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Metastatic Colorectal Cancer

Oncology 2 original drugs
2
Novel Drugs
3
Reformulations
0
Active Trials
25
Drug Targets

Oncology indication. Metastatic Colorectal Cancer has 2 FDA-approved novel treatments, led by Roche across 25 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Metastatic Colorectal Cancer Market Leaders

Companies with the most FDA-approved novel Metastatic Colorectal Cancer drugs.

Phase 3 Readouts Pro

12 active Phase 3 trials with confidence-graded completion dates.

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Q4 2026
Tunlametinib plus Vemurafenib
Shanghai Kechow Pharma, Inc.
Estimated · aging NCT06008119
Q2 2027
XLJDOD compound granule
Jiangsu Famous Medical Technology Co., Ltd.
Estimated · stale NCT05709249
Q2 2027
JMT101
Shanghai JMT-Bio Inc.
Estimated · aging NCT07134205
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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Metastatic Colorectal Cancer Treatments by Mechanism

Top 12 mechanisms across 56 industry trials with a known mechanism of action.

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Kinase Inhibitor
7 trials 3 active 5 sponsors
Programmed Death Receptor-1 Blocking Antibody
8 trials 1 active 4 sponsors
VEGFR-1/VEGFR-2/VEGFR-3
7 trials 1 active 3 sponsors
Vascular Endothelial Growth Factor Inhibitor
6 trials 1 active 3 sponsors
Nucleoside Metabolic Inhibitor
3 trials 1 active 3 sponsors
CTLA-4-directed Blocking Antibody
2 trials 1 active 1 sponsor
AXL/FLT-3/KIT/MER/MET/RET/ROS1/TIE-2/TRKB/TYRO3/VEGFR-1/VEGFR-2/VEGFR-3
2 trials 1 active 1 sponsor
Programmed Death Ligand-1 Blocker
2 trials 1 active 2 sponsors
ALK/ROS1/NTRK1/TRKB/TRKC
1 trials 1 active 1 sponsor
Epidermal Growth Factor Receptor Antagonist
13 trials 6 sponsors
Vascular Endothelial Growth Factor Receptor 2 Antagonist
3 trials 1 sponsor
Poly(ADP-Ribose) Polymerase Inhibitor
2 trials 2 sponsors

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Metastatic Colorectal Cancer Clinical Pipeline by Phase

819 industry-sponsored trials across 416 sponsors

Precision Medicine Biomarkers

All biomarkers →

Biomarkers used for patient selection in Metastatic Colorectal Cancer

Novel Metastatic Colorectal Cancer Drugs by Company (New molecular entities)

2 companies have an FDA-approved novel drug for Metastatic Colorectal Cancer.

Reformulations (3 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.

Metastatic Colorectal Cancer Drug Targets

Molecular targets of approved and investigational Metastatic Colorectal Cancer drugs — 25 targets tracked.

Biosimilars (6 BLA approved) Click to expand

Biosimilars are biological products highly similar to FDA-approved reference biologics with no clinically meaningful differences in safety, purity, or potency.

Related Indications

Other Oncology indications

Drug Categories:

  • Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
  • Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
  • Biosimilars: BLA-approved biologics highly similar to reference products
  • Generics: ANDA-approved copies of small molecule drugs

View data sources and methodology