Romidepsin
FDA approved · RxHistone deacetylase inhibitor
Also known as: Istodax, Chromadax, FK228, Antibiotic FR 901228, FK-228, romidepsina, romidepsine
Strong, human-grade evidence
- Regulatory standing. FDA-approved prescription medicine
- Human trials. Backed by controlled human studies
- Registered human trials. 105 registered studies on ClinicalTrials.gov, most advanced Phase 3
- 2 cited sources. Includes primary / regulatory sources
Computed with the same four public criteria as every profile. The human-evidence grade on an indexed profile is set automatically and may change when it is hand-reviewed. It is not a safety score, not a purity rating, and not medical advice, and not a claim that this compound treats, cures, or prevents any condition.
What it is
Romidepsin, sold as Istodax, is a bicyclic depsipeptide originally isolated from the bacterium Chromobacterium violaceum. It acts as a prodrug that, once inside cells, inhibits histone deacetylase enzymes, which changes gene expression and can trigger growth arrest and death in certain cancer cells.
What the evidence shows
Romidepsin is FDA approved for cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy. A related approval for peripheral T-cell lymphoma was later withdrawn, and other uses studied across more than 100 registered trials remain investigational.
Key facts
Registered human trials
Live from ClinicalTrials.gov, refreshed daily.
FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma
Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas
Romidepsin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Published literature
Live from Europe PMC. This is how much has been published, not how much is proven in humans.
New and emerging HDAC inhibitors for cancer treatment.
Histone Deacetylase Inhibitors as Anticancer Drugs.
Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma.
Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy.
Sources
- PubChem compound record (CID 5352062)
- FDA drug label on DailyMed
- Registered trials on ClinicalTrials.gov
- Published papers on Europe PMC
Risks, side effects and study doses are only published on hand-reviewed profiles. Want this one reviewed, or spotted something wrong? Tell us.