Delving into the Latest Updates on Gallium Maltolate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms-

Target

RNRs

Action

inhibitors

Mechanism

RNR inhibitors(Ribonucleotide reductase inhibitors)

Therapeutic Areas

NeoplasmsNervous System DiseasesOther Diseases

Active Indication

Diffuse Intrinsic Pontine GliomaDiffuse Midline GliomaHigh grade glioma+ [4]

Inactive Indication

Bacterial InfectionsBladder CancerCastration-Resistant Prostatic Cancer+ [4]

Originator Organization

Titan Pharmaceuticals, Inc.

Active Organization

Medical College of Wisconsin

Imaging Biometrics LLC

Inactive Organization

Titan Pharmaceuticals, Inc.

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

RegulationOrphan Drug (United States)

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Structure/Sequence

Molecular FormulaC18H15GaO9

InChIKeyASYYOZSDALANRF-UHFFFAOYSA-K

CAS Registry108560-70-9

In this study, we want to find out more about the side effects of an investigational drug for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma, Gallium Maltolate (GaM) and what doses of GaM are safe for people to take. Everyone in this study will receive GaM which is still experimental and is not approved by the U.S. Food and Drug Administration. We do not know all the ways that this drug may affect people. We hope the information from this study will help us develop a better treatment for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma in the future.

Start Date15 May 2026

Sponsor / Collaborator

Medical College of Wisconsin

NCT04319276

/ Active, not recruitingPhase 1IIT

A Phase 1 Clinical Trial of Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma

This is a phase 1 investigational study to assess the safety and preliminary efficacy of oral gallium maltolate (GaM) in participants with relapsed glioblastoma (GBM).

Start Date11 Nov 2022

Sponsor / Collaborator

Medical College of Wisconsin

NCT00050687

/ TerminatedPhase 1/2

A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies

This study will test the safety, tolerance, and efficacy of different doses of oral gallium maltolate. Patients will receive oral gallium maltolate twice daily for 28-consecutive days followed by 14 days off treatment. This dosing cycle will be repeated. Adverse effects will be assessed and the levels of gallium in serum will be measured. Any effect of the drug on the cancer and any improvement in cancer-related symptoms will also be measured.

Start Date01 Jun 2001

Sponsor / Collaborator

Titan Pharmaceuticals, Inc.

100 Clinical Results associated with Gallium Maltolate

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100 Translational Medicine associated with Gallium Maltolate

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100 Patents (Medical) associated with Gallium Maltolate

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57

Literatures (Medical) associated with Gallium Maltolate

01 Sep 2025·TOXICOLOGY AND APPLIED PHARMACOLOGY

Gallium maltolate and cisplatin co-treatment effectively targets triple-negative breast cancer in spheroid and mouse models

Article

Author: Lo, Kai-Yin ; Liu, Ching-Yu ; Hsieh, Yu-Chen ; Pan, Chun-Kai ; Yang, Ya-Wen ; Pan, Zi-Yu

Triple-negative breast cancer (TNBC) is a subtype of breast cancer that lacks targeted therapies and is characterized by high invasiveness and metastatic potential. Our previous work demonstrated that GaM (gallium maltolate) blocks cell cycle progression and impairs ribosomal synthesis in TNBC cells. Moreover, GaM treatment promotes ferroptosis activation, and its combination with cisplatin exhibits synergistic effects. To further evaluate the efficacy of these treatments, we applied them to three-dimensional spheroid and mouse models. Two types of spheroids were generated: one composed solely of TNBC cells (MDA-MB-231) and the other a co-culture with normal breast cells (MCF10A). In both MDA/MCF10A and MDA-MB-231 spheroids, we observed enhanced p53 activation and increased p21 expression, with the effects being more pronounced in the MDA-MB-231 spheroids. These effects were stronger with the combination treatment than with either treatment alone. Similar results were observed in a xenograft model, where tumors formed from MDA-MB-231 cells in nude mice. The combination therapy reduced tumor size to a similar extent as cisplatin alone and did not cause adverse effects in mice. The combination therapy induced apoptosis, nucleolar stress, and ferroptosis. Additionally, the treatment inhibited cell migration and metastasis - by increasing E-cadherin levels and reducing metalloproteases. These findings provide a strong foundation for further mechanistic studies and potential clinical applications.

01 Aug 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Identification and characterization of tubulin as Ga(III)-binding protein in T24 cells

Article

Author: Jia, Shuaile ; Zhang, Shuo ; Yang, Xue ; Wang, Yuchuan ; Chen, Junxin

Gallium-based metallic drugs and agents have been widely applied for the diagnosis and treatment of diseases such as non-Hodgkin's lymphoma (NHL), but there are few reports on the potential Ga(III)-binding proteins and the related cytotoxic mechanisms for Ga(III). Herein, by using human urinary bladder cancer T24 cells as a model, we identify and report that tubulin is a Ga(III)-binding protein target in T24 cells. Our analyses, including the employment of a series of methods based on immobilized metal affinity chromatography (IMAC), cellular thermal shift assay (CETSA), and immunofluorescence experiments, collectively explained this finding. Our results suggest that the binding of Ga(III) to tubulin led to significant changes in the morphology and distribution of microtubules in cells. The blocked microtubule formation or microtubule depolymerization as a result of the binding of Ga(III) to tubulin may be an important molecular mechanism by which Ga(III) exerts its cytotoxic effects in T24 cells to inhibit tumor cell growth.

01 Dec 2024·Bioactive Materials

Antimicrobial hydrogel foam dressing with controlled release of gallium maltolate for infection control in chronic wounds

Article

Author: Bryan, Laura ; Fletcher, Alan ; Welch, Shannara ; Cosgriff-Hernandez, Elizabeth ; Lan, Ziyang ; Ang, Nicolai ; Whitfield-Cargile, Canaan ; Richardson, Lauren ; Guo, Leopold

Effective treatment of infection in chronic wounds is critical to improve patient outcomes and prevent severe complications, including systemic infections, increased morbidity, and amputations. Current treatments, including antibiotic administration and antimicrobial dressings, are challenged by the increasing prevalence of antibiotic resistance and patients' sensitivity to the delivered agents. Previous studies have demonstrated the potential of a new antimicrobial agent, Gallium maltolate (GaM); however, the high burst release from the GaM-loaded hydrogel gauze required frequent dressing changes. To address this need, we developed a hydrogel foam-based wound dressing with GaM-loaded microspheres for sustained infection control. First, the minimal inhibitory and bactericidal concentrations (MIC and MBC) of GaM against two Staphylococcus aureus strains isolated from chronic wounds were identified. No significant adverse effects of GaM on dermal fibroblasts were shown at the MIC, indicating an acceptable selectivity index. For the sustained release of GaM, electrospraying was employed to fabricate microspheres with different release kinetics. Systematic investigation of loading and microsphere size on release kinetics indicated that the larger microsphere size and lower GaM loading resulted in a sustained GaM release profile over the target 5 days. Evaluation of the GaM-loaded hydrogel dressing demonstrated cytocompatibility and antibacterial activities with a zone of inhibition test. An equine distal limb wound model was developed and utilized to demonstrate the efficacy of GaM-loaded hydrogel foam in vivo. This antimicrobial hydrogel foam dressing displayed the potential to combat methicillin-resistant S. aureus (MRSA) infection with controlled GaM release to improve chronic wound healing.

1

News (Medical) associated with Gallium Maltolate

13 Jul 2023

·www.biospace.com

IQ-AI Announces Orphan Drug Designation for GaM in Pediatric GBM

MILWAUKEE, WI / ACCESSWIRE / July 13, 2023 / Imaging Biometrics, LLC (IB), a wholly-owned subsidiary of IQ-AI Ltd (LSE:IQAI)(OTCQB:IQAIF), today announced the U.S. Food and Drug Administration (US FDA) has granted Orphan Drug Designation (ODD) for gallium maltolate (GaM) for the treatment of pediatric glioblastoma multiforme (GBM). In February, IB was granted Orphan Drug Designation for adult GBM. The US FDA has since confirmed that the designation granted in February applies to both adult and pediatric GBM patients. GBM is the most common and aggressive primary brain tumor in adults and children. There are currently no effective treatments for pediatric glioblastoma. Oral GaM recently demonstrated significant survival benefit in a pre-clinical study for pediatric GBM. The results of the study, performed in the lab of Dr. Kathleen Schmainda, PhD and led by Dr. Mona Al-Gizawiy, PhD from the Medical College of Wisconsin (MCW), were presented at the 2023 Society of Neuro Oncology (SNO) Pediatric Conference in Washington, DC last month. Median overall survival was more than 2x longer in the group treated with GaM compared to the untreated controls. These promising results, coupled with the easy administration by capsule, make this a very attractive potential treatment option for both pediatric and adult patients. "We are very pleased that the FDA has now confirmed that the orphan drug designation for GaM applies to all GBM populations including pediatric patients," said Trevor Brown, CEO of IQ-AI. About Imaging Biometrics® LLC: IB is a wholly-owned subsidiary of IQ-AI Limited, (LON:IQAI)(OTCQB:IQAIF), and focuses on delivering quantitative imaging platforms and therapeutics that transform how clinicians diagnose and treat patients more efficiently and effectively. For more information about Imaging Biometrics, visit the company's website at . Follow IB on Twitter, @IQAI_IB. Contact Information: Michael Schmainda Tel: 262-439-8252 SOURCE: IQ AI Ltd. View source version on accesswire.com:

Orphan DrugClinical Result

100 Deals associated with Gallium Maltolate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Gallium Maltolate	-	DB05420

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 2	United States	Titan Pharmaceuticals, Inc.	01 Jun 2001
Castration-Resistant Prostatic Cancer	Phase 2	United States	Titan Pharmaceuticals, Inc.	01 Jun 2001
Refractory Multiple Myeloma	Phase 2	United States	Titan Pharmaceuticals, Inc.	01 Jun 2001
Diffuse Intrinsic Pontine Glioma	Phase 1	-	Medical College of Wisconsin	15 May 2026
Diffuse Midline Glioma	Phase 1	-	Medical College of Wisconsin	15 May 2026
High grade glioma	Phase 1	-	Medical College of Wisconsin	15 May 2026
Rhabdoid Tumor of the CNS	Phase 1	-	Medical College of Wisconsin	15 May 2026
Typical Teratoid Rhabdoid Tumor	Phase 1	-	Medical College of Wisconsin	15 May 2026
Humoral Hypercalcemia of Malignancy	Phase 1	United States	Titan Pharmaceuticals, Inc.	-
Osteitis Deformans	Phase 1	United States	Titan Pharmaceuticals, Inc.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNO2023	Phase 1	Recurrent Glioblastoma	-	Oral Gallium Maltolate 500 mg/day	khriaunwcp(qcvsrmhhwa) = isegldkplq uqbulsmudm (yxuionlqtv )	-	10 Nov 2023
				Oral Gallium Maltolate 1,000 mg/day	khriaunwcp(qcvsrmhhwa) = mqeztznion uqbulsmudm (yxuionlqtv )