Mesothelioma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

March 06 20:09 2025
Mesothelioma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Mesothelioma Pipeline Insight 2025” report provides comprehensive insights about 45+ companies and 50+ pipeline drugs in Mesothelioma pipeline landscape. It covers the Mesothelioma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Mesothelioma therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Download our comprehensive report now to explore clinical-stage developments and strategic collaborations transforming the industry! @ Mesothelioma Pipeline Outlook Report

Key Takeaways from the Mesothelioma Pipeline Report

  • In March 2025, Genmab initiated a Phase 1/2 study of Rina-S (GEN1184), a folate receptor alpha (FRα)-targeted antibody-drug conjugate, to evaluate its safety, tolerability, pharmacokinetics (PK), and antitumor activity in participants with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma.
  • DelveInsight’s Mesothelioma pipeline report depicts a robust space with 45+ active players working to develop 50+ pipeline therapies for Mesothelioma treatment.
  • The leading Mesothelioma Companies such as Polaris Pharmaceuticals, AstraZeneca, MedImmune LLC, Takeda, RS Oncology LLC, Vivace Therapeutics, Inc., VM Oncology, LLC, KaliVir Immunotherapeutics, UTC Therapeutics Inc., Tango Therapeutics, Inc., Verismo Therapeutics, SpringWorks Therapeutics, Inc., Gilead Sciences, Nurix Therapeutics, Inc., Amphera BV, Merck Sharp & Dohme LLC, Constellation Pharmaceuticals, BridGene Biosciences Inc., Aromics Therapeutics, and Ascentage Pharma Group Inc. and others.
  • Promising Mesothelioma Therapies such as Pembrolizumab, Lenvatinib, Nivolumab, Ipilimumab, ZD1839, Zometa, Durvalumab, and others.

Learn how leading Mesothelioma Companies are positioning themselves for success in the evolving pharmaceutical market—access the full report today!” @ Mesothelioma Clinical Trials Assessment

Mesothelioma Emerging Drugs

  • Pegargiminase: Polaris Pharmaceuticals

Pegargiminase (ADI‑PEG 20), is a biologic in late-stage clinical development for a wide range of cancers. It is a novel therapeutic protein being developed for cancers with a unique metabolic trait. Pegargiminase deprives the cancer cells of the amino acid Arginine by converting plasma-borne arginine into citrulline. At the core of their deficiency is a down-regulation of Argininosuccinate Synthase (ASS1), an enzyme needed to synthesize arginine. To survive, the cancer cells must “rewire” their metabolism. This exerts a stress on the cells that renders them more susceptible to conventional chemotherapies. Pegargiminase has also gained Orphan Drug Designation for mesothelioma both in the U.S. and in Europe. Currently, the drug is in Preregistration stage of its development for the treatment of Mesothelioma.

  • Volrustomig: AstraZeneca

Volrustomig is an engineered Fragment Crystallizable (Fc) domain bispecific human immunoglobulin G1 (IgG1) monoclonal antibody directed against the human negative immunoregulatory checkpoint receptors programmed cell death protein 1 (PD-1; PDCD1; CD279) and cytotoxic T-lymphocyte-associated antigen 4 (CTLA4; CTLA-4), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, volrustomig targets and binds to both PD-1 and CTLA4 expressed on tumor-infiltrating T lymphocytes (TILs), and inhibits the PD-1- and CTLA4-mediated downregulation of T-cell activation and proliferation. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Mesothelioma.

  • Tremelimumab: MedImmune LLC

Tremelimumab is a type of monoclonal antibody and a type of immune checkpoint inhibitor. It is a drug that binds to the protein CTLA-4 to help immune cells kill cancer cells better and is used to treat different types of cancer. Tremelimumab is directed against cytotoxic T- lymphocyte-associated protein 4 (CTLA-4). By blocking the activity of CTLA-4, tremelimumab “releases the brakes” on T cell activation and boosts the immune response against cancer cells. It is a fully human monoclonal antibody, which stimulates the immune system to destroy cancer cells through binding to the protein CTLA-4, expressed on the surface of activated T-lymphocytes. Tremelimumab has been granted Orphan Drug Designation and Fast Track Designation form the US Food and Drug Administration. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Mesothelioma.

  • TAK-500: Takeda

TAK-500 is a first-in-class STING agonist immunostimulatory antibody drug conjugate (iADC) that delivers dazostinag to CCR2+ myeloid cells in the tumor microenvironment. By targeting the STING pathway and CCR2 expressing myeloid cells, TAK-500 may offer enhanced potency via improved PK and selective delivery. TAK-500 has three possible mechanisms of action: activation of IFN response, reprogramming of suppressive intratumoral CCR2+ myeloid cells, and blockade of suppressive tumor-associated macrophage recruitment. Activation of STING leads to the production of proinflammatory cytokines that activate dendritic cells, macrophages, and natural killer cells, and subsequently mobilize adaptive immune cells against tumor cells. Combining TAK-500 with radiation and/or checkpoint inhibitors led to enhanced antitumor activity in preclinical studies. Dying tumor cells release tumor antigens and tumor-derived cGAMP, which continue to activate the STING pathway. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of Mesothelioma.

  • RSO-021: RS Oncology LLC

RSO-021 is a naturally occurring, sulfur-rich, cyclic oligopeptide of the thiopeptide class, which covalently inactivates PRX3, leading to catastrophic oxidative stress and cell death. It is a novel first-in-class small molecule that irreversibly binds and inhibits mitochondrial peroxiredoxin 3 (PRX3). Inhibition of the PRX3 antioxidant signaling network in mitochondria results in selective killing of malignant cells by upregulation of oxidative stress; in contrast, healthy tissue is spared. In pre-clinical models RSO-021 reduces tumor growth in mice, sensitizes tumor cells to apoptosis and reduces the expression of pro-metastatic epithelial to mesenchymal (EMT) genes. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of Mesothelioma.

The Mesothelioma Pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Mesothelioma with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Mesothelioma Treatment.
  • Mesothelioma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Mesothelioma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Mesothelioma market.

From early-stage research to late-phase Mesothelioma Clinical Trials, our analysis covers key Mesothelioma Companies, innovative treatment approaches, and the next wave of Emerging Drugs. Don’t miss this opportunity to stay informed—download now! @ Mesothelioma Treatment Drugs

Mesothelioma Companies

Polaris Pharmaceuticals, AstraZeneca, MedImmune LLC, Takeda, RS Oncology LLC, Vivace Therapeutics, Inc., VM Oncology, LLC, KaliVir Immunotherapeutics, UTC Therapeutics Inc., Tango Therapeutics, Inc., Verismo Therapeutics, SpringWorks Therapeutics, Inc., Gilead Sciences, Nurix Therapeutics, Inc., Amphera BV, Merck Sharp & Dohme LLC, Constellation Pharmaceuticals, BridGene Biosciences Inc., Aromics Therapeutics, and Ascentage Pharma Group Inc. and others.

Stay updated with the latest Mesothelioma Pipeline Insights—download our report for a deep dive into the next generation of therapeutics! @ Mesothelioma Market Drivers and Barriers, and Future Perspectives

Scope of the Mesothelioma Pipeline Report

  • Coverage- Global
  • Mesothelioma Companies- Polaris Pharmaceuticals, AstraZeneca, MedImmune LLC, Takeda, RS Oncology LLC, Vivace Therapeutics, Inc., VM Oncology, LLC, KaliVir Immunotherapeutics, UTC Therapeutics Inc., Tango Therapeutics, Inc., Verismo Therapeutics, SpringWorks Therapeutics, Inc., Gilead Sciences, Nurix Therapeutics, Inc., Amphera BV, Merck Sharp & Dohme LLC, Constellation Pharmaceuticals, BridGene Biosciences Inc., Aromics Therapeutics, and Ascentage Pharma Group Inc. and others
  • Mesothelioma Therapies- Pembrolizumab, Lenvatinib, Nivolumab, Ipilimumab, ZD1839, Zometa, Durvalumab, and others.
  • Mesothelioma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Mesothelioma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Find answers in our latest Mesothelioma Pipeline Insights report, featuring in-depth coverage of Clinical Trials, regulatory trends, and upcoming breakthroughs. Download now to stay at the forefront of pharmaceutical innovation!” @ Mesothelioma Emerging Drugs and Companies

Table of Content

  1. Introduction
  2. Executive Summary
  3. Mesothelioma: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Mesothelioma – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Preregistration)
  8. Pegargiminase: Polaris Pharmaceuticals
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. Tremelimumab: MedImmune LLC
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I/II)
  14. TAK-500: Takeda
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. Drug name: Company name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Mesothelioma Key Companies
  21. Mesothelioma Key Products
  22. Mesothelioma- Unmet Needs
  23. Mesothelioma- Market Drivers and Barriers
  24. Mesothelioma- Future Perspectives and Conclusion
  25. Mesothelioma Analyst Views
  26. Mesothelioma Key Companies
  27. Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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