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Peptide

Romidepsin (Istodax)

Romidepsin is a bicyclic depsipeptide histone deacetylase (HDAC) inhibitor derived from Chromobacterium violaceum. FDA-approved November 2009 for relapsed/refractory CTCL and June 2011 for PTCL. Phase 2 CTCL trials: ORR 34-35% with 6% CR. Phase 2 PTCL: ORR 25-38% with durable responses (median DOR 28 months). Acts as prodrug with intracellular disulfide reduction releasing zinc-binding thiol to inhibit HDACs.

Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.

Best evidence
Grade A
Conditions studied
2
Outcomes
12
Graded outcomes
4242

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

2 conditions, plus general outcomes

Peripheral T-Cell Lymphoma

Peripheral T-Cell Lymphoma: outcomes studied for Romidepsin (Istodax)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Overall Response Rate (PTCL)

Pivotal Phase 2 trial (n=130): ORR 25% with 15% CR/CRu. NCI multicenter study (n=47): ORR 38% with 17% CR. Responses seen across all major PTCL subtypes. Led to FDA approval June 2011.

Improves (the measure goes up)Moderate effect12 studies

Studies that measured overall response rate (ptcl)

and 2 more in the citations list

Duration of Response (PTCL)

Pivotal trial: Median DOR 28 months in responders. NCI trial: Median DOR 8.9 months (range 2-74 months). Durable responses possible in heavily pretreated patients (median 3 prior therapies).

Improves (the measure goes up)Large effect7 studies

Studies that measured duration of response (ptcl)

Response by Prior Therapy

Responses observed regardless of number or type of prior therapies. Patients with up to 11 prior treatments responded. 38% of patients had prior stem cell transplant and still achieved responses.

Improves (the measure goes up)Moderate effect8 studies

Studies that measured response by prior therapy

Cutaneous T-Cell Lymphoma

Cutaneous T-Cell Lymphoma: outcomes studied for Romidepsin (Istodax)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Overall Response Rate (CTCL)

Two pivotal Phase 2 trials in relapsed/refractory CTCL (n=71, n=96): ORR 34-35% with 6% CR in both studies. Among 68 patients with advanced disease, 38% achieved response including 5 CRs. Led to FDA approval Nov 2009.

Improves (the measure goes up)Moderate effect11 studies

Studies that measured overall response rate (ctcl)

and 1 more in the citations list

Pruritus Improvement (CTCL)

43% (28/65) of patients with moderate-severe pruritus at baseline achieved improvement. Important quality of life benefit in CTCL where pruritus is often debilitating.

Improves (the measure goes down)Moderate effect7 studies

Studies that measured pruritus improvement (ctcl)

General

General: outcomes studied for Romidepsin (Istodax)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Immune Function

39 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect10 studies

Studies that measured immune function

Anti-Cancer Activity

20 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes up)Moderate effect13 studies

Studies that measured anti-cancer activity

and 3 more in the citations list

Cancer Cell Apoptosis

3 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes up)Small effect7 studies

Studies that measured cancer cell apoptosis

Liver Protection

5 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes up)Small effect5 studies

Studies that measured liver protection

Safety/Tolerability

3 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Small effect3 studies

Studies that measured safety/tolerability

Mortality

2 preclinical studies support this finding. Primarily preclinical evidence.

Improves (the measure goes down)Small effect2 studies
Cardiac Protection

2 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Small effect2 studies

Key findings

  • Overall Response Rate (PTCL)Peripheral T-Cell LymphomaImproves (the measure goes up)
  • Overall Response Rate (CTCL)Cutaneous T-Cell LymphomaImproves (the measure goes up)
  • Pruritus Improvement (CTCL)Cutaneous T-Cell LymphomaImproves (the measure goes down)

Studies cited

47 studies from PubMed

  1. The HDAC inhibitor romidepsin renders liver cancer vulnerable to RTK targeting and immunologically active.Nature communications, 2025 · PMID 40855049
  2. Acetylation-dependent regulation of core spliceosome modulates hepatocellular carcinoma cassette exons and sensitivity to PARP inhibitors.Nature communications, 2024 · PMID 38890388
  3. Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study.The Lancet. Haematology, 2024 · PMID 38796193
  4. Duvelisib plus romidepsin in relapsed/refractory T cell lymphomas: a phase 1b/2a trial.Nature medicine, 2024 · PMID 38886623
  5. Multicenter phase 2 study of romidepsin plus lenalidomide for previously untreated peripheral T-cell lymphoma.Blood advances, 2023 · PMID 37327113
  6. Romidepsin (FK228) improves the survival of allogeneic skin grafts through downregulating the production of donor-specific antibody via suppressing the IRE1α-XBP1 pathway.Journal of Zhejiang University. Science. B, 2022 · PMID 35557040
  7. Organ-specific toxicity of romidepsin in patients with preexisting cardiovascular disease: a retrospective analysis.Leukemia & lymphoma, 2022 · PMID 35272538
  8. Romidepsin Treatment in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: A Systematic Review and Meta-Analysis.American journal of therapeutics, 2022 · PMID 34264886
  9. Effect of 3BNC117 and romidepsin on the HIV-1 reservoir in people taking suppressive antiretroviral therapy (ROADMAP): a randomised, open-label, phase 2A trial.The Lancet. Microbe, 2022 · PMID 35544074
  10. Early intervention with 3BNC117 and romidepsin at antiretroviral treatment initiation in people with HIV-1: a phase 1b/2a, randomized trial.Nature medicine, 2022 · PMID 36253609
  11. Romidepsin (FK228), A Histone Deacetylase Inhibitor and its Analogues in Cancer Chemotherapy.Current medicinal chemistry, 2021 · PMID 32013816
  12. Romidepsin (FK228) regulates the expression of the immune checkpoint ligand PD-L1 and suppresses cellular immune functions in colon cancer.Cancer immunology, immunotherapy : CII, 2021 · PMID 32632663
  13. Tamoxifen enhances romidepsin-induced apoptosis in T-cell malignant cells via activation of FOXO1 signaling pathway.Leukemia & lymphoma, 2021 · PMID 33508992
  14. Romidepsin hepatocellular carcinoma suppression in mice is associated with deregulated gene expression of bone morphogenetic protein and Notch signaling pathway components.Molecular biology reports, 2021 · PMID 33393006
  15. Romidepsin and metformin nanomaterials delivery on streptozocin for the treatment of Alzheimer's disease in animal model.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie, 2021 · PMID 34323698
  16. Combined oral 5-azacytidine and romidepsin are highly effective in patients with PTCL: a multicenter phase 2 study.Blood, 2021 · PMID 33171487
  17. Romidepsin: A New Drug for the Treatment of Cutaneous T-Cell LymphomaOnco Targets Ther, 2020 · PMID 32386044
  18. The Histone Deacetylase Inhibitor Romidepsin Spares Normal Tissues While Acting as an Effective Radiosensitizer in Bladder Tumors in Vivo.International journal of radiation oncology, biology, physics, 2020 · PMID 31987970
  19. Deciphering the molecular effects of romidepsin on germ cell tumours: DHRS2 is involved in cell cycle arrest but not apoptosis or induction of romidepsin effectors.Journal of cellular and molecular medicine, 2019 · PMID 30460772
  20. Romidepsin-associated cardiac toxicity and ECG changes: A case report and review of the literature.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 2018 · PMID 27708192
  21. Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T-cell lymphomaCancer Med, 2017 · PMID 27981793
  22. Romidepsin induces G2/M phase arrest via Erk/cdc25C/cdc2/cyclinB pathway and apoptosis induction through JNK/c-Jun/caspase3 pathway in hepatocellular carcinoma cells.Biochemical pharmacology, 2017 · PMID 28012958
  23. Review of bioanalytical assays for the quantitation of various HDAC inhibitors such as vorinostat, belinostat, panobinostat, romidepsin and chidamine.Biomedical chromatography : BMC, 2017 · PMID 27511598
  24. Nursing Roles in Cardiac Safety: Romidepsin in Patients With T-Cell Lymphoma.Oncology nursing forum, 2016 · PMID 26906133
  25. Cyclic depsipeptides as potential cancer therapeutics.Anti-cancer drugs, 2015 · PMID 25419631
  26. Romidepsin targets multiple survival signaling pathways in malignant T cells.Blood cancer journal, 2015 · PMID 26473529
  27. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responsesJ Hematol Oncol, 2014 · PMID 24493070
  28. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapyJ Clin Oncol, 2012 · PMID 22271479
  29. Romidepsin for cutaneous T-cell lymphomaClin Cancer Res, 2012 · PMID 22474089
  30. Romidepsin: a guide to its clinical use in cutaneous T-cell lymphoma.American journal of clinical dermatology, 2012 · PMID 22066664
  31. Romidepsin for cutaneous T-cell lymphoma.Clinical cancer research : an official journal of the American Association for Cancer Research, 2012 · PMID 22535155
  32. Romidepsin for previously treated patients with peripheral or aggressive T-cell lymphomas.Clinical advances in hematology & oncology : H&O, 2012 · PMID 22706545
  33. Romidepsin: a histone deacetylase inhibitor for refractory cutaneous T-cell lymphoma.The Annals of pharmacotherapy, 2012 · PMID 22968522
  34. Targeted cancer therapy: giving histone deacetylase inhibitors all they need to succeed.Future medicinal chemistry, 2012 · PMID 22416777
  35. Histone deacetylase inhibitors in the treatment of cancer: overview and perspectives.Future medicinal chemistry, 2012 · PMID 22857533
  36. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphomaBlood, 2011 · PMID 21355097
  37. Romidepsin (Istodax, NSC 630176, FR901228, FK228, depsipeptide): a natural product recently approved for cutaneous T-cell lymphomaJ Antibiot (Tokyo), 2011 · PMID 21788432
  38. Romidepsin: a new therapy for cutaneous T-cell lymphoma and a potential therapy for solid tumorsExpert Rev Anticancer Ther, 2011 · PMID 30571499
  39. Romidepsin (Istodax, NSC 630176, FR901228, FK228, depsipeptide): a natural product recently approved for cutaneous T-cell lymphoma.The Journal of antibiotics, 2011 · PMID 21587264
  40. Therapeutic advances in cutaneous T-cell lymphoma.Skin therapy letter, 2011 · PMID 21591544
  41. Romidepsin in the treatment of T-cell lymphoma: profile report.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2011 · PMID 22050341
  42. Epigenetics in cancer: what's the future?Oncology (Williston Park, N.Y.), 2011 · PMID 21548464
  43. Romidepsin: a novel histone deacetylase inhibitor for cancer.Expert opinion on investigational drugs, 2011 · PMID 21699444
  44. Romidepsin (Istodax) for cutaneous T-cell lymphoma.The Medical letter on drugs and therapeutics, 2010 · PMID 20508581
  45. Romidepsin: a new therapy for cutaneous T-cell lymphoma and a potential therapy for solid tumors.Expert review of anticancer therapy, 2010 · PMID 20645688
  46. Phase 2 multicenter trial of the histone deacetylase inhibitor romidepsin in patients with relapsed or refractory cutaneous T-cell lymphomaJ Clin Oncol, 2009 · PMID 19826119
  47. Romidepsin for the treatment of cutaneous T-cell lymphoma.Drugs of today (Barcelona, Spain : 1998), 2009 · PMID 20126671