Drugs / PEGULICIANINE ACETATE
PEGULICIANINE ACETATE
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LUMISIGHT | — | 2024-04-17 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06957821 | Jun 2026 → Jul 2028 expected | carotid artery disorder, peripheral arterial disease | Massachusetts General Hospital | Not yet recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT01626066 | Jun 2012 → Aug 2014 | breast cancer, soft tissue sarcoma | David Kirsch | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT03441464 | Mar 2019 → Feb 2021 | prostate cancer | Lumicell, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03834272 | Mar 2019 → Aug 2025 | peritoneal carcinomatosis | Lumicell, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02584244 | Aug 2016 → Dec 2026 expected | colorectal cancer, esophageal adenocarcinoma, gastric cancer, pancreatic adenocarcinoma | Lumicell, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02438358 | Jun 2015 → Sep 2017 | breast cancer | Lumicell, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04440982 | Sep 2020 → Nov 2023 | breast cancer | Lumicell, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03321929 | Feb 2018 → Apr 2020 | breast cancer | Lumicell, Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03686215 | Nov 2019 → Dec 2021 | breast cancer | Lumicell, Inc. | Completed | Mixed |
| Phase not applicable2 trials | ||||||
| — | NCT04276909 | Jan 2026 | malignant pancreatic neoplasm | Lumicell, Inc. | Withdrawn | No outcome recorded |
| — | NCT03717142 | May 2019 → Sep 2023 | glioblastoma, low grade glioma, metastatic malignant neoplasm in the brain | Lumicell, Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2025-04-28 | Lumicell, Inc. | Results Lumicell Announces Promising Feasibility Trial Findings Using Pegulicianine in Gastrointestinal Cancer Patients lumicell.com ↗
Post-surgical specimens imaged ex vivo demonstrated strong, tumor-specific fluorescence signals, correlating with pathologically confirmed cancerous tissue. |
| 2024-12-13 | Lumicell, Inc. | Results Lumicell Announces Poster Presentations at the 2024 San Antonio Breast Cancer Symposium Focused on Patient Benefit of Using LumiSystem™ During Lumpectomy lumicell.com ↗
New data suggests that patients were satisfied with their cosmetic outcomes following the removal of suspicious tissue detected by fluorescence-guided imaging during lumpectomy surgery, and prefer to avoid a second surgery |
| 2024-11-20 | Lumicell, Inc. | Regulatory Lumicell Granted Permanent HCPCS Code for Intraoperative Fluorescence Imaging Margin Assessment lumicell.com ↗
today announced LUMISIGHT™ (pegulicianine) was granted a permanent Healthcare Common Procedure Coding System (HCPCS) code for Hospital Outpatient Prospective Payment System (OPPS) by the Centers for Medicare & Medicaid Services (CMS). |
| 2024-09-05 | Lumicell, Inc. | Regulatory CMS Grants Transitional Pass-Through Payment for LUMISIGHT™ (pegulicianine) and Increases Access for Patients with Breast Cancer lumicell.com ↗ |
| 2024-07-15 | Lumicell, Inc. | Regulatory Lumicell Announces New Category III CPT® Code for Intraoperative Fluorescence Imaging Margin Assessment in Support of Market Launch lumicell.com ↗
Add-on CPT code granted following U.S. FDA approval of LUMISIGHT™ (pegulicianine) and Lumicell™ DVS, together referred to as LumiSystem™, with commercial availability in Q4 2024 |
| 2024-04-18 | Lumicell, Inc. | Regulatory Lumicell’s Cutting-Edge Imaging Platform Receives Historic FDA Approval to Illuminate Residual Breast Cancer lumicell.com ↗
today announced the U.S. Food & Drug Administration (FDA) approved the company’s New Drug Application (NDA) for its LUMISIGHT™ (pegulicianine) optical imaging agent and its Premarket Approval (PMA) application for Lumicell™ Direct Visualization System (DVS), together referred to as LumiSystem™. |
| 2024-03-25 | Lumicell, Inc. | Results Lumicell Introduces Further Research and Insights in Fluorescence-Guided Surgery at the Society of Surgical Oncology (SSO) Annual Meeting lumicell.com ↗
Carlos HF Chan, M.D., PhD., Associate Professor, Department of Surgery, University of Iowa Hospitals and Clinics, shared interim results from Feasibility of the Pegulicianine Fluorescence Guided Surgery for Detection of Peritoneal Surface Malignancies. |
| 2024-03-06 | Lumicell, Inc. | Regulatory Lumicell Announces FDA Advisory Committee’s Positive Recommendation on the Benefit-Risk Profile of LUMISIGHT™ in the Detection of Cancerous Tissue During Breast Conserving Surgery lumicell.com ↗ |
| 2023-05-22 | Lumicell, Inc. | Regulatory Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for LUMISIGHT™ Optical Imaging Agent for Breast Cancer lumicell.com ↗ |
| 2023-04-27 | Lumicell, Inc. | Results Lumicell™ DVS Pivotal Trial Results Published in NEJM Evidence and to Be Presented at ASBrS Assess Safety and Effectiveness of System for Identifying Residual Breast Cancer During Lumpectomy lumicell.com ↗
The study also evaluated the safety of Lumicell’s investigational optical imaging agent LUMISIGHT™ (pegulicianine), with a serious adverse event rate of 0.5%, similar to that of other contrast agents. |
| 2017-12-17 | Lumicell, Inc. | Results Lumicell Presents Phase 2 Clinical Data Showing LUM System Provided lumicell.com ↗
The Phase 2 data demonstrated that the integrated LUM System provided complete and instantaneous detection of residual cancer in tumor cavity and the ability to detect all breast cancer sub-types including invasive ductal cancer (IDC), invasive lobular cancer (ILC) and ductal carcinoma in situ (DCIS) during lumpectomy surgery. |
| 2016-04-13 | Lumicell, Inc. | Results Lumicell Successfully Completes Phase 2a Feasibility Study lumicell.com ↗
Lumicell, a leader in the field of image-guided cancer surgery, today announced it successfully completed its Phase 2a feasibility study on the Company’s groundbreaking LUM Imaging System, consisting of an optical contrast agent, LUM015, and the LUM Imaging Device. |
| 2016-01-06 | Lumicell, Inc. | Results Lumicell Publishes Data Supporting LUM015, Fluorescent Probe for Imaging Cancer, in Science Translational Medicine lumicell.com ↗ |
All press releases naming this drug 50 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PEGULICIANINE ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594345 ↗ |
| Known as | LUM015 | “This study is being conducted to see if LUM015 can be safely given to human patients before surgery at a dose that allows the removed tumor tissue to be identified when imaged...” NCT04276909 ↗8“Patients will be injected with one of 3 study doses of LUM015 and tissue will be imaged in vivo with the LUM imaging device.” NCT03834272 ↗ “The LUM Imaging System is a portable combination product consisting of an imaging device and an imaging agent (LUM015).” NCT03441464 ↗ “Patients in this arm will receive the study drug, LUM015.” NCT03686215 ↗ “the imaging agent LUM015” NCT03717142 ↗ |
| Known as | LUM015 ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594345 ↗ |
| Known as | Lumicell | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594345 ↗ |
| Known as | Lumisight | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594345 ↗ |
| Known as | Pegulicianine | “Participants received an injection of a novel imaging agent (pegulicianine) a mean (SD) of 3.2 (0.9) hours prior to surgery at a dose of 1 mg/kg.” PMID 35544130 ↗ Jul 2022 |
| Modality | Diagnostic / imaging agent | “a new imaging agent (LUM015), like a fluorescent contrast agent or dye” NCT01626066 ↗ |
| Route | Intravenous | “LUM015 assigned dose given once by IV push” NCT01626066 ↗ |