Is Lonafarnib approved by the US FDA?

Drugs@FDA lists 1 application product line for Lonafarnib, including ZOKINVY (Prescription).

Is Lonafarnib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lonafarnib: Zokinvy.

Are there safety signals or safety updates for Lonafarnib?

US FDA: 1 entry (latest 2024-03-21).

Active substance

Lonafarnib

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZOKINVY	50MG; 75MG	capsule · oral	SENTYNL THERAPS INC	Prescription	20 Nov 2020

EMA European Union — centrally authorised medicines

Zokinvy Integral Pharma Solutions EU Limited · Authorised · authorised 18 Jul 2022

Therapeutic indication (EMA)

Zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of Hutchinson-Gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous LMNA mutation with progerin-like protein accumulation or a homozygous or compound heterozygous ZMPSTE24 mutation.

Safety signals and safety-related labeling changes

US FDA 21 Mar 2024 ZOKINVY — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for lonafarnib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.