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Ethyol (AMIFOSTINE)
Ethyol works by protecting the kidneys and salivary glands from damage caused by chemotherapy and radiation.
Ethyol (AMIFOSTINE) is a small molecule drug developed by Clinigen Healthcare and currently owned by Cosette. It targets the D(3) dopamine receptor and is classified as an amifostine. Ethyol is FDA-approved for preventing cancer chemotherapy-induced renal impairment and xerostomia secondary to radiation therapy. It has a short half-life of 0.15 hours and high bioavailability of 99%. Ethyol is off-patent with multiple generic manufacturers.
At a glance
| Generic name | AMIFOSTINE |
|---|---|
| Sponsor | Cosette |
| Drug class | amifostine |
| Target | D(3) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1995 |
Mechanism of action
ETHYOL is prodrug that is dephosphorylated by alkaline phosphatase in tissues to pharmacologically active free thiol metabolite. This metabolite is believed to be responsible for the reduction of the cumulative renal toxicity of cisplatin and for the reduction of the toxic effects of radiation on normal oral tissues. The ability of ETHYOL to differentially protect normal tissues is attributed to the higher capillary alkaline phosphatase activity, higher pH and better vascularity of normal tissues relative to tumor tissue, which results in more rapid generation of the active thiol metabolite as well as higher rate constant for uptake into cells. The higher concentration of the thiol metabolite in normal tissues is available to bind to, and thereby detoxify, reactive metabolites of cisplatin. This thiol metabolite can also scavenge reactive oxygen species generated by exposure to either cisplatin or radiation.
Approved indications
- Prevention of Cancer Chemotherapy-Induced Renal Impairment
- Prevention of Xerostomia Secondary to Radiation Therapy
Common side effects
- Nausea/Vomiting ≥Grade 3
- Nausea/Vomiting All Grades
- Hypotension ≥Grade 3
- Hypotension All Grades
- Nausea/Vomiting ≥Grade 3
- Nausea/Vomiting All Grades
Key clinical trials
- A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With Sterotactic Body Radiotherapy for Treatment in Patients With Locally Advanced Pancreatic Cancer. (PHASE1,PHASE2)
- A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer (PHASE2)
- Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy (PHASE1)
- A Study of Amifostine (Ethyol) in Patients With Colorectal Cancer (PHASE2)
- Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer (PHASE1)
- Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation (PHASE1)
- AminoMedixTM for Kidney Protection During Radionuclide Therapy
- Amifostine & High-Dose Combination Chemotherapy in Treating Patients With Acute ML or CML (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ethyol CI brief — competitive landscape report
- Ethyol updates RSS · CI watch RSS
- Cosette portfolio CI