Amifostine

Overview

A phosphorothioate proposed as a radiation-protective agent. It causes splenic vasodilation and may block autonomic ganglia.

Background

A phosphorothioate proposed as a radiation-protective agent. It causes splenic vasodilation and may block autonomic ganglia.

Indication

For reduction in the cumulative renal toxicity in patients with ovarian cancer (using cisplatin) and moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer.

Associated Conditions

Dry Mouth
Nephrotoxicity
Prophylaxis of Radiation proctitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors	2021/12/22	NCT05167370	Phase 2	Terminated	Children's Hospital Medical Center, Cincinnati
Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer	2018/10/11	NCT03702985	Phase 2	UNKNOWN	Fudan University
Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy	2013/11/29	NCT01998529	Phase 1	Completed	M.D. Anderson Cancer Center
A Phase II Clinical Trial on Comparison of Effectiveness and Safeness of Different Amifostine Regimens	2013/01/07	NCT01762514	Phase 2	UNKNOWN	Sun Yat-sen University
A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity	2012/04/26	NCT01586117	Phase 2	UNKNOWN	Chinese Academy of Medical Sciences
A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia	2011/06/02	NCT01364259	Phase 3	Terminated	Stanford University
Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine	2011/02/02	NCT01288625	Phase 4	Withdrawn	Sun Pharmaceutical Industries Limited
A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer	2008/01/25	NCT00601198	Phase 2	Terminated	University of Cincinnati
Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma	2007/12/11	NCT00571298	Phase 1	Completed	Brigham and Women's Hospital
Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia	2007/07/19	NCT00503776	Phase 2	Terminated	Vanderbilt-Ingram Cancer Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ethyol	Clinigen Limited	76310-017	INTRAVENOUS	500 mg in 10 mL	12/16/2019

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
Amifostine for Injection	南京绿叶制药有限公司	国药准字H20100082	化学药品	注射剂	6/30/2020
Amifostine for Injection	开封明仁药业有限公司	国药准字H20227121	化学药品	注射剂	9/21/2022
Amifostine for Injection	四川汇宇海玥医药科技有限公司	国药准字H20249418	化学药品	注射剂	11/22/2024
Amifostine for Injection	广汇汽车服务集团股份公司	国药准字H20010403	化学药品	注射剂	6/4/2020
Amifostine for Injection	南京绿叶制药有限公司	国药准字H20040343	化学药品	注射剂	6/30/2020
Amifostine for Injection	深圳市资福药业有限公司	国药准字H20052339	化学药品	注射剂	1/25/2022
Amifostine for Injection	开封明仁药业有限公司	国药准字H20113488	化学药品	注射剂	6/11/2021

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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