Drugs / Romidepsin
last change Jul 2026 re-read 2 minutes ago

Romidepsin

Peptide

Developed for
peripheral T-cell lymphoma, not otherwise specified · lymphoma · plasma cell myeloma · primary cutaneous T-cell lymphoma · Hodgkins lymphoma · T-cell non-Hodgkin lymphoma · anaplastic large cell lymphoma · diffuse large B-cell lymphoma
+138 more · HIV infectious disease · leukemia · angioimmunoblastic T-cell lymphoma · chronic lymphocytic leukemia/small lymphocytic lymphoma · extranodal nasal NK/T cell lymphoma · mantle cell lymphoma · mature T-cell and NK-cell non-Hodgkin lymphoma · mycosis fungoides · non-Hodgkin lymphoma · non-small cell lung carcinoma · renal cell carcinoma · small cell lung carcinoma · urinary bladder cancer · Burkitt lymphoma · cancer · colorectal cancer · esophageal cancer · hepatosplenic T-cell lymphoma · male breast carcinoma · metastatic malignant neoplasm · metastatic neoplasm · mycosis fungoides and variants · myelodysplastic syndrome · myelodysplastic/myeloproliferative neoplasm · nodal marginal zone B-cell lymphoma · primary cutaneous T-cell non-Hodgkin lymphoma · prostate cancer · acute leukemia of ambiguous lineage · acute lymphoblastic leukemia · acute myeloid leukemia with 11q23 abnormalities · acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) · acute myeloid leukemia with t(8;21)(q22;q22) translocation · acute promyelocytic leukemia · adult epithelioid sarcoma · adult extraskeletal osteosarcoma · adult fibrosarcoma · adult liposarcoma · adult malignant hemangiopericytoma · adult malignant mesenchymoma · adult T-cell leukemia/lymphoma · ALK-negative anaplastic large cell lymphoma · alveolar soft part sarcoma · anaplastic astrocytoma · anaplastic oligodendroglioma · angiosarcoma · B-cell adult acute lymphocytic leukemia · B-cell chronic lymphocytic leukemia · blast phase chronic myelogenous leukemia, BCR-ABL1 positive · breast adenocarcinoma · breast carcinoma · childhood acute lymphoblastic leukemia · childhood acute myeloid leukemia · childhood brain stem glioma · childhood central nervous system germ cell tumor · childhood central nervous system primitive neuroectodermal neoplasm · childhood cerebellar astrocytic neoplasm · childhood cerebral astrocytoma · childhood choroid plexus neoplasm · childhood medulloblastoma · childhood spinal cord tumor · chondrosarcoma · colorectal carcinoma · craniopharyngioma · cutaneous melanoma · enteropathy-associated T-cell lymphoma · esophageal adenocarcinoma · Ewing sarcoma/peripheral primitive neuroectodermal tumor · follicular lymphoma · gastric adenocarcinoma · gastrin-producing neuroendocrine tumor · gastrointestinal stromal tumor · giant cell glioblastoma · glioma · gliosarcoma · glucagonoma · grade II meningioma · grade III lymphomatoid granulomatosis · grade III meningioma · graft versus host disease · hairy cell leukemia · head and neck carcinoma · Her2-receptor negative breast cancer · high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement · hypopharynx squamous cell carcinoma · immunodeficiency 132b · inflammatory breast carcinoma · intraocular lymphoma · large-cell immunoblastic lymphoma · laryngeal squamous cell carcinoma · leiomyosarcoma · lip and oral cavity squamous cell carcinoma · low-grade astrocytoma · lung cancer · lung carcinoid tumor · lung carcinoma · malignant epithelial tumor of ovary · malignant pancreatic neoplasm · malignant pleural mesothelioma · MALT lymphoma · melanoma · monomorphic epitheliotropic intestinal T-cell lymphoma · mycosis fungoides variant · neoplasm · neuroendocrine neoplasm · neurofibrosarcoma · Nodal T-follicular helper cell lymphoma, follicular type · oropharynx squamous cell carcinoma · ovarian cancer · pancreatic ductal adenocarcinoma · pancreatic endocrine carcinoma · pancreatic insulinoma · pediatric infratentorial ependymoma · pediatric supratentorial ependymoma · peritoneum cancer · pleural mesothelioma · PPoma · prostate carcinoma · renal pelvis/ureter urothelial carcinoma · rhabdomyosarcoma · small cell carcinoma · small intestine lymphoma · soft tissue sarcoma · somatostatinoma · splenic marginal zone lymphoma · synovial sarcoma · T-cell large granular lymphocyte leukemia · T-cell prolymphocytic leukemia · testicular lymphoma · thyroid gland carcinoma · thyroid gland follicular carcinoma · thyroid gland papillary carcinoma · triple-negative breast carcinoma · undifferentiated pleomorphic sarcoma · urethra cancer · urinary bladder carcinoma · urothelial carcinoma · virus associated tumor · Waldenstrom macroglobulinemia
Investigated by
National Cancer Institute (NCI) · Celgene Corporation · Memorial Sloan Kettering Cancer Center · Columbia University · Amgen · AstraZeneca
+67 more · Fondazione Italiana Linfomi - ETS · Jennifer Amengual · Mayo Clinic · Northwestern University · Ohio State University Comprehensive Cancer Center · Peter MacCallum Cancer Centre, Australia · SWOG Cancer Research Network · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · The Lymphoma Academic Research Organisation · University of Nebraska · University of Virginia · Weill Medical College of Cornell University · ANRS, Emerging Infectious Diseases · Aarhus University Hospital · Anne Beaven, MD · BCN Checkpoint · Bayer · Big Ten Cancer Research Consortium · Biologics, Inc. · Bionor Immuno AS · Bloodwise · Boehringer Ingelheim · Bristol-Myers Squibb · Canadian Cancer Trials Group · City of Hope Medical Center · Dana-Farber Cancer Institute · ECOG-ACRIN Cancer Research Group · Fight AIDS and Infectious Diseases Foundation · Fox Chase Cancer Center · GWT-TUD GmbH · Genentech, Inc. · Germans Trias i Pujol Hospital · H. Lee Moffitt Cancer Center and Research Institute · HIVACAT · Hospital Clinic of Barcelona · Hospital de Sant Pau · INSERM SC10-US19 · IrsiCaixa · Janssen-Cilag Ltd. · M.D. Anderson Cancer Center · Merck Sharp & Dohme LLC · National Comprehensive Cancer Network · National Institute of Allergy and Infectious Diseases (NIAID) · Priyanka Sharma · Rhizen Pharmaceuticals SA · Rockefeller University · Royal Marsden NHS Foundation Trust · Rutgers Cancer Institute of New Jersey · Rutgers, The State University of New Jersey · Samsung Medical Center · Seagen Inc. · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · St. Francis Hospital & Medical Center, Hartford CT · Stanford University · Takeda · University Hospital of Cologne · University of Birmingham · University of Chicago · University of Michigan Rogel Cancer Center · University of Oxford · University of Texas Southwestern Medical Center · University of Washington · Virginia Commonwealth University · Walter Hanel · Washington University School of Medicine · Weiyun Ai · Yale University

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (3) US (FDA) ISTODAX 2011-06-16 – 2021-07-30 fda.gov
Refused (EMA) EU (EMA) Istodax 2013-02-12 europa.eu
Approved US (FDA) ISTODAX 2009-11-05 fda.gov

Trials 94 · started per year

today
US approved 2009
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT01913119 Jul 2013 extranodal nasal NK/T cell lymphoma Samsung Medical Center Completed No outcome recorded
Phase 134 trials
Phase 1 NCT06963346 Jun 2025 → Apr 2028 urinary bladder cancer H. Lee Moffitt Cancer Center and Research Institute Suspended No outcome recorded
Phase 1 NCT05230368 Dec 2022 → Dec 2025 immunodeficiency 132b ANRS, Emerging Infectious Diseases Completed No outcome recorded
Phase 1 NCT04639843 Nov 2022 adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, extranodal nasal NK/T cell lymphoma, hepatosplenic T-cell lymphoma +1 National Cancer Institute (NCI) Withdrawn No outcome recorded
Phase 1 NCT04774068 Sep 2021 → Oct 2024 anaplastic large cell lymphoma, mycosis fungoides variant Walter Hanel Completed No outcome recorded
Phase 1 NCT04447027 Dec 2020 → Jul 2024 peripheral T-cell lymphoma, not otherwise specified, primary cutaneous T-cell lymphoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT04233697 Feb 2020 → Jul 2022 T-cell non-Hodgkin lymphoma Columbia University Withdrawn No outcome recorded
Phase 1 NCT03432741 Mar 2018 → Aug 2022 Hodgkins lymphoma, breast adenocarcinoma, mycosis fungoides, nodal marginal zone B-cell lymphoma Mayo Clinic Terminated No outcome recorded
Phase 1 NCT02512497 Dec 2017 → Oct 2023 T-cell large granular lymphocyte leukemia, T-cell prolymphocytic leukemia, peripheral T-cell lymphoma, not otherwise specified, primary cutaneous T-cell lymphoma Ohio State University Comprehensive Cancer Center Completed No outcome recorded
Phase 1 NCT02616965 Feb 2017 → Aug 2022 primary cutaneous T-cell lymphoma Fox Chase Cancer Center Completed No outcome recorded
Phase 1 NCT02757248 Nov 2016 primary cutaneous T-cell lymphoma Anne Beaven, MD Withdrawn No outcome recorded
Phase 1/221 trials
Phase 1/2 NCT04257448 May 2020 → Jul 2024 pancreatic ductal adenocarcinoma GWT-TUD GmbH Completed No outcome recorded
Phase 1/2 NCT03770000 Mar 2019 → May 2021 T-cell non-Hodgkin lymphoma Rhizen Pharmaceuticals SA Completed No outcome recorded
Phase 1/2 NCT03547700 Sep 2018 → Aug 2020 peripheral T-cell lymphoma, not otherwise specified University of Michigan Rogel Cancer Center Terminated No outcome recorded
Phase 1/2 NCT03161223 May 2018 → Feb 2023 overdue T-cell non-Hodgkin lymphoma University of Virginia Recruiting No outcome recorded
Phase 1/2 NCT03278782 Nov 2017 → Jul 2027 expected anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, mycosis fungoides, peripheral T-cell lymphoma, not otherwise specified M.D. Anderson Cancer Center Active not recruiting No outcome recorded
Phase 1/2 NCT02281279 Oct 2016 → Oct 2020 B-cell adult acute lymphocytic leukemia, Burkitt lymphoma, MALT lymphoma, Waldenstrom macroglobulinemia +10 Mayo Clinic Withdrawn No outcome recorded
Phase 1/2 NCT02393794 Jul 2015 → Jul 2026 overdue triple-negative breast carcinoma Priyanka Sharma Active not recruiting No outcome recorded
Phase 1/2 NCT03141203 Jul 2015 → Aug 2020 peripheral T-cell lymphoma, not otherwise specified University of Birmingham Completed No outcome recorded
Phase 1/2 NCT02341014 Jan 2015 → Jan 2023 T-cell non-Hodgkin lymphoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1/2 NCT02223208 Sep 2014 → Oct 2020 overdue ALK-negative anaplastic large cell lymphoma, Nodal T-follicular helper cell lymphoma, follicular type, angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma, not otherwise specified Fondazione Italiana Linfomi - ETS Active not recruiting No outcome recorded
Phase 234 trials
Phase 2 NCT04747236 Feb 2021 → Jun 2028 expected University of Virginia Recruiting No outcome recorded
Phase 2 NCT03534180 Aug 2018 → Apr 2021 anaplastic large cell lymphoma City of Hope Medical Center Completed No outcome recorded
Phase 2 NCT02788201 Mar 2017 → Oct 2019 urinary bladder cancer, urothelial carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT02850016 Jan 2017 → Dec 2020 HIV infectious disease Rockefeller University Completed No outcome recorded
Phase 2 NCT02232516 Jun 2015 → Aug 2020 anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal nasal NK/T cell lymphoma, hepatosplenic T-cell lymphoma +2 Northwestern University Completed No outcome recorded
Phase 2 NCT01822886 Jan 2013 → Dec 2014 peripheral T-cell lymphoma, not otherwise specified Fondazione Italiana Linfomi - ETS Completed No outcome recorded
Phase 2 NCT01353664 May 2011 → Sep 2012 cancer, lymphoma Celgene Corporation Completed No outcome recorded
Phase 2 NCT00765102 Sep 2008 → Mar 2010 plasma cell myeloma Celgene Corporation Terminated No outcome recorded
Phase 2 NCT00426764 Jun 2007 → Nov 2010 peripheral T-cell lymphoma, not otherwise specified Celgene Corporation Completed No outcome recorded
Phase 2 NCT00383565 Sep 2006 → Apr 2011 diffuse large B-cell lymphoma, mantle cell lymphoma National Cancer Institute (NCI) Terminated No outcome recorded
Phase 32 trials
Phase 3 NCT03355768 Sep → Nov 2018 peripheral T-cell lymphoma, not otherwise specified Jennifer Amengual Withdrawn No outcome recorded
Phase 3 NCT01796002 Jan 2013 → Dec 2019 peripheral T-cell lymphoma, not otherwise specified The Lymphoma Academic Research Organisation Completed No outcome recorded
Phase not applicable2 trials
NCT02551718 Sep 2015 → Jun 2020 acute leukemia of ambiguous lineage, acute lymphoblastic leukemia University of Washington Completed No outcome recorded
NCT02203578 Nov 2014 → Jun 2016 graft versus host disease Rutgers, The State University of New Jersey Terminated No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02061449 Background Mar 2014 → Nov 2018 primary cutaneous T-cell lymphoma NYU Langone Health Terminated No outcome recorded
Phase 21 trial
Phase 2 NCT03041012 Comparator Jan 2017 → Aug 2021 HIV infectious disease Aarhus University Hospital Completed No outcome recorded
Phase 33 trials
Phase 3 NCT03593018 Comparator Nov 2018 → Feb 2021 angioimmunoblastic T-cell lymphoma The Lymphoma Academic Research Organisation Completed No outcome recorded
Phase 3 NCT03703375 Comparator Nov 2018 → Feb 2021 T-cell non-Hodgkin lymphoma Celgene Corporation Completed No outcome recorded
Phase 3 NCT01482962 Comparator Jun 2012 → Jun 2015 peripheral T-cell lymphoma, not otherwise specified Millennium Pharmaceuticals, Inc. Completed No outcome recorded

Evidence & citations 20 cited values

Every value below carries the sentence it was read from. 104 sources stand behind the page.

FieldValueCited text
Known as Romidepsin Romidepsin (NSC 630176, FR901228, FK228, formerly referred to as depsipeptide) is a histone deacetylase inhibitor with potent cytotoxic activity against human tumor cell lines...” NCT00048334
86

Romidepsin (dose escalation) Starting dose: 12mg/ms iv day +1 and +8” NCT02223208

“Pentostatin, Romidepsin, Ruxolitinib” NCT02788201

“Regorafenib Romidepsin Ruxolitinib” NCT02551718

NCT02783625

NCT02232516

NCT01933594

NCT00106418

NCT00053963

NCT01796002

NCT01638533

NCT01998035

NCT01445340

NCT04257448

NCT01280526

NCT01353664

NCT03770000

NCT00024180

NCT00383565

NCT00042822

NCT00098527

NCT01979276

NCT05230368

NCT01947140

NCT01537744

NCT00079443

NCT02616874

NCT03141203

NCT01897012

NCT02616965

NCT02850016

NCT01755975

NCT06963346

NCT00077194

NCT02341014

NCT04447027

NCT00112463

NCT04639843

NCT00098813

NCT00765102

NCT00066638

NCT01302808

NCT02393794

NCT03432741

NCT03547700

NCT00086827

NCT03278782

NCT01913119

NCT00098397

NCT00963274

NCT03355768

NCT00426764

NCT01742793

NCT02281279

NCT00019318

NCT02181218

NCT04747236

NCT03041012

NCT00077337

NCT03534180

NCT00084682

NCT01456039

NCT01846390

NCT02512497

NCT02203578

NCT04233697

NCT02512172

NCT02092116

NCT01738594

NCT03161223

NCT02757248

NCT03593018

NCT01324310

NCT01324323

NCT00106431

NCT01822886

NCT00062075

NCT00007345

NCT04774068

NCT01938833

NCT02061449

NCT00091195

NCT00379639

NCT01482962

NCT00084461

NCT03703375

NCT00114257

Known as CHROMADAX ChEMBL registry synonym — accepted as the source's own label CHEMBL343448
Known as CYCLIC (1.FWDARW.2)-DISULFIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL343448
Known as CYCLIC PEPTIDE DERIV.(E)-(1S,4S,10S,21R)-7-[(Z)-ETHYLIDENE]-4,21-DIISOPROPYL-2- OXA-12,13-DITHIA-5,8,20,23- TETRAAZABICYCLO[8.7.6]TRICOS-16-ENE-3,6,9,19,22-PENTONEL-VALINE ChEMBL registry synonym — accepted as the source's own label CHEMBL343448
Known as depsipeptide “Phase I trial of the histone deacetylase inhibitor, depsipeptide (FR901228, NSC 630176), in patients with refractory neoplasms.” PMID 11895901 Mar 2002
11

“Romidepsin (depsipeptide or FK228) is a histone deacetylase inhibitor, one of a new class of agents active in T-cell lymphoma.” PMID 21355097 Feb 2011

“romidepsin (depsipeptide, FK228)” NCT00106431

depsipeptide (romidepsin)” NCT00091195

NCT00104884

NCT00085527

NCT00085540

NCT00431990

NCT00299351

NCT00037817

NCT00087295

NCT00094978

Known as DEPSIPEPTIDEANTIBIOTIC FR 901228ROMIDEPSINROMIDEPSINAPI0005301FK228OXA-12,13-DITHIA-5,8,20,23-TETRAZABICYCLO[8.7.6]TRICOSANE ChEMBL registry synonym — accepted as the source's own label CHEMBL343448
Known as FK228 “A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of Depsipeptide (FK228) in Patients That Have Completed a Prior Clinical Study With Depsipeptide.” NCT00299351
5

“Romidepsin (depsipeptide or FK228) is a histone deacetylase inhibitor, one of a new class of agents active in T-cell lymphoma.” PMID 21355097 Feb 2011

“histone deacetylase (HDAC) inhibitor Depsipeptide FK228 (DP).” NCT00037817

“romidepsin (depsipeptide, FK228)” NCT00106431

NCT00106613

NCT00106301

Known as FR901228 “the histone deacetylase (HDAC) inhibitor Depsipeptide FR901228 (DP) mediates cell cycle arrest and apoptosis in cultured lung and esophageal cancer, and malignant pleural...” NCT00094978
4

“Phase I trial of the histone deacetylase inhibitor, depsipeptide (FR901228, NSC 630176), in patients with refractory neoplasms.” PMID 11895901 Mar 2002

“Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15.” NCT00085527

“Romidepsin (FR901228)” NCT01445340

NCT00020202

Known as FR901288 “Determine objective response rate in patients with locally advanced or metastatic neuroendocrine tumors treated with FR901288 (romidepsin).” NCT00084461
Known as Istodax “A Phase IB/II Study of Escalating Doses of Romidepsin (Istodax®) in Association With CHOP” NCT01280526
2

“lenalidomide (Revlimid) and romidepsin (Istodax)” NCT01742793

NCT01902225

Known as N-(3-HYDROXY-7-MERCAPTO-1-OXO-4-HEPTENYL)VALYL- CYSTEINYL-2,3-DIDEHYDRO-2- AMINOBUTANOYL-,.XI.-LACTONE ChEMBL registry synonym — accepted as the source's own label CHEMBL343448
Known as NSC 630176 “Romidepsin (NSC 630176, FR901228, FK228, formerly referred to as depsipeptide) is a histone deacetylase inhibitor with potent cytotoxic activity against human tumor cell lines...” NCT00048334
2

“Phase I trial of the histone deacetylase inhibitor, depsipeptide (FR901228, NSC 630176), in patients with refractory neoplasms.” PMID 11895901 Mar 2002

“Phase II trial of romidepsin (NSC-630176)” PMID 18941712 Oct 2008

Known as NSC754143 ChEMBL registry synonym — accepted as the source's own label CHEMBL343448
Known as RMD “histone deacetylase inhibitor (HDACi) romidepsin (RMD) as latency-reversing agent” PMID 34750296 Mar 2022
Known as ROMIDEPSIN (FK228 ,DEPSIPEPTIDE) ChEMBL registry synonym — accepted as the source's own label CHEMBL343448
Known as ROMIDEPSINA ChEMBL registry synonym — accepted as the source's own label CHEMBL343448
Known as ROMIDEPSINE ChEMBL registry synonym — accepted as the source's own label CHEMBL343448
Action Inhibit “histone deacetylase inhibitor” NCT00007345
Modality Peptide “romidepsin (depsipeptide)” NCT00098813
Route Intravenous intravenously” NCT00007345