The FDA accepted EIT Pharma’s lonafarnib NDA for chronic hepatitis D, supported primarily by the phase 3 D-LIVR trial.
EIT Pharma announced on August 11, 2026, that the
"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, in a statement.1
Drug: Lonafarnib, oral investigational therapy
Indication: Chronic hepatitis D
Status: NDA accepted by FDA
Evidence: Phase 3 D-LIVR; >400 patients
Primary end point: ≥2-log decline in HDV RNA plus ALT normalization at week 48 vs placebo — met with statistical significance in 2022 topline data2
Results: Updated efficacy and safety figures not released with NDA acceptance
CHD occurs in individuals with hepatitis B virus infection and can progress to cirrhosis, liver failure, hepatocellular carcinoma, and death. No oral therapy is currently FDA approved for CHD in the United States. Lonafarnib remains investigational and is not approved by the FDA or another regulatory authority for this indication.1
What the Phase 3 D-LIVR Trial Evaluated
The NDA is supported primarily by the global, randomized, placebo-controlled phase 3 D-LIVR study, described by EIT Pharma as the largest clinical trial conducted in CHD to date. The study enrolled >400 patients across 21 countries and evaluated lonafarnib-based regimens over 48 weeks.2 The submission also includes phase 1 and 2 clinical findings, nonclinical evidence, and manufacturing information.1
D-LIVR's composite primary end point was a ≥2-log decline in HDV RNA combined with normalization of alanine aminotransferase (ALT) at week 48 compared with placebo; topline data reported in 2022 by original trial sponsor Eiger BioPharmaceuticals indicated that both lonafarnib-based regimens met this end point with statistical significance versus placebo.2
The current NDA announcement did not provide participant characteristics, dosing group breakdowns, comparator details beyond placebo control, updated statistical analysis, or numerical efficacy results. It also did not report adverse event rates, treatment discontinuations, laboratory abnormalities, serious adverse events, or deaths.
Lonafarnib Mechanism and FDA Regulatory Status
Lonafarnib is an oral investigational agent designed to interfere with a key step in the HDV life cycle. EIT Pharma characterized it as a first-in-class candidate and the only oral therapeutic in late-stage clinical development for CHD.1
The program previously received FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations, according to the company. Such designations can support development and regulatory interactions but do not demonstrate efficacy or guarantee approval. EIT Pharma acquired the late-stage program in 2024 and reported plans to continue working with the FDA during review.
The principal next step is completion of FDA review. Outstanding questions include the benefit-risk profile, appropriate regimen and duration, long-term outcomes, and whether further analyses or postmarketing studies may be requested. Until a regulatory decision is issued, lonafarnib's safety and efficacy for CHD remain unestablished.
"Patients living with chronic hepatitis D urgently need novel therapies targeting distinct steps in the HDV lifecycle," said Jeffrey Glenn, MD, cofounder of EIT Pharma and professor of medicine and microbiology and immunology at Stanford University, noted in the release.
