Tgfb Inhibitors Clinical Trial Pipeline Accelerates As 25+ Pharma Companies Rigorously Develop Drugs For Market Entry Delveinsight
| Drugs | Company | Phase | Indication | RoA |
| Elritercept (HS-20106) | Takeda/Hansoh Pharma | III | Anemia; Myelofibrosis | SC |
| OT-101 | Autotelic/Oncotelic Therapeutics | III | Glioblastoma | Intracranial microperfusion;Intratumorally/Intravenously |
| Vactosertib | MedPacto | II | mCRC; NSCLC; r/rMM, Desmoid | Oral |
| AdAPT-001 | EpicentRx | II | Sarcoma; Refractory Solid tumors | Intratumoral injection |
| AK130 | Akeso Biopharma | II | Pancreatic cancer | IV infusion |
| STP707 | Sirnaomics | I | Solid tumors | IV infusion |
Arunima Dabral, Associate Consultant of Competitive Intelligence and Consulting at DelveInsight, said that the TGF-β therapeutic landscape is expected to evolve toward more selective, context-specific, and precision-driven pathway modulation, supported by increasing clinical development and strategic investment across oncology, hematology, pulmonary hypertension, and other disease areas. The field is gradually moving beyond broad pathway inhibition toward approaches designed to improve target specificity, tissue selectivity, therapeutic window, and clinical tolerability, while combination strategies are gaining importance as developers seek to address the complex and interconnected roles of TGF-β signaling in immune suppression, fibrosis, angiogenesis, and abnormal tissue remodeling. Continued advancement into late-stage clinical development is expected to provide greater validation of the pathway, although challenges related to biological complexity, patient selection, systemic safety, and translating pathway engagement into meaningful clinical outcomes remain. Overall, the future outlook is promising but dependent on clinical validation, with the greatest potential likely to come from differentiated approaches that enable selective pathway modulation and rational integration with complementary therapeutic mechanisms.
Recent Developments in the TGFb Inhibitor Treatment Space
- In September 2026, Keros Therapeutics, Inc. announced that it expects to receive a USD 20 million development milestone payment under the terms of the license agreement of elritercept with partner Takeda, following the dosing of the first patient in the ELRiSE MF clinical trial. ELRiSE MF is a Phase III, multicenter, double-blind, randomized trial to compare the efficacy and safety of elritercept to placebo in patients with myelofibrosis (“MF”) and anemia on concurrent ruxolitinib therapy. In April 2026, GSK plc announced the completion of its acquisition of 35Pharma Inc., a Canada-based, private, clinical-stage biopharmaceutical company specialising in the development of novel protein-based and TGF-beta superfamily therapeutics. The acquisition includes HS235, a potential best-in-class molecule for the treatment of pulmonary hypertension (PH). Under the terms of the agreement, GSK has acquired 100% of the equity of 35Pharma Inc. for USD 950 million. In February 2026, Oncotelic Therapeutics, Inc. and Sapu Bioscience announced key advancements in its global intellectual property portfolio supporting OT-101, its proprietary TGF-β antisense therapeutic platform, strengthening protection across neurology, oncology, and central nervous system (CNS) drug delivery. In November 2025, Tiumbio Co., Ltd. shared the interim Phase II clinical data for its“first-in-class” Tosposertib (TU2218), a dual inhibitor against TGFβ type I receptor (TGFβRI /ALK5) and VEGFR2. The study evaluated Tosposertib in combination with MSD's Keytruda (pembrolizumab) as a first-line therapy for patients with recurrent/metastatic(r/m) head and neck squamous cell carcinoma (HNSCC). In September 2025, MedPacto, a Korean biotechnology company, launched a phase II clinical trial of its investigational drug vactosertib for osteosarcoma in Korea and the U.S. In September 2025, Akeso Inc. has announced that the first patient has been dosed in its registrational Phase II study (AK130-202), evaluating AK130, a fully independently developed TIGIT/TGF-β bifunctional antibody fusion protein, in combination with ivonescimab (PD-1/VEGF bispecific antibody), for treating locally advanced or metastatic pancreatic cancer in patients who have failed up to two prior lines of systemic therapy. In July 2025, Keros Therapeutics, Inc. announced that the first patient was dosed in the Phase III RENEW clinical trial of elritercept in adults with transfusion-dependent anemia with very low, low, or intermediate risk myelodysplastic syndromes (“MDS”). The dosing of the first patient triggers a USD 10 million milestone payment to Keros under the global license agreement with Takeda.
Scope of the TGFb Inhibitors Pipeline Report
- Coverage: Global TGFb Inhibitors Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination TGFb Inhibitors Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III TGFb Inhibitors Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal TGFb Inhibitors Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Key TGFb Inhibitors Companies: Takeda, Hansoh Pharma, iOnctura, Sirnaomics, EpicentRx, Akeso Biopharma, Scholar Rock, Oncotelic Inc., MedPacto, Inc., and others Key Pipeline TGFb Inhibitors: Elritercept/HS-20106, IOA-359, STP707, AdAPT-001, AK130, SRK-181, OT-101, STP705, STP355, Vactosertib, and others
Table of Contents
| 1. | TGFb Inhibitors Pipeline Report Introduction |
| 2. | TGFb Inhibitors Pipeline Report Executive Summary |
| 3. | TGFb Inhibitors Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | TGFb Inhibitors Clinical Trial Therapeutics |
| 6. | TGFb Inhibitors Pipeline: Late-Stage Products (Pre-registration) |
| 7. | TGFb Inhibitors Pipeline: Late-Stage Products (Phase III) |
| 8. | TGFb Inhibitors Pipeline: Mid-Stage Products (Phase II) |
| 9. | TGFb Inhibitors Pipeline: Early-Stage Products (Phase I) |
| 10. | TGFb Inhibitors Pipeline Therapeutics Assessment |
| 11. | Inactive Products in the TGFb Inhibitors Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products in the TGFb Inhibitors Pipeline |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
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