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Elraglusib

Phase 1

Advanced Malignant Solid Tumor | Small molecule | Oncology |Actuate Therapeutics, Inc.|Last Updated: Jul 20, 2026

Target and mechanism

Molecular targetGSK3B
Target classInhibitor
ModalitySmall molecule

Also known as Elraglusib Oral Tablets

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment100

FDA Designations

RARE_PEDIATRIC_DISEASEORPHAN_DRUG

Clinical trial landscape

Elraglusib · 1 trial · 1 indication

Phase 1 1
NCT07714395Evaluate Preliminary Anti-tumor Activity of Elraglusib in Adult Participants With Advanced Solid TumorsAdvanced Malignant Solid Tumor
NOT YET_RECRUITING100 Analytics
PHASE1NOT YET_RECRUITING
Evaluate Preliminary Anti-tumor Activity of Elraglusib in Adult Participants With Advanced Solid Tumors
Advanced Malignant Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and dose-limiting toxicities (DLTs) of elraglusib tablets
Determined at the end of Cycle 1 (each cycle is 21/28days) for each dose group tested up to 24 moths.

Dose escalation/de-escalation decisions and the MTD will be determined at the end of Cycle 1 (each cycle is 21/28days).

Secondary Endpoints

Pharmacokinetic Assessment
From date of first dose through completion of Initial 21-day cycle. (Assessed Cycle 1 Only-up to 28 days) for each dose cohort, up to 24 months.
Pharmacodynamic Assessment
From Day 1 Dosing through completion of Day 21 of Cycle 1 only. (Assessed Cycle 1 only, up to 28-days) for each dose cohort up to 24 months.
Tumor Assessments
Baseline and per standard of care every 9 (±1) weeks during treatment and during follow-up through disease progression for unto 30 months.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Elraglusib Monotherapy Dose escalation/de-escalationEXPERIMENTALElraglusib 250 mg tablets will be administered once daily with food in 21-day cycles. DG-1: 125mg (Days 1, 3, 5 of a 21 day cycle) DG1: (Starting Dose) 125 mg/QD for 21 days DG2: 250mg/QD for 21 days DG3: 500mg QD for 21 days DG4: 750mg/QD for 21 days, Dosing will continue until MTD or MED is identified. Any higher dose levels which are explored will not exceed 50% increment relative to the prior cohort rounded down to the nearest 250 mg dose (or 125 mg dose if necessary).

Interventions

NameTypeDescription
Elraglusib Oral TabletsDRUGElraglusib Oral Tablet, 250 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Participants must meet all of the following criteria to be eligible for inclusion in the study: 1. Able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan,...

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Recent Changes (Last 90 Days)

LOWJul 20, 2026NCT07714395NEW_TRIAL: changed
LOWJul 20, 2026NCT07714395NEW_TRIAL: changed

Frequently asked questions about Elraglusib

What is Elraglusib used for?

Elraglusib is an investigational small molecule being developed for the treatment of advanced malignant solid tumors. It is currently in Phase 1 clinical development, and the drug has not yet been approved by the FDA. Elraglusib is also known as Elraglusib Oral Tablets.

Who makes Elraglusib?

Elraglusib is being developed by Actuate Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol ACTU. The company is conducting clinical trials to evaluate the drug's safety and preliminary anti-tumor activity in adult participants with advanced solid tumors.

What phase is Elraglusib in?

Elraglusib is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA for any use. The drug has received FDA designations for rare pediatric disease and orphan drug status, reflecting its potential in treating serious conditions.

What clinical trials is Elraglusib in?

Elraglusib is being studied in a Phase 1 clinical trial with the identifier NCT07714395. The trial is titled 'Evaluate Preliminary Anti-tumor Activity of Elraglusib in Adult Participants With Advanced Solid Tumors' and is designed to enroll 100 participants aged 18 years and older. The trial is not yet recruiting.

Is Elraglusib the same as Elraglusib Oral Tablets?

Yes, Elraglusib is also known as Elraglusib Oral Tablets. The drug is administered orally as a tablet formulation. This alternative name is used in clinical and regulatory contexts to specify the dosage form of the investigational therapy.