Romidepsin Drug Asset Due Diligence Report 2026

This Romidepsin Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Approved

Highest phase

101

Registered trials

112

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Romidepsin can convert its Cyclic Peptide profile and HDACs biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Romidepsin (query alias: romidepsin)
Modality / target	Cyclic Peptide; HDACs; HDAC inhibitors, Epigenetic drug
Highest global status	Approved
Originator	Celgene Corp.
Active developers	The Johns Hopkins University, Celgene Corp., Bristol Myers Squibb Co.

The MCP disease footprint includes Peripheral T-Cell Lymphoma, Cutaneous T-Cell Lymphoma, Metastatic Triple-Negative Breast Carcinoma. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT04747236	Phase 2	Recruiting	50	Progression free survival
NCT06963346	Phase 1	Suspended	12	Romidepsin Maximum Tolerated Dose (MTD)
NCT05230368	Phase 1	Completed	9	Incidence of Serious Adverse Events (SAE) and severe clinical or biological adverse events (AE) related to the study drugs

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

Phase I/II Study of Ixazomib and Romidepsin in Relapsed/ Refractory Peripheral T-cell Lymphoma (PTCL)

Phase 1/2; n=11; evaluation: not stated. Reported fields: Phase I: Maximum Tolerated Dose (MTD) = NA mg/m^2 ; -; -

4453Real-World Evidence for Duvelisib and Romidepsin Combination in Patients with Relapsed/Refractory Peripheral T-Cell Lymphomas

Not Applicable; n=not disclosed; evaluation: not stated. Reported fields: Adverse Event: anemia = anemia (n=3)

Romidepsin, Azacitidine, Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-Cell Lymphoma

临床1期; n=26; evaluation: 积极. Reported fields: ORR = 56 %

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Romidepsin addresses Peripheral T-Cell Lymphoma, Cutaneous T-Cell Lymphoma, Metastatic Triple-Negative Breast Carcinoma. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Cyclic Peptide—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 1 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2004-04-19	Gloucester Pharma buys rights to novel anti-cancer compound from Fujisawa	Phase 2	Financial terms not disclosed

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “Protein polypeptide combined with I-type HDACs and capable of improving solid tumor resisting curative effect of HDAC inhibitor and application of protein polypeptide”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Class crowding and differentiation versus other PD-(L)1/VEGF agents
Immune and anti-angiogenic safety, including bleeding and cardiovascular risk
Biomarker strategy, indication selection, and head-to-head endpoint execution

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

GO