pegulicianine
Trade name: Lumisight
Small moleculeapprovedImaging agentFast Track FDA
Approved
Apr 17, 2024
Clinical trial activity
4 trials · 7 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
0
Phase 3
0
Phase 4
0
Earliest trial started Jun 1, 2012 (NCT01626066)
Timeline
2010s
- Jan 1, 2012
Earliest Phase 1 Sponsor(trial)
2020s
- Apr 17, 2024
Lumicell, Inc. — Earliest FDA Approval
- Apr 17, 2024
Lumicell, Inc. — NDA Organization
Indications
Mechanism of action
- Matrix metalloproteinase-1BINDING AGENT
MMP1 binding agent
- Unspecified targetOTHER
Diagnostic agent
Pegulicianine is a prodrug that is optically inactive when intact; it requires cleavage by cathepsins and matrix metalloproteases (MMPs). The levels of these enzymes are higher in and around tumor and tumor-associated cells than normal cells.
Approval history
- approvedPriority reviewFast trackApr 17, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- Yes
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Black box warningFirst in class
Sources
- ChEMBLCHEMBL4594345 ↗
Also known as
- lum015
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06957821 | Early Phase 1 (Phase 1) | Oct 30, 2025 | Harvard University, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) |
| NCT02584244 | N/A | May 1, 2016 | Harvard University, Lumicell, Inc., National Cancer Institute (NCI) |
| NCT02438358 | N/A | Jun 1, 2015 | Harvard University, Lumicell, Inc., National Cancer Institute (NCI) |
| NCT01626066 | Phase 1 | Jun 1, 2012 | American Society of Clinical Oncology, Duke University |
Showing 4 of 4 trials
Page 1 / 1
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Harvard University | Academic/Hospital | 3 | 1 | 2 | 2015 |
| Lumicell, Inc. | For profit | 2 | 2 | 1 | 2015 |
| National Cancer Institute (NCI) | Government | 2 | 0 | 1 | 2015 |
| American Society of Clinical Oncology | Academic/Hospital | 1 | 0 | 1 | 2012 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 1 | 0 | 1 | 2025 |
| National Institutes of Health (NIH) | Government | 1 | 0 | 1 | 2025 |
7 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Lumicell, Inc. | For profit | NDA | Apr 17, 2024 |