NDAINTRAVENOUSSOLUTION
Approved
Mar 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
ROMIDEPSIN (romidepsin) by Teva is (hdac) inhibitor. First approved in 2020.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Romidepsin is an intravenous histone deacetylase (HDAC) inhibitor approved by the FDA on March 13, 2020. It works by inhibiting HDACs, enzymes that remove acetyl groups from histones, leading to accumulation of acetylated histones and triggering cell cycle arrest and apoptosis in cancer cells. The exact mechanism of its antineoplastic effect in clinical settings remains incompletely characterized.
Peak
Product is at peak lifecycle stage with moderate competitive pressure (30%), indicating stable commercial operations and established market presence.
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
Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)
Started Sep 2018
11 enrolled
Lymphoma, T-Cell, Peripheral
Romidepsin Maintenance After Allogeneic Stem Cell Transplantation
Started Dec 2017
23 enrolled
Cutaneous T-cell LymphomaT-Prolymphocytic LeukemiaT-Large Granulocytic Leukemia+2 more
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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.