Prescription medicine
Lonafarnib Brand names: Zokinvy
Lonafarnib (Zokinvy) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the lonafarnib FDA label on DailyMed (effective July 2, 2025, Sentynl Therapeutics, Inc.); the NDA 213969 record on Drugs@FDA; every lonafarnib label on DailyMed.
Highlights of the record
FDA label of July 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m 2 and above: To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS) For the treatment of processing-deficient Progeroid Laminopathies with either: Heterozygous LMNA mutation with progerin-like protein accumulation Homozygous or compound heterozygous ZMPSTE24 mutations ZOKINVY is a farnesyltrans
Forms and strengths
- 50 mg
- 75 mg
Capsule.
On the market
- Earliest approval on file
- November 20, 2020 Zokinvy, Sentynl Theraps Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 26, 2029 Zokinvy capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 77 through July 30, 2026
What is lonafarnib used for?
From the label: indications and usageZOKINVY is indicated in patients 12 months of age and older with a body surface area (BSA) of 0.39 m 2 and above: To reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS) For the treatment of processing-deficient Progeroid Laminopathies with either: Heterozygous LMNA mutation with progerin-like protein accumulation Homozygous or compound heterozygous ZMPSTE24 mutations ZOKINVY is a farnesyltransferase inhibitor indicated in patients 12 months of age and older with a body surface area of 0.39 m 2 and above: ( 1 ) To reduce risk of mortality in Hutchinson-Gilford Progeria Syndrome. […]
FDA pharmacologic class: Farnesyltransferase Inhibitor.
Source: FDA drug label (Zokinvy), Sentynl Therapeutics, Inc., effective July 2, 2025 (SPL set 97391d0c-943e-4c5a-8423-68e163aa7f50), via openFDA; the full label on DailyMed
Is there a generic for lonafarnib (Zokinvy)?
No generic lonafarnib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Zokinvy capsules, the last expiring on July 26, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the lonafarnib label say about other medicines?
The lonafarnib label names 7 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atorvastatin | contraindications | CONTRAINDICATIONS ZOKINVY is contraindicated in patients taking: Strong CYP3A inhibitors [see Drug Interactions ( 7.1 )] Strong or moderate CYP3A inducers [see Drug Interactions ( 7.1 )] Midazolam [see Drug Interactions ( 7.2 )] Lovastatin, simvastatin, or atorvastatin [see Drug Interactions ( 7.2 )] Strong CYP3A … |
| Dabigatran | drug interactions | … adverse reactions. Prevention or Management When ZOKINVY is coadministered with P-gp substrates (e.g., digoxin, dabigatran) where minimal concentration changes may lead to serious or life-threatening toxicities, monitor for adverse reactions and reduce the dosage of the P-gp substrate in accordance with its approved … |
| Digoxin | drug interactions | … substrate's adverse reactions. Prevention or Management When ZOKINVY is coadministered with P-gp substrates (e.g., digoxin, dabigatran) where minimal concentration changes may lead to serious or life-threatening toxicities, monitor for adverse reactions and reduce the dosage of the P-gp substrate in accordance with … |
| Loperamide | drug interactions | Clinical Impact; Lonafarnib is a weak inhibitor of P-gp and strong inhibitor of CYP3A. Coadministration of ZOKINVY with loperamide increases the AUC and C max of loperamide [see Clinical Pharmacology ()] which may increase the risk of loperamide's adverse reactions. |
| Lovastatin | contraindications | CONTRAINDICATIONS ZOKINVY is contraindicated in patients taking: Strong CYP3A inhibitors [see Drug Interactions ( 7.1 )] Strong or moderate CYP3A inducers [see Drug Interactions ( 7.1 )] Midazolam [see Drug Interactions ( 7.2 )] Lovastatin, simvastatin, or atorvastatin [see Drug Interactions ( 7.2 )] Strong CYP3A … |
| Midazolam | contraindications | CONTRAINDICATIONS ZOKINVY is contraindicated in patients taking: Strong CYP3A inhibitors [see Drug Interactions ( 7.1 )] Strong or moderate CYP3A inducers [see Drug Interactions ( 7.1 )] Midazolam [see Drug Interactions ( 7.2 )] Lovastatin, simvastatin, or atorvastatin [see Drug Interactions ( 7.2 )] Strong CYP3A … |
| Simvastatin | contraindications | CONTRAINDICATIONS ZOKINVY is contraindicated in patients taking: Strong CYP3A inhibitors [see Drug Interactions ( 7.1 )] Strong or moderate CYP3A inducers [see Drug Interactions ( 7.1 )] Midazolam [see Drug Interactions ( 7.2 )] Lovastatin, simvastatin, or atorvastatin [see Drug Interactions ( 7.2 )] Strong CYP3A … |
Source: FDA drug label (Zokinvy), Sentynl Therapeutics, Inc., effective July 2, 2025 (SPL set 97391d0c-943e-4c5a-8423-68e163aa7f50), via openFDA; the full label on DailyMed
What do FAERS reports show for lonafarnib?
The FDA Adverse Event Reporting System holds 77 reports that list lonafarnib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 24 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Lonafarnib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other