Advanced Renal Cell Carcinoma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

March 03 20:52 2025
Advanced Renal Cell Carcinoma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Advanced Renal Cell Carcinoma Pipeline Insight” report provides comprehensive insights about 50+ companies and 60+ pipeline drugs in Advanced Renal Cell Carcinoma 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.

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Key Takeaways from the Advanced Renal Cell Carcinoma Pipeline Report

  • In February 2025:- Hoffmann-La Roche– This study will evaluate the safety of tobemstomig (RO7247669) in combination with atixinib alone or with tiragolumab (anti-TIGIT) and axitinib as compared to pembrolizumab and axitinib in participants with previously untreated, unresectable locally advanced or metastatic clear-cell renal cell carcinoma (ccRCC).
  • In February 2025:- Exelixis– This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.
  • In February 2025: Bristol-Myers Squibb– The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study’s substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.
  • In February 2025:- Merck Sharp & Dohme LLC:- This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that the higher dose of belzutifan is superior to the standard dose in terms of objective response rate (ORR).
  • DelveInsight’s Advanced Renal Cell Carcinoma pipeline report depicts a robust space with 50+ active players working to develop 60+ pipeline therapies for Advanced Renal Cell Carcinoma treatment.
  • The leading Advanced Renal Cell Carcinoma Companies such as Merck Sharp & Dohme, Chia Tai Tianqing Pharmaceutical, Hoffmann-La Roche, CoImmune, Infinity Pharmaceuticals, NiKang Therapeutics, Molecure S.A., Daiichi Sankyo, Janux Therapeutics, MedImmune, Eli Lilly and Company, Jiangsu HengRui Medicine Co., Ltd., Allogene Therapeutics, Chongqing Precision Biotech Co., Ltd, Pfizer, Exelixis, BeiGene, Xencor, and others.
  • Promising Advanced Renal Cell Carcinoma Therapies such as KY1044, JK08, Pembrolizumab, Savolitinib, Sunitinib, TT-10, and others.

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Advanced Renal Cell Carcinoma Emerging Drugs Profile

  • Belzutifan: Merck Sharp & Dohme

Belzutifan is an inhibitor of hypoxia-inducible factor 2 alpha (HIF-2a). Belzutifan binds to HIF-2a, and in conditions of hypoxia or impairment of VHL protein function, belzutifan inhibits the HIF-2a-HIF-1ß interaction, leading to reduced transcription and expression of HIF-2a target genes. Currently, the drug is being evaluated in the Phase III stage of its development for the treatment of advanced renal cell carcinoma.

  • IPI-549: Infinity Pharmaceuticals

Eganelisib is a first-in-class, oral, once-daily, immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma). Selective PI3K-gamma inhibition represents a unique and potentially transformative approach within immuno-oncology (I/O), and IPI-549 has the potential to be a first-in-class therapy. Preclinical research conducted by Infinity and academic collaborators demonstrates that IPI-549 works by reprogramming key immune suppressive cells (called M2 macrophages or myeloid derived suppressor cells (MDSCs)) within the tumor microenvironment from a pro-tumor function to an anti-tumor function, decreasing immune suppression and increasing immune activation, ultimately leading to the activation and proliferation of T cells that can attack cancer cells. Currently, the drug is being evaluated in the Phase II stage of its development for the treatment of advanced renal cell carcinoma.

  • JANX008: Janux Therapeutics

JANX008 is an EGFR-TRACTr that is designed to overcome CRS and known on-target EGFR healthy tissue toxicities. Epidermal growth factor receptor (EGFR) is a clinically validated target highly expressed on many solid tumors that are being underserved by current therapies. JANX008 targets EGFR for the treatment of multiple solid cancers including, but not limited to, colorectal cancer (CRC), squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). Currently, the drug is being evaluated in the Phase I stage of its development for the treatment of advanced renal cell carcinoma.

The Advanced Renal Cell Carcinoma pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Advanced Renal Cell Carcinoma 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 Advanced Renal Cell Carcinoma Treatment.
  • Advanced Renal Cell Carcinoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Advanced Renal Cell Carcinoma 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 Advanced Renal Cell Carcinoma market.

Learn more about Advanced Renal Cell Carcinoma Drugs Opportunities in our groundbreaking Advanced Renal Cell Carcinoma research and development projects @ Advanced Renal Cell Carcinoma Unmet Needs

Advanced Renal Cell Carcinoma Companies

Merck Sharp & Dohme, Chia Tai Tianqing Pharmaceutical, Hoffmann-La Roche, CoImmune, Infinity Pharmaceuticals, NiKang Therapeutics, Molecure S.A., Daiichi Sankyo, Janux Therapeutics, MedImmune, Eli Lilly and Company, Jiangsu HengRui Medicine Co., Ltd., Allogene Therapeutics, Chongqing Precision Biotech Co., Ltd, Pfizer, Exelixis, BeiGene, Xencor, and others.

Advanced Renal Cell Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

  • Oral
  • Intravenous
  • Subcutaneous
  • Parenteral
  • Topical

Advanced Renal Cell Carcinoma Products have been categorized under various Molecule types such as

  • Recombinant fusion proteins
  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy

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Scope of the Advanced Renal Cell Carcinoma Pipeline Report

  • Coverage- Global
  • Advanced Renal Cell Carcinoma Companies- Merck Sharp & Dohme, Chia Tai Tianqing Pharmaceutical, Hoffmann-La Roche, CoImmune, Infinity Pharmaceuticals, NiKang Therapeutics, Molecure S.A., Daiichi Sankyo, Janux Therapeutics, MedImmune, Eli Lilly and Company, Jiangsu HengRui Medicine Co., Ltd., Allogene Therapeutics, Chongqing Precision Biotech Co., Ltd, Pfizer, Exelixis, BeiGene, Xencor, and others.
  • Advanced Renal Cell Carcinoma Therapies- KY1044, JK08, Pembrolizumab, Savolitinib, Sunitinib, TT-10, and others.
  • Advanced Renal Cell Carcinoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Advanced Renal Cell Carcinoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

For a detailed overview of our latest research findings and future plans, read the full details of Advanced Renal Cell Carcinoma pipeline on our website @ Advanced Renal Cell Carcinoma Emerging Drugs and Companies

Table of Content

  1. Introduction
  2. Executive Summary
  3. Advanced Renal Cell Carcinoma: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Advanced Renal Cell Carcinoma– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Belzutifan: Merck Sharp & Dohme
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. IPI-549: Infinity Pharmaceuticals
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I)
  14. JANX008: Janux Therapeutics
  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. Advanced Renal Cell Carcinoma Key Companies
  21. Advanced Renal Cell Carcinoma Key Products
  22. Advanced Renal Cell Carcinoma- Unmet Needs
  23. Advanced Renal Cell Carcinoma- Market Drivers and Barriers
  24. Advanced Renal Cell Carcinoma- Future Perspectives and Conclusion
  25. Advanced Renal Cell Carcinoma Analyst Views
  26. Advanced Renal Cell Carcinoma Key Companies
  27. Appendix

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