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amifostine trihydrate
Amifostine is a prodrug that is converted to an active free thiol compound, which acts as a cytoprotective and radioprotective agent by scavenging free radicals and reducing DNA damage.
Amifostine is a prodrug that is converted to an active free thiol compound, which acts as a cytoprotective and radioprotective agent by scavenging free radicals and reducing DNA damage. Used for Reduction of cumulative renal toxicity associated with repeated cisplatin administration in patients with advanced ovarian cancer, Reduction of xerostomia (dry mouth) in patients undergoing postoperative radiation treatment for head and neck cancer.
At a glance
| Generic name | amifostine trihydrate |
|---|---|
| Also known as | Ethyol, ethyol, ethanethiol, ethiofos, gammaphos |
| Sponsor | City of Hope Medical Center |
| Drug class | Cytoprotective agent |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Amifostine is dephosphorylated by alkaline phosphatase to form WR-1065, the active metabolite, which preferentially accumulates in normal tissues due to higher alkaline phosphatase activity. The active thiol metabolite neutralizes reactive oxygen species and electrophilic compounds, protecting normal cells from chemotherapy and radiation-induced damage while having limited protective effect on tumor cells due to their lower alkaline phosphatase activity.
Approved indications
- Reduction of cumulative renal toxicity associated with repeated cisplatin administration in patients with advanced ovarian cancer
- Reduction of xerostomia (dry mouth) in patients undergoing postoperative radiation treatment for head and neck cancer
Common side effects
- Nausea and vomiting
- Hypotension
- Hypocalcemia
- Allergic reactions
- Somnolence
- Hiccups
Key clinical trials
- 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)
- Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer (PHASE3)
- Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer (PHASE2)
- Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia (PHASE2)
- Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer (PHASE1, 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 |
|---|---|
| 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:
- amifostine trihydrate CI brief — competitive landscape report
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- City of Hope Medical Center portfolio CI