GSK 3 Inhibitor - Target Population, Competitive Landscape, and Market Forecast - 2040

Key Highlights:

• GSK-3 (both a and B isoforms) regulates critical cellular functions like metabolism, inflammation, neuroplasticity, and apoptosis. Its dysregulation is implicated in Alzheimer's, bipolar disorder, cancer, diabetes, and more.
• While Some GSK-3 inhibitors are in development, lithium remains the only one approved for clinical use-primarily in bipolar disorder.
• Among novel inhibitors, elraglusib (9-ING-41) is the most advanced, currently in Phase II trials for various cancers, especially pancreatic adenocarcinoma and soft tissue sarcomas.
• In June 2025, Actuate Therapeutics reported promising biomarker and machine learning data from its Phase II trial of elraglusib in first-line metastatic pancreatic cancer at ASCO.
• In June 2025, Actuate Therapeutics announced positive Phase II results showing that elraglusib combined with gemcitabine/nab-paclitaxel significantly improved survival in metastatic pancreatic cancer patients. In February 2024, AMO Pharma announced a collaboration with the Population Health Research Institute (PHRI) at McMaster University to launch the TaRGET proof-of-concept clinical trial, exploring AMO-02 (tideglusib), a GSK3B inhibitor.
• The emerging drug pipeline for GSK-3 Inhibitor is diverse and includes Some promising candidates, such as AMO-02 (AMO Pharma), Elraglusib (Actuate Therapeutics) and others.

DelveInsight's "GSK 3 Inhibitor- Target Population, Competitive Landscape, and Market Forecast - 2040" report delivers an in-depth understanding of the GSK 3 Inhibitor, historical and Competitive Landscape as well as the GSK 3 Inhibitor market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The GSK 3 Inhibitor market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM GSK 3 Inhibitor market size from 2020 to 2040. The report also covers current GSK 3 Inhibitor treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2040

GSK 3 Inhibitor Understanding

GSK 3 Inhibitor Overview

Glycogen synthase kinase-3 (GSK-3) is a serine/threonine protein kinase with two isoforms-GSK-3a and GSK-3B-that plays a key regulatory role in numerous cellular processes such as metabolism, cell proliferation, neurodevelopment, and inflammation. Unlike many kinases, GSK-3 is constitutively active in resting cells and is turned off by upstream signals like insulin and AKT. It participates in important pathways like Wnt/B-catenin and insulin signaling, making it a central node in diseases ranging from diabetes and cancer to neurodegenerative and psychiatric disorders.

GSK-3 inhibitors work by reducing the enzyme's activity either directly or indirectly. These can be categorized into ATP-competitive inhibitors (which bind to the enzyme's ATP site), non-ATP-competitive inhibitors (like tideglusib, which irreversibly bind elsewhere), substrate-competitive inhibitors, and indirect modulators like lithium, which blocks GSK-3 by interfering with magnesium binding and enhancing its phosphorylation. Each class offers different advantages in terms of selectivity, duration, and therapeutic effect.

GSK 3 Inhibitor Epidemiology

The GSK 3 Inhibitor epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases of selected indications for GSK-3 inhibitors, total eligible patient pool for GSK-3 inhibitors in selected indications and total treated cases in selected indications for GSK-3 inhibitors in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2040.

• The total diagnosed prevalent cases of myotonic dystrophy in the 7MM were ~107,900 in 2024.
• In EU4 and the UK, Germany accounted for the highest number of myotonic dystrophy treated cases with approximately 2,655 in 2024.
• Among the EU4, Germany accounted for the highest number of pancreatic cancer prevalent cases in 2024.
• Japan accounted for ~47,257 incident pancreatic cancer cases in 2024.

GSK 3 Inhibitor Chapters

The drug chapter segment of the GSK 3 Inhibitor reports encloses a detailed analysis of late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the GSK 3 Inhibitor clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Emerging Drugs

9-ING-41 (Elraglusib): Actuate Therapeutics

9-ING-41 (Elraglusib), developed by Actuate Therapeutics, is a selective small-molecule inhibitor of glycogen synthase kinase-3 beta (GSK-3B), a key regulator of multiple cellular processes including proliferation, DNA damage repair, and immune response modulation. By targeting GSK-3B, 9-ING-41 enhances tumor sensitivity to chemotherapy, reduces fibrotic signaling, and may boost anti-tumor immune activity. It is currently being evaluated across a range of malignancies including metastatic pancreatic cancer, glioblastoma, and soft tissue sarcoma.

• In May 2025, Actuate Therapeutics announced the presentation of topline Phase II data for elraglusib in first-line metastatic pancreatic cancer at the ASCO Annual Meeting. The data highlighted significant survival benefits from the elraglusib combination therapy.
• In April 2025, Actuate Therapeutics announced the presentation of promising data on elraglusib in advanced salivary gland carcinoma at the AACR Annual Meeting 2025. The findings suggest enhanced response rates, particularly in patients with tumors overexpressing nuclear GSK-3B.

AMO-02: AMO Pharma

AMO-02 (tideglusib) is in development for the treatment of congenital myotonic dystrophy and has potential for use in additional CNS, neuromuscular and other orphan indications. AM0-02 is a clinical stage investigational medicine for the treatment of the severe form of congenital myotonic dystrophy known as DM1 or Steinert disease. In cellular and animal models of DM1 as well as in muscle biopsies from patients, activity of glycogen synthase kinase 3 beta (GSK3B) has been shown to increase. AMO-02 is an inhibitor that has been shown to normalise levels of GSK3B in transgenic models and in ex vivo tissue samples in patients with DM1 and to reduce levels of the mRNA that is pathogenic for DM1.

• In May 2024, AMO Pharma completed a meeting with the US FDA and outlined plans to advance its investigational drug AMO-02 (tideglusib) into a Phase III trial for adult-onset myotonic dystrophy type 1 (DM1).

GSK 3 Inhibitor Market Outlook

Glycogen synthase kinase-3 (GSK-3) is a well-established target involved in key cellular functions such as metabolism, apoptosis, and neuroplasticity. Despite its importance, lithium remains the only approved GSK-3 inhibitor, and solely for psychiatric use in bipolar disorder. Lithium's clinical utility highlights the relevance of GSK-3 modulation, but its non-selectivity and narrow therapeutic margin have constrained its broader adoption. No GSK-3 inhibitor is currently approved for non-psychiatric or disease-modifying indications, reflecting a significant unmet need.

The landscape is now beginning to evolve. AMO-02 (tideglusib), developed by AMO Pharma, is in clinical development for congenital myotonic dystrophy type 1 (CDM1)-a rare genetic neuromuscular disease with no approved therapy. Early trials have shown promising functional and biomarker improvements, supported by designations like the Rare Pediatric Disease status and UK Innovation Passport.

In oncology, 9-ING-41 by Actuate Therapeutics is progressing through Phase II trials in multiple cancers, including metastatic pancreatic Cancer, glioblastoma and non-Hodgkin's lymphoma. Its selective GSK-3B inhibition may enhance tumor cell death and improve responses to chemotherapy and immunotherapy.

Other than these, 4M Therapeutics is developing a portfolio of preclinical-stage GSK3B-targeting compounds. Its lead program, 4MT2001, is being developed for bipolar disorder and is currently in IND-enabling toxicology studies. Unlike lithium, 4MT2001 aims to offer greater selectivity and improved safety, addressing a key limitation of current GSK-3 inhibition. The company is also advancing the 4MT-01 series for agitation in Alzheimer's disease.

After years of stagnation, the GSK-3 inhibitor landscape is gaining clinical and commercial traction-driven not by legacy compounds like lithium, but by mid- and late-stage, disease-specific programs with the potential to transform treatment standards. As pivotal data emerge over the next few years, GSK-3 could finally claim its place as a core therapeutic target across oncology, neuromuscular, and CNS disorders. The future of GSK-3 inhibition lies with those poised for the clinic, not the lab-and that future is now taking shape.

GSK 3 Inhibitor Drugs Uptake

This section focuses on the uptake rate of potential GSK 3 Inhibitor expected to be launched in the market during 2025-2040.

GSK 3 Inhibitor Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

The presence of numerous drugs under different stages is expected to generate immense opportunity for GSK 3 Inhibitor market growth over the forecasted period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for GSK 3 Inhibitor therapies.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on GSK 3 Inhibitor evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. University such as University of Pennsylvania and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or GSK 3 Inhibitor market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Key Updates on GSK 3 Inhibitor

In May 2025, Actuate Therapeutics announced statistically significant topline results from its global Phase II trial evaluating elraglusib in the first-line treatment of metastatic pancreatic cancer.

In January 2025, Actuate Therapeutics announced that the European Medicines Agency (EMA) granted Orphan Medicinal Product Designation to elraglusib for the treatment of pancreatic cancer. This designation supports the drug's development by offering regulatory and market exclusivity incentives in the EU.

In November 2024, Actuate Therapeutics announced that the FDA granted Rare Pediatric Disease Designation to elraglusib for the treatment of Ewing sarcoma. This designation highlights the drug's potential to address an unmet need in pediatric oncology and may qualify it for a priority review voucher upon approval.

In September 2024, Actuate Therapeutics obtained complete responses and provided update on clinical trial of elraglusib for the treatment of Relapsed/Refractory Ewing Sarcoma.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of the GSK 3 Inhibitor, explaining its mechanism, and emerging GSK 3 inhibitor.
• Comprehensive insight into the competitive landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the GSK 3 Inhibitor market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM GSK 3 Inhibitor market.

GSK 3 Inhibitor Report Insights

• GSK 3 Inhibitor Targeted Patient Pool
• Therapeutic Approaches
• GSK 3 Inhibitor Pipeline Analysis
• GSK 3 Inhibitor Market Size and Trends
• Existing and future Market Opportunity

GSK 3 Inhibitor Report Key Strengths

• Ten years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

GSK 3 Inhibitor Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

• What was the GSK 3 Inhibitor total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2040?
• Which is the most lucrative market for GSK 3 inhibitor?
• What are the pricing variations among different geographies for approved therapies?
• What are the risks, burdens, and unmet needs of treatment with GSK 3 Inhibitor? What will be the growth opportunities across the 7MM for the patient population of GSK 3 inhibitor?
• What are the key factors hampering the growth of the GSK 3 inhibitor market?
• What are the indications for which GSK 3 inhibitor are being developed to overcome the limitations of existing treatments?
• What key designations have been granted to GSK 3 inhibitor?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the GSK 3 inhibitor Market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.