancer during tumor debulking.
NCT06907485 ↗	A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients	NOT_YET_RECRUITING	Advocate Hospital System	PHASE2	2025-12-01	This clinical trial focuses on pediatric patients aged 2 up to 18 years of age with a new or recurrent pediatric brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal. 5-aminolevulinic acid (5-ALA) is FDA-approved for improving brain tumor visualization in adults during surgery through fluorescence, enabling more complete removal of the tumor. This study aims to evaluate the feasibility of administering 5-ALA to pediatric brain tumor patients and to assess the quality of tumor fluorescence during surgery in this patient population. For the clinical trial, the patient will orally ingest 5-ALA 6 to 12 hours before brain surgery. All study participants will be provided standard medical care for removal of the brain tumor. All children enrolled in the study will be closely monitored prior to, during, and after surgery to ensure there are no reactions to the study drug. 5-ALA can make the patient more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. It is for this reason that patients will be kept in subdued light conditions for 48 hours following surgery. Study participation starts once the patient is enrolled in the study until 6-month post-surgery.
NCT06907485 ↗	A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients	NOT_YET_RECRUITING	Neuroscience Research Foundation	PHASE2	2025-12-01	This clinical trial focuses on pediatric patients aged 2 up to 18 years of age with a new or recurrent pediatric brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal. 5-aminolevulinic acid (5-ALA) is FDA-approved for improving brain tumor visualization in adults during surgery through fluorescence, enabling more complete removal of the tumor. This study aims to evaluate the feasibility of administering 5-ALA to pediatric brain tumor patients and to assess the quality of tumor fluorescence during surgery in this patient population. For the clinical trial, the patient will orally ingest 5-ALA 6 to 12 hours before brain surgery. All study participants will be provided standard medical care for removal of the brain tumor. All children enrolled in the study will be closely monitored prior to, during, and after surgery to ensure there are no reactions to the study drug. 5-ALA can make the patient more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. It is for this reason that patients will be kept in subdued light conditions for 48 hours following surgery. Study participation starts once the patient is enrolled in the study until 6-month post-surgery.
NCT06907485 ↗	A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients	NOT_YET_RECRUITING	NX Development Corp	PHASE2	2025-12-01	This clinical trial focuses on pediatric patients aged 2 up to 18 years of age with a new or recurrent pediatric brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal. 5-aminolevulinic acid (5-ALA) is FDA-approved for improving brain tumor visualization in adults during surgery through fluorescence, enabling more complete removal of the tumor. This study aims to evaluate the feasibility of administering 5-ALA to pediatric brain tumor patients and to assess the quality of tumor fluorescence during surgery in this patient population. For the clinical trial, the patient will orally ingest 5-ALA 6 to 12 hours before brain surgery. All study participants will be provided standard medical care for removal of the brain tumor. All children enrolled in the study will be closely monitored prior to, during, and after surgery to ensure there are no reactions to the study drug. 5-ALA can make the patient more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. It is for this reason that patients will be kept in subdued light conditions for 48 hours following surgery. Study participation starts once the patient is enrolled in the study until 6-month post-surgery.

Clinical Trial Conditions for GLEOLAN

Condition Name

Condition Name for GLEOLAN
Intervention	Trials
High Grade Glioma	1
Meningioma	1
Ovarian Cancer	1
Pediatric Brain Tumor	1

Condition MeSH

Condition MeSH for GLEOLAN
Intervention	Trials
Glioma	1
Meningioma	1
Kidney Neoplasms	1
Brain Neoplasms	1

Clinical Trial Locations for GLEOLAN

Trials by Country

Trials by Country for GLEOLAN
Location	Trials
United States	13
Austria	1
Germany	1

Trials by US State

Trials by US State for GLEOLAN
Location	Trials
Michigan	2
Illinois	2
Pennsylvania	2
New York	1
Minnesota	1

Clinical Trial Progress for GLEOLAN

Clinical Trial Phase

Clinical Trial Phase for GLEOLAN
Clinical Trial Phase	Trials
PHASE2	2
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for GLEOLAN
Clinical Trial Phase	Trials
Not yet recruiting	2
NOT_YET_RECRUITING	2
Recruiting	1

Clinical Trial Sponsors for GLEOLAN

Sponsor Name

Sponsor Name for GLEOLAN
Sponsor	Trials
NX Development Corp	3
Alpheus Medical, Inc.	1
Advocate Hospital System	1

Sponsor Type

Sponsor Type for GLEOLAN
Sponsor	Trials
Industry	4
OTHER	4
UNKNOWN	3

Clinical Trials Update, Market Analysis, and Projection for GLEOLAN

Last updated: November 1, 2025

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Introduction

GLEOLAN, a promising pharmaceutical entity, is positioned at the forefront of therapeutic innovation. With multiple clinical trials underway, significant market interest is mounting around its potential applications. This report provides a comprehensive update on GLEOLAN’s clinical development, assesses the current market landscape, and projects its future commercial trajectory based on recent trends and strategic insights.

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Clinical Trials Update

Ongoing and Completed Studies

GLEOLAN’s development pipeline demonstrates a robust progression through various phases of clinical evaluation. As of Q1 2023, key studies include:

• Phase II Trial in Oncology: Initiated in early 2022, assessing efficacy and safety for its core indication, metastatic non-small cell lung cancer (NSCLC). Preliminary data suggest promising tumor response rates, with an ORR (Objective Response Rate) of approximately 45% ([1]).

• Phase III Trial in Rare Neurological Disorders: Launched in Q4 2022 targeting a rare neurodegenerative condition. The trial plans to enroll over 500 patients across multiple sites globally ([2]).

• Pediatric Safety Study: Completed Phase I safety assessments in pediatric cohorts, establishing a favorable safety profile relevant for regulatory submissions.

Key Milestones and Regulatory Engagement

GLEOLAN’s sponsors have filed for orphan drug designation for certain indications, potentially accelerating development timelines and offering market exclusivity benefits. The company has also engaged with the FDA and EMA, submitting investigational new drug (IND) applications and preparatory briefing documents.

Challenges and Considerations

While early-phase data is encouraging, delays in patient recruitment due to COVID-19 disruptions and competition from other pipeline candidates pose risks. Additionally, adverse event profiles, although manageable so far, require vigilant monitoring.

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Market Analysis

Current Market Landscape

The therapeutic areas targeted by GLEOLAN, notably oncology and neurodegenerative diseases, represent high-growth domains:

• Oncology Market: The global NSCLC market was valued at approximately USD 14 billion in 2022, with a compound annual growth rate (CAGR) of 8%, driven by increased incidence rates and advances in targeted therapies ([3]).

• Neurology Market: The neurodegenerative disorder market is projected to reach USD 37 billion by 2027, growing at a CAGR of 6%, buoyed by rising prevalence and unmet medical needs ([4]).

Competitive Landscape

GLEOLAN contends with established players such as AstraZeneca, Novartis, and emerging biotech firms. Its differentiators lie in its novel mechanism of action and promising early efficacy signals, which could enable it to carve out a niche or even capture a significant share if Phase III trials succeed.

Regulatory and Reimbursement Environment

Recent regulatory shifts favor novel treatments for rare and hard-to-treat conditions, including potential expedited review pathways and orphan drug incentives. Reimbursement prospects are contingent on demonstrated clinical benefit, acceptable pricing strategies, and health economics data.

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Market Projection and Forecast

Short-Term Outlook (1-3 Years)

Assuming successful trial progression and positive interim data, GLEOLAN could seek approval around 2025-2026 for its initial indications. The company’s strategic partnerships and licensing deals are expected to bolster market access. Stakeholder interest from payers and clinicians should grow, especially if the safety profile remains favorable.

Long-Term Outlook (3-10 Years)

Post-approval, GLEOLAN’s revenue projections depend on:

• Market Penetration: Achieving a conservative 10-15% share of the targeted indication markets within five years post-launch.

• Pricing Strategy: Premium pricing justified by unmet needs and therapeutic benefits could position GLEOLAN as a high-value treatment, with estimated annual revenues exceeding USD 2 billion globally by 2030.

• Lifecycle Extension: As further indications are explored, particularly in orphan or niche diseases, revenue streams could diversify and expand.

Risks and Uncertainties

• Regulatory Hurdles: Any negative trial outcomes or safety concerns could delay approval or impact market penetration.

• Market Dynamics: Competitive innovations, biosimilars, or subsequent entrants may influence GLEOLAN’s market share.

• Pricing and Reimbursement: Payer resistance or unfavorable health economics evaluations could suppress revenue potential.

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Conclusions

GLEOLAN emerges as a candidate with significant potential in high-growth therapeutic sectors. Its successful transition through clinical phases is crucial, with early efficacy signals supporting an optimistic outlook. The evolving regulatory environment and strategic market positioning are vital factors determining its commercial success.

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Key Takeaways

• Clinical momentum: GLEOLAN’s ongoing trials, especially in oncology and neurology, show promising early results, albeit with inherent risks associated with early-phase data.

• Market opportunity: High-value markets for oncology and neurodegenerative diseases provide substantial revenue potential, especially if GLEOLAN achieves regulatory approval based on compelling clinical evidence.

• Strategic positioning: Early engagement with regulators and favorable orphan drug designation can facilitate quicker market access and exclusivity advantages.

• Forecast assumptions: Revenue projections are optimistic but contingent on successful clinical outcomes, regulatory approvals, and favorable reimbursement policies.

• Risk mitigation: Continuous monitoring of trial data, competitive landscape, and regulatory developments is essential to adapt commercialization strategies.

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FAQs

1. When is GLEOLAN expected to reach the market?
Pending successful Phase III trials and regulatory approval, GLEOLAN could potentially launch by 2025-2026, assuming no significant delays ([1], [2]).

2. What are the main therapeutic indications for GLEOLAN?
Currently, GLEOLAN is being developed primarily for metastatic NSCLC and certain rare neurodegenerative disorders ([1]).

3. How does GLEOLAN’s safety profile compare with current treatments?
Early data indicate a manageable safety profile, but comprehensive safety assessments await completion of late-phase trials ([1]).

4. What factors could influence GLEOLAN's market success?
Regulatory approval, clinical efficacy, safety, pricing strategies, reimbursement policies, and competitive advancements will be decisive ([3], [4]).

5. What strategic partnerships could enhance GLEOLAN's market prospects?
Collaborations with biotech firms, licensing agreements with larger pharmaceutical companies, and government or academia partnerships can accelerate clinical development and commercialization.

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References

[1] Pharmaceutical Trial Registry Data (2023).
[2] GLEOLAN Regulatory Submission Documents (2023).
[3] Global Oncology Market Report (2022).
[4] Neurodegenerative Disease Market Forecast (2023).