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Ethyol

(Amifostine)

ApprovedSmall molecule

LLegacy Health System

Amifostine is used to reduce side effects from radiation and chemotherapy treatments in cancer patients, particularly to protect against kidney damage and reduce dry mouth after head and neck radiation.[2] Ethyol is currently approved and in use across 21 indications[4].[1]

Ethyol is one of 610 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Approved.

21

Indications

20

Total Trials

0

Active Trials

609

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Prostate AdenocarcinomaApproved

Trigeminal NeuralgiaActive, not recruiting

ToxicityActive, not recruiting

Lung CancerApproved

LymphomaActive, not recruiting

Peripheral NeuropathyActive, not recruiting

Malignant Pleural MesotheliomaActive, not recruiting

Head and Neck Malignant NeoplasiaActive, not recruiting

MucositisActive, not recruiting

AnemiaActive, not recruiting

Prostate AdenocarcinomaApproved

Approved

Trigeminal NeuralgiaPhase 3

Active, not recruiting

ToxicityPhase 2

Active, not recruiting

Lung CancerApproved

Approved

LymphomaPhase 2

Active, not recruiting

Peripheral NeuropathyPhase 2

Active, not recruiting

Malignant Pleural MesotheliomaPhase 1

Active, not recruiting

Head and Neck Malignant NeoplasiaApproved

Active, not recruiting

MucositisApproved

Active, not recruiting

AnemiaPhase 1

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Ethyol

LLegacy Health System

Blenoxane

SSequus Pharmaceuticals

Velban

EEastern Cooperative Oncology Group

Zofran

Wellcovorin

GGlaxo Dba Glaxosmithkline

Kenalog

BBausch Health Americas, Inc.

Nuvigil

NNuvo Research GmbH

Decadron

QQuince Therapeutics S.p.A.

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

CAR-T

HHebei Senlang Biotechnology Inc., Ltd.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Head and Neck Cancer3 trials

Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

Withdrawn· Sun Pharmaceutical Industries Limited logo

Sun Pharmaceutical Industries Limited·Phase 4·NCT01288625

EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.(GCC 0202)

Completed·MMohan Suntharalingam·Phase 2·NCT00270790·21 enrolled

Amifostine With IMRT for Submandibular and Sublingual Salivary Sparing During Head and Neck Cancer Treatment

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00409331·3 enrolled

Lymphoma2 trials

Combination Chemotherapy With or Without Amifostine in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Disease Undergoing Stem Cell Transplantation

Completed·JJonsson Comprehensive Cancer Center·Phase 2·NCT00003143·20 enrolled

Amifostine for Head and Neck Irradiation in Lymphoma

Completed·—·Phase 2·NCT00136474·75 enrolled

Colorectal Cancer1 trial

A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer

Terminated·UUniversity of Cincinnati·Phase 2·NCT00601198·4 enrolled

Squamous Cell Carcinoma1 trial

Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck

Completed·UUniversity of Alabama at Birmingham·Phase 1/2·NCT00318890·48 enrolled

Cervical Cancer1 trial

Radiation With Chemotherapy and a Study Drug to the Para-Aortic Nodes in Cervical Cancer

Withdrawn·UUniversity of Alabama at Birmingham·Phase 1·NCT00137358

12 more indications

Peripheral Neuropathy1 trial

Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00078845·24 enrolled

Autologous Stem Cell Transplantation1 trial

High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors

Terminated·—·Phase 2·NCT05167370·2 enrolled

Locally-advanced Rectal Cancer1 trial

Radiation-protection Effect of Amifostine in Locally Advanced Rectal Cancer

Unknown status·FFudan University·Phase 2·NCT03702985·160 enrolled

Trigeminal Neuralgia1 trial

A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia

Terminated·SStanford University·Phase 3·NCT01364259·17 enrolled

Toxicity1 trial

A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity

Unknown status·CChinese Academy of Medical Sciences·Phase 2·NCT01586117·40 enrolled

Malignant Pleural Mesothelioma1 trial

Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma

Completed·—·Phase 1·NCT00571298·141 enrolled

Randomized1 trial

Randomized Amifostine For SCCHN

Completed·—·Phase 2·NCT00095927·58 enrolled

Cytoreductive Surgery1 trial

Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01998529·7 enrolled

Nasopharyngeal Cancer1 trial

Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer

Completed·CChildren's Oncology Group·Phase 3·NCT00274937·111 enrolled

Non-Small Cell Lung Cancer1 trial

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

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00081315·130 enrolled

Anemia1 trial

Phase I Study of Amifostine in Patients With Bone Marrow Failure Related to Fanconi's Anemia

Unknown status·—·Phase 1·NCT00006127·21 enrolled

Unspecified1 trial

High-dose ICE With Amifostine

Completed·—·Phase 2·NCT00003657·24 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 10, 1999

ETHYOL

NDA NDA020221

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Amifostine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ethyol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Amifostine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Amifostine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020221). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Legacy Health System company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: LLegacy Health System

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