Colorectal Cancer Pipeline 2025: MOA, ROA, FDA-Approved Drugs, and Clinical Trial Progress Assessment by DelveInsight

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Colorectal Cancer pipeline constitutes 195+ key companies continuously working towards developing 200+ Colorectal Cancer treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Colorectal Cancer Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Colorectal Cancer Market.

The Colorectal Cancer Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Colorectal Cancer Pipeline Report: https://www.delveinsight.com/sample-request/colorectal-cancer-crc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Colorectal Cancer treatment therapies with a considerable amount of success over the years.
• Colorectal Cancer companies working in the treatment market are Plus Therapeutics, Processa Pharmaceutic als, Shanghai Henlius Biotech, Apollomics, Novartis Pharmaceuticals, Sumitomo Pharma Oncology, Purple Biotech Ltd., Nektar Therapeutics, ALX Oncology Inc., Guojian Pharmaceutical, Daiichi Sankyo, Gritstone Bio, Inc, Suzhou Suncadia Biopharmace uticals Co., Ltd., G1 Therapeutics, Amgen, Mirati Therapeutics, and others, are developing therapies for the Colorectal Cancer treatment
• Emerging Colorectal Cancer therapies in the different phases of clinical trials are- 188RNL-BAM, PCS11T, HLX13, Geptanolimab, HDM201, TP-1454, NT219, NKTR, 255, Evorpacept (ALX148), CPGJ 602 Sunshine, Trastuzumab deruxtecan, GRT-C901, SHR-1701, Trilaciclib, Lumakras (sotorasib), MRTX849, and others are expected to have a significant impact on the Colorectal Cancer market in the coming years.
• In February 2026, The FDA has agreed to review a new combination therapy for patients with previously treated metastatic colorectal cancer, a population with limited treatment options and poor outcomes following standard chemotherapy. According to a press release from Exelixis, Inc., the U.S. Food and Drug Administration has accepted a new drug application for zanzalintinib (formerly XL092) in combination with the immunotherapy Tecentriq (atezolizumab) for adult patients with metastatic colorectal cancer who have already received prior treatments.
• In August 2025, Marking a significant advancement in personalized cancer care, the US FDA has approved Agilent Technologies Inc.'s MMR IHC Panel pharmDx (Dako Omnis), a new companion diagnostic (CDx) test for colorectal cancer (CRC). This approval offers oncologists and pathologists a vital tool to identify patients most likely to benefit from targeted immunotherapy treatments.
• In August 2025, The FDA has granted approval for the MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic to detect patients with mismatch repair-deficient (dMMR) colorectal cancer (CRC) who may qualify for treatment with nivolumab (Opdivo), either alone or in combination with ipilimumab (Yervoy).
• In August 2025, Agilent Technologies Inc. (NYSE: A) announced that the FDA has approved its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic (CDx) for colorectal cancer. The test helps identify patients with mismatch repair-deficient (dMMR) colorectal cancer (CRC) who may be eligible for treatment with Bristol Myers Squibb's Opdivo® (nivolumab) as monotherapy or in combination with Yervoy® (ipilimumab). The MMR IHC Panel pharmDx (Dako Omnis) is authorized for exclusive use with the Agilent Dako Omnis automated staining system.
• In April 2025, Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company specializing in PLK1 inhibition for developing novel cancer therapies, announced the completion of patient enrollment in its ongoing Phase 2 CRDF-004 trial. This study is evaluating the effectiveness of onvansertib combined with standard-of-care treatment for first-line RAS-mutated metastatic colorectal cancer (mCRC).
• In February 2025, Pfizer's combination therapy for metastatic colorectal cancer (mCRC) successfully met one of its primary objectives-improving progression-free survival (PFS)-in a Phase III clinical trial, strengthening its potential for full regulatory approval. The BREAKWATER trial (NCT05217446), an open-label, active-controlled study, evaluated a treatment regimen combining Pfizer's Braftovi (encorafenib), Eli Lilly's Erbitux (cetuximab), and the chemotherapy regimen mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin). The trial focused on treatment-naive mCRC patients with a BRAF V600E mutation.
• In February 2025, Averto Medical announced that its ColoSealTM Intraluminal Colonic Diversion (ICD) System has received Breakthrough Device Designation from the FDA. This groundbreaking device aims to improve recovery and outcomes for patients undergoing colorectal surgery by potentially removing the need for a temporary ostomy.
• In January 2025, The FDA has approved Amgen's KRAS G12C inhibitor, Lumakras, for use in combination with Vectibix to treat advanced colorectal cancer. Additionally, in December 2024, EndoQuest Robotics received FDA IDE approval to initiate a clinical trial assessing its surgical robot for the removal of colorectal lesions. The study, involving 50 participants across five sites in the US, will evaluate the robot's safety and effectiveness in performing endoscopic submucosal dissection (ESD) procedures (NCT06133387).
• In November 2024, Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company focused on developing tumor-activated immuno-oncology therapies, has released initial clinical data from its ongoing Phase 1C trial. The study evaluates vilastobart (XTX101), a tumor-activated, Fc-enhanced, high-affinity anti-CTLA-4, in combination with atezolizumab (Tecentriq®) for patients with advanced solid tumors and colorectal cancer.
• In September 2024, FRUZAQLA® (fruquintinib) is a kinase inhibitor approved for treating adults with metastatic colorectal cancer (mCRC). This novel oral targeted therapy is designed for once-daily use, providing a non-chemotherapy alternative for patients who have previously received treatments such as fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, along with anti-vascular endothelial growth factor (VEGF) therapy.
• In January 2024, Bristol Myers Squibb (BMS) recently disclosed encouraging findings from the Phase III CheckMate -8HW study involving Opdivo (nivolumab) and Yervoy (ipilimumab) as an initial treatment choice for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). This open-label, randomized Phase III trial aims to assess the effectiveness of combining Opdivo and Yervoy compared to the chemotherapy selected by the investigator.

Colorectal Cancer Overview
Colorectal cancer, also known as bowel cancer or colon cancer, refers to cancer that develops in the colon or rectm, which are parts of the digestive system. It typically starts as small, noncancerous clumps of cells called polyps that form on the inner lining of the colon or rectm. Over time, some of these polyps can become cancerous.

Get a Free Sample PDF Report to know more about Colorectal Cancer Pipeline Therapeutic Assessment-
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Emerging Colorectal Cancer Drugs Under Different Phases of Clinical Development Include:
• 188RNL-BAM: Plus Therapeutics
• PCS11T: Processa Pharmaceutic als
• HLX13: Shanghai Henlius Biotech
• Adagrasib: Mirati Therapeutics
• XL092: Exelixis
• EO2040: Enterome
• Etrumadenant: Arcus Biosciences
• LYL845: Lyell Immunopharma
• Geptanolimab: Apollomics
• HDM201: Novartis Pharmaceuticals
• TP-1454: Sumitomo Pharma Oncology
• NT219: Purple Biotech Ltd.
• NKTR-255: Nektar Therapeutics
• Evorpacept (ALX148): ALX Oncology Inc.
• CPGJ 602 Sunshine: Guojian Pharmaceutical
• Trastuzumab deruxtecan: Daiichi Sankyo
• GRT-C901: Gritstone Bio, Inc
• SHR-1701: Suzhou Suncadia Biopharmace uticals Co., Ltd.
• Trilaciclib: G1 Therapeutics
• Lumakras (sotorasib): Amgen
• MRTX849: Mirati Therapeutics

Route of Administration
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
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Molecule Type
Products have been categorized under various Molecule types, such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Colorectal Cancer Pipeline Therapeutics Assessment
• Colorectal Cancer Assessment by Product Type
• Colorectal Cancer By Stage and Product Type
• Colorectal Cancer Assessment by Route of Administration
• Colorectal Cancer By Stage and Route of Administration
• Colorectal Cancer Assessment by Molecule Type
• Colorectal Cancer by Stage and Molecule Type

DelveInsight's Colorectal Cancer Report covers around 200+ products under different phases of clinical development like
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Colorectal Cancer product details are provided in the report. Download the Colorectal Cancer pipeline report to learn more about the emerging Colorectal Cancer therapies
https://www.delveinsight.com/sample-request/colorectal-cancer-crc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Colorectal Cancer Therapeutics Market include:
Key companies developing therapies for Colorectal Cancer are - Daiichi Sankyo Company, Mirati Therapeutics, Apollomics, Treos Bio Zrt, AskAt, Effector Therapeutics, Menarini Group, ImmunityBio, Arcus Biosciences, Abraxis Bioscience, Chia Tai Tianqing Pharmaceutical Group, Aadi, LLC, BioNTech SE, Novartis, Immunovative Therapies, Transgene, Cardiff Oncology, Genentech, Sumitomo Pharma Oncology, GamaMabs Pharma, Qilu Pharmaceutical, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., PharmaMar, Suzhou Zelgen Biopharmaceuticals, Innovent Biologics, Sinomab, Yooyoung Pharmaceutical, Amal Therapeutics, Celleron Therapeutics, Merck Sharp & Dohme Corp, Isofol Medical, Surgimab, EpicentRx, Inc, Apros Therapeutics, Eisai Co., Ltd., Puma Biotechnology, G1 Therapeutics, Mologen AG, Celyad Oncology, Jiangsu HengRui Medicine, Evelo Biosciences, Sinocelltech, Moderna Therapeutics, Sichuan Kelun Pharmaceutical Research Institute, Nektar Therapeutics, MedPacto, Karyopharm Therapeutics, Gritstone Oncology, Lumicell, Inc., IDEAYA Biosciences, Cantargia AB, NextCure, Inc., Lokon Pharma AB, Chongqing Precision Biotech Co., Ltd, Bold Therapeutics, OBI Pharma, Inc, Gritstone Oncology, IGM Biosciences, Rgenix, Inc., Precision Biologics, Inc, MacroGenics, Academia Sinica, Innovative Cellular Therapeutics, Merck KGaA, Lyell Immunopharma, and others.

Colorectal Cancer Pipeline Analysis:
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 key 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.
The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Colorectal Cancer drugs and therapies
https://www.delveinsight.com/sample-request/colorectal-cancer-crc-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Colorectal Cancer Pipeline Market Drivers
• Emergence of targeted therapies for mCRC treatment, technical Advancement in molecular subtyping of CRC tumors, increase in product development activities are some of the important factors that are fueling the Colorectal Cancer Market.

Colorectal Cancer Pipeline Market Barriers
• However, limitations in understanding secondary resistance, high Cost of Treatment • Challenges related to precision oncology in mCRC management and other factors are creating obstacles in the Colorectal Cancer Market growth.

Scope of Colorectal Cancer Pipeline Drug Insight
• Coverage: Global
• Key Colorectal Cancer Companies: Plus Therapeutics, Processa Pharmaceutic als, Shanghai Henlius Biotech, Apollomics, Novartis Pharmaceuticals, Sumitomo Pharma Oncology, Purple Biotech Ltd., Nektar Therapeutics, ALX Oncology Inc., Guojian Pharmaceutical, Daiichi Sankyo, Gritstone Bio, Inc, Suzhou Suncadia Biopharmace uticals Co., Ltd., G1 Therapeutics, Amgen, Mirati Therapeutics, and others
• Key Colorectal Cancer Therapies: 188RNL-BAM, PCS11T, HLX13, Geptanolimab, HDM201, TP-1454, NT219, NKTR, 255, Evorpacept (ALX148), CPGJ 602 Sunshine, Trastuzumab deruxtecan, GRT-C901, SHR-1701, Trilaciclib, Lumakras (sotorasib), MRTX849, and others
• Colorectal Cancer Therapeutic Assessment: Colorectal Cancer current marketed and Colorectal Cancer emerging therapies
• Colorectal Cancer Market Dynamics: Colorectal Cancer market drivers and Colorectal Cancer market barriers

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

This release was published on openPR.