BIZENGRI
GrowthmAbzenocutuzumab
BLASOLUTIONINJECTIONPriority Review
Approved
Dec 2024
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
BIZENGRI (zenocutuzumab) is zenocutuzumab-zbco is a bispecific antibody that binds to the extracellular domains of her2 and her3 expressed on the surface of cells, including tumor cells, inhibiting her2:her3 dimerization and preventing nrg1 binding to her3. First approved in 2024.
Drug data last refreshed 11h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIZENGRI (zenocutuzumab-zbco) is a bispecific antibody that simultaneously binds HER2 and HER3, blocking their dimerization and NRG1 signaling to inhibit tumor cell proliferation. It was approved in December 2024 for NRG1 fusion-positive cancers, representing a novel mechanism targeting a previously underexploited pathway. The drug mediates both direct signaling inhibition and antibody-dependent cellular cytotoxicity (ADCC).
Growth
Recently approved bispecific in early commercial phase with modest competitive pressure (30%), indicating building commercial infrastructure and expanding team opportunities.
Mechanism of Action
Zenocutuzumab-zbco is a bispecific antibody that binds to the extracellular domains of HER2 and HER3 expressed on the surface of cells, including tumor cells, inhibiting HER2:HER3 dimerization and preventing NRG1 binding to HER3. Zenocutuzumab-zbco decreased cell proliferation and signaling through…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers
Started Nov 2022
13 enrolled
NSCLC Harboring NRG1 FusionMetastatic Castration-resistant Prostate Cancer
A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)
Started Jan 2015
250 enrolled
Solid Tumours Harboring NRG1 FusionNSCLC Harboring NRG1 FusionPancreatic Cancer Harboring NRG1 Fusion+1 more
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.