Drug

Nimotuzumab

In clinical development

ClassEpidermal growth factor receptor erbB1 inhibitorEmerging researchLate-stage development

Also known as Nituzumab.

RxNorm587741 ChEMBLCHEMBL2108359UNII6NS400BXKH

Research papers

Active clinical trials

Epidermal growth factor receptor

Primary target

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

An Exploratory Clinical Study of HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A Prospective, Randomized, Phase II Study of Nimotuzumab Combined With Immunotherapy and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Clinical trial2026-07-09Results expected Q2 2028 · ClinicalTrials.gov

A Single-arm Phase II Study of HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients With KRAS G12D Mutations

Clinical trial2026-06-03Results expected Q1 2027 · ClinicalTrials.gov

A Prospective, Multicenter, Single Arm Study of SBRT Combined With Nimotuzumab and Mono-chemotherapy in the Treatment of Locally Advanced Pancreatic Cancer

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Nimotuzumab Combined With Toripalimab/Gemcitabine/Cisplatin as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Clinical Study

Clinical trial2026-05-30Primary completion · ClinicalTrials.gov

Postoperative Radiotherapy And Nimotuzumab With or Without Benmelstobart Adjuvant Therapy in Patients With Head and Neck Squamous Cell Carcinoma Having Intermediate-Risk Pathological Factors: A Multicenter Prospective Randomized Controlled Study

Clinical trial2026-04-30Results expected Q4 2028 · ClinicalTrials.gov

A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial of Postoperative Radiotherapy Combined With Nimotuzumab Followed by Benmelstobart in High-Risk Patients With Head and Neck Squamous Cell Carcinoma Who Are Ineligible for Cisplatin Chemotherapy

Clinical trial2026-04-17Results expected Q1 2028 · ClinicalTrials.gov

Efficacy and Safety of Neoadjuvant Chemoradiation Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Clinical trial2026-03-11Results expected Q2 2027 · ClinicalTrials.gov

Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer

Clinical trial2026-01-21Results expected Q4 2030 · ClinicalTrials.gov

Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer

Clinical trial2026-01-21Results expected Q4 2030 · ClinicalTrials.gov

A Pilot Study to Assess Feasibility and Preliminary Efficacy of Neoadjuvant Nimotuzumab, Toripalimab, and Chemotherapy in Locally Advanced Tonsillar Cancer

Clinical trial2026-01-20Results expected Q4 2026 · ClinicalTrials.gov

Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer.

Research2023-08-30Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Nimotuzumab

Aliases & brands

Nituzumab

RxNorm CUI

587741

ChEMBL ID

CHEMBL2108359

UNII

6NS400BXKH

Primary mechanism

Epidermal growth factor receptor erbB1 inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Epidermal growth factor receptor

EGFR · P00533

INHIBITOREpidermal growth factor receptor erbB1 inhibitor

Clinical trials

103 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

103

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 103

Phase 15Phase 1 / 25Phase 263Phase 2 / 36Phase 318Phase 42Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized Controlled Trial on the Efficacy and Pain Impact of Nimotuzumab Combined with a Painkiller in Comprehensive Treatment of Advanced Squamous Cell Carcinoma of Head and Neck

Active, not recruitingPH IVBiotech Pharmaceutical Co., Ltd.n=1712025

Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma

Unknown statusPH IVKey trialBiotech Pharmaceutical Co., Ltd.n=2,0002017

RecruitingPH IIIShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong Universityn=3702031

Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer

RecruitingPH IIIKey trialCancer Institute and Hospital, Chinese Academy of Medical Sciencesn=2,0002030

Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer

RecruitingPH IIIKey trialCancer Institute and Hospital, Chinese Academy of Medical Sciencesn=2,0002030

Recent completions

Trials that read out recently, adding to the completed evidence base.

Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age

CompletedPH IIThe First Affiliated Hospital with Nanjing Medical Universityn=562025

An Multicenter, Randomized，Double-blind, Controlled Clinical Study of Nimotuzumab in Combined With First-line Chemotherapy for Treatment of IVB Stage,Rrecurrent or Persistent Cervical Squamous Cell Carcinoma

CompletedPH IIIBiotech Pharmaceutical Co., Ltd.n=1182024

Concurrent Nimotuzumab and Intensity-modulated Radiotherapy for Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma

CompletedPH IIZhejiang Cancer Hospitaln=302023

A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Squamous Cell Carcinoma Based on Nutritional Risk Screening Score (NRS2002)

CompletedPH IICancer Institute and Hospital, Chinese Academy of Medical Sciencesn=552023

A Phase I/II Open-Label Study of Nimotuzumab in Combination With Nivolumab in Patients With Advanced Non-small Cell Lung Cancer

CompletedPH IRoswell Park Cancer Instituten=72022

A Single Center and Single Arm Study of TIP (Paclitaxel + Ifosfamide + Cisplatin) Combined With Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer

CompletedPH IISun Yat-sen Universityn=292022

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 · 37 cites

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Deoxycytidine

Studied across the same disease area as Nimotuzumab in the shared literature.

1 shared disease1 shared paper

Gemcitabine

Studied across the same disease area as Nimotuzumab in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials