TheraRadar
Data updated: May 26, 2026

ZALTRAP (ziv-aflibercept)

Vascular Endothelial Growth Factor Inhibitors Genetically Validated Trial Activity: Declining 2 active trials
Oncology Approved 2012-08-03

ZALTRAP is indicated for the treatment of Colorectal Cancer.

Source: FDA Label • Sanofi • Vascular Endothelial Growth Factor Inhibitor

How ZALTRAP Works

Ziv-aflibercept functions as a soluble receptor that binds to human VEGF-A, VEGF-B, and placental growth factor (PlGF). By binding to these endogenous ligands, the drug prevents them from interacting with and activating their cognate receptors. This inhibition results in decreased neovascularization and vascular permeability, which hinders the proliferation of endothelial cells and the growth of new blood vessels.

Development Insights

National Cancer Institute (NCI) conducting 9 trials (56%)
63 indications explored (Broad Platform)
metastatic malignant solid neoplasm (2 trials)
metastatic melanoma (2 trials)
recurrent melanoma (2 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
13
Years on Market

Details

Status
Prescription
First Approved
2012-08-03
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: ZIV-AFLIBERCEPT

ZALTRAP Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2012 to 2023 · 1 indication expansions
Dec 2023 SUPPL
Label · Labeling
Jun 2020 SUPPL
Label · Labeling
Mar 2020 SUPPL
Label · Labeling

What ZALTRAP Treats

1 indications

ZALTRAP is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Colorectal Cancer
Source: FDA Label

ZALTRAP Target & Pathway

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Target

VEGF (Vascular Endothelial Growth Factor) Growth Factor

A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.

Pathway Context

VEGF binds to VEGFR on blood vessel cells to stimulate new vessel formation

VEGFR (Vascular Endothelial Growth Factor Receptor) receptor

Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.

ZALTRAP Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in ZALTRAP's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZALTRAP treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to ZALTRAP

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CAPECITABINE
CAPECITABINE
1 shared
AMNEAL PHARMS
Shared indications:
Colorectal Cancer
CYRAMZA
RAMUCIRUMAB
1 shared
Eli Lilly
Shared indications:
Colorectal Cancer
ERBITUX
CETUXIMAB
1 shared
IMCLONE
Shared indications:
Colorectal Cancer
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Clinical Trial Registry

15 trials
Trial Sponsor ID Phase Status Title
NCT02298959 NCI-2014-01984 NCI-2014-01984, 15-703 Ph 1 active not recruiting Testing the PD-1 Antibody, MK3475, Given With Ziv-aflibercept in Patients With Advanced Cancer
NCT06121180 MCC-21341 R2810-ONC-2128 Ph 2 recruiting Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma
NCT02159989 results posted NCI-2014-01107 NCI-2014-01107, 2013-0665 Ph 1 completed Sapanisertib and Ziv-Aflibercept in Treating Patients With Recurrent Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
NCT03712904 results posted 18P.457 JT 11801 Ph 2 terminated Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma
NCT01782443 results posted 12-456 Ph 2 completed Ziv-Aflibercept for Advanced Progressive Carcinoid Tumors
NCT02101918 results posted NCI-2014-00642 NCI-2014-00642, 2013-0954 Ph 2 completed Ziv-Aflibercept in Treating and Computed Tomography Perfusion Imaging in Predicting Response in Patients With Pancreatic Neuroendocrine Tumors That Are Metastatic or Cannot Be Removed by Surgery
NCT01747551 results posted 12-401 Ph 2 completed FOLFOX +/- Ziv-Aflibercept for Esophageal and Gastric Cancer
NCT01258855 results posted NCI-2011-02498 NCI-2011-02498, PHII-107 Ph 2 completed Aldesleukin With or Without Ziv-Aflibercept in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
NCT02192541 results posted 140150 14-C-0150 Ph 1 terminated Ganetespib and Ziv-Aflibercept in Refractory Gastrointestinal Carcinomas, Non-Squamous Non-Small Cell Lung Carcinomas, Urothelial Carcinomas, and Sarcomas
NCT00828139 results posted NCI-2009-01182 NCI-2009-01182, SWOG-S0802 Ph 2 completed S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer
NCT00729157 results posted NCI-2009-00178 NCI-2009-00178, MSKCC-08066 Ph 2 completed Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
NCT02235324 3C-13-7 NCI-2014-01806, HS-14-00081 Ph 2 withdrawn Ziv-Aflibercept Followed by Ziv-Aflibercept, Fluorouracil, and Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer
NCT01889680 NSABP FC-8 Ph 2 withdrawn Safety and Effectiveness Study of Chemotherapy and Ziv-aflibercept to Treat Metastatic Colorectal Cancer
NCT00650923 NCI-2009-00678 NCI-2009-00678, CDR0000590174 Ph 1 completed Aflibercept, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed or Recurrent Glioblastoma Multiforme, Gliosarcoma, or Other Malignant Glioma
NCT00622414 NCI-2009-01062 NCI-2009-01062, COG-ADVL0714 Ph 1 completed Aflibercept in Treating Young Patients With Relapsed or Refractory Solid Tumors
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ZALTRAP FDA Label Details

Indications & Usage

FDA Label (PDF)

ZALTRAP is indicated for the treatment of Colorectal Cancer.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment