# CPI-008

Source: https://onco.cc/drugs/cpi-008/  
OnCo record `cpi-008` (Imaging agent). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

CPI-008 (cRGD-ZW800-1) is an experimental dye that sticks to tumour tissue so surgeons can see it under near-infrared light. It has been tested in phase 2 trials and has European orphan status for head and neck cancer.

## Summary

CPI-008 is the code for cRGD-ZW800-1, a cyclic RGD peptide joined to the near-infrared dye ZW800-1. ClinicalTrials.gov lists investigator-led phase 2 trials in oral cancer (NCT04191460, completed) and laryngeal and hypopharyngeal cancer (NCT05752149, recruiting) at Erasmus Medical Center, and in pancreatic and bile duct tumours at Leiden University Medical Center (NCT05518071, completed). On 22 June 2026 the EMA granted orphan designation EU/3/26/3253 for the treatment of head and neck cancer to Curadel Surgical Innovations B.V.

## Fields

- Kind: Imaging agent
- Status: phase-2
- Last checked: 2026-11-04
- Also known as: cRGD-ZW800-1; cyclo(arginyl-glycyl-aspartyl-D-tyrosyl-lysyl)-nizaracianine-1
- Tags: pipeline; orphan-designation
- Code: CPI-008
- Modality: Tumour-targeted near-infrared fluorescence imaging agent
- Mechanism: A cyclic RGD peptide, which binds integrins on tumour cells and new blood vessels, joined to the zwitterionic near-infrared dye nizaracianine (ZW800-1), so that tumour tissue fluoresces under a near-infrared camera during surgery.

## Sources

- ClinicalTrials.gov NCT05752149: cRGD-ZW800-1 in laryngeal and hypopharyngeal cancer surgery (phase 2): https://clinicaltrials.gov/study/NCT05752149
- ClinicalTrials.gov NCT04191460: cRGD-ZW800-1 in oral cancer surgery (phase 2): https://clinicaltrials.gov/study/NCT04191460
- EMA orphan designation EU/3/26/3253: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-26-3253
- ClinicalTrials.gov: NCT04191460 (oral cancer): https://clinicaltrials.gov/study/NCT04191460
- ClinicalTrials.gov: NCT05518071 (pancreatic and bile duct): https://clinicaltrials.gov/study/NCT05518071

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/)
- technologies: [Fluorescence-guided surgery](https://onco.cc/technologies/fluorescence-guided-surgery/)
- companies: [Curadel Surgical Innovations](https://onco.cc/companies/curadel-pharma/)

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