Lonafarnib
As of the edition of 20 October 2026, Lonafarnib is a small molecule: marketed, first approved in 2020 (US); acts on FNTA and FNTB; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Zokinvy
- First approved
- 20 November 2020 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- AnGes; 3 holders in all
- Registered trials
- 34, 7 stopped early
- Disease areas
- Cancer; Digestive system; Infections; Inherited and neonatal; Nutrition and metabolism; Nervous system
US protection
US protection ends in 2027.
The last listed US exclusivity ends in 2027. The application that gives this date is held by Sentynl Therapeutics.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
3 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product3 company-target rows are on route B because of Lonafarnib.
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Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 10 | 6 | 1 | 2 |
| Phase 2 | 19 | 13 | 2 | 3 |
| Phase 3 | 4 | 2 | 0 | 2 |
| All trials | 34 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eiger BioPharmaceuticals | Originator and Lead sponsor of trials | 2020 to now |
| TMC Pharma | Applicant | 2022 to now |
| AnGes | Applicant | 2024 to now |
| Sentynl Therapeutics | Acquired holder | 2024 to now |