Colorectal Cancer Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
DelveInsight’s, “Colorectal Cancer Pipeline Insight 2025” report provides comprehensive insights about 195+ companies and 200+ pipeline drugs in Colorectal Cancer 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.
Explore our latest breakthroughs in Colorectal Cancer Research. Learn more about our innovative pipeline today! @ Colorectal Cancer Pipeline Outlook
Key Takeaways from the Colorectal Cancer Pipeline Report
- In March 2025, HiberCell, Inc. announced a study of phase 1b, safety, pharmacokinetic, and efficacy, multicenter, dose-escalating Study of Imprime PGG™ Injection dosed in combination with Cetuximab and concomitant irinotecan therapy. Enrolled patients will have a confirmed diagnosis of recurrent or progressive colorectal carcinoma following treatment with a 5-fluorouracil-containing regimen.
- In March 2025, Bristol-Myers Squibb organized a study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.
- In March 2025, Seagen conducted a study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.
- In March 2025, Janssen Research & Development, LLC announced a study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
- DelveInsight’s Colorectal Cancer pipeline report depicts a robust space with 195+ active players working to develop 200+ pipeline therapies for Acute Lymphocytic Leukemia treatment.
- The leading Colorectal Cancer Companies such as Exelixis, Mirati Therapeutics, Merck Sharp & Dohme LLC, Daiichi Sankyo Company, Inspirna, Lyell Immunopharma, Genentech, Cantargia AB, Arcus Biosciences, Inc., Neogap Therapeutics AB, Criterium, Inc., Daiichi Sankyo, Inc., Bristol-Myers Squibb, Celyad Oncology SA, Pfizer, Akeso, Menarini Group, Elpiscience (Suzhou) Biopharma, Ltd., BeyondBio Inc., Shanghai Henlius Biotech, Rottapharm Biotech, Innovative Cellular Therapeutics Inc., BioNTech SE, and others.
- Promising Colorectal Cancer Therapies such as Patritumab Deruxtecan, Adagrasib, Geptanolimab, PolyPEPI1018, Grapiprant, eFT508, MEN1611, Aldoxorubicin Hydrochloride, Etrumadenant, AL2846, ABI-009, RO7198457, Dabrafenib, AlloStim, TG6002, Onvansertib, BLYG8824A, Napabucasin, GM102, QL1203, CPGJ602, PM060184, Donafenib, IBI310, Spartalizumab, CMAB009, YYB101, ATP128, Vicriviroc, CXD101, Arfolitixorin, SGM-101, RRx-001, APR003, E7386, Trastuzumab, Trilaciclib, MGN1703, BBI608, CYAD-101, SHR-A1811, EDP1503, SCT-I10A, KL-140, V941, NKTR-255, TEW-7197, MGD019, KPT-8602, GRT-C901, LUM015, IDE196, CAN04, NC410, LOAd703, CEA CAR-T cells, BOLD-100, OBI-833, GRT-C903, IGM-8444, RGX-202-01, NE-201, DS-8201, GCC19CART, M 9140, LYL845, and others.
Stay informed about the cutting-edge advancements in Colorectal Cancer treatments. Download for updates and be a part of the revolution in care @ Colorectal Cancer Clinical Trials Assessment
Colorectal Cancer Emerging Drugs Profile
- XL092 : Exelixis
XL092 is an investigational small molecule, oral tyrosine kinase inhibitors (TKI) that inhibits the activity of receptor tyrosine kinases involved in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes like oncogenesis, metastasis, and tumor angiogenesis. Currently it is in Phase III stage of clinical trial evaluation to treat Colorectal Cancer.
- Adagrasb : Mirati Therapeutics
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers. The drug candidate is being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated colorectal cancer. Currently being evaluated in the Phase III studies.
- Olaparib : Merck Sharp & Dohme LLC/Astrazeneca
Olaparib is an investigational is a first-in-class Poly (ADP-ribose) polymerase PARP inhibitors and the first targeted treatment that potentially exploit DNA damage response (DDR) pathway deficiencies, like BRCA mutations, to preferentially kill cancer cells. Olaparib is being jointly developed and commercialized by AstraZeneca and Merck. Currently the drug is being evaluated in Phase III for the treatment of Colorectal Cancer.
- DS-8201: Daiichi Sankyo
DS-8201 a proprietary antibody-drug conjugate (ADC) is a smart chemotherapy comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetra peptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered. The drug is been developed in collaboration with AstraZeneca. The drug is in Phase II stage of clinical trials.
- Ompenaclid: Inspirna
Ompenaclid is a first in class oral small molecule inhibitor of the creatine transport channel SLC6A8 a novel target that is enriched under hypoxic conditions and provides tumor cells with an additional energy source. Ompenaclid triggers tumor regressions in CRC patients by inducing apoptosis of tumor cells. It is based on Rgenix technology. The drug is in Phase II stage of clinical trials.
- LYL845: Lyell Immunopharma
LYL845, an autologous tumor-infiltrating lymphocytes (TIL). It is administered through the intravenous route. It is being developed based on an ex vivo epigenetic reprogramming (Epi-R) technology platform is currently being investigated in a Phase 1 clinical trial in patients suffering with relapsed or refractory metastatic colorectal cancer.
- RG6286: Genentech
RG6286 (BLYG-8824A) is under development for the treatment of relapsed or refractory, advanced, or metastatic colorectal cancer. It is new chemical entity, administered through an intravenous route currently being investigated in a Phase 1 clinical trial.
The Colorectal Cancer Pipeline Report Provides Insights into
- The report provides detailed insights about companies that are developing therapies for the treatment of Colorectal Cancer 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 Colorectal Cancer Treatment.
- Colorectal Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
- Colorectal Cancer 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 Colorectal Cancer market
Learn more about Colorectal Cancer Drugs opportunities in our groundbreaking Colorectal Cancer Research and development projects @ Colorectal Cancer Unmet Needs
Colorectal Cancer Companies
Exelixis, Mirati Therapeutics, Merck Sharp & Dohme LLC, Daiichi Sankyo Company, Inspirna, Lyell Immunopharma, Genentech, Cantargia AB, Arcus Biosciences, Inc., Neogap Therapeutics AB, Criterium, Inc., Daiichi Sankyo, Inc., Bristol-Myers Squibb, Celyad Oncology SA, Pfizer, Akeso, Menarini Group, Elpiscience (Suzhou) Biopharma, Ltd., BeyondBio Inc., Shanghai Henlius Biotech, Rottapharm Biotech, Innovative Cellular Therapeutics Inc., BioNTech SE and others.
Colorectal Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
- Oral
- Intravenous
- Subcutaneous
- Parenteral
- Topical
Colorectal Cancer Products have been categorized under various Molecule types such as
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Peptide
- Polymer
- Gene therapy
Discover the latest advancements in Colorectal Cancer treatment by visiting our website. Stay informed about how we’re transforming the future of disease @ Colorectal Cancer Market Drivers and Barriers, and Future Perspectives
Scope of the Colorectal Cancer Pipeline Report
- Coverage- Global
- Colorectal Cancer Companies- Exelixis, Mirati Therapeutics, Merck Sharp & Dohme LLC, Daiichi Sankyo Company, Inspirna, Lyell Immunopharma, Genentech, Cantargia AB, Arcus Biosciences, Inc., Neogap Therapeutics AB, Criterium, Inc., Daiichi Sankyo, Inc., Bristol-Myers Squibb, Celyad Oncology SA, Pfizer, Akeso, Menarini Group, Elpiscience (Suzhou) Biopharma, Ltd., BeyondBio Inc., Shanghai Henlius Biotech, Rottapharm Biotech, Innovative Cellular Therapeutics Inc., BioNTech SE, and others.
- Colorectal Cancer Therapies- Patritumab Deruxtecan, Adagrasib, Geptanolimab, PolyPEPI1018, Grapiprant, eFT508, MEN1611, Aldoxorubicin Hydrochloride, Etrumadenant, AL2846, ABI-009, RO7198457, Dabrafenib, AlloStim, TG6002, Onvansertib, BLYG8824A, Napabucasin, GM102, QL1203, CPGJ602, PM060184, Donafenib, IBI310, Spartalizumab, CMAB009, YYB101, ATP128, Vicriviroc, CXD101, Arfolitixorin, SGM-101, RRx-001, APR003, E7386, Trastuzumab, Trilaciclib, MGN1703, BBI608, CYAD-101, SHR-A1811, EDP1503, SCT-I10A, KL-140, V941, NKTR-255, TEW-7197, MGD019, KPT-8602, GRT-C901, LUM015, IDE196, CAN04, NC410, LOAd703, CEA CAR-T cells, BOLD-100, OBI-833, GRT-C903, IGM-8444, RGX-202-01, NE-201, DS-8201, GCC19CART, M 9140, LYL845, and others.
- Colorectal Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- Colorectal Cancer 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 Colorectal Cancer Pipeline on our website @ Colorectal Cancer Emerging Drugs and Companies
Table of Content
- Introduction
- Executive Summary
- Colorectal Cancer: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Late Stage Products (Phase III)
- Comparative Analysis
- XL092: Exelixis
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Early Stage Products (Phase I)
- LYL845: Lyell Immunopharma
- Inactive Products
- Colorectal Cancer Key Companies
- Colorectal Cancer Key Products
- Colorectal Cancer – Unmet Needs
- Colorectal Cancer – Market Drivers and Barriers
- Colorectal Cancer – Future Perspectives and Conclusion
- Colorectal Cancer Analyst Views
- Colorectal Cancer Key Companies
- Appendix
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