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BBI608

NCIC Clinical Trials Group · Phase 3 active Small molecule

BBI608 is a Wnt/β-catenin pathway inhibitor Small molecule drug developed by NCIC Clinical Trials Group. It is currently in Phase 3 development for Colorectal cancer (in combination with chemotherapy), Pancreatic cancer (in combination with chemotherapy), Gastric cancer (in combination with chemotherapy). Also known as: Napabucasin, BB608, BBI-608.

BBI608 is a Wnt/β-catenin pathway inhibitor that targets cancer stem cells by blocking their self-renewal capacity.

BBI608 is a Wnt/β-catenin pathway inhibitor that targets cancer stem cells by blocking their self-renewal capacity. Used for Colorectal cancer (in combination with chemotherapy), Pancreatic cancer (in combination with chemotherapy), Gastric cancer (in combination with chemotherapy).

Likelihood of approval
61.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Oncology Phase 3 boost +3.0pp
    Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030 —
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameBBI608
Also known asNapabucasin, BB608, BBI-608
SponsorNCIC Clinical Trials Group
Drug classWnt/β-catenin pathway inhibitor
Targetβ-catenin / Wnt signaling pathway
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

BBI608 inhibits the Wnt signaling pathway, which is critical for cancer stem cell maintenance and tumor growth. By disrupting β-catenin-mediated transcription, the drug aims to eliminate the population of cancer stem cells responsible for tumor initiation, progression, and chemotherapy resistance. This mechanism is intended to work synergistically with conventional chemotherapy agents.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about BBI608

What is BBI608?

BBI608 is a Wnt/β-catenin pathway inhibitor drug developed by NCIC Clinical Trials Group, indicated for Colorectal cancer (in combination with chemotherapy), Pancreatic cancer (in combination with chemotherapy), Gastric cancer (in combination with chemotherapy).

How does BBI608 work?

BBI608 is a Wnt/β-catenin pathway inhibitor that targets cancer stem cells by blocking their self-renewal capacity.

What is BBI608 used for?

BBI608 is indicated for Colorectal cancer (in combination with chemotherapy), Pancreatic cancer (in combination with chemotherapy), Gastric cancer (in combination with chemotherapy).

Who makes BBI608?

BBI608 is developed by NCIC Clinical Trials Group (see full NCIC Clinical Trials Group pipeline at /company/ncic-clinical-trials-group).

Is BBI608 also known as anything else?

BBI608 is also known as Napabucasin, BB608, BBI-608.

What drug class is BBI608 in?

BBI608 belongs to the Wnt/β-catenin pathway inhibitor class. See all Wnt/β-catenin pathway inhibitor drugs at /class/wnt-catenin-pathway-inhibitor.

What development phase is BBI608 in?

BBI608 is in Phase 3.

What are the side effects of BBI608?

Common side effects of BBI608 include Nausea, Vomiting, Diarrhea, Fatigue, Abdominal pain.

What does BBI608 target?

BBI608 targets β-catenin / Wnt signaling pathway and is a Wnt/β-catenin pathway inhibitor.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing