Glioblastoma Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

DelveInsight's, "Glioblastoma Pipeline Insight, 2025" report provides comprehensive insights about 200+ companies and 220+ pipeline drugs in Glioblastoma pipeline landscape. It covers the Glioblastoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Glioblastoma 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 Glioblastoma Pipeline Report

* On 29 August 2025, BPGbio announced a Phase 2 study that will assess the effects of adding BPM31510 onto a conventional treatment framework of RT and concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma.
* On 27 August 2025, Inovio Pharmaceuticals conducted a phase 1/2, open-label, multi-center trial to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in combination with cemiplimab in subjects with newly-diagnosed glioblastoma (GBM). INO-5401 and INO-9012 will be delivered by intramuscular (IM) injection followed by electroporation (EP) in combination with cemiplimab and chemoradiation and radiation. There will be 2 cohorts in this trial.
* On 26 August 2025, Polaris Group conducted a study of Weekly ADI-PEG 20 (36 mg/m2) or placebo will be combined with Stupp Protocol (Stupp 2005) radiotherapy and TMZ as noted for the Phase 1 portion. Furthermore, ADI-PEG 20 or placebo treatment may continue after adjuvant TMZ if there is no progressive disease, for up to a total of 2 years of ADI-PEG 20 or placebo treatment.
* DelveInsight's Glioblastoma pipeline report depicts a robust space with 200+ active players working to develop 220+ pipeline therapies for Glioblastoma treatment.
* The leading Glioblastoma Companies such as Denovo Biopharma, AstraZeneca, Pfizer, Chimerix, Bristol-Myers Squibb, Orbus Therapeutics, Northwest Biotherapeutics, Day One Biopharmaceuticals, AiVita Biomedical, Ascletis Pharma Inc., Bristol Myers Squibb, Kazia Therapeutics, HebaBiz Biotech, Biohaven Pharmaceuticals, Vigeo Therapeutics, Hoffman-La-Roche, TVAX Biomedical, Laminar Pharmaceuticals, Kintara Therapeutics, Medicenna Therapeutics, Symphogen A/S, MimiVax, Incyte Corporation, Istari Oncology, Immunomic Therapeutics, Celgene, Sanofi, Merck Sharp & Dohme LLC, Oblato, Inc., GlaxoSmithKline, NuvOx Pharma, Epitopoietic Research Corporation, AnHeart Therapeutics, DNAtrix, Arog Pharmaceuticals, CANbridge Pharmaceuticals, Jiangsu Hengrui Medicine, BPGbio, Inc., BioMimetix, CNS Pharmaceuticals and others.
* Promising Glioblastoma Pipeline Therapies such as Axumin, Intravenous Solution, PolyMVA, MDNA55, Erlotinib HCl (OSI-774), BPM31510, Temozolomide (TMZ), and others.

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Glioblastoma Emerging Drugs Profile

* BMX-001: BioMimetix

BMX-001 is a metalloporphyrin, a novel class of redox-active, small molecule. The active center is designed to mimic the center of superoxide dismutase. The primary mechanism of action is modulation of cellular signaling pathways. BMX-001 inhibits both NFkB and HIF-1a. By inhibiting these pro-survival and pro-angiogenic transcription factors, BMX-001 augments tumor killing by radiation therapy and inhibits tumor regrowth. The inhibition of NFkB blocks major components of the inflammatory cascade which simultaneously results in protection of normal tissue from radiation induced injury. BMX-001 is also being developed in head and neck cancer, anal cancer, and rectal cancer. Currently, the drug is in the Phase III stage of its development for the treatment of glioblastoma.

* Enzastaurin: Denovo BioPharma

DB102 (enzastaurin) is an orally available investigational first-in-class small molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that has been studied in more than 3,000 patients across a range of solid and hematological tumor types. DB102 was originally developed by Eli Lilly and for which Denovo has acquired worldwide rights. DB102 received Orphan Drug Designation in DLBCL and glioblastoma multiforme (GBM) from the FDA and EMA and Fast Track Designation from the FDA. DB102 is the world's first oral small-molecule kinase inhibitor targeting PKC. A retrospective analysis found that it has significant curative effects in high-risk DLBCL patients who are DGM1 positive. The company has initiated a biomarker guided Phase III clinical study evaluating the DB102 (enzastaurin) in combination with temozolomide and radiation as first line therapy to treat newly-diagnosed glioblastoma multiforme (GBM).

* MDNA55: Medicenna Therapeutics, Inc.

MDNA55 is an Empowered Superkine developed as a therapeutic for recurrent glioblastoma multiforme (rGBM), a uniformly fatal form of brain cancer. By using a highly specific IL-4 Superkine as the vehicle to deliver a potent bacterial toxin to the tumor cells, MDNA55 has the potential to purge bulk tumors and disrupt their supporting networks, while reactivating the immune system to tackle cancer. MDNA55 is designed to be a molecular trojan horse. It is a genetic fusion of two molecules: a circularly permuted IL-4 Superkine and the catalytic domain of the pseudomonas exotoxin A.

Genetic fusion allows MDNA55 to harness the selectivity of the Superkine for cancers that overexpress the target IL-4 receptor (IL-4R) and deliver the cell-killing toxin directly into the tumor, its microenvironment and cancer stem cells. Since the IL-4 receptor is not found in a healthy brain and the exotoxin is only active in the cancer cell cytoplasm, this helps ensure that healthy cells are unaffected.

When MDNA55 binds the target IL-4R, it is swallowed inside the tumor cell through a process called endocytosis. Once inside the tumor, proteases cleave the drug and activate the catalytic domain of the exotoxin to begin the process of apoptosis (cell death) involving a protein called elongation factor-2. The drug is currently under Phase II of development.

* MN-166: MediciNova

MN-166 is a first-in-class, orally bioavailable, small molecule glial attenuator that suppresses the pro-inflammatory cytokines IL-1Ss, TNF-a, and IL-6 and might up-regulate the anti-inflammatory cytokine IL-10. It has additionally been shown to be a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its attenuation of neuroinflammation. While considered a New Molecular Entity, or NME, in the United States and Europe, it involves the redirection of an approved drug, ibudilast, which was first approved in Japan more than 20 years ago. Ibudilast has been prescribed to over 3.2 million patients and has a good post-marketing safety profile. Currently, the drug is in Phase II trial for the treatment of Glioblastoma.

* TNG456: Tango Therapeutics, Inc.

TNG456 is an experimental targeted therapy developed to address the aggressive nature of glioblastoma, one of the most treatment-resistant brain tumors. Designed to inhibit key molecular pathways involved in tumor proliferation and immune evasion, TNG456 aims to enhance both direct tumor suppression and immune system activation. Preclinical data suggest potential synergy when used alongside standard-of-care therapies like radiotherapy or temozolomide. Its mechanism may involve disrupting tumor metabolism or modulating the tumor microenvironment. TNG456 represents a promising candidate in the evolving landscape of glioblastoma therapeutics, currently under investigation for efficacy and safety. The drug is currently in Phase I/II stage of its development for the treatment of glioblastoma.

The Glioblastoma Pipeline Report provides insights into

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

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Glioblastoma Companies

Denovo Biopharma, AstraZeneca, Pfizer, Chimerix, Bristol-Myers Squibb, Orbus Therapeutics, Northwest Biotherapeutics, Day One Biopharmaceuticals, AiVita Biomedical, Ascletis Pharma Inc., Bristol Myers Squibb, Kazia Therapeutics, HebaBiz Biotech, Biohaven Pharmaceuticals, Vigeo Therapeutics, Hoffman-La-Roche, TVAX Biomedical, Laminar Pharmaceuticals, Kintara Therapeutics, Medicenna Therapeutics, Symphogen A/S, MimiVax, Incyte Corporation, Istari Oncology, Immunomic Therapeutics, Celgene, Sanofi, Merck Sharp & Dohme LLC, Oblato, Inc., GlaxoSmithKline, NuvOx Pharma, Epitopoietic Research Corporation, AnHeart Therapeutics, DNAtrix, Arog Pharmaceuticals, CANbridge Pharmaceuticals, Jiangsu Hengrui Medicine, BPGbio, Inc., BioMimetix, CNS Pharmaceuticals and others.

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

* Intravenous
* Subcutaneous
* Oral
* Intramuscular

Glioblastoma Products have been categorized under various Molecule types such as

* Monoclonal antibody
* Small molecule
* Peptide

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Scope of the Glioblastoma Pipeline Report

* Coverage- Global
* Glioblastoma Companies- Denovo Biopharma, AstraZeneca, Pfizer, Chimerix, Bristol-Myers Squibb, Orbus Therapeutics, Northwest Biotherapeutics, Day One Biopharmaceuticals, AiVita Biomedical, Ascletis Pharma Inc., Bristol Myers Squibb, Kazia Therapeutics, HebaBiz Biotech, Biohaven Pharmaceuticals, Vigeo Therapeutics, Hoffman-La-Roche, TVAX Biomedical, Laminar Pharmaceuticals, Kintara Therapeutics, Medicenna Therapeutics, Symphogen A/S, MimiVax, Incyte Corporation, Istari Oncology, Immunomic Therapeutics, Celgene, Sanofi, Merck Sharp & Dohme LLC, Oblato, Inc., GlaxoSmithKline, NuvOx Pharma, Epitopoietic Research Corporation, AnHeart Therapeutics, DNAtrix, Arog Pharmaceuticals, CANbridge Pharmaceuticals, Jiangsu Hengrui Medicine, BPGbio, Inc., BioMimetix, CNS Pharmaceuticals and others.
* Glioblastoma Pipeline Therapies- Axumin, Intravenous Solution, PolyMVA, MDNA55, Erlotinib HCl (OSI-774), BPM31510, Temozolomide (TMZ), and others.
* Glioblastoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Glioblastoma 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 Glioblastoma Pipeline on our website @ Glioblastoma Emerging Drugs and Companies [https://www.delveinsight.com/sample-request/glioblastoma-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=ypr]

Table of Contents

* Introduction
* Executive Summary
* Glioblastoma: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Glioblastoma- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Enzastaurin: Denovo BioPharma
* Mid Stage Products (Phase II)
* MDNA55: Medicenna Therapeutics, Inc.
* Early Stage Products (Phase I/II)
* TNG456: Tango Therapeutics, Inc.
* Preclinical and Discovery Stage Products
* RGN6024: Reglagene, Inc.
* Inactive Products
* Glioblastoma Key Companies
* Glioblastoma Key Products
* Glioblastoma- Unmet Needs
* Glioblastoma- Market Drivers and Barriers
* Glioblastoma- Future Perspectives and Conclusion
* Glioblastoma Analyst Views
* Glioblastoma Key Companies
* Appendix

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