pafolacianine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| indocyanine fluorescence dye group | 5497 | 1628423-76-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Cytalux is a fluorescent drug that targets folate receptor (FR) which may be overexpressed in ovarian cancer. Pafolacianine binds to FR-expressing cancer cells with affinity of approximately 1 nM, internalizes via receptor mediated endocytosis, and concentrates in FR-positive cancer tissues.
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Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 29, 2021 | FDA | ON TARGET LABROTORIES, INC |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | V04CX10 | VARIOUS DIAGNOSTIC AGENTS OTHER DIAGNOSTIC AGENTS Other diagnostic agents |
| MeSH PA | D064907 | Diagnostic Uses of Chemicals |
| MeSH PA | D015335 | Molecular Probes |
| FDA MoA | N0000193981 | Fluorescence Contrast Activity |
| FDA EPC | N0000193983 | Optical Imaging Agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Imaging ovarian cancer and malignant lesions | indication | 767427005 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | CYTALUX | ON TARGET LABS | N214907 | Nov. 29, 2021 | RX | SOLUTION | INTRAVENOUS | 10881747 | Aug. 26, 2033 | CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS |
| EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | CYTALUX | ON TARGET LABS | N214907 | Nov. 29, 2021 | RX | SOLUTION | INTRAVENOUS | 9061057 | Aug. 26, 2033 | CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS |
| EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | CYTALUX | ON TARGET LABS | N214907 | Nov. 29, 2021 | RX | SOLUTION | INTRAVENOUS | 9333270 | Aug. 26, 2033 | CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS |
| EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | CYTALUX | ON TARGET LABS | N214907 | Nov. 29, 2021 | RX | SOLUTION | INTRAVENOUS | 9789208 | Aug. 26, 2033 | CYTALUX IS AN OPTICAL IMAGING AGENT INDICATED IN ADULT PATIENTS WITH OVARIAN CANCER AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | CYTALUX | ON TARGET LABS | N214907 | Nov. 29, 2021 | RX | SOLUTION | INTRAVENOUS | Dec. 16, 2025 | ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT AND NONMALIGNANTPULMONARY LESIONS IN ADULT PATIENTS WITH KNOWN OR SUSPECTED CANCER IN THE LUNG |
| EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | CYTALUX | ON TARGET LABS | N214907 | Nov. 29, 2021 | RX | SOLUTION | INTRAVENOUS | Nov. 29, 2026 | NEW CHEMICAL ENTITY |
| EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | CYTALUX | ON TARGET LABS | N214907 | Nov. 29, 2021 | RX | SOLUTION | INTRAVENOUS | Nov. 29, 2028 | AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS IN ADULT PATIENTS WITH OVARIAN CANCER |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Folate receptor alpha | Membrane receptor | BINDING AGENT | Kd | 7.98 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL4297412 | ChEMBL_ID |
| C000720187 | MESH_SUPPLEMENTAL_RECORD_UI |
| 1628858-03-6 | SECONDARY_CAS_RN |
| DB15413 | DRUGBANK_ID |
| 018897 | NDDF |
| 018898 | NDDF |
| D12249 | KEGG_DRUG |
| C5446780 | UMLSCUI |
| CHEMBL4594383 | ChEMBL_ID |
| 11569 | INN_ID |
| 135565623 | PUBCHEM_CID |
| 2586857 | RXNORM |
| 40145 | MMSL |
| d09831 | MMSL |
| F7BD3Z4X8L | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Cytalux | HUMAN PRESCRIPTION DRUG LABEL | 1 | 81052-138 | INJECTION | 3.20 mg | INTRAVENOUS | NDA | 16 sections |
| Cytalux | HUMAN PRESCRIPTION DRUG LABEL | 1 | 81052-138 | INJECTION | 3.20 mg | INTRAVENOUS | NDA | 16 sections |