Drugs / amifostine
last change Mar 2023 re-read 8 days ago

amifostine

also known as Ethyol · amifostine trihydrate · WR-2721
Developed for
poisoning · head and neck cancer · myelodysplastic syndrome · radiation-induced disorder · lung cancer · leukemia · cervical cancer · chemotherapy-induced toxicity
+20 more · lymphoma · mouth disorder · prostate cancer · endometrial cancer · mucositis · acute myeloid leukemia · acute radiation syndrome · esophagitis · Fanconi anemia · myelodysplastic/myeloproliferative disease · myeloid leukemia · nasopharyngeal neoplasm · peripheral neuropathy · pneumonitis · rectal cancer · stomatitis · toxic polyneuropathy · trigeminal neuralgia · Hodgkins lymphoma · non-Hodgkin lymphoma
Investigated by
National Cancer Institute (NCI) · MedImmune LLC · Children's Oncology Group · M.D. Anderson Cancer Center · University of Arizona · ALZA
+43 more · Dana-Farber Cancer Institute · European Organisation for Research and Treatment of Cancer - EORTC · Gynecologic Oncology Group · Jonsson Comprehensive Cancer Center · Radiation Therapy Oncology Group · Rush University Medical Center · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Washington University School of Medicine · Abramson Cancer Center at Penn Medicine · AstraZeneca · Children's Cancer Group · Children's Hospital Medical Center, Cincinnati · Chinese Academy of Medical Sciences · Dalian Merro Pharmaceutical Co. Ltd · Fudan University · Groupe Oncologie Radiotherapie Tete et Cou · Masonic Cancer Center, University of Minnesota · Massachusetts General Hospital · Mohan Suntharalingam · Mt. Sinai Medical Center, Miami · NRG Oncology · NYU Langone Health · Northwestern University · Original BioMedicals Co. Ltd. · Providence Hospital · Rush North Shore Medical Center · SWOG Cancer Research Network · Schering-Plough · Scripps Health · Stanford University · Sun Pharmaceutical Industries, Inc. · Sun Yat-sen University · The Cleveland Clinic · The Dale & Frances Hughes Cancer Center · University of Alabama at Birmingham · University of California, San Francisco · University of Cincinnati · University of Florida · University of Illinois at Chicago · University of Miami · University of Michigan Rogel Cancer Center · University of Tennessee · Vanderbilt-Ingram Cancer Center

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) ETHYOL — 1996-03-15 – 1999-06-24 fda.gov ↗
Approved US (FDA) ETHYOL — 1995-12-08 fda.gov ↗

Trials 62

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials
Phase 1 NCT02587442 Oct 2015 → Mar 2016 acute radiation syndrome Original BioMedicals Co. Ltd. Unknown No outcome recorded
Phase 1 NCT00006127 Apr 2000 → ? Fanconi anemia Dana-Farber Cancer Institute Unknown No outcome recorded
Phase 1 NCT00004919 Dec 1999 → Mar 2003 childhood malignant neoplasm National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT00003926 Nov 1998 → Aug 2002 central nervous system neoplasm, childhood germ cell tumor, chordoma, kidney cancer +5 Masonic Cancer Center, University of Minnesota Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT00003268 Jan 1998 → Dec 2003 myeloid leukemia, poisoning Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Completed No outcome recorded
Phase 1 NCT00004036 Nov 1997 → ? cancer of unknown primary site, leukemia, myelodysplastic syndrome, myeloproliferative neoplasm +3 The Cleveland Clinic Unknown No outcome recorded
Phase 1 NCT00003144 Aug 1997 → Apr 2001 cancer of unknown primary site, poisoning NYU Langone Health Completed No outcome recorded
Phase 1 NCT00137358 — cervical cancer University of Alabama at Birmingham Withdrawn No outcome recorded Stop: Business
Phase 1/27 trials · 1 missed
Phase 1/2 NCT00086099 Jul 2004 → Dec 2005 acute myeloid leukemia MedImmune LLC Completed No outcome recorded
Phase 1/2 NCT00012012 Aug 2001 → Sep 2007 cervical cancer, radiation-induced disorder Radiation Therapy Oncology Group Completed Missed primary
Phase 1/2 NCT00003415 Sep 1998 → Nov 2002 leukemia, myelodysplastic syndrome University of Arizona Completed No outcome recorded
Phase 1/2 NCT00003193 Jan 1998 → Sep 2005 chemotherapy-induced oral mucositis, head and neck cancer Massachusetts General Hospital Completed No outcome recorded
Phase 1/2 NCT00003251 Dec 1997 → ? head and neck cancer, poisoning, radiation-induced disorder University of Illinois at Chicago Unknown No outcome recorded
Phase 1/2 NCT00003225 Jul 1997 → Mar 2000 colorectal cancer Jonsson Comprehensive Cancer Center Completed No outcome recorded
Phase 1/2 NCT00003582 May 1988 → Dec 1996 cancer of unknown primary site, head and neck cancer University of Miami Completed No outcome recorded
Phase 236 trials · 1 missed
Phase 2 NCT03702985 May 2018 → Nov 2019 — Fudan University Unknown No outcome recorded
Phase 2 NCT01762514 Jan 2013 → Jun 2019 bone marrow disorder, mucositis, nasopharyngeal neoplasm, salivary gland disorder Sun Yat-sen University Unknown No outcome recorded
Phase 2 NCT01586117 Feb 2012 → Dec 2013 rectal cancer Chinese Academy of Medical Sciences Unknown No outcome recorded
Phase 2 NCT05167370 Dec 2010 → Apr 2011 brain cancer Children's Hospital Medical Center, Cincinnati Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00409331 Dec 2006 → Jan 2009 head and neck cancer M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 2 NCT00601198 Oct 2006 → Jan 2010 colorectal cancer University of Cincinnati Terminated No outcome recorded Stop: Business
Phase 2 NCT00503776 Jan 2006 → Aug 2008 head and neck cancer, mucositis Vanderbilt-Ingram Cancer Center Terminated No outcome recorded Stop: Business
Phase 2 NCT00098683 Jan 2005 → Oct 2007 myelodysplastic syndrome, myelodysplastic/myeloproliferative disease Children's Oncology Group Completed No outcome recorded
Phase 2 NCT00078845 May 2004 → May 2007 breast cancer, lung cancer, ovarian cancer, prostate cancer +1 M.D. Anderson Cancer Center Completed No outcome recorded
Phase 2 NCT00081315 Nov 2003 → Aug 2006 esophagitis, non-small cell lung carcinoma, pneumonitis MedImmune LLC Completed No outcome recorded
Phase 37 trials · 1 missed
Phase 3 NCT01364259 Sep 2008 → Jan 2014 trigeminal neuralgia Stanford University Terminated No outcome recorded
Phase 3 NCT00274937 Feb 2006 → Dec 2014 nasopharyngeal squamous cell carcinoma, undifferentiated carcinoma of nasopharynx Children's Oncology Group Completed No outcome recorded
Phase 3 NCT00058071 Mar 2003 → Dec 2007 cancer of unknown primary site, gestational trophoblastic neoplasm, peripheral neuropathy, poisoning Gynecologic Oncology Group Completed No outcome recorded
Phase 3 NCT00158691 Mar 2001 → ? head and neck cancer Groupe Oncologie Radiotherapie Tete et Cou Completed No outcome recorded
Phase 3 NCT00004166 Oct 1999 → Jan 2003 ovarian carcinoma Northwestern University Completed No outcome recorded
Phase 3 NCT00003994 Mar 1999 → Oct 2007 hepatoblastoma Children's Oncology Group Completed No outcome recorded
Phase 3 NCT00003313 Sep 1998 → Jul 2002 lung carcinoma, mouth disorder, poisoning, radiation-induced disorder Radiation Therapy Oncology Group Completed Missed primary
Phase 43 trials
Phase 4 NCT00158041 Jan 2002 → Jan 2005 head and neck cancer, lung cancer, lymphoma Mt. Sinai Medical Center, Miami Completed No outcome recorded
Phase 4 NCT00003252 Dec 1997 → Sep 2004 cancer of unknown primary site, chemotherapy-induced toxicity Rush North Shore Medical Center Completed No outcome recorded
Phase 4 NCT01288625 — stomatitis Sun Pharmaceutical Industries, Inc. Withdrawn No outcome recorded
Phase not applicable1 trial
— NCT00130143 Jun 2003 → Sep 2004 head and neck cancer, lung cancer The Dale & Frances Hughes Cancer Center Completed No outcome recorded
Comparator or background therapy17 trials
Phase 1 NCT01998529 Background Aug 2014 → Aug 2020 lung cancer M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT00571298 Background Nov 2007 → Nov 2011 malignant pleural mesothelioma Brigham and Women's Hospital Completed No outcome recorded
Phase 1 NCT00217542 Background Jul 2005 → Jul 2008 melanoma, renal cell carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT00052884 Background Jan 2004 → Sep 2007 plasma cell neoplasm, poisoning Eastern Cooperative Oncology Group Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT00003927 Background May 1999 → Mar 2023 breast cancer City of Hope Medical Center Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2008-03-15 Sun Pharmaceutical Industries, Inc. Regulatory Sun Pharmaceutical announces USFDA approval to market generic Ethyol ® (With 180 day marketing exclusivity) sunpharma.com ↗
Mumbai, March 15, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of MedImmune’s Ethyol®, amifostine f or injection 500mg.

All press releases naming this drug 3 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 83 sources stand behind the page.

FieldValueCited text
Known as Amifostine “Prospective randomized study in order to compare intravenous versus subcutaneous administration of amifostine in patients receiving radiotherapy for head and neck cancer.” NCT00158691 ↗
77

“Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia” NCT00086099 ↗

“Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT” NCT00167908 ↗

“RadProtect® is not a full-closed micelle, and uses ferrous iron to provide linkage between PEG-b-PGA and amifostine.” NCT02587442 ↗

NCT05167370 ↗

NCT00002643 ↗

NCT00003048 ↗

NCT00003657 ↗

NCT00217542 ↗

NCT00003624 ↗

NCT00003415 ↗

Show 67 more sources

Known as amifostine trihydrate “amifostine (amifostine trihydrate) in reducing the toxicity associated with platinum agents” NCT00003994 ↗
9

“Drug: amifostine trihydrate” NCT00006012 ↗

“Drug: amifostine trihydrate” NCT00003127 ↗

“Drug: Amifostine trihydrate” NCT00040365 ↗

“Drug: amifostine trihydrate” NCT00004919 ↗

“Drug: amifostine trihydrate” NCT00003926 ↗

“Drug: amifostine trihydrate” NCT00003425 ↗

“Drug: amifostine trihydrate” NCT00003313 ↗

“Drug: amifostine trihydrate” NCT00003927 ↗

NCT00003211 ↗

Known as Ethyol “OBJECTIVES: Radiation Therapy Oncology Group (RTOG) 0116 was designed to test the ability of amifostine (Ethyol; MedImmune LLC, Gaithersburg, MD), a cytoprotective agent, to...” PMID 21892091 ↗ Oct 2011
11

“Radiation Therapy Oncology Group (RTOG) trial 98-01, a phase III study testing the ability of a radioprotector (Amifostine [Ethyol, WR-2721]) to reduce the toxicity of an...” PMID 11917283 ↗ Jan 2002

“Amifostine (Ethyol) 1125 mg/m2 will be given intravenously daily over 5 minutes starting 30 minutes prior to chemotherapy (melphalan or thiotepa) on days -5, -4, -3, -2, and on...” NCT05167370 ↗

“Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer” NCT00081315 ↗

“A Randomized Study of Ethyol (Amifostine) With Platinum Based Salvage Chemotherapy in Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation” NCT00003143 ↗

“Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia” NCT00086099 ↗

“Determination of the cytoprotective agent WR-2721 (Amifostine, Ethyol) and its metabolites in human blood” PMID 9771955 ↗ 1998

“A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer” NCT00601198 ↗

“Amifostine (WR 2721, Ethyol)” NCT00003582 ↗

“Amifostine (Ethyol)” NCT00003415 ↗

“Ethyol (Amifostine)” NCT00130143 ↗

Show 1 more source

Known as WR-2721 “Radiation Therapy Oncology Group (RTOG) trial 98-01, a phase III study testing the ability of a radioprotector (Amifostine [Ethyol, WR-2721]) to reduce the toxicity of an...” PMID 11917283 ↗ Jan 2002
3

“The purpose of this study was to determine whether amifostine (WR-2721) prevents or ameliorates clinically significant (grade 2 to 4) neurotoxicity associated with cisplatin...” PMID 14615449 ↗ Nov 2003

“Determination of the cytoprotective agent WR-2721 (Amifostine, Ethyol) and its metabolites in human blood” PMID 9771955 ↗ 1998

“Amifostine (WR 2721, Ethyol)” NCT00003582 ↗

Route Intravenous “Amifostine IV over 15 minutes” NCT00002643 ↗