Napabucasin

drug
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Also known as BBI-608BBI608NapabucasinaNapabucasine

Summary

Napabucasin (CHEMBL64130) is a phase-3 clinical-stage small molecule; indicated across 8 conditions including non-small cell lung carcinoma and colorectal carcinoma.

At a glance

  • Status: Max clinical phase 3 (not approved)
  • Modality: Small molecule
  • Indications: 8 conditions
  • Clinical trials: 24
  • Chemistry: 240.21 Da · C14H8O4

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL64130
NameNapabucasin
TypeSmall molecule
Max phase3
FDA approvedno
PubChem CID10331844
Molecular formulaC14H8O4
Molecular weight240.21
InChIKeyDPHUWDIXHNQOSY-UHFFFAOYSA-N

SMILES: CC(=O)C1=CC2=C(O1)C(=O)C3=CC=CC=C3C2=O

IUPAC name: 2-acetylbenzo[f][1]benzofuran-4,9-dione

Also known as: BBI-608, BBI608, Napabucasin, Napabucasina, Napabucasine, NAPABUCASIN

Patent coverage: 325 distinct patent families (909 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 707 (78%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 2 (assay-derived). Sample: Aldehyde dehydrogenase 1A1, Signal transducer and activator of transcription 3.

Bioactivity

ChEMBL activities: 6 potent at pChembl ≥ 5 of 7 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

TargetpChemblTypeValueUnitActivity ID
ALDH1A16.37IC50425.3nMCHEMBL_ACT_24348831
STAT35.92IC501209nMCHEMBL_ACT_25837030
STAT35.8IC501586nMCHEMBL_ACT_26128176
STAT35.72EC501900nMCHEMBL_ACT_18405948
STAT35.7EC502000nMCHEMBL_ACT_18405944
STAT35.5IC503200nMCHEMBL_ACT_22810899

Target pathways

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

Indications & clinical

Indications

8 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).

IndicationTrial phaseMONDOEFO
non-small cell lung carcinoma3MONDO:0005233EFO:0003060
colorectal carcinoma3MONDO:0024331EFO:1001951
pancreatic ductal adenocarcinoma3MONDO:0005184MONDO:0005184
colorectal neoplasm3MONDO:0005335MONDO:0005575
hepatocellular carcinoma1MONDO:0007256EFO:0000182
glioblastoma1MONDO:0018177EFO:0000519
hematopoietic and lymphoid system neoplasm1MONDO:0002334MONDO:0044881
neoplasm1MONDO:0005070MONDO:0004992

Clinical trials

Total trials: 24.

Phase distribution

PhaseTrials
PHASE110
PHASE36
PHASE1/PHASE26
PHASE22

Top trials by phase / activity

NCTPhaseStatusTitle
NCT01830621PHASE3COMPLETEDBBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma
NCT02178956PHASE3COMPLETEDA Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
NCT02753127PHASE3COMPLETEDA Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
NCT02826161PHASE3TERMINATEDA Study of Napabucasin (BBI-608) Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer
NCT02993731PHASE3COMPLETEDA Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
NCT03522649PHASE3UNKNOWNA Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer
NCT01325441PHASE1/PHASE2COMPLETEDA Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies
NCT01776307PHASE2COMPLETEDA Study of BBI608 in Adult Patients With Advanced Colorectal Cancer
NCT02024607PHASE1/PHASE2COMPLETEDA Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer
NCT02279719PHASE1/PHASE2COMPLETEDA Study of BBI608 in Combination With Sorafenib, or BBI503 in Combination With Sorafenib in Adult Patients With Hepatocellular Carcinoma
NCT02315534PHASE1/PHASE2COMPLETEDA Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma
NCT02347917PHASE1/PHASE2COMPLETEDA Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma
NCT02851004PHASE1/PHASE2TERMINATEDSpecial Combination of BBI608 and Pembrolizumab
NCT03647839PHASE2COMPLETEDModulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer
NCT01775423PHASE1COMPLETEDA Study of BBI608 in Adult Patients With Advanced Malignancies
NCT02231723PHASE1COMPLETEDA Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer
NCT02352558PHASE1COMPLETEDA Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies
NCT02358395PHASE1COMPLETEDA Study of BBI608 Administrated With Sorafenib in Adult Patients With Advanced Hepatocellular Carcinoma
NCT02432326PHASE1COMPLETEDA Study of BBI608 and BBI503 Administered in Combination to Adult Patients With Advanced Solid Tumors
NCT02467361PHASE1COMPLETEDA Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers
NCT02641873PHASE1COMPLETEDA Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer
NCT03411122PHASE1COMPLETEDA Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers
NCT03525405PHASE1COMPLETEDA Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects
NCT04299880PHASE1COMPLETEDRollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols

Clinical evidence (CIViC)

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

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

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