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 Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOLINZA (vorinostat) is an oral histone deacetylase (HDAC) inhibitor approved by the FDA in October 2006 for cutaneous T-cell lymphoma and studied across 25+ oncology indications including multiple myeloma, lung cancer, glioblastoma, and mesothelioma. The drug works by inhibiting HDAC enzymes, leading to increased histone acetylation, altered gene expression, and induction of apoptosis in cancer cells. It represents a foundational precision oncology mechanism with broad clinical potential across hematologic and solid tumors.
$3MPart D
LOE ApproachingDeclining
1.8 years to LOEWith loss of exclusivity approaching in 2028, the brand team is likely contracting and transitioning from growth to managed decline and generic transition strategies.
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 Jul 2026
118 enrolled
Neuroblastoma
An Exploratory Evaluation of the Safety and Efficacy of Vorinostat in Pitt Hopkins Syndrome
Started Mar 2026
5 enrolled
Pitt Hopkins Syndrome
Rett REVOLUTION Trial: An Exploratory Evaluation of the Safety and Efficacy of Vorinostat in Rett Syndrome
Started Mar 2026
15 enrolled
Rett 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.