TGFb Inhibitor Pipeline Summary

• The TGF-β Inhibitor Pipeline is witnessing significant research and development activity, driven by the growing need for innovative therapies targeting cancer, fibrosis, and other diseases associated with abnormal transforming growth factor-beta (TGF-β) signaling.
• The leading TGF-β Inhibitor Companies include EpicentRx, Scholar Rock, Sirnaomics, SiSaf, iOnctura, Keros Therapeutics, Isarna Therapeutics, TiumBio, Agomab Therapeutics, IO Biotech, Elpiscience Biopharmaceuticals, Jiangsu Hengrui Medicine, Sunshine Lake Pharma, Roche, Enveda Biosciences, Bristol Myers Squibb, Eli Lilly and Company, Avacta Group, Leads Biolabs, and Merck & Co., among others.

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Key Factors Driving the Growth of the TGF-β Inhibitor Pipeline

• Rising Prevalence of Cancer and Fibrotic Diseases

The increasing burden of solid tumors and fibrotic conditions is driving research into therapies targeting TGF-β signaling.

• Role of TGF-β in Tumor Progression

The involvement of TGF-β in tumor growth, metastasis, immune evasion, and treatment resistance is increasing interest in developing targeted therapies.

• Growing Demand for Combination Therapies

Combining TGF-β inhibitors with immunotherapies, chemotherapy, and targeted treatments may improve therapeutic responses in selected patients.

• Advancements in Targeted Drug Development

Progress in small-molecule inhibitors, monoclonal antibodies, ligand traps, and other targeted approaches is expanding the TGF-β inhibitor pipeline.

• Increasing Research into Fibrosis Treatment

The critical role of TGF-β in extracellular matrix deposition and tissue scarring is encouraging the development of potential treatments for pulmonary, liver, and other fibrotic diseases.

• Advances in Biomarker-Based Patient Selection

Improved understanding of TGF-β pathway activity is supporting research into personalized treatment strategies and patient selection approaches.

DelveInsight’s “TGF-β Inhibitor Pipeline Insight, 2026” report provides comprehensive insights about 25+ companies and 30+ pipeline drugs in the TGF-β Inhibitor pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

TGF-β Inhibitor Understanding: Overview

Transforming growth factor is a secreted multifunctional cytokine that signals via plasma membrane TGF-β type I and type II receptors and intercellular SMAD transcriptional effectors. Aberrant inter- and intracellular TGF-β signaling can contribute to cancer progression. In normal cells and early stages of cancer, TGF-β can stimulate epithelial growth arrest and elicit a tumor suppressor function.

However, in late stages of cancer, when the cytostatic effects of TGF-β in cancer cells are blocked, TGF-β signaling can act as tumor promoter by its ability to stimulate epithelial-to-mesenchymal transition of cancer cells, by stimulating angiogenesis, and by promoting evasion of immune responses.

The inhibition of the TGF-β signaling pathway has emerged as a viable and promising therapeutic target for developing a cancer treatment.

In the early malignant stage, TGF-β secreted by tumor or stromal cells plays a tumor suppressor role by inducing cell-cycle arrest and promoting apoptosis. TGF-β causes late G1 cycle arrest by regulating the expression of cyclin-dependent kinases (CDK) inhibitors, p21 and c-Myc, to inhibit cell cycle progression.

In addition, TGF-β can induce apoptosis by upregulating apoptotic regulators such as Bcl-2-like protein 11 (BIM), BCL-2 interacting killer (BIK), and death associated protein kinase (DAPK). Cancer cells often bypass the TGF-β-induced cytostatic effects and apoptosis by mutating key components of the TGF-β pathway.

In pre-malignant cancer progression, the function of TGF-β signaling changes from a tumor suppressor to a tumor promoter. TGF-β is also responsible for regulating stroma cells in the tumor microenvironment (TME).

Transforming growth factor beta (TGF-β) is a multifunctional cytokine that plays a pivotal role in regulating a wide range of biological processes essential for maintaining cellular homeostasis and tissue integrity. These processes include cell proliferation, differentiation, apoptosis, immune modulation, extracellular matrix production, and tissue remodeling.

Under normal physiological conditions, TGF-β contributes to wound healing and immune regulation.

However, dysregulation of the TGF-β signaling pathway is implicated in the pathogenesis of numerous diseases, making it a highly attractive and versatile therapeutic target. Chronic overexpression or aberrant activation of TGF-β has been observed in several disease states, notably in fibrotic disorders, various cancers, and ophthalmic conditions such as age-related macular degeneration. 

In ophthalmology, specific genetic variants that influence the TGF-β pathway have been associated with a heightened risk of developing more severe forms of AMD, indicating that TGF-β may actively contribute to disease onset and progression by promoting chronic inflammation, fibrosis, and angiogenesis within ocular tissues.

In oncology, the role of TGF-β is complex and highly context-dependent. In early-stage cancers, it may function as a tumor suppressor by inhibiting cell proliferation and inducing apoptosis.

However, as tumors evolve, cancer cells often hijack the TGF-β pathway to promote epithelial-to-mesenchymal transition (EMT), immune evasion, angiogenesis, and metastasis, effectively transforming TGF-β into a pro-oncogenic factor.

Beyond direct inhibition of TGF-β ligands or their receptors, alternative approaches aim to selectively modulate specific components of the TGF-β signaling pathway or interfere with downstream signaling mechanisms.

These strategies may include targeting intracellular mediators, transcriptional regulators, or other pathway components that contribute to the pro-tumorigenic effects of TGF-β while potentially preserving its physiological functions. 

Such selective or indirect approaches are being explored to improve the therapeutic window of TGF-β pathway inhibition and reduce the potential toxicity associated with broad blockade of TGF-β signaling.

"TGF-β Inhibitor Pipeline Insight, 2026" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the TGF-β Inhibitor pipeline landscape is provided which includes the disease overview and TGF-β Inhibitor treatment guidelines. The assessment part of the report embraces, in depth TGF-β Inhibitor commercial assessment and clinical assessment of the pipeline products under development.

In the TGF-β Inhibitor Pipeline Report, a detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, TGF-β Inhibitor collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

TGF-β Inhibitor Pipeline Report Highlights

• The TGF-β Inhibitor Companies and academics are working to assess challenges and seek opportunities that could influence TGF-β Inhibitor R&D. The TGF-β Inhibitor Therapies under development are focused on novel approaches to treat/improve TGF-β Inhibitor.

TGF-β Inhibitor Emerging Drugs Analysis

This segment of the TGF-β Inhibitor Pipeline Report includes a detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical, and Discovery. It also helps to understand clinical trial details, expressed pharmacological action, agreements and collaborations, and the latest TGF-β Inhibitor news and press releases.

TGF-β Inhibitor Emerging Drugs

• Elritercept (HS-20106): Takeda/Hansoh Pharma

Elritercept (HS-20106) is a TGF-β pathway inhibitor and engineered ligand-trap fusion protein, originally developed as KER-050 by Keros Therapeutics and licensed to Hansoh Pharma for development in Greater China, with Takeda involved in its global development.

The drug consists of a modified ligand-binding domain of activin receptor type IIA (ActRIIA) fused to the Fc domain of a human antibody. By binding and trapping selected ligands of the TGF-β superfamily, including activin A, elritercept is designed to modulate aberrant signaling involved in ineffective blood-cell production.

Currently, the drug is in Phase III stage of its clinical trial for the treatment of Anaemia and Myelofibrosis.

• AdAPT-001: EpicentRx

AdAPT-001 represents a novel investigational immunotherapy leveraging a replicative type 5 adenovirus. This adenovirus is equipped with a TGF-β receptor-immunoglobulin Fc fusion trap designed to neutralize TGF-β isoforms 1 and 3, which are implicated in fibrosis, angiogenesis, hypoxia, and immunosuppression within the tumor microenvironment.

By targeting these cytokines, AdAPT-001 aims to enhance tumor sensitivity to checkpoint blockade therapies. The combination of AdAPT-001 with checkpoint inhibitors has not only improved toxicity and adverse event profiles compared to checkpoint inhibitors alone but has also demonstrated no dose-limiting toxicities, serious adverse events related to AdAPT-001, or necessary dose reductions thus far.

This suggests a potentially safer and more effective treatment strategy for resistant tumors. Currently, the drug is in Phase II stage of its clinical trial for the treatment of several tumor types including STS, colorectal cancer, breast cancer and hepatocellular carcinoma.

• AK130: Akeso Biopharma

AK130 is a TIGIT/TGF-β bifunctional antibody fusion protein being developed as an immuno-oncology therapy. It consists of an anti-TIGIT monoclonal antibody fused with the extracellular domain of human TGF-β receptor II (TGF-βRII).

By simultaneously blocking TIGIT-CD155 signaling and trapping TGF-β, AK130 is designed to relieve immune suppression, enhance the activity of tumor-infiltrating CD8+ T cells and NK cells, and reduce TGF-β-mediated immunosuppressive effects in the tumor microenvironment.

Akeso has developed AK130 for the treatment of advanced solid tumors and is evaluating it both as monotherapy and in combination with ivonescimab. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Pancreatic Cancer.

• STP707: Sirnaomics

STP707 is an RNAi-based dual TGF-β1/COX-2 inhibitor being developed for the treatment of solid tumors. It consists of two small interfering RNA (siRNA) molecules targeting TGF-β1 and COX-2 mRNAs, formulated in Sirnaomics’ proprietary histidine-lysine polypeptide (HKP+H) nanoparticle delivery system for intravenous administration.

By silencing TGF-β1 and COX-2 gene expression, STP707 is designed to reduce TGF-β1-mediated immunosuppression and COX-2-mediated pro-tumorigenic signaling, thereby enhancing antitumor immune responses and promoting T-cell infiltration into the tumor microenvironment.

Sirnaomics is developing STP707 for solid tumors, including liver cancer. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Solid tumors.

Further product details are provided in the report……..

TGF-β Inhibitor Pipeline Therapeutic Assessment

This segment of the TGF-β Inhibitor Pipeline Report provides insights about the different TGF-β Inhibitor drugs segregated based on the following parameters that define the scope of the report, such as:

Major TGF-β Inhibitor Companies

There are approx. 20+ key TGF-β Inhibitor Companies which are developing the therapies TGF-β Inhibitor. The companies which have their TGF-β Inhibitor drug candidates in the most advanced stage, i.e. Phase III include, Takeda and others.

TGF-β Inhibitor Phases

DelveInsight’s TGF-β Inhibitor Pipeline Report covers around 20+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

TGF-β Inhibitor Route of Administration

TGF-β Inhibitor pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

TGF-β Inhibitor Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

TGF-β Inhibitor Product Type

TGF-β Inhibitor Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

TGF-β Inhibitor Clinical Trials Activities

The TGF-β Inhibitor Pipeline Report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses TGF-β Inhibitor therapeutic drugs key players involved in developing key drugs.

TGF-β Inhibitor Pipeline Development Activities

The TGF-β Inhibitor Pipeline Report covers detailed information on collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging TGF-β Inhibitor drugs.

TGF-β Inhibitor Pipeline Report Insights

• TGF-β Inhibitor Pipeline Analysis
• TGF-β Inhibitor Therapeutic Assessment
• TGF-β Inhibitor Unmet Needs
• Impact of TGF-β Inhibitor Drugs

TGF-β Inhibitor Pipeline Report Assessment

• TGF-β Inhibitor Pipeline Product Profiles
• TGF-β Inhibitor Therapeutic Assessment
• TGF-β Inhibitor Pipeline Assessment
• Inactive Drugs Assessment
• TGF-β Inhibitor Unmet Needs

Key Questions Answered in the TGF-β Inhibitor Pipeline Report

Current TGF-β Inhibitor Treatment Scenario and Emerging Therapies:

• How many companies are developing TGF-β Inhibitor drugs?
• How many TGF-β Inhibitor drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of TGF-β Inhibitor?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the TGF-β Inhibitor therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for TGF-β Inhibitor and their status?
• What are the key designations that have been granted to the emerging drugs?

Key TGF-β Inhibitor Companies

• Takeda
• Hansoh Pharma
• iOnctura
• Sirnaomics
• EpicentRx
• Akeso Biopharma
• Scholar Rock
• Oncotelic Inc.
• MedPacto, Inc.

Key TGF-β Inhibitor Products

• Elritercept/HS-20106
• IOA-359
• STP707
• AdAPT-001
• AK130
• SRK-181
• OT-101
• STP705
• STP355
• Vactosertib

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