Pafolacianine

Summary

Pafolacianine (CHEMBL4297412) is an approved small molecule (ATC V04CX10); indicated across 2 conditions including ovarian cancer and skin neoplasm.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: V04CX10
• Indications: 2 conditions
• Clinical trials: 9

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297412
Name	Pafolacianine
Type	Small molecule
Max phase	4
ATC	V04CX10

Also known as: OTL 0038, OTL 38, OTL-0038, Otl-38, OTL-38, Otl0038, OTL0038, Otl38, OTL38, Pafolacianine, PAFOLACIANINE

Parent form; salt/anhydrous children: CHEMBL4594383

Patent coverage: 99 distinct patent families (247 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
ovarian cancer	3	MONDO:0008170	MONDO:0008170
skin neoplasm	1	MONDO:0002531	EFO:0004198

Clinical trials

Total trials: 9.

Phase distribution

Phase	Trials
PHASE1	3
PHASE3	2
PHASE2	2
Not specified	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03180307	PHASE3	COMPLETED	OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
NCT04241315	PHASE3	COMPLETED	ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
NCT02317705	PHASE2	COMPLETED	Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
NCT02872701	PHASE2	COMPLETED	OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
NCT02602119	PHASE1	COMPLETED	Intraoperative Imaging of Pulmonary Nodules by OTL38
NCT02629549	PHASE1	TERMINATED	Intraoperative Imaging of Pituitary Adenomas by OTL
NCT04941378	PHASE1	WITHDRAWN	OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer
NCT02645409	Not specified	COMPLETED	Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
NCT02852252	Not specified	COMPLETED	Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).