NDAINTRAVENOUSPOWDER
Approved
Nov 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
ISTODAX (romidepsin) by Bristol Myers Squibb is (hdac) inhibitor. First approved in 2009.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISTODAX (romidepsin) is an intravenous histone deacetylase (HDAC) inhibitor approved in 2009 for peripheral and cutaneous T-cell lymphomas and multiple other hematologic and solid tumor indications. It works by inhibiting HDACs, leading to accumulation of acetylated histones, cell cycle arrest, and apoptosis in cancer cells. The drug is administered as an IV powder formulation.
$0.489MPart D
LOE ApproachingWith LOE approaching and limited Part D spending ($489K in 2023), the ISTODAX franchise is in a consolidation phase with smaller team requirements focused on managing competitive transition.
Mechanism of Action
(HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression. HDACs also deacetylate non-histone proteins, such as transcription factors. In vitro, romidepsin causes the accumulation of acetylated histones,…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
Started Feb 2021
50 enrolled
PTCL
Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma
Started Feb 2020
0Lymphoma, T-Cell
Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma
Started Mar 2019
33 enrolled
T Cell Lymphoma
ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma
Started Feb 2019
150 enrolled
Lymphoma, T-Cell, Peripheral
Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)
Started Sep 2018
11 enrolled
Lymphoma, T-Cell, Peripheral
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.