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| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5859 | 2230217-17-9 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Pegulicianine is a prodrug that is optically inactive when intact and produces a fluorescent signal after its peptide chain is cleaved by cathepsins and matrix metalloproteases (MMPs). The levels of these enzymes are higher in and around tumor and tumor-associated cells than normal cells.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 17, 2024 | FDA | Lumicell |
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| Source | Code | Description |
|---|---|---|
| ATC | V04CX13 | VARIOUS DIAGNOSTIC AGENTS OTHER DIAGNOSTIC AGENTS Other diagnostic agents |
| MeSH PA | D004396 | Coloring Agents |
| MeSH PA | D005456 | Fluorescent Dyes |
| MeSH PA | D007202 | Indicators and Reagents |
| MeSH PA | D049408 | Luminescent Agents |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Fluorescence imaging in breast cancer | indication | 767427005 |
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| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 39MG BASE/VIAL | LUMISIGHT | LUMICELL | N214511 | April 17, 2024 | RX | POWDER | INTRAVENOUS | 9155471 | Oct. 12, 2031 | A METHOD COMPRISING ADMINISTERING PEGULICIANINE TO A HUMAN AND OBTAINING AN IMAGE OF A TUMOR BED AFTER TUMOR RESECTION TO DISTINGUISH IN SITU CANCER CELLS FROM HEALTHY CELLS |
| EQ 39MG BASE/VIAL | LUMISIGHT | LUMICELL | N214511 | April 17, 2024 | RX | POWDER | INTRAVENOUS | 10285759 | Dec. 8, 2031 | A METHOD COMPRISING ADMINISTERING PEGULICIANINE TO A HUMAN AND OBTAINING AN IMAGE OF A TUMOR BED AFTER TUMOR RESECTION TO DISTINGUISH IN SITU CANCER CELLS FROM HEALTHY CELLS |
| EQ 39MG BASE/VIAL | LUMISIGHT | LUMICELL | N214511 | April 17, 2024 | RX | POWDER | INTRAVENOUS | 9032965 | Dec. 8, 2031 | A METHOD COMPRISING ADMINISTERING PEGULICIANINE TO A HUMAN AND OBTAINING AN IMAGE OF A TUMOR BED AFTER TUMOR RESECTION TO DISTINGUISH IN SITU CANCER CELLS FROM HEALTHY CELLS |
| EQ 39MG BASE/VIAL | LUMISIGHT | LUMICELL | N214511 | April 17, 2024 | RX | POWDER | INTRAVENOUS | 9532835 | Dec. 8, 2031 | A METHOD COMPRISING ADMINISTERING PEGULICIANINE TO A HUMAN AND OBTAINING AN IMAGE OF A TUMOR BED AFTER TUMOR RESECTION TO DISTINGUISH IN SITU CANCER CELLS FROM HEALTHY CELLS |
| EQ 39MG BASE/VIAL | LUMISIGHT | LUMICELL | N214511 | April 17, 2024 | RX | POWDER | INTRAVENOUS | 9763577 | Sept. 14, 2034 | A METHOD COMPRISING ADMINISTERING PEGULICIANINE TO A HUMAN AND OBTAINING AN IMAGE OF A TUMOR BED AFTER TUMOR RESECTION TO DISTINGUISH IN SITU CANCER CELLS FROM HEALTHY CELLS |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 39MG BASE/VIAL | LUMISIGHT | LUMICELL | N214511 | April 17, 2024 | RX | POWDER | INTRAVENOUS | April 17, 2029 | NEW CHEMICAL ENTITY |
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| ID | Source |
|---|---|
| C000731949 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4043166 | VANDF |
| C5446783 | UMLSCUI |
| CHEMBL4594345 | ChEMBL_ID |
| 11474 | INN_ID |
| 2230217-18-0 | SECONDARY_CAS_RN |
| T6HE85WN0Q | UNII |
| D12887 | KEGG_DRUG |
| 384602 | MMSL |
| 42779 | MMSL |
| d10183 | MMSL |
| 019728 | NDDF |
| 019729 | NDDF |
| CHEBI:757843 | CHEBI |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| LUMISIGHT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82292-040 | Injection, powder, lyophilized, for solution | 10 mg | Intravenous | NDA | 17 sections |