Delving into the Latest Updates on Temozolomide with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-1,2,3,5-tetrazine-8-carboxamide, 3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-as-tetrazine-8-carboxamide, 3-methyl-4-oxo-3,4-dihydroimidazo(5,1-d)(1,2,3,5)tetrazine-8-carboxamide

+ [28]

Target

DNA

Action

inhibitors

Mechanism

DNA inhibitors(DNA inhibitors), DNA alkylating agents

Therapeutic Areas

NeoplasmsNervous System DiseasesSkin and Musculoskeletal Diseases+ [10]

Active Indication

Ewing SarcomaMalignant glioma of brainMalignant melanoma, metastatic+ [89]

Inactive Indication

Acoustic NeuromaAcute myeloid leukaemia with 11q23 abnormalityAdrenocortical Carcinoma+ [94]

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization

National Cancer Institute

Novartis AG

Merck Sharp & Dohme Corp.

+ [29]

Inactive Organization

The Herbert Irving Comprehensive Cancer Center

Hexal AG

Barbara Ann Karmanos Cancer Institute

+ [38]

License Organization

Double Bond Pharmaceutical International AB

Institut Gustave Roussy EURL

Belarusian State University

+ [1]

Drug Highest PhaseApproved

First Approval Date

European Union (26 Jan 1999),

AstrocytomaGlioblastoma MultiformeGlioma

RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China)

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Structure/Sequence

Molecular FormulaC6H6N6O2

InChIKeyBPEGJWRSRHCHSN-UHFFFAOYSA-N

CAS Registry85622-93-1

Glioblastoma multiform (GBM) is the most common malignant primary brain tumor in adults. Despite maximal treatment tumor relapse occurs regularly accompanied by unfavourable prognosis. Among other reasons, it is believed that this could be in part due to the existence of the so-called tumor stem cells (TSCs), a cellular subfraction within GBM which escape therapy by being highly resistant to irradiation and chemotherapy and thus constituting the source of tumor recurrence.
GBM, like many other cancers, show a sub-population of aldehyde dehydrogenase (ALDH) overexpressing TSCs. More specifically, ALDH1A1, a cytoplasmatic isoform of ALDH, proved to be a novel stem cell marker in human GBM. In addition, ALDH1A1 has been shown to be a mediator for resistance of GBM to temozolomide (TMZ) and a reliable predictor of clinical outcome; prognosis of patients with a high level of ALDH1A1 expression was poor compared with that of patients with low levels. Consequently, ALDH1A1 may serve as a potential target to improve treatment of human GBM through inhibition of the enzyme.
Disulfiram (DSF) has been used for more than sixty years in the treatment of chronic alcoholism because of the unpleasant symptoms it provokes after ethanol intake. The underlying mechanism is believed to be the accumulation of acetaldehyde in the blood, due to inhibition of the liver ALDHs. Actually, DSF is a strong inhibitor of ALDH1A1 and relatively non-toxic at therapeutic (for chronic alcoholism) doses that can penetrate the blood-brain barrier. In addition, DSF has been shown to be cytotoxic on GBM stem-like cells, inhibiting the growth of TMZ resistant GBM cells and blocking self-renewal by
100% , while it has been identified as an inhibitor of human GBM stem cells in high-throughput chemical screens. Interestingly, a number of these actions were copper-dependent.
In the current Phase II clinical trial, DSF/copper combination will be tested as an adjunctive and concurrent chemotherapy in the treatment of newly diagnosed GBM. According to our hypothesis, initiation of DSF chemotherapy after the resection of the tumor and before the introduction of the standard radio-chemotherapy will inhibit ALDH1A1 of GBM TSCs making them more susceptible to radio-chemotherapy and possibly reducing the recurrence rate of GBM. On the other hand, the addition of copper will probably enhance the cytotoxic effects of DSF possibly through augmentation of its pro-apoptotic and proteasomal inhibitory actions.

Start Date01 Jan 2027

Sponsor / Collaborator

Universität Ulm

[+2]

NCT07120984

/ Not yet recruitingPhase 2

A Phase II Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma

The purpose of this study is to explore the safety and efficacy of the antibody-cytokine fusion protein L19TNF alone or in combination with alkylating chemotherapy in patients with recurrent IDH mutant glioma.

Start Date30 Jan 2026

Sponsor / Collaborator

Philogen SpA

NCT07141771

/ Not yet recruitingPhase 1/2IIT

An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing

Small-cell lung cancer (SCLC) has a high degree of malignancy and extremely poor prognosis, slow progress in the treatment of ES-SCLC, and a more ideal posterior therapy needs to be explored. This is an I / II, phase umbrella study to explore afterline treatment options following progression of frontline platinum-containing therapy for small cell lung cancer.
This study includes 2 parts:
Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required).
Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days.
Based on the optimal selection of patients with recurrent broad-stage small cell lung cancer with different molecular and clinical characteristics, we further explored different treatment modes suitable for different populations through umbrella cohort studies.

Start Date31 Dec 2025

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

100 Clinical Results associated with Temozolomide

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100 Translational Medicine associated with Temozolomide

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100 Patents (Medical) associated with Temozolomide

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13,128

Literatures (Medical) associated with Temozolomide

01 Jan 2026·COLLOIDS AND SURFACES B-BIOINTERFACES

Tumor exosome-based drug delivery system targeting ferroptosis and apoptosis for glioblastoma therapy

Article

Author: Han, Bo ; Xu, Yechang ; Ming, Yang ; Peng, Tao ; Tang, Qian ; Liang, Lijun ; Chen, Daquan ; Liu, Yingchao ; Han, Wenhui

Temozolomide (TMZ) is a first-line chemotherapy drug to treat glioblastoma (GBM), but still encounters blood-brain barrier (BBB), and chemotherapy resistance. To address these issues, sensible combination therapy of TMZ with other novel therapeutic techniques is required. Herein, we developed a tumor cell exosome membrane (EM) based drug delivery platform (EMNPs@TMZ) for encapsulating reactive oxygen species (ROS) responsive fucoidan (Fuc) nanoparticles (FNPs). EMNPs@TMZ system can co-deliver TMZ and luteolin (Lut) for the combined targeting apoptosis and ferroptosis. Interestingly, Lut can induce ferroptosis by inhibiting Nrf2 expression, and also inhibit DNA repair through Wnt/β-catenin, promoting TMZ induced cell apoptosis. More importantly, this nanoparticle drug delivery system has tumor dual-targeting effect, which enhances the inhibitory effect on glioma growth, thereby improving the survival rate of mice models, and has no significant side effects during the treatment process, particularly in the orthotopic patient-derived xenograft (PDX) model. This biomimetic nanoparticle provides a promising strategy for ferroptosis combination chemotherapy for GBM therapy.

01 Jan 2026·TALANTA

A cell-permeable fluorescent probe for imaging of DNA repair protein ALKBH2

Article

Author: Anindya, Roy ; Rathnam, Sharan Shanmuga Vuppaladadium ; Rankawat, Sourbh ; Ray, Sandipan ; Khan, Faiz Ahmed ; Shaji, Unnikrishnan P ; Jangra, Jitender ; Khatua, Rashmi Ranjan

ALKBH2 is a key DNA repair enzyme that removes various methyl-adducts, including N1-methyl-adenine and N3-methyl-cytosine, from genomic DNA. ALKBH2 overexpression is observed in many cancer and leads to temozolomide resistance in glioblastoma cell lines. The growing significance of ALKBH2 as a promising therapeutic target in cancer has highlighted the need for suitable chemical tools to enable its detailed study and functional characterization. To address this gap, we developed a fluorescent probe for rapid and selective detection of ALKBH2 in live cancer cells. Building on our previously reported finding that the HIV protease inhibitor ritonavir selectively binds and inhibits ALKBH2, we synthesized a BODIPY-labeled ritonavir (rit-BD) as an imaging agent. Rit-BD showed peak absorption (A_max) and emission (E_max) to be 576 nm and 586 nm, respectively. Our results from the binding experiment demonstrate that rit-BD binds to ALKBH2 in vitro with micromolar affinity. The limit of detection (LOD) for ALKBH2 with Rit-BD was estimated to be 115 ng/ml (4.7 nM) with a linear range of 0.5-330 μg/ml (14 nM-10 μM). Furthermore, In vitro and in cellulo experiments and live-cell imaging confirmed that rit-BD could be used to label ALKBH2 in the living cell nucleus. Our findings establish rit-BD as a unique dual-purpose agent for visualizing ALKBH2 dynamics and inhibiting DNA repair activity in cancer cells.

01 Jan 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Determination of temozolomide and its metabolite 5-aminoimidazole-4-carboxamide in plasma using UPLC-MS/MS: Implications for therapeutic drug monitoring with high-grade gliomas

Article

Author: Han, Chuanguang ; Qiu, Jinhui ; Shen, Shengwei ; Wang, Zhiwei ; Ma, Huihui ; Zhang, Ning ; Shen, Chenlin ; Song, Shuai

Temozolomide (TMZ) combined with radiotherapy is the standard regimen for high-grade gliomas (HGG). TMZ exhibits linear pharmacokinetics and consistent blood-brain barrier penetration, metabolizing to equimolar 5-aminoimidazole-4-carboxamide (AIC) and methyl diazonium cation, forming the basis of the Two-Ratio Hypothesis (plasma-to-cerebrospinal fluid TMZ/AIC ratios) for therapeutic drug monitoring. We developed a validated ultra-performance liquid chromatography-tandem mass spectrometry method to quantify TMZ and AIC in HGG patients. Addressing polarity differences, TMZ was enriched by ethyl acetate liquid-liquid extraction while AIC underwent strong cation exchange SPE. This method demonstrated linearity (TMZ: 77.66-19,415 ng/mL, AIC: 5.00-2000 ng/mL; r² > 0.99), precision (intra-batch RSD ≤ 11.85 %, inter-batch RSD ≤10.23 %), accuracy (RE: -7.48 to 4.94 % for TMZ; -5.25 to 5.26 % for AIC), recovery (97.26-102.5 %), and stability compliant with FDA/Chinese Pharmacopoeia guidelines. Analysis of 46 plasma samples (37 patients) revealed higher dose-normalized TMZ peak concentrations (1-h post-dose) in concurrent chemoradiotherapy versus adjuvant chemotherapy (3.54 vs. 2.48 μg/mL, P < 0.05). Females showed 52.4 % greater TMZ exposure than males (3.55 vs. 2.33 μg/mL, P < 0.05), while AIC exhibited no statistically significant gender- or treatment-related variations. Gender-adjusted TMZ-AIC correlation was moderate (r_s= 0.540, P < 0.01). This study provides the first analytical validation of the Two-Ratio Hypothesis and reveals gender-dependent TMZ pharmacokinetics, supporting personalized neuro-oncology dosing.

333

News (Medical) associated with Temozolomide

17 Oct 2025

·www.globenewswire.com

BPGbio Presents Phase 2 Glioblastoma Data on BPM31510 at ESMO 2025

BPGbio has completed phase 2b enrollment in late August this year for treatment of GBM with BPM31510 Data further validate the MOA of BPM31510’s direct targeting of mitochondrial redox machinery to re-potentiate apoptosis in highly aggressive tumor type Oct. 16, 2025 -- BPGbio Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, today announced that it will present two posters on its lead investigational drug BPM31510 for Glioblastoma (GBM) in collaboration with Stanford University School of Medicine and other major US cancer centers at the European Society for Medical Oncology (ESMO) Congress 2025 held from October 17 – 20 in Berlin, Germany. BPGbio has completed the phase 2b enrollment of GBM trial late August this year. Together, the presentations highlight new insights into the mitochondrial-targeting investigational therapy BPM31510, including both biomarker-driven pharmacodynamic analyses in patients with recurrent GBM and interim progress from an ongoing Phase 2 trial in newly diagnosed GBM patients. “We are excited to share the latest data from our ongoing phase 2 GBM trial at ESMO, which highlight BPM31510’s unique mechanism of reprogramming tumor metabolism to potentially improve treatment outcomes in glioblastoma, one of the most aggressive tumors” said Niven R. Narain, Ph.D., President and CEO of BPGbio. “We appreciate our world-class partners like Stanford and Aixial Group for their continued collaboration and support as we advance BPM31510 into late-stage development.” 1. Interim Analysis of a Phase 2 Study of BPM31510 with Vitamin K in Combination with Standard Chemoradiation in Newly Diagnosed GBM Patients Collaborators: BPGbio, Stanford University, Aixial Group Design: Phase 2, single-arm, open-label trial (BPM31510IV-11; NCT04752813) testing BPM31510 with Vitamin K alongside radiotherapy and temozolomide (TMZ) in newly diagnosed GBM. Endpoints: Primary endpoints are progression-free survival at 6 months (PFS6) and 12 months (PFS12); secondary endpoints include overall survival and safety. Update: Interim PFS6 landmark data from 25 patients will be presented, assessing whether mitochondrial reprogramming by BPM31510 enhances standard-of-care efficacy 2. Biomarker Analysis of BPM31510 in Recurrent, Bevacizumab-Refractory High-Grade Glioma Shows Effects on Metabolic and Tumor Progression Markers Collaborators: BPGbio, Stanford University Insights: Phase 1 pharmacodynamic data (BPM31510IV-06; NCT03020602) Demonstrate the pharmacodynamic effect of BPM31510 on mitochondrial oxidative phosphorylation BPM31510IV is BPGbio’s lead candidate in late-stage development for aggressive solid tumors such as glioblastoma multiforme (GBM) and pancreatic cancer. Other topical and oral formulations of the investigational agent are also being developed as a potential treatment for several rare diseases including Primary CoQ10 Deficiency (PCQD). The compound has demonstrated a tolerable safety profile and is being studied for potential clinical benefits across multiple disease indications. Validated by BPGbio’s NAi Interrogative Biology platform, BPM31510 is designed to induce a hallmark shift in the tumor microenvironment (TME) by modulating mitochondrial oxidative phosphorylation in aggressive tumors, promoting programmed cell death (apoptosis). In many mitochondrial diseases, restoring CoQ10 levels can overcome the effect of mutations in genes that lead to mitochondrial dysfunction. BPM31510 has been granted Orphan Drug Designation by the FDA for GBM, pancreatic cancer, and epidermolysis bullosa (EB), as well as Rare Pediatric Disease Designation for primary CoQ10 deficiency and EB. BPGbio is a leading biology-first AI-powered clinical stage biopharma focused on mitochondrial biology and protein homeostasis. The company has a deep pipeline of AI-developed therapeutics spanning oncology, rare disease and neurology, including several in late-stage clinical trials. BPGbio’s novel approach is underpinned by NAi, its proprietary Interrogative Biology Platform, protected by over 500 US and international patents; one of the world’s largest clinically annotated non-governmental biobanks with longitudinal samples; and exclusive access to the most powerful supercomputer in the world. With these tools, BPGbio is redefining how patient biology can be modeled using bespoke Bayesian AI specifically designed for solving large-scale biology challenges. Headquartered in greater Boston, the company is at the forefront of a new era in medicine, combining biology, multi-modal data, and AI to transform the way we understand, diagnose, and treat disease. The content above comes from the network. if any infringement, please contact us to modify.

Orphan DrugClinical Result

16 Oct 2025

·www.einpresswire.com

NovelWise Pharmaceutical Receives FDA Fast Track Designation for NBM-BMX in Metastatic Uveal Melanoma

Fast Track designation underscores NovelWise’s clinical momentum and the potential of NBM-BMX as a first-in-class HDAC8 inhibitor for metastatic uveal melanoma SAN DIEGO, CA, UNITED STATES, October 16, 2025 / EINPresswire.com / -- Designation supported by robust preclinical data in uveal melanoma and clinical data from prior Phase I studies of NBM-BMX ; expedites path for a first-in-class selective HDAC8 inhibitor San Diego, Calif. — October 14, 2025 — NovelWise Pharmaceutical Corporation USA (“NovelWise”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for NBM-BMX, a selective HDAC8 inhibitor, for the treatment of metastatic uveal melanoma (mUM). The FDA granted the designation based on its review of NovelWise’s robust preclinical data in uveal melanoma models together with clinical data from prior Phase I studies of NBM-BMX. Fast Track is designed to facilitate development and expedite review of investigational medicines intended to treat serious conditions with unmet medical need, offering early and frequent FDA interactions, rolling review, and potential eligibility for Priority Review if criteria are met. “Fast Track status is a meaningful accelerator for NBM-BMX and a strong signal of the program’s potential,” said John Soong, MD, Chief Executive Officer of NovelWise. “The FDA’s decision—supported by our preclinical data in uveal melanoma and our completed Phase I experience—allows us to move faster and smarter with regulators as we advance toward patients who urgently need better options.” Clinical Development Next Steps NovelWise will initiate site initiation visits in late October and open enrollment in a Phase Ib/II study in early November 2025 evaluating NBM-BMX as a single agent in mUM. The study will assess safety, pharmacokinetics, and signals of antitumor activity. Details will be posted to ClinicalTrials.gov prior to first-patient-in. Building on Prior Clinical Experience NBM-BMX has an established clinical foundation from completed Phase I trials, which informed dose selection, safety monitoring, and scheduling for the upcoming mUM study. In parallel, NBM-BMX is being investigated in an ongoing Phase Ib/II glioblastoma (GBM) program in combination with temozolomide (TMZ). Learnings from that program will further refine development in mUM. About NBM-BMX NBM-BMX is a next-generation, selective histone deacetylase 8 (HDAC8) inhibitor designed to modulate epigenetic drivers in solid tumors. NBM-BMX is investigational and has not been approved by the FDA or any regulatory authority. About Metastatic Uveal Melanoma Uveal melanoma is the most common primary intraocular malignancy in adults. Patients who progress to metastatic disease—most often to the liver—face poor outcomes and limited treatment options, underscoring the need for novel mechanisms and expedited development pathways. About NovelWise Pharmaceutical NovelWise Pharmaceutical Corporation USA is a clinical-stage biotechnology company developing precision small-molecule medicines in oncology. The company’s lead program, NBM-BMX (HDAC8 inhibitor), is in clinical development across multiple indications, including metastatic uveal melanoma and glioblastoma. For more information, please contact NWP-US-info.tw@novelwisepharma.com. ________________________________________ Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the timing of clinical trial initiation, site activation and enrollment, the potential benefits of FDA Fast Track designation, and the therapeutic potential of NBM-BMX. These statements involve risks and uncertainties that could cause actual results to differ materially, including risks related to clinical trial execution, regulatory interactions and outcomes, manufacturing, and competitive developments. NovelWise undertakes no obligation to update forward-looking statements, except as required by law. Media & Investor Contact Annie Pai Project Leader/ Director of Clinical Operations NovelWise Pharmaceutical Corporation USA annie.pai@novelwisepharma.com | +1 (910) 297-9045 Annie Pai NovelWise Pharmaceutical Corporation USA +1 910-297-9045 annie.pai@novelwisepharma.com Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 1Fast Track

07 Oct 2025

·www.prnewswire.com

Beactica conducts first advisory meeting with the Swedish Medical Products Agency regarding the development of BEA-17

UPPSALA, Sweden, Oct. 7, 2025 /PRNewswire/ -- Beactica Therapeutics AB, the Swedish precision medicine company, today announced that it has conducted a first scientific advisory meeting with the Swedish Medical Products Agency regarding the drug candidate BEA-17. Specifically, the company's plans for the preclinical development aimed at enabling dosing of BEA-17 in humans were discussed. The Swedish Medical Products Agency expressed its support for Beactica's plans. Positive discussions were also held regarding the design and setup of a first clinical trial with BEA-17. "It is an important milestone for BEA-17 and Beactica to have completed the first formal meeting with regulatory authorities. It was a successful meeting where we received support for our plans, and we now have a clear picture of what needs to be done in the continued work towards a planned clinical trial application." said Beactica's CEO, Dr Per Källblad. About BEA-17 BEA-17 is a first-in-class small molecule targeted degrader of lysine demethylase 1 (LSD1) and its co-factor CoREST. In syngeneic animal models of cancer, the compound has shown promising potentiation of immune-modulating treatments in several cancer forms, including anti-PD1 checkpoint inhibitors in colon cancer (CT26) and standard of care (temozolomide and radiation) in glioblastoma (GL261). Pharmacokinetic studies of BEA-17 show good blood-brain-barrier penetration and oral availability. BEA-17 is investigational and not approved anywhere globally. Its efficacy and safety in humans have not been established. BEA-17 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of glioblastoma (GBM). About Beactica Therapeutics Beactica Therapeutics AB is a privately held precision medicine company with a pipeline of novel small molecule therapeutics aimed at treating diseases with significant unmet medical need. Beactica's approach is centered around the Eclipsor™ platform that enables the efficient development of allosteric modulators and targeted protein degraders. Beactica deliver value to patients and shareholders by advancing its programmes to clinical proof of concept. For more information, please visit . Beactica Therapeutics contact Per Källblad M.Sc. Ph.D. CEO [email protected] Tel: +46 18 56 08 80 This information was brought to you by Cision The following files are available for download: SOURCE Beactica Therapeutics AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan Drug

100 Deals associated with Temozolomide

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External Link

KEGG	Wiki	ATC	Drug Bank
D06067	Temozolomide	L01AX03	DB00853

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ewing Sarcoma	Japan	Ohara Pharmaceutical Co., Ltd.	21 Feb 2019
Ewing Sarcoma	Japan	MSD KK (Tokyo)	21 Feb 2019
Malignant glioma of brain	European Union	Teva Pharmaceuticals Europe BV	28 Jan 2010
Malignant glioma of brain	Iceland	Teva Pharmaceuticals Europe BV	28 Jan 2010
Malignant glioma of brain	Liechtenstein	Teva Pharmaceuticals Europe BV	28 Jan 2010
Malignant glioma of brain	Norway	Teva Pharmaceuticals Europe BV	28 Jan 2010
Malignant melanoma, metastatic	Australia	Merck Sharp & Dohme (Australia) Pty Ltd.	13 Nov 2009
Glioblastoma	China	Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.	30 Apr 2004
Astrocytoma	European Union	Merck Sharp & Dohme BV	26 Jan 1999
Astrocytoma	Iceland	Merck Sharp & Dohme BV	26 Jan 1999
Astrocytoma	Liechtenstein	Merck Sharp & Dohme BV	26 Jan 1999
Astrocytoma	Norway	Merck Sharp & Dohme BV	26 Jan 1999
Glioblastoma Multiforme	European Union	Merck Sharp & Dohme BV	26 Jan 1999
Glioblastoma Multiforme	Iceland	Merck Sharp & Dohme BV	26 Jan 1999
Glioblastoma Multiforme	Liechtenstein	Merck Sharp & Dohme BV	26 Jan 1999
Glioblastoma Multiforme	Norway	Merck Sharp & Dohme BV	26 Jan 1999
Glioma	European Union	Merck Sharp & Dohme BV	26 Jan 1999
Glioma	Iceland	Merck Sharp & Dohme BV	26 Jan 1999
Glioma	Liechtenstein	Merck Sharp & Dohme BV	26 Jan 1999
Glioma	Norway	Merck Sharp & Dohme BV	26 Jan 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neuroblastoma	NDA/BLA	European Union	ORPHELIA Pharma SAS	14 Nov 2024
Uterine Leiomyosarcoma	Phase 3	United States	Alliance for Clinical Trials in Oncology	30 Mar 2022
Brain Stem Glioma	Phase 3	United States	National Cancer Institute	26 Jan 2011
Brain Stem Glioma	Phase 3	Canada	National Cancer Institute	26 Jan 2011
Cerebral Astrocytoma, Adult	Phase 3	United States	National Cancer Institute	26 Jan 2011
Cerebral Astrocytoma, Adult	Phase 3	Canada	National Cancer Institute	26 Jan 2011
High grade glioma	Phase 3	United States	National Cancer Institute	26 Jan 2011
High grade glioma	Phase 3	Canada	National Cancer Institute	26 Jan 2011
Pediatric Cerebellar Astrocytoma	Phase 3	United States	National Cancer Institute	26 Jan 2011
Pediatric Cerebellar Astrocytoma	Phase 3	Canada	National Cancer Institute	26 Jan 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03426891 (CTgov)	Phase 1	Glioblastoma Multiforme	21	Radiotherapy+Vorinostat+Temozolomide+Pembrolizumab (Dose Escalation Phase)	qazurlaetp = dgrdsocavo rpfirksoco (sxnfvsvcdk, ywnkwwmnfc - jjeklazsvi) View more	-	06 Oct 2025
				Radiotherapy+Vorinostat+Temozolomide+Pembrolizumab (Radiotherapy and Maintenance Phase)	ctstaekqbe(yaaiocktkk) = dupolfxcox jeyxwtpusm (brjurbhrta, ucteyumccm - ctrqprjmpg) View more
NCT03137888 (CTgov)	Phase 2	Gliosarcoma \| Glioblastoma	30	Spectroscopic Magnetic Resonance Imaging+Temozolomide	fpfjgmrxzl = mvwruoojim ioeutybzod (lgfmmvywff, qyxcjfwvlr - rodzurpsrp) View more	-	03 Aug 2025
NCT04574856 (Phase 2 Study of Multiparametric Magnetic Resonance Imaging-Guided High-Dose Response-Adaptive Radiation Therapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma, Pubmed \| Int J Radiat Oncol Biol Phys)	Phase 2	Glioblastoma	30	Temozolomide (Patients with newly diagnosed GBM)	xzvmiajioi(eayzqzmsrt) = setvpkayua uoggxjfszj (vtdfvqayfy ) View more	Positive	01 Jul 2025
NCT00629343 (CTgov)	Phase 1	Mesothelioma, Malignant \| Soft Tissue Sarcoma	27	Temozolomide+Azacitidine	fnajxajcxu = zsuqcjbzcz yyoatcqsdf (lunrxjqqmm, vpoyidjjly - vukbpmjitc) View more	-	05 Jun 2025
NCT02761070 (JCOG1308C, ASCO2025)	Phase 3	Recurrent Glioblastoma	146	Bevacizumab	gppwvkyrhi(ctvblgtsup) = 19.4% in arm A xahdnifhjg (jogiwuxemq ) View more	Negative	30 May 2025
				Dose-dense Temozolomide
ASCO2025	Not Applicable	Leiomyosarcoma Maintenance	20	Doxorubicin plus dacarbazine	rrmxlkndpp(aisivaxcyk) = vpshlouwka yftdwtkkzs (fzkxynvynl )	Positive	30 May 2025
NCT04280848 (Phase II study of UCPVax in newly diagnosed glioblastoma, ASCO2025)	Phase 2	Glioblastoma Adjuvant non-mutated IDH1 \| unmethylated MGMT status	-	UCPVax + Temozolomide	yxuyudiksf(cytabovfnk) = ujrrgqtvys ggdjxyisaj (baqxhcbnky ) View more	Positive	30 May 2025
NCT00626990 (CATNON, ASCO2025)	Phase 3	Glioma Adjuvant IDH mutation \| total copy number alterations \| methylation subtype	751	Radiotherapy alone	wtupbcaeey(tglfukoqqi) = 8.5 years rvzohltzac (vgrdsrjeef ) View more	Positive	30 May 2025
				Concurrent Temozolomide
ASCO2025	Not Applicable	-	159	temozolomide (Pancreatic NETs (PNETs))	gpwsmuphxl(nqeupzuwlc) = rghodewpjr qudydfjsbv (jpjnbjdkgh ) View more	Positive	30 May 2025
				temozolomide (Gastrointestinal NETs (GINETs))	gpwsmuphxl(nqeupzuwlc) = tfvjdodltq qudydfjsbv (jpjnbjdkgh ) View more
ASCO2025	Phase 2	High Risk Neuroblastoma	34	HITS (Irinotecan, Temozolomide, Naxitamab, GM-CSF)	jwsanitkrw(dzffjghpro) = cpwaghjiid ljijqitvsk (enbepocaqv ) View more	Positive	30 May 2025
				NICE (Naxitamab, GM-CSF, Ifosfamide, Carboplatin, Etoposide)	jwsanitkrw(dzffjghpro) = qzcgckdjsj ljijqitvsk (enbepocaqv ) View more