Last reviewed · How we verify
Istodax (ROMIDEPSIN)
Romidepsin inhibits HDACs, leading to increased acetylation of histones and non-histone proteins, causing cell cycle arrest and apoptosis in cancer cells.
Romidepsin (Istodax), marketed by Teva Pharms USA Inc, is an HDAC inhibitor approved for the treatment of cutaneous T-cell lymphoma (CTCL) with a key composition patent expiring in 2028. Its mechanism of action, which leads to increased acetylation and apoptosis in cancer cells, provides a strong therapeutic rationale and differentiates it from other treatments. However, the primary risk lies in the competitive landscape, with multiple same-class drugs such as vorinostat, panobinostat, and belinostat, all of which are patent-protected until 2026, 2028, and 2027, respectively.
At a glance
| Generic name | ROMIDEPSIN |
|---|---|
| Sponsor | Teva Pharms Usa Inc |
| Drug class | Histone Deacetylase Inhibitor |
| Target | HDACs |
| Modality | Recombinant protein |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2009 |
Mechanism of action
Romidepsin works by blocking HDACs, which normally remove acetyl groups from histones and other proteins. This blockage results in the accumulation of acetylated proteins, disrupting normal gene expression and leading to the death of cancer cells.
Approved indications
- Cutaneous T-cell lymphoma (CTCL)
Common side effects
- nausea
- asthenia/fatigue
- infections
- vomiting
- anorexia
- hypomagnesemia
- diarrhea
- pyrexia
- anemia
- thrombocytopenia
- dysgeusia
- constipation
Drug interactions
- Warfarin or Coumarin Derivatives
- Strong CYP3A4 inhibitors
- Rifampin and strong CYP3A4 inducers
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.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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
- Teva Pharms Usa Inc portfolio CI