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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 11 indications[4].[1]

Ethyol is one of 313 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Approved.

11

Indications

20

Total Trials

0

Active Trials

312

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Prostate AdenocarcinomaApproved

Lung CancerApproved

Head and Neck Malignant NeoplasiaActive, not recruiting

MucositisActive, not recruiting

XerostomiaActive, not recruiting

Rectum CancerApproved

Myelodysplastic SyndromeApproved

Prostate CancerApproved

Ovarian CancerActive, not recruiting

Multiple MyelomaApproved

Prostate AdenocarcinomaApproved

Approved

Lung CancerApproved

Approved

Head and Neck Malignant NeoplasiaApproved

Active, not recruiting

MucositisApproved

Active, not recruiting

XerostomiaApproved

Active, not recruiting

Rectum CancerApproved

Approved

Myelodysplastic SyndromeApproved

Approved

Prostate CancerApproved

Approved

Ovarian CancerApproved

Active, not recruiting

Multiple MyelomaApproved

Approved

Showing 10 of 11 indications

Competition

Competitive Landscape

312 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Ethyol

LLegacy Health System

Nizoral

LHRH Agonist

Xaluritamig

Radium-223

Perflutren Lipid Microspheres

SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Gallium Ga 68 Gozetotide

Pasritamig

Johnson & Johnson

Trexall

Jazz Pharmaceuticals

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

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

Clinical

Trials by Indication[1]

Head and Neck Cancer3 trials

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

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

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

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

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

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

12 more indications

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

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

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

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

Randomized1 trial

Randomized Amifostine For SCCHN

Completed·—·Phase 2·NCT00095927·58 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

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

Colorectal Cancer1 trial

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

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