Last reviewed 2026-04-20 · How we verify

Istodax

At a glance

Approved indications

• Peripheral T-cell lymphoma
• Primary cutaneous T-cell lymphoma

Common side effects

• Nausea
• Asthenia/Fatigue
• Infections
• Vomiting
• Anorexia
• Anemia
• Electrocardiogram ST-T wave changes
• Dysgeusia
• Constipation
• Pruritus
• Hypomagnesemia
• Diarrhea

Serious adverse events

• Infections
• Fatigue
• Sepsis
• Pyrexia
• Supraventricular arrhythmia
• Central line infection

Key clinical trials

• Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma (PHASE1)
• Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents (PHASE1)
• Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies (PHASE1)
• Evaluation of the Safety and the Tolerability of a Combination of Two HIV Inducers in Patients With Undetectable Viral Load (PHASE1)
• Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL (PHASE2)
• Study of Pembrolizumab (MK-3475) in Combination With Romidepsin (PHASE1, PHASE2)
• A Study of Enhancing Response to MK-3475 in Advanced Colorectal Cancer (PHASE1)
• Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas (PHASE1, PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Istodax CI brief — competitive landscape report
• Istodax updates RSS · CI watch RSS
• Celgene portfolio CI