Colorectal Cancer Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, 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 Colorectal Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Colorectal Cancer pipeline 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 Colorectal Cancer Pipeline Report

* On 29 August 2025, Merck Sharp & Dohme LLC announced a phase 3 Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer (MK-3475-C66).
* On 28 August 2025, Oncoinvent AS conducted a phase 1/2a open label study to evaluate the dose, safety, tolerability and efficacy of an IP -emitting radionuclide therapy (Radspherin Registered ) in subjects with peritoneal carcinomatosis (PC) from colorectal carcinoma following complete CRS (cytoreduction score CC-0) and HIPEC.
* 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.

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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

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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

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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

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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

About Us

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