CLINICAL TRIALS PROFILE FOR ROMIDEPSIN

505(b)(2) Clinical Trials for ROMIDEPSIN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01755975 ↗	Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma	Active, not recruiting	Biologics, Inc.	Phase 1/Phase 2	2012-12-01	The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.
New Combination	NCT01755975 ↗	Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma	Active, not recruiting	Celgene Corporation	Phase 1/Phase 2	2012-12-01	The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.
New Combination	NCT01755975 ↗	Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma	Active, not recruiting	Saint Francis/Mount Sinai Regional Cancer Center	Phase 1/Phase 2	2012-12-01	The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.
New Combination	NCT01755975 ↗	Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma	Active, not recruiting	University of Nebraska	Phase 1/Phase 2	2012-12-01	The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.
New Combination	NCT01755975 ↗	Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma	Active, not recruiting	Weill Medical College of Cornell University	Phase 1/Phase 2	2012-12-01	The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.
New Combination	NCT01755975 ↗	Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma	Active, not recruiting	Memorial Sloan Kettering Cancer Center	Phase 1/Phase 2	2012-12-01	The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.

All Clinical Trials for ROMIDEPSIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00007345 ↗	Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	2001-03-08	Background: NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors (1-3). NSC 630176, herein referred to as depsipeptide, shows a lack of cross resistance with several commonly used cytotoxic agents such as vincristine, 5-fluorouracil, mitomycin C and cyclophosphamide (2). However, it has been defined as a P-glycoprotein (Pgp) substrate by COMPARE analysis of the National Cancer Institute (NCI) drug screen cytotoxicity profile (4). Depsipeptide is a member of a novel class of antineoplastic agents, the histone deacetylase inhibitors. In the phase I trial conducted at the National Cancer Institute (NCI), responses were observed at the maximum tolerated dose (MTD) in patients with cutaneous and peripheral T-cell lymphoma. Objectives: In patients with cutaneous T-cell lymphoma, the primary end points to be examined are overall response rate, complete response rate and duration of response. In patients with relapsed peripheral T-cell lymphoma, the endpoints to be examined are overall response rate and complete response rate. To evaluate the tolerability of depsipeptide with extended cycles of therapy. Eligibility: Patients with cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) or other peripheral T-cell lymphomas are eligible. Design: Depsipeptide will be administered at 14 mg/m^2, over 4 hours on days 1, 8 and 15. This trial will accrue in six cohorts; Arm 1, patients with cutaneous T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 2, patients with peripheral T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 3, patients with cutaneous and peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens; Arm 4, patients with other mature T-cell lymphomas; Arm 5, a replicate arm of arm 1; Arm 6, patients with peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens; Arm 7, patients with cutaneous T cell lymphoma who have received vorinostat. Dose may be adjusted based on toxicities.
NCT00019318 ↗	Depsipeptide in Treating Patients With Solid Tumors	Completed	National Cancer Institute (NCI)	Phase 1	1997-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of depsipeptide in treating patients who have solid tumors for which no standard therapy exists.
NCT00024180 ↗	FR901228 in Treating Patients With Hematologic Cancer	Completed	National Cancer Institute (NCI)	Phase 1	2002-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer.
NCT00024180 ↗	FR901228 in Treating Patients With Hematologic Cancer	Completed	Ohio State University Comprehensive Cancer Center	Phase 1	2002-01-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer.
NCT00042822 ↗	FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	2002-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.
NCT00042822 ↗	FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	2002-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.
NCT00048334 ↗	Depsipeptide to Treat Thyroid and Other Advanced Cancers	Completed	National Cancer Institute (NCI)	Phase 1	2002-10-26	This phase I study will evaluate the experimental drug Romidepsinin patients with advanced cancer. The study will: 1) determine how well patients tolerate Romidepsin; 2) measure blood levels of Romidepsin during treatment; 3) analyze the cellular and molecular effects of the drug; and 4) determine if Romidepsin can shrink tumors. Romidepsin has been shown to kill cancer cells growing in the laboratory and to shrink tumors in animals with various tumor types. In preliminary studies, several patients with a type of lymphoma and one patient with kidney cancer responded to treatment. Patients 18 years of age and older with advanced cancer (excluding acute leukemia) may be eligible for this study. Candidates are screened with a medical history and physical examination, x-rays and CT scans, and blood and urine tests. Patients with thyroid cancer may also have magnetic resonance imaging (MRI). This test uses a magnetic field instead of x-rays to obtain images or body organs and tissues. Participants receive three infusions of Romidepsin administered through an intravenous line over 4 hours on days 1, 3 and 5 of a 21-day treatment cycle. The intravenous line is a catheter (plastic tube) placed in a vein and may be a peripheral line, inserted in a vein in the arm, or a central line, in which the tube is placed under the skin of the chest or neck into a major vein. Patients are hospitalized for the first 6 days of the first cycle to monitor heart rate. Those who tolerate the treatment well may continue as an outpatient. In addition to drug therapy, participants undergo the following procedures: - Blood tests: Small amounts of blood are drawn frequently during the first five days of treatment to measure Romidepsin levels and to see how the body uses and excretes the drug. A heparin lock (an indwelling device to keep the vein open) may be put in the vein to prevent the need for repeated needle sticks. - Biopsies (removal of a small sample of tumor tissue): Tumors that are accessible may be biopsied at the start of the study and at different times during treatment. Biopsies are done no more than three times per cycle, and no more than nine biopsies are done within a year. The samples are examined for the effects of Romidepsin on proteins that control the way cells divide and stay alive. - Apheresis: This procedure is done to collect white blood cells and cancer cells for research. Blood is collected through a needle in an arm vein and directed into a machine that separates it into its components by centrifugation (spinning). The white cells are removed and the red cells are returned to the patient through the same needle or through another needle in the other arm. - Scans and x-rays: Imaging studies are usually done before starting treatment. Some of them are repeated at every 2 cycles (6 weeks), and some at the end of the patient's participation in the study. The tests may include chest x-rays, plain x-rays of affected bones, CT scans of the chest, abdomen, and pelvis, bone scans, and a MUGA scan (special X-ray of the heart) or echocardiogram (ultrasound of the heart) to test heart function before and during the study. MRI or positron emission tomography (PET) scans may also be done to detect tumors. PET scans use a small amount of a radioactive substance injected into a vein. The radioactivity is detected by a special camera during scanning to detect cancer cells. - Other tests include an electrocardiogram (recording of the electrical activity of the heart) before and after each dose of depsipeptide. Eye exams are done if there are vision changes or if the doctor recommends an eye test.

Clinical Trial Conditions for ROMIDEPSIN

Condition Name

Condition Name for ROMIDEPSIN
Intervention	Trials
Lymphoma	12
Cutaneous T-cell Lymphoma	8
Peripheral T-cell Lymphoma	8
Multiple Myeloma	6

Condition MeSH

Condition MeSH for ROMIDEPSIN
Intervention	Trials
Lymphoma	56
Lymphoma, T-Cell	46
Lymphoma, T-Cell, Peripheral	29
Lymphoma, T-Cell, Cutaneous	18

Clinical Trial Locations for ROMIDEPSIN

Trials by Country

Trials by Country for ROMIDEPSIN
Location	Trials
United States	246
Italy	34
Japan	20
United Kingdom	10
Korea, Republic of	7

Trials by US State

Trials by US State for ROMIDEPSIN
Location	Trials
New York	23
California	21
Texas	16
Maryland	15
Illinois	15

Clinical Trial Progress for ROMIDEPSIN

Clinical Trial Phase

Clinical Trial Phase for ROMIDEPSIN
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	1
Phase 3	5

Clinical Trial Status

Clinical Trial Status for ROMIDEPSIN
Clinical Trial Phase	Trials
Completed	48
Recruiting	15
Terminated	15

Clinical Trial Sponsors for ROMIDEPSIN

Sponsor Name

Sponsor Name for ROMIDEPSIN
Sponsor	Trials
National Cancer Institute (NCI)	35
Celgene Corporation	28
Celgene	21

Sponsor Type

Sponsor Type for ROMIDEPSIN
Sponsor	Trials
Other	105
Industry	71
NIH	36

Last updated: August 1, 2026

Romidepsin clinical trials update, market analysis, and revenue projections (2019–2035)

Executive summary: Romidepsin (Istodax) is an IV histone deacetylase (HDAC) inhibitor indicated for cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and for peripheral T-cell lymphoma (PTCL) after at least one prior therapy. Commercial impact remains tied to survival, line-of-therapy positioning, and competition from newer epigenetic and immuno-oncology agents in T-cell lymphomas. A durable, revenue-relevant pipeline exists through post-approval combinations and ongoing studies, but absent clear late-stage registrational readouts, market upside is likely to be incremental rather than category-expanding.

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What is romidepsin’s current clinical trials pipeline status (phase, readouts, and timelines)?

Answer: Romidepsin’s pipeline is dominated by combination trials in T-cell lymphoma and related hematologic malignancies, with ongoing studies typically aimed at improving depth/duration of response versus historical single-agent benchmarks. Clinical value is most likely to translate into revenue through (1) label expansion into additional T-cell lymphoma subtypes or (2) improved positioning in earlier lines via combination evidence.

Key pipeline themes

• Combination regimens in CTCL/PTCL: HDAC inhibition paired with agents targeting immune checkpoints, cytokine signaling, or other epigenetic pathways.
• Biomarker-led subsets: trials using baseline epigenetic signatures, immune milieu, or pharmacodynamic markers to enrich responders.
• Earlier-line exploration: attempts to move romidepsin toward second-line or later in potentially curable contexts, though the majority of efforts historically focus on relapsed/refractory disease.

How to interpret “update” for decision-making

• Phase distribution matters: Phase 1/2 updates drive market sentiment but do not reliably change commercial forecasts without randomized or registrational signals.
• Readout quality matters: durable response rate, time to progression, and bridging to subsequent therapies are the metrics that translate to payer and guideline adoption.
• Competitive timing matters: T-cell lymphoma has seen fast uptake of novel agents and combinations; without clear differentiation, trial successes may not convert to share gains.

Clinical trials update requires up-to-date registry interrogation for precision (trial status, exact cohorts, and latest reported response rates). No verified, up-to-date trial list or readout table can be provided here without risking factual errors.

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What patents protect romidepsin and how do they affect generic or biosimilar risk?

Answer: Romidepsin is a small-molecule oncology drug, so “biosimilar risk” is not applicable. Generic risk depends on small-molecule patent and exclusivity expirations, plus any formulation or method-of-use protections.

Patent estate drivers that typically constrain generic entry

• Composition-of-matter patents covering the active pharmaceutical ingredient (API).
• Formulation patents covering drug product composition, stabilizers, or delivery characteristics.
• Method-of-use patents covering dosing schedules or specific therapeutic uses (CTCL/PTCL).
• Orange Book listings and the timing of any Paragraph IV (ANDA) certifications (if applicable).

This prompt asks for market analysis and projections; producing a patent-protection table with numbers, assignees, and expiration dates would require validated patent/patents-plus-Orange Book data for romidepsin. Without that, any specific expiration dates or patent counts would be unreliable.

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What is the Orange Book status of romidepsin (listed products, exclusivity, and patent expirations)?

Answer: Romidepsin has an FDA-approved branded product (Istodax). Determinants for generic timing include listed patents and exclusivity in the Orange Book, plus any pediatric exclusivity or non-patent exclusivities tied to approved indications.

Accurate Orange Book status requires live listing retrieval. The response cannot include product-by-product patent tables or certified expiration timelines without risking fabrication.

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How does romidepsin compare with key competitors in CTCL and PTCL?

Answer: Romidepsin sits in a competitive landscape where treatment decisions increasingly depend on combination strategies and emerging targeted/immunologic agents. Versus modern competitors, romidepsin’s differentiator is its mechanistic class (HDAC inhibition) and documented efficacy in relapsed/refractory T-cell lymphomas across CTCL/PTCL settings.

Competitive comparison dimensions investors and commercial teams use

• Line-of-therapy fit: whether romidepsin is predominantly used after multiple prior therapies versus gaining traction earlier through combination trials.
• Depth and durability of response: especially time-to-progression and treatment-free interval.
• Safety and discontinuation rates: tolerability drives access, adherence, and real-world persistence.
• Combination leverage: ability to pair with agents that increase response while maintaining manageable toxicity.

Precise head-to-head numerical comparisons require the specific comparator list and the latest trial outcomes. That level of detail cannot be provided without introducing unverifiable or outdated trial data.

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Where does romidepsin generate revenue exposure (by indication, geography, and payer type)?

Answer: Revenue exposure is primarily linked to:

• CTCL and PTCL relapsed/refractory treatment patterns
• US commercialization where FDA labeling, prescribing behavior, and payer coverage are most consequential
• Branded tender pricing and wholesaler purchasing driven by oncology budget cycles

Commercial drivers

• Oncology channel behavior: oncology drugs with limited prescriber pools can sustain revenue if dosing intensity stays stable.
• Guideline influence: incorporation into treatment algorithms depends on durable response metrics and comparators.
• Switching effects: if novel agents gain earlier-line status, romidepsin’s use may shift to later lines with lower incident volume.

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Romidepsin market analysis: current share, demand drivers, and commercial sustainability

Answer: Romidepsin’s market is best modeled as a niche oncology asset with demand linked to T-cell lymphoma incidence, proportion treated in later lines, and persistence on IV therapy. Growth, if it occurs, is typically driven by trial-validated combinations or label expansion rather than broad chemo-like first-line penetration.

Demand model structure

• Incidence funnel: estimated CTCL/PTCL treated population by US/EU5
• Treatment line distribution: percent receiving ≥1 prior systemic therapy
• Therapy sequencing: share of HDAC-inhibitor class usage (including cross-competition)
• Patient persistence: median number of cycles and discontinuation due to toxicity/progression

Key risks to revenue

• Clinical displacement: superior combinations and targeted therapies in relapsed/refractory CTCL/PTCL can reduce eligible volume.
• Payer tightening: high-cost oncology drugs face authorization hurdles when guideline preference shifts.
• Manufacturing and supply: IV oncology products can see demand shocks if supply constraints arise, though those risks are product-specific.

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Romidepsin revenue projection 2025–2035: base, bull, bear scenarios

Answer: Without audited commercial baselines, the only defensible approach is scenario logic rather than numeric revenue claims. A revenue forecast must anchor to (1) current annual sales, (2) net pricing and discount rate, (3) volume trend by line of therapy, and (4) competitor penetration.

Scenario framework (logic-based)

Bear case (limited incremental adoption):

• Romidepsin remains confined to later-line CTCL/PTCL.
• Combination uptake does not translate into sustained label or payer preference changes.
• Competing epigenetic or immune agents capture incremental relapsed demand.

Base case (steady class role with modest gains):

• Ongoing combination trial readouts support continued use.
• Stable dosing and persistence keep volume steady.
• Growth comes from incremental guideline presence rather than broad adoption.

Bull case (label expansion or practice-changing data):

• Registrational-quality efficacy emerges from a combination or new subgroup.
• Clinician practice shifts to earlier lines for eligible patients.
• Payer access improves as evidence strengthens.

Numeric projections require a current-year sales anchor and verified trial impact timing, neither of which are provided in the prompt.

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What generic entry risks exist for romidepsin? (ANDA, Paragraph IV, timing)

Answer: For a marketed small molecule like romidepsin, generic entry risk is governed by:

• Remaining patent life in relevant jurisdictions
• Exclusivity windows attached to approvals
• Likelihood of ANDA filings and Paragraph IV certifications
• Complexity of drug product manufacturing and stability constraints

Accurate timing and likelihood analysis requires Orange Book and patent-by-patent status for romidepsin.

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What patent litigation affects romidepsin and how does it change commercialization?

Answer: Patent litigation can delay generic entry via:

• Automatic or statutory stays upon first Paragraph IV filings
• Settlements that induce delayed launch (pay-for-delay structures)
• Injunction threats tied to specific patents and product attributes

No litigation docket data is supplied here. Providing specific case names, court venues, filing dates, or settlement dates would risk factual errors.

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Key Takeaways

• Romidepsin remains a niche but established option in relapsed/refractory CTCL and PTCL, with commercial performance tied more to treatment-line positioning and combination uptake than to large first-line penetration.
• Clinical value is most likely to convert into revenue if ongoing studies produce practice-changing efficacy that shifts use toward earlier lines and improves payer preference.
• Generic/biosimilar risk analysis requires Orange Book and patent status to establish any credible entry timeline, and cannot be stated precisely without verified listing data.
• Revenue projections must be anchored to an audited baseline; in the absence of that, only scenario logic can be provided without fabricating numeric forecasts.

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FAQs

1. What dosing schedule and administration factors drive romidepsin real-world persistence in relapsed CTCL/PTCL?
2. Which romidepsin combination trial readouts most influence payer formulary decisions?
3. How does romidepsin’s safety profile compare with other HDAC inhibitors used in T-cell lymphoma?
4. What endpoints (ORR, DoR, PFS) correlate best with subsequent label expansion for romidepsin-like agents?
5. What manufacturing and drug product considerations matter most for potential generic substitution of IV HDAC inhibitors?

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References

No sources are provided in the prompt and no verified, up-to-date clinical/patent/market data is included in this response.