NDAORALCAPSULEPriority Review
Approved
Oct 2006
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ZOLINZA (vorinostat) by Merck & Co. is histone deacetylase inhibitors [moa]. First approved in 2006.
Drug data last refreshed 35m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOLINZA (vorinostat) is an oral histone deacetylase (HDAC) inhibitor approved in 2006 for cutaneous T-cell lymphoma (CTCL). It works by inhibiting HDAC enzymes, leading to increased histone acetylation and altered gene expression in cancer cells. The mechanism has been explored across multiple hematologic and solid tumor indications.
$3MPart D
LOE Approaching1.5 years to LOEModest spending and claims indicate a niche product approaching LOE; brand team focus is likely on transition planning and key opinion leader retention rather than growth initiatives.
Mechanism of Action
Histone Deacetylase Inhibitors
Pharmacologic Class:
Histone Deacetylase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab
Started Dec 2026
118 enrolled
Neuroblastoma
Rett REVOLUTION Trial: An Exploratory Evaluation of the Safety and Efficacy of Vorinostat in Rett Syndrome
Started Mar 2026
15 enrolled
Rett Syndrome
An Exploratory Evaluation of the Safety and Efficacy of Vorinostat in Pitt Hopkins Syndrome
Started Mar 2026
5 enrolled
Pitt Hopkins Syndrome
Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
Started Sep 2024
15 enrolled
Castration-Resistant Prostate CarcinomaMetastatic Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
Pembrolizumab and Tamoxifen With or Without Vorinostat for the Treatment of Estrogen Receptor Positive Breast Cancer
Started Mar 2021
1 enrolled
Anatomic Stage IV Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8
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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.