lonafarnib
Trade name: Zokinvy
Approved
Nov 20, 2020
Lonafarnib, sold under the brand name Zokinvy, is a medication used to reduce the risk of death due to Hutchinson-Gilford progeria syndrome and for the treatment of certain processing-deficient progeroid laminopathies in people one year of age and older. It is under trial for its use as combination treatment for Hepatitis D Virus. — Wikipedia
Clinical trial activity
5 trials · 3 clinical orgs · 2 marketing orgs
Earliest trial started Aug 1, 2018 (NCT03600714)
Timeline
2010s
- Apr 18, 2011
Orphan Drug Designation
- Jan 1, 2018
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2018
Eiger BioPharmaceuticals — Earliest Phase 3 Sponsor(trial)
2020s
- Nov 20, 2020
Eiger BioPharmaceuticals — Earliest FDA Approval
- Nov 20, 2020
Sentynl Theraps Inc — Marketing Organization
- Nov 20, 2020
Eiger BioPharmaceuticals — Marketing Organization
- Nov 20, 2020
Eiger BioPharmaceuticals — NDA Secondary Org
- Nov 20, 2020
Eiger BioPharmaceuticals — NDA Organization
Indications
Approved for
Mechanism of action
- Protein farnesyltransferaseANTAGONIST
Protein farnesyltransferase antagonist
Approval history
- approvedPriority reviewBreakthroughNov 20, 2020
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaLonafarnib ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06775041 | Phase 2 | Jan 31, 2025 | — |
| NCT05229991 | Phase 3 | May 15, 2021 | Ben Gurion University, Eiger BioPharmaceuticals |
| NCT03719313 | Phase 3 | Dec 1, 2018 | Eiger BioPharmaceuticals |
| NCT03600714 | Phase 2 | Aug 1, 2018 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| NCT03895528 | N/A | — | Eiger BioPharmaceuticals |
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Eiger BioPharmaceuticals | For profit | 3 | 2 | 2 | 2018 |
| Ben Gurion University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 1 | 1 | 1 | 2018 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Eiger BioPharmaceuticals | For profit | MKTG | Nov 20, 2020 |
| Eiger BioPharmaceuticals | For profit | NDA2 | Nov 20, 2020 |
| Eiger BioPharmaceuticals | For profit | NDA | Nov 20, 2020 |
| Sentynl Theraps Inc | For profit | MKTG | Nov 20, 2020 |