NDAORALCAPSULEPriority Review
Approved
Feb 2015
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
4/8 — Partial
Priority Review
FARYDAK (panobinostat lactate) by Secura Bio is (hdac) inhibitor that inhibits the enzymatic activity of hdacs at nanomolar concentrations. Approved for including bortezomib, an immunomodulatory agent, myeloma. First approved in 2015.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FARYDAK (panobinostat lactate) is an oral histone deacetylase (HDAC) inhibitor approved in 2015 for multiple myeloma in combination with bortezomib and an immunomodulatory agent. It works by inhibiting HDAC enzymatic activity, leading to increased histone acetylation, chromatin relaxation, and transcriptional activation that triggers cell cycle arrest and apoptosis in transformed cells.
LOE Approaching2.1 years to LOE
Product is approaching loss of exclusivity with only 2.2 years of patent protection remaining; team likely focused on lifecycle extension and managed decline strategies.
Mechanism of Action
(HDAC) inhibitor that inhibits the enzymatic activity of HDACs at nanomolar concentrations. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. Inhibition of HDAC activity results in increased acetylation of histone proteins, an epigenetic…
Indications (3)
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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.