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A grade III or grade IV glioma arising from the central nervous system. This category includes glioblastoma, anaplastic astrocytoma, anaplastic ependymoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma.
Biomarker and diagnostic research for malignant glioma has been reported in the published literature.
4 FDA-approved treatments are available for malignant glioma, including CARMUSTINE (GLIADEL, approved 1996), DORDAVIPRONE (MODEYSO, approved 2025), and TOVORAFENIB (OJEMDA, approved 2024). An additional 113 compounds hold orphan drug designation.
Brand Name | Generic Name | Mechanism | Approved | Market Status |
|---|
186 clinical trials registered, 47 recruiting. Interventions under study include drug therapy, procedural interventions, biologic therapy, and other interventions. Pipeline includes 3 PHASE4, 2 PHASE3, 31 PHASE2. Research is sponsored by a mix of industry and academic institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT06305910](https://clinicaltrials.gov/study/NCT06305910) |
Data assembled from 4 of 12 sources · Last updated Sep 19, 2026, 3:00 PM UTC
MODEYSO | DORDAVIPRONE | — | 2025 | Available |
OJEMDA | TOVORAFENIB | — | 2024 | Available |
AVASTIN | BEVACIZUMAB | — | 2004 | Available |
GLIADEL | CARMUSTINE | — | 1996 | Available |
The following drugs have received orphan drug designation from the FDA for malignant glioma. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name. Generic Name. Sponsor. Designated. Exclusivity End. Designation Status. allogenic natural killer cell derived from induced pluripotent stem cells. allogenic natural killer cell derived from induced pluripotent stem cells. XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. 2026. —. Designated. liposomal curcumin. liposomal curcumin. SignPath Pharma, Inc.. 2025. —. Designated. imiquimod-ferulic acid. imiquimod-ferulic acid. Celista Pharmaceuticals LLC. 2025. —. Designated. 4-[211At]astato-L-phenylalanine. 4-[211At]astato-L-phenylalanine. Telix Pharmaceuticals (US) Inc.. 2025. —. Designated. niraparib. niraparib. GSK. 2025. —. Designated. small molecule inhibitor of protein arginine methyl transferase 5 (PRMT5). small molecule inhibitor of protein arginine methyl transferase 5 (PRMT5). Tango Therapeutics, Inc.. 2025. —. Designated. tinostamustine. tinostamustine. Purdue Pharma L.P.. 2025. —. Designated. interleukin-12. interleukin-12. Therapyx, Inc.. 2025. —. Designated. short hairpin RNA (shRNA) targeting NANOG mRNA. short hairpin RNA (shRNA) targeting NANOG mRNA. Exousia AI. 2025. —. Designated. 7-Nitro-1H-indazole. 7-Nitro-1H-indazole. nNOS U.S., Inc.. 2025. —. Designated. cintredekin besudotox. cintredekin besudotox. Precision Neuromed. 2025. —. Designated. 5,6-dimethyl-N-[1-(phenylmethyl)-3-pyrrolidinyl]-thieno[2,3-d]pyrimidin-4-amine, monobenzenesulfonate. 5,6-dimethyl-N-[1-(phenylmethyl)-3-pyrrolidinyl]-thieno[2,3-d]pyrimidin-4-amine, monobenzenesulfonate....
Gene therapy approaches for malignant glioma have been reported in the published literature.
186 trials found
CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults |
PHASE1 |
OX2 Therapeutics |
RECRUITING |
[NCT00870129](https://clinicaltrials.gov/study/NCT00870129) | Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors | NA | Memorial Sloan Kettering Cancer Center | RECRUITING |
[NCT05717153](https://clinicaltrials.gov/study/NCT05717153) | Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma | EARLY_PHASE1 | Mayo Clinic | RECRUITING |
[NCT06703255](https://clinicaltrials.gov/study/NCT06703255) | A Phase 2 Study of HX301 in Patients with High-grade Giloma | PHASE1 | Hangzhou Hanx Biopharmaceuticals, Ltd. | RECRUITING |
[NCT04655404](https://clinicaltrials.gov/study/NCT04655404) | A Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion | EARLY_PHASE1 | Nationwide Children's Hospital | RECRUITING |
338 publications have been identified in PubMed for malignant glioma. Research spans Basic Science / Preclinical (34%), Review / Meta-Analysis (28%), and Diagnostic / Biomarker (10%).
Research Type | Count | % of Total |
|---|---|---|
Laboratory research | 116 | 34% |
Research summaries | 93 | 28% |
Testing and diagnosis research | 35 | 10% |
Disease patterns and progression | 31 | 9% |
New treatment approaches | 28 | 8% |
Clinical study results | 20 | 6% |
Patient case studies | 10 | 3% |
Other research | 5 | 1% |
Goyal S (2026). [PMID: 42087646](https://pubmed.ncbi.nlm.nih.gov/42087646/). *Neurol India*. [Review / Meta-Analysis]
Sasayama T (2026). [PMID: 41727338](https://pubmed.ncbi.nlm.nih.gov/41727338/). *Neurooncol Adv*. [Clinical Trial Publication]
Botezatu IV (2026). [PMID: 42295419](https://pubmed.ncbi.nlm.nih.gov/42295419/). *J Neurooncol*. [Diagnostic / Biomarker]
Reuter J (2026). [PMID: 41880051](https://pubmed.ncbi.nlm.nih.gov/41880051/). *J Neurooncol*. [Clinical Trial Publication]
Leite E Silva MH (2026). [PMID: 41109657](https://pubmed.ncbi.nlm.nih.gov/41109657/). *Exp Neurol*. [Review / Meta-Analysis]
Goh LSH (2026). [PMID: 41501375](https://pubmed.ncbi.nlm.nih.gov/41501375/). *Exp Mol Med*. [Review / Meta-Analysis]
Fernández-Ruiz R (2026). [PMID: 41828575](https://pubmed.ncbi.nlm.nih.gov/41828575/). *Int J Mol Sci*. [Gene Therapy / Novel Therapeutics]
Jiang Y (2026). [PMID: 41648527](https://pubmed.ncbi.nlm.nih.gov/41648527/). *bioRxiv*. [Basic Science / Preclinical]
Belenki D (2026). [PMID: 41802968](https://pubmed.ncbi.nlm.nih.gov/41802968/). *Environ Int*. [Review / Meta-Analysis]
Dai J (2026). [PMID: 42109665](https://pubmed.ncbi.nlm.nih.gov/42109665/). *Front Oncol*. [Basic Science / Preclinical]