Colorectal Cancer Pipeline Outlook 2025 Clinical Trials, Medication, Therapies, Companies By Delveinsight

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"Colorectal Cancer Pipeline"Colorectal Cancer companies are Plus Therapeutics, Processa Pharmaceuticals, 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.

(Albany, United States) – The fight against colorectal cancer (CRC), one of the most prevalent and deadly cancers worldwide, is witnessing transformative advancements in clinical trials, drug development, and regulatory approvals. According to the latest analysis by DelveInsight , the “Colorectal Cancer Pipeline Insight, 2025” report offers an extensive outlook into the clinical and commercial landscape, covering 195+ companies working on 200+ treatment therapies across stages of development. The report provides a comprehensive evaluation of clinical trials, therapies, mechanisms of action (MoA), routes of administration (RoA), and company developments , underscoring the dynamic progress in the colorectal cancer treatment ecosystem.

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Recent Colorectal Cancer Regulatory & Clinical Developments (2024–2025)

• March 27, 2025 – LIXTE Biotechnology Holdings, in collaboration with the Netherlands Cancer Institute and Roche, dosed its first patient in a clinical trial for unresponsive metastatic colorectal cancer (MSI Low).
• January 25, 2025 – Exelixis presented new results from its Phase Ib/II STELLAR-001 trial combining zanzalintinib with Tecentriq (atezolizumab) at ASCO GI 2025 .
• January 2025 – Marengo Therapeutics received FDA Fast Track Designation for invikafusp alfa (STAR0602), a first-in-class dual T cell agonist targeting advanced CRC with TMB-H.
• January 2025 – Mirror Biologics entered a collaboration with Merck KGaA to test its immunotherapy AlloStim with Bavencio (avelumab) in Phase II trials for metastatic CRC.
• January 16, 2025 – FDA approved sotorasib (Lumakras, Amgen) with panitumumab (Vectibix) for KRAS G12C-mutated metastatic CRC.
• December 2024 – Pfizer secured FDA approval for BRAFTOVI® (encorafenib) + cetuximab + mFOLFOX6 for BRAF V600E mutation-positive CRC under the FDA Project FrontRunner pathway.
• September 2024 – FRUZAQLA® (fruquintinib) gained approval as an oral targeted therapy for mCRC, offering a non-chemotherapy option.
• January 2024 – Bristol Myers Squibb (BMS) shared encouraging Phase III CheckMate -8HW results using Opdivo + Yervoy for MSI-H/dMMR mCRC.
• November 2023 – FDA approved fruquintinib (Fruzaqla) for metastatic CRC patients with prior chemotherapy and targeted therapy exposure.

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Key Highlights from the Colorectal Cancer Pipeline Report

• Global R&D Landscape : Over 195 companies are actively developing 200+ pipeline therapies , spanning preclinical, Phase I, II, and III trials, with some nearing market entry.
• Leading 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.
• Emerging Mechanisms of Action : Innovations span monoclonal antibodies, small molecules, peptides, gene therapies, and checkpoint inhibitors , diversifying treatment options.
• Routes of Administration : Therapies are being developed across oral, parenteral, intravenous, subcutaneous, and topical routes to enhance patient convenience and compliance.
• Collaborations & Partnerships : Increasing alliances between pharma companies and academic institutions are fueling accelerated development and approvals.

Colorectal Cancer Overview

Colorectal cancer (CRC) originates in the colon or rectum, often from polyps that transform into malignant tumors over time. It is the third most common cancer worldwide and a leading cause of cancer-related mortality. Risk factors include age over 50, genetic predispositions (e.g., Lynch syndrome), inflammatory bowel disease, diet high in processed meats, obesity, smoking, and sedentary lifestyle.

Early detection remains critical. Diagnostic approaches include colonoscopy, imaging, biopsy, and stool-based screening. While surgery remains the primary treatment for localized CRC, patients with advanced or metastatic stages rely on chemotherapy, targeted therapy, radiation, and emerging immunotherapies .

Stay ahead of the curve with DelveInsight's“Colorectal Cancer Pipeline Insight, 2025” report. Gain exclusive access to detailed analyses of 195+ companies, 200+ emerging therapies, regulatory milestones (EMA, PDMA, FDA), and the latest clinical trial insights shaping the colorectal cancer treatment landscape @ Colorectal Cancer Competitive Landscape and Therapeutics

Colorectal Cancer Emerging Therapies in the Pipeline

Some of the most promising pipeline therapies include:

• 188RNL-BAM (Plus Therapeutics)
• PCS11T (Processa Pharmaceuticals)
• HLX13 (Shanghai Henlius Biotech)
• Adagrasib (MRTX849) (Mirati Therapeutics)
• Zanzalintinib (XL092) (Exelixis)
• EO2040 (Enterome)
• Etrumadenant (Arcus Biosciences)
• LYL845 (Lyell Immunopharma)
• Geptanolimab (Apollomics)
• HDM201 (Novartis)
• TP-1454 (Sumitomo Pharma Oncology)
• NT219 (Purple Biotech)
• NKTR-255 (Nektar Therapeutics)
• Evorpacept (ALX148) (ALX Oncology)
• Trastuzumab deruxtecan (Daiichi Sankyo)
• GRT-C901 (Gritstone Bio)
• SHR-1701 (Suzhou Suncadia Biopharmaceuticals)
• Trilaciclib (G1 Therapeutics)
• Lumakras (sotorasib) (Amgen)

These candidates demonstrate innovation in targeting KRAS, BRAF, immune checkpoints, angiogenesis, and T-cell pathways , highlighting the diversification of CRC treatment.

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

Colorectal Cancer Therapeutic Assessment

• Molecule Types : monoclonal antibodies, small molecules, peptides, polymers, and gene therapies.
• Route of Administration : oral, intravenous, subcutaneous, parenteral, and topical.
• Stage-wise Development : Phase III (late-stage), Phase II (mid-stage), Phase I (early-stage), pre-clinical, discovery, and discontinued candidates.

Colorectal Cancer Market Dynamics

Colorectal Cancer Market Drivers

• Emergence of targeted therapies and precision oncology.
• Molecular subtyping of CRC tumors enabling tailored treatments.
• Rising product development activity and industry collaborations.
• Growing regulatory support with fast-track designations and accelerated approvals .

Colorectal Cancer Market Barriers

• Limited understanding of secondary resistance mechanisms .
• High treatment costs and reimbursement challenges.
• Complexity of precision oncology integration in clinical practice.
• Unmet need in patients with microsatellite stable CRC and refractory disease.

Download Sample PDF Report to know more about Colorectal Cancer drugs and therapies

Scope of the Colorectal Cancer Market Report

• Coverage : Global CRC clinical trials and therapies.
• Companies Covered : Amgen, Pfizer, Novartis, Daiichi Sankyo, Mirati, G1 Therapeutics, Plus Therapeutics, Processa, Henlius, Apollomics, and others.
• Therapies Assessed : From monoclonal antibodies to gene therapies .
• Pipeline Segmentation : By stage, RoA, MoA, and molecule type.
• Additional Insights : Collaborations, licensing, mergers & acquisitions, and financing activities.

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in life sciences. With expertise spanning drug development, market analysis, and healthcare consulting , DelveInsight supports pharmaceutical and biotech companies in navigating complex challenges, identifying growth opportunities, and accelerating innovation in oncology and beyond.

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