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drugsProductNot mapped hereapproved

Romidepsin

Romidepsin is an epigenetic drug for T-cell lymphomas of the skin and lymph nodes; its US lymph-node indication was withdrawn when a confirmatory trial failed.

Approved 2009 for CTCL and 2011 for PTCL (accelerated). Ro-CHOP (2021) failed to improve PFS when added to CHOP, and the PTCL indication was voluntarily withdrawn in 2021; the CTCL indication and use with azacitidine in TFH lymphoma remain. Nausea, fatigue, cytopenias and QT effects.

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Romidepsin (cyclic depsipeptide)
PubChem
Modality
Class I HDAC inhibitor (cyclic peptide)
Mechanism
Inhibits histone deacetylases 1/2, inducing histone hyperacetylation, cell-cycle arrest and apoptosis; activity in T-cell lymphomas including TFH type with TET2/DNMT3A mutations.
Brand / code
Istodax
Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Generic romidepsin is available.

Commercial insurance
covered on label

Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens. Prior authorisation is uncommon.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not appraisedSearch NICE
Notes
EU licence for PTCL withdrawn; no UK licence.
NHS England
Not routinely funded

Sources: NICE search: romidepsin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2009Cutaneous T-cell lymphoma after ≥1 systemic therapy
US2011Peripheral T-cell lymphoma after ≥1 therapyWithdrawn 2021 after Ro-CHOP

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
64 studies2 recruiting59 Phase 25 Phase 3
Search “Romidepsin” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Romidepsin
intervention: Romidepsin
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Romidepsin" OR ABSTRACT:"Romidepsin" OR TITLE:"Istodax" OR ABSTRACT:"Istodax") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Romidepsin, not a curated reading list.

Connected

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