NDAORALCAPSULEPriority Review
Approved
Nov 2020
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
7
Data completeness
4/8 — Partial
Priority Review
ZOKINVY (lonafarnib) by Sentynl Therapeutics is farnesyltransferase inhibitors [moa]. First approved in 2020.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOKINVY (lonafarnib) is an oral farnesyltransferase inhibitor approved in November 2020 for a rare genetic disorder affecting protein prenylation. It works by blocking farnesyl transferase, preventing abnormal protein modifications at the cellular level. The drug targets a narrow patient population with a specific genetic condition.
LOE Approaching2.8 years to LOE
Product is transitioning toward loss of exclusivity in 2029 with limited market size typical of rare disease franchises, suggesting smaller dedicated teams focused on patient retention and value defense.
Mechanism of Action
Farnesyltransferase Inhibitors
Pharmacologic Class:
Farnesyltransferase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria
Started Aug 2009
85 enrolled
Progeria
Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer
Started Aug 2009
27 enrolled
Breast Cancer
A Study to Evaluate the Safety, Tolerability, and Activity of Lonafarnib and Docetaxel (Study P04467AM1)(TERMINATED)
Started Jun 2007
5 enrolled
Prostate CancerBreast CancerOvarian Cancer+2 more
Study of Lonafarnib Versus Placebo in Subjects With Either Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) (Study P02978AM3)(TERMINATED)
Started May 2005
47 enrolled
Myelodysplastic SyndromesLeukemia, Myelomonocytic, ChronicMyelodysplasia+1 more
Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (P03480)
Started Dec 2003
110 enrolled
Breast Cancer
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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.