NDAINTRAVENOUSPOWDERPriority Review
Approved
Jul 2014
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
17
Data completeness
6/8 — Strong
Priority Review
BELEODAQ (belinostat) by Acrotech Biopharma is histone deacetylase inhibitors [moa]. Approved for histone deacetylase inhibitor [epc]. First approved in 2014.
Drug data last refreshed 18h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BELEODAQ (belinostat) is a histone deacetylase (HDAC) inhibitor administered intravenously as a powder for reconstitution. It works by inhibiting HDAC enzymes, leading to accumulation of acetylated histones and altered gene expression in cancer cells. The drug is indicated for peripheral T-cell lymphoma (PTCL), a rare hematologic malignancy.
LOE Approaching1.1 years to LOE
Declining commercial opportunity with loss of exclusivity approaching October 2027; small orphan indication limits team expansion.
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 (17)
To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
Started Oct 2023
504 enrolled
Peripheral T Cell Lymphoma
Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma
Started Dec 2021
7 enrolled
Metastatic Uveal Melanoma
Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics
Started May 2021
12 enrolled
Metastatic Breast CancerRecurrent Ovarian Carcinoma
Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer
Started Mar 2021
26 enrolled
Metastatic Breast CancerMetastatic Castration-resistant Prostate CancerMetastatic Ovarian Carcinoma+1 more
Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation
Started Oct 2020
0Metastatic Adenocarcinoma
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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.