Drugs / Zenocutuzumab
Zenocutuzumab
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT05588609 | Nov 2022 → Jul 2025 | castration-resistant prostate carcinoma | Partner Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03321981 | Jan 2018 → Oct 2022 | breast carcinoma | Merus B.V. | Completed | No outcome recorded |
| Phase 2 | NCT02912949 | Jan 2015 → Dec 2026 expected | — | Partner Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT04100694 Background | — | breast cancer, cancer of unknown primary site, cholangiocarcinoma, colorectal cancer +5 | Merus B.V. | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-07-02 | Partner Therapeutics, Inc. | Results Partner Therapeutics Announces Publication of Results From the eNRGy Trial of Zenocutuzumab in Patients with NRG1+ Cholangiocarcinoma in Journal of Clinical Oncology (JCO) partnertx.com ↗
Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, announced that results from the cholangiocarcinoma cohort of the eNRGy trial (NCT02912949) have been published in the Journal of Clinical Oncology (JCO). |
| 2026-05-11 | Partner Therapeutics, Inc. | Regulatory Partner Therapeutics Announces FDA Approval of BIZENGRI® (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner’s National Priority Voucher partnertx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved BIZENGRI ® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. |
| 2026-05-06 | Partner Therapeutics, Inc. | Regulatory Partner Therapeutics Announces Receipt of FDA Commissioner’s National Priority Voucher for BIZENGRI® (Zenocutuzumab-zbco) in NRG1 Fusion-Positive Cholangiocarcinoma partnertx.com ↗ |
| 2026-04-14 | Partner Therapeutics, Inc. | Regulatory Partner Therapeutics announces submission of supplemental Biologics License Application (sBLA) to FDA for BIZENGRI® (zenocutuzumab-zbco) in NRG1 Fusion Positive Cholangiocarcinoma and Inclusion in updated NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) partnertx.com ↗ |
| 2026-02-20 | Partner Therapeutics, Inc. | Results Zenocutuzumab Treatment Beyond Progression Demonstrates Continued Benefit in Patients with NRG1+ Non-Small Cell Lung Cancer: New Results from the eNRGy Trial partnertx.com ↗
In this analysis, continued zenocutuzumab treatment beyond RECIST progression provided meaningful, sometimes long-lasting, clinical benefit while maintaining a favorable tolerability profile. |
| 2026-02-05 | Partner Therapeutics, Inc. | Regulatory Zenocutuzumab‑zbco Receives FDA Orphan Drug Designation for Treatment of Cholangiocarcinoma partnertx.com ↗
Partner Therapeutics, Inc. (PTx), a privately held, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to zenocutuzumab‑zbco for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma. |
| 2026-01-09 | Partner Therapeutics, Inc. | Results Continued Zenocutuzumab Treatment Beyond Progression Shows Benefit in Patients with NRG1+ Pancreatic Cancer and Cholangiocarcinoma: New Results from the eNRGy Trial Presented at ASCO GI partnertx.com ↗
In this analysis, zenocutuzumab provided ongoing benefit after radiographic progression, including multi-year disease control in some patients. |
| 2025-12-06 | Partner Therapeutics, Inc. | Results Zenocutuzumab-zbco (BIZENGRI®) Shows Durable Efficacy in Patients with Treatment-Naïve NRG1+NSCLC: Updated eNRGy Trial Results Presented at IASLC-ASCO NACLC partnertx.com ↗
Among 20 treatment-naïve and 121 previously treated patients, zenocutuzumab demonstrated an overall response rate (ORR) of 35% and 31%, respectively. |
| 2025-10-23 | Partner Therapeutics, Inc. | Regulatory Zenocutuzumab-zbco Granted FDA Breakthrough Therapy Designation for NRG1+ Cholangiocarcinoma; Data Highlighting Potential of Zenocutuzumab-zbco in NRG1+ Cholangiocarcinoma to be Presented at AACR-NCI-EORTC partnertx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to zenocutuzumab-zbco for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion. |
| 2025-02-05 | Partner Therapeutics, Inc. | Results New England Journal of Medicine Publishes Results of Global, Multicenter eNRGy Study Evaluating Zenocutuzumab-zbco (BIZENGRI ® ) in NRG1+ cancer partnertx.com ↗
The overall response rate and durability of responses we observed in the eNRGy trial are noteworthy. |
| 2024-12-04 | Partner Therapeutics, Inc. | Regulatory Merus Announces FDA Approval of BIZENGRI ® (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer (NSCLC) Based on Safety and Efficacy Data From the eNRGy Study partnertx.com ↗
Merus N.V. (Nasdaq: MRUS) [Merus, the Company, we, or our], a clinical-stage oncology company developing innovative, full-length, multispecific antibodies (Biclonics ® and Triclonics ® ), announced today that the U.S. Food and Drug Administration (FDA) approved BIZENGRI ® (zenocutuzumab-zbco), the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 ( NRG1 ) gene fusion who have disease progression on or after prior systemic therapy. |
All press releases naming this drug 12 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zenocutuzumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03321981 ↗ |
| Known as | Bizengri | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298025 ↗ |
| Known as | MCLA-128 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05588609 ↗ |
| Known as | Zeno | “Zenocutuzumab, or Zeno, is a treatment that is being tested to see if it can stop cancer that is growing because of NRG1 gene fusions.” PMID 38348690 ↗ Feb 2024 |
| Known as | Zenocutuzumab-zbco | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298025 ↗ |
| Action | Inhibit | “inhibits NRG1 binding” PMID 38348690 ↗ Feb 2024 |
| Modality | Monoclonal antibody | “HER2/HER3 bispecific antibody” NCT04100694 ↗ |
| Route | Intravenous | “750 mg intravenously every 2 weeks” PMID 39908431 ↗ Feb 2025 |