Data updated: May 26, 2026
ROMIDEPSIN
Trial Activity: Declining 6 active trials
Oncology
Approved 2020-03-13
Romidepsin treats cutaneous T-cell lymphoma (CTCL) in adult patients. It is used for those who have already received at least one prior systemic therapy for their condition. This medication provides a treatment option for managing this specific type of lymphoma after other systemic approaches have been tried.
Source: FDA Label • Fresenius Kabi
How ROMIDEPSIN Works
Romidepsin works by inhibiting histone deacetylase (HDAC) enzymes, which normally remove acetyl groups from histones and other proteins to regulate gene expression. By blocking these enzymes, the drug causes acetylated histones to accumulate, which can lead to cell cycle arrest and the death of cancer cells.
Development Insights
Celgene conducting 6 trials (13%)
180 indications explored (Broad Platform)
→ refractory mature t-cell and nk-cell non-hodgkin lymphoma (5 trials)
→ lymphoma (5 trials)
→ recurrent primary cutaneous t-cell non-hodgkin lymphoma (4 trials)
2
Indications
--
Phase 3 Trials
6
Years on Market
Details
- Status
- Prescription
- First Approved
- 2020-03-13
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER, SOLUTION
ROMIDEPSIN Approval History
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2020 to 2021
What ROMIDEPSIN Treats
1 indicationsROMIDEPSIN is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cutaneous T-Cell Lymphoma
Source: FDA Label
ROMIDEPSIN Competitive Set
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Direct competitors
1
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Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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What's emerging in ROMIDEPSIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ROMIDEPSIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ROMIDEPSIN
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
48 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03547700 results posted | BTCRC-HEM15-028 | Ph 1, Ph 2 | terminated | Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL) |
| NCT02783625 | 16-042 | Ph 1 | completed | Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas |
| NCT03593018 | ORACLE | Ph 3 | completed | Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL |
| NCT01846390 | LY15 | Ph 1 | completed | Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma |
| NCT06963346 | MCC-22623 ESR 23-22189 | Ph 1 | suspended | Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents |
| NCT04447027 results posted | 200127 20-C-0127 | Ph 1 | completed | Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies |
| NCT04747236 PTCL | PTCL-001 FD-R-006814-01 | Ph 2 | recruiting | Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL |
| NCT03278782 | 2017-0272 NCI-2018-01051, 2017-0272 | Ph 1, Ph 2 | active not recruiting | Study of Pembrolizumab (MK-3475) in Combination With Romidepsin |
| NCT02512172 | J1538 IRB00060125 | Ph 1 | completed | A Study of Enhancing Response to MK-3475 in Advanced Colorectal Cancer |
| NCT02393794 | IIT-2014-CISRomiNivoTNBC RM-CL-BRST-PI-002783, IIT-2014-PS-BRST-CISRomiTNBC | Ph 1, Ph 2 | active not recruiting | Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC) |
| NCT04257448 SEPION | SEPION AX-CL-PANC-PI-008619 | Ph 1, Ph 2 | completed | Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer |
| NCT02512497 | OSU-16242 NCI-2015-01555 | Ph 1 | completed | Romidepsin Maintenance After Allogeneic Stem Cell Transplantation |
| NCT03432741 | MC1689 NCI-2018-00149, MC1689 | Ph 1 | terminated | Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer |
| NCT01938833 results posted | 13C.387 2013-035, JT 2987 | Ph 1, Ph 2 | terminated | Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer |
| NCT03041012 eCLEAR | eCLEAR-001 2015-002234-53 | Ph 2 | completed | Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART |
| NCT02616965 | HM-085 16-1009 | Ph 1 | completed | A Study to Assess the Feasibility of Romidepsin Combined With Brentuximab Vedotin in Cutaneous T-cell Lymphoma |
| NCT01638533 | NCI-2012-01040 NCI-2012-01040, CDR0000737061 | Ph 1 | completed | Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction |
| NCT04774068 | OSU-19264 NCI-2021-00728 | Ph 1 | completed | Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas |
| NCT01755975 results posted | 12-170 | Ph 1, Ph 2 | completed | Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma |
| NCT03703375 results posted | OA-CL-LYM-LYSARC-13134C U1111-1220-8294 | Ph 3 | active not recruiting | Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma |
| NCT02616874 | BCN02-Romi | Ph 1 | completed | Study to Evaluate the Safety and Effect of HIVconsv Vaccines in Combination With Histone Deacetylase Inhibitor Romidepsin on the Viral Rebound Kinetic After Treatment Interruption in Early Treated HIV-1 Infected Individuals |
| NCT02341014 results posted | 14-179 | Ph 1, Ph 2 | completed | Combination Therapy With Carfilzomib, Romidepsin, Lenalidomide in Patients With Relapsed or Refractory B- and T-cell Lymphomas |
| NCT03534180 results posted | 18119 NCI-2018-00810, 18119 | Ph 2 | completed | Venetoclax and Romidepsin in Treating Patients With Recurrent or Refractory Mature T-Cell Lymphoma |
| NCT01947140 PDX+Romi | AAAJ5656 | Ph 1, Ph 2 | completed | Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies |
| NCT04639843 | 200169 20-C-0169 | Ph 1 | withdrawn | Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma |
| NCT03770000 results posted | RP6530+Romidepsin-1805 | Ph 1, Ph 2 | completed | Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma |
| NCT02850016 ROADMAP results posted | MCA-0896 | Ph 2 | completed | Romidepsin Plus 3BNC117 Phase 2a Study |
| NCT03141203 RomiCar | RG_13-107 2013-001879-20 | Ph 1, Ph 2 | completed | Evaluation of the Combination of Romidepsin and Carfilzomib in Relapsed/Refractory Peripheral T Cell Lymphoma Patients |
| NCT03161223 | AAAR0365 | Ph 1, Ph 2 | recruiting | Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma |
| NCT01933594 results posted | A5315 11892, ACTG 5315 | Ph 1, Ph 2 | completed | Evaluating the Safety and Efficacy of Romidepsin in Combination With Antiretroviral Therapy in HIV-Infected Adults With Suppressed Viral Load |
| NCT02181218 | 201407160 | Ph 1 | completed | Phase I Study of Romidepsin, Gemcitabine, Oxaliplatin, and Dexamethasone in Patients With Relapsed/Refractory Aggressive Lymphomas |
| NCT04233697 | AAAR5207 | Ph 1 | withdrawn | Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma |
| NCT01353664 results posted | ROMI-ADVM-004 2010-023040-32 | Ph 2 | completed | A Rollover Study for Patients Who Participated in Other Romidepsin Protocols |
| NCT00765102 results posted | GPI-08-0006 | Ph 2 | terminated | Trial of Romidepsin and Bortezomib for Multiple Myeloma |
| NCT01324323 results posted | ROMI-ADVM-002 2010-022149-75 | Ph 1 | completed | Influence of Rifampin on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer |
| NCT01324310 results posted | ROMI-ADVM-001 2010-022144-20 | Ph 1 | completed | Influence of Ketoconazole on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer |
| NCT01738594 results posted | NU 12H06 STU00071042, NCI-2012-01952 | Ph 1 | terminated | Dose-Escalation Trial of Carfilzomib With and Without Romidepsin in Cutaneous T-Cell Lymphoma |
| NCT01456039 results posted | ROMI-TCL-001 | Ph 1, Ph 2 | completed | A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL) |
| NCT01897012 | NCI-2013-01272 NCI-2013-01272, TX035 | Ph 1 | completed | Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas |
| NCT02061449 | 13-00686 | Ph 1 | terminated | Poly ICLC, Radiation, and Romidepsin for Advanced Cutaneous T Cell Lymphoma |
| NCT03355768 | AAAR5550 | Ph 3 | withdrawn | Romidepsin Versus Combination of Romidepsin Plus Pralatrexate in PTCL |
| NCT01590732 | 2012-0183 NCI-2018-01827, 2012-0183 | Ph 1 | completed | Romidepsin, Ifosfamide, Carboplatin, and Etoposide in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphoma |
| NCT01482962 results posted | C14012 2011-003545-18, DRKS00004503 | Ph 3 | completed | Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma |
| NCT01979276 Romi Poma results posted | 1306014005 | Ph 1, Ph 2 | terminated | Study of Pomalidomide, Dexamethasone, and Romidepsin for Rel/Ref Myeloma |
| NCT00963274 | MCC-12215 P30CA016059, MCC-12215 | Ph 1 | completed | Bortezomib and Romidepsin in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| NCT02092116 REDUC results posted | BPC01-001 2013-004747-23 | Ph 1, Ph 2 | completed | Safety and Efficacy of Romidepsin and the Therapeutic Vaccine Vacc-4x for Reduction of the Latent HIV-1 Reservoir |
| NCT02757248 | Pro00060068 | Ph 1 | withdrawn | Ph1 Volasertib Plus Romidepsin in R/R PTCL and CTCL |
| NCT02281279 | MC1288 NCI-2014-02186, RM-FOL-PI-0034 | Ph 1, Ph 2 | withdrawn | Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ROMIDEPSIN FDA Label Details
Indications & Usage
FDA Label (PDF)ROMIDEPSIN is indicated for the treatment of Cutaneous T-Cell Lymphoma.
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Full clinical data, patents, trials, and competitive landscape for romidepsin.
Data Sources
FDA Approval: ANDA206254 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment