Icotinib

Overview

Icotinib is a potent and specific epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Icotinib was approved in China by the SFDA in June, 2011 and in January 2014, Beta Pharma, Inc. was given a “May Proceed” from the US FDA to conduct a Phase I study for the evaluation of icotinib as a treatment of EGFR+ Non-Small Cell Lung Cancer (NSCLC).

Indication

Icotinib hydrochloride is a novel epidermal growth factor receptor (EGFR)–tyrosine kinase inhibitor, exhibits encouraging efficacy and tolerability in patients with advanced non-small-cell lung cancer (NSCLC) who failed previous chemotherapy.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations	2025/05/02	NCT06955325	Phase 3	Not yet recruiting	The First Affiliated Hospital of Guangzhou Medical University
Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations	2024/07/24	NCT06517953	Phase 2	Recruiting	Sun Yat-sen University
Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations	2023/09/18	NCT06041776	Phase 3	Recruiting	Betta Pharmaceuticals Co., Ltd.
A Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection	2022/08/24	NCT05514314	Phase 2	Not yet recruiting	Wu Nan
Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma	2021/11/24	NCT05132985	Phase 2	Not yet recruiting	Liaoning Tumor Hospital & Institute
A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer	2021/11/03	NCT05104788	Phase 2	Recruiting	Peking University Cancer Hospital & Institute
Befotertinib and Icotinib in Treatment-naive Patients With Advanced EGFR-Mutant Lung Cancer	2021/08/17	NCT05007938	Phase 2	Active, not recruiting	Betta Pharmaceuticals Co., Ltd.
Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Concomitant Mutation NSCLC	2021/03/15	NCT04797806	Phase 3	UNKNOWN	Tianjin Medical University Cancer Institute and Hospital
Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study	2020/10/05	NCT04575415	N/A	UNKNOWN	Guangdong Association of Clinical Trials
D-0316 Versus Icotinib in Patients With Locally Advanced or Metastatic EGFR Sensitising Mutation Positive NSCLC	2019/12/20	NCT04206072	Phase 2	Active, not recruiting	Betta Pharmaceuticals Co., Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Icotinib Hydrochloride Tablets	贝达药业股份有限公司	国药准字H20110061	化学药品	片剂	2/1/2021

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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