The FDA accepts EIT Pharma’s NDA for oral lonafarnib for chronic hepatitis D, supported by the Phase 3 D-LIVR study in more than 400 patients.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
EIT Pharma has secured FDA acceptance for review of its New Drug Application for lonafarnib in chronic hepatitis D (CHD), moving the investigational oral therapy into a formal regulatory review. If approved, lonafarnib could become an oral treatment option for a disease with substantial risks of cirrhosis, liver failure, hepatocellular carcinoma, and death.
CHD develops when hepatitis D virus (HDV) infects people who already have hepatitis B virus (HBV). HDV accelerates liver disease progression, while treatment options in the United States remain limited and there are currently no FDA-approved oral therapies specifically for CHD.
The NDA includes data from the Phase 3 D-LIVR study, along with Phase 1/2 clinical data, non-clinical studies, and manufacturing information.
Lonafarnib Targets HDV Virion Assembly
Lonafarnib is an oral farnesyltransferase inhibitor that interferes with a critical step in the HDV lifecycle. The virus requires prenylation, specifically farnesylation, of its large delta antigen to interact with hepatitis B surface antigen and assemble and release new HDV particles. Blocking this process can inhibit production of infectious HDV particles.
This host-targeted antiviral approach distinguishes lonafarnib from therapies that directly target viral replication or viral entry.
Phase 3 D-LIVR Supports the NDA
The global, randomized, placebo-controlled Phase 3 D-LIVR study (NCT03719313) enrolled more than 400 patients across 21 countries and evaluated lonafarnib-based treatment regimens over 48 weeks. EIT Pharma described D-LIVR as the largest clinical trial conducted to date in chronic hepatitis D.
The company did not disclose detailed Phase 3 efficacy or safety results in the NDA acceptance announcement. The regulatory filing therefore represents a review milestone rather than evidence of FDA approval. Lonafarnib’s safety and efficacy for CHD remain unestablished pending regulatory review.
Earlier clinical studies established proof of concept for the drug’s antiviral activity. In a randomized Phase 2a study, lonafarnib produced dose-dependent reductions in HDV RNA, supporting prenylation inhibition as a therapeutic strategy for chronic HDV infection.
Regulatory Pathway
Lonafarnib previously received FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations for CHD. EIT Pharma acquired the late-stage program in 2024 and subsequently advanced the regulatory package toward submission.
“FDA acceptance of our NDA is an important milestone in our mission to bring a potential new oral treatment to people living with chronic hepatitis D,” said Leen Kawas, PhD, chief executive officer of EIT Pharma.
Jeffrey Glenn, MD, PhD, a co-founder of EIT Pharma and Stanford University professor, said the regulatory milestone represents an important step toward providing patients with a treatment that targets a distinct stage of the HDV lifecycle.
The company will now work with the FDA throughout the review while preparing for potential commercialization. If approved, the oral route, room-temperature storage, and potential suitability for longer-term treatment could offer practical advantages compared with therapies requiring more burdensome administration.
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About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.