High-Grade Glioma Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, And Companies

DelveInsight's, “High-Grade Glioma Pipeline Insight 2025” report provides comprehensive insights about 150+ companies and 150+ pipeline drugs in High-Grade Glioma pipeline landscape. It covers the High-Grade Glioma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the High-Grade Glioma 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 High-Grade Glioma Pipeline Report

• On 29 August 2025, Kintara Therapeutics Inc . initiated a Phase 1/2, open-label study designed to determine the safety and maximum tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma. The study will also evaluate the pharmacokinetic (PK) properties of the drug and assess tumor response to treatment.
• On 27 August 2025, Eli Lilly and Company announced a clinical study aimed at evaluating the benefit of adding abemaciclib to the chemotherapy agent temozolomide in patients with newly diagnosed high-grade glioma following radiotherapy.
• On 27 August 2025, the University of Florida reported that investigators have demonstrated in preclinical studies that RNA liposomes (RNA-LP) activate antigen-presenting cells (APCs), induce antigen-specific T-cell immunity, and can substitute for dendritic cells (DCs) in a cell therapy model for high-grade glioma (HGG). They also showed the feasibility and activity of this approach in preclinical models and in canine patients with spontaneous malignant glioma. In one arm of the current study, researchers will investigate the safety and immunologic activity of RNA-LP vaccines in pediatric patients with recurrent pHGG.
• DelveInsight's High-Grade Glioma pipeline report depicts a robust space with 150+ active players working to develop 150+ pipeline therapies for High-Grade Glioma treatment.
• The leading High-Grade Glioma Companies such as Mateon Therapeutics, BioMimetix, Oblato, Inc, PTC Therapeutics, Lee's Pharmaceutical Limited, Nuvation Bio, Inc., Laminar Pharmaceuticals, Basilea Pharmaceutica, Aadi, LLC, Erimos Pharmaceuticals and others.
• Promising High-Grade Glioma Pipeline Therapies such as Lomustine, Temozolomide, Depatuxizumab mafodotin, etoposide, cyclophosphamide, celecoxib, Karenitecin (BNP1350), Bevacizumab and Erlotinib, Gliolan, Dostarlimab and others.

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High-Grade Glioma Emerging Drugs Profile

• OT101: Mateon Therapeutics

OT101, a first-in-class RNA therapeutic, is designed to abrogate the immunosuppressive actions of TGF-beta 2. In a completed Phase II clinical study, OT-101 exhibited clinically meaningful single-agent activity and induced durable complete and partial responses in recurrent and refractory adult High-Grade Glioma patients, including adults with GBM. Further development of OT-101 may offer renewed hope for salvage therapy of pediatric DIPG patients who have this rare and fatal disease.

• BMX-001: BioMimetix

BMX-001 is being studied in a phase II randomized trial studying the safety and efficacy of the investigational drug in patients with newly diagnosed High-Grade Glioma patients who are being treated with brain radiation and temozolomide.

• OKN-007: Oblato, Inc.

OKN-007 is being developed by Oblato, Inc for the treatment of High-Grade Glioma. It is currently in phase I/II stage of development.

• PTC596: PTC Therapeutics

PTC596 is an orally active small molecule that targets tumor stem cell populations by reducing the function, activity and amount of BMI1. PTC596 acts by altering and destroying the BMI1 protein through a process called phosphorylation. PTC596 has potently inhibited BMI1 function in multiple tumor cell lines. In in vitro tests, PTC596 has preferentially targeted chemotherapy resistant cancer stem cells. Specifically, PTC596 preferentially depleted cancer stem cells in assays with tumor cell lines from fibrosarcoma, prostate and colon cancers. Conversely, the cytotoxic chemotherapies carboplatin, temozolomide, methotrexate and indibulin enriched the population of cancer stem cells in this assay. It is currently in phase I stage of development.

The High-Grade Glioma Pipeline Report provides insights into

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

Learn more about High-Grade Glioma Drugs opportunities in our groundbreaking High-Grade Glioma research and development projects @ High-Grade Glioma Unmet Needs

High-Grade Glioma Companies

Mateon Therapeutics, BioMimetix, Oblato, Inc, PTC Therapeutics, Lee's Pharmaceutical Limited, Nuvation Bio, Inc., Laminar Pharmaceuticals, Basilea Pharmaceutica, Aadi, LLC, Erimos Pharmaceuticals and others.

High-Grade Glioma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Infusion
• Intradermal
• Intramuscular
• Intranasal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Molecule Type

High-Grade Glioma Products have been categorized under various Molecule types such as

• Gene therapies
• Small molecule
• Vaccines
• Polymers
• Peptides
• Monoclonal antibodies
• Product Type

Discover the latest advancements in High-Grade Glioma treatment by visiting our website. Stay informed about how we're transforming the future of Immunotherapy @ High-Grade Glioma Market Drivers and Barriers, and Future Perspectives

Scope of the High-Grade Glioma Pipeline Report

• Coverage- Global
• High-Grade Glioma Companies- Mateon Therapeutics, BioMimetix, Oblato, Inc, PTC Therapeutics, Lee's Pharmaceutical Limited, Nuvation Bio, Inc., Laminar Pharmaceuticals, Basilea Pharmaceutica, Aadi, LLC, Erimos Pharmaceuticals and others.
• High-Grade Glioma Pipeline Therapies- Lomustine, Temozolomide, Depatuxizumab mafodotin, etoposide, cyclophosphamide, celecoxib, Karenitecin (BNP1350), Bevacizumab and Erlotinib, Gliolan, Dostarlimab and others.
• High-Grade Glioma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• High-Grade Glioma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

For a detailed overview of our latest research findings and future plans, read the full details of High-Grade Glioma Pipeline on our website @ High-Grade Glioma Emerging Drugs and Companies

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