Recent Updates
Recently added Catalysts

ABI-6250

Phase 2

Chronic Hepatitis D Infection | Small molecule | Infectious Disease |Assembly Biosciences, Inc.|Last Updated: Aug 13, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

ABI-6250 · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT07762027A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus InfectionChronic Hepatitis D Infection
NOT YET_RECRUITING80 Analytics
PHASE2NOT YET_RECRUITING
A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection
Chronic Hepatitis D Infection
NCT0776202780
Unlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of subjects with adverse events (AEs), premature treatment discontinuation and abnormal laboratory results.
Through study completion, an average of 1.5 years.
Evaluating the change from baseline in HDV RNA & ALT levels
Through study completion, an average of 1.5 years.
Proportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results
From enrollment to 10 days after the last dose, at pre-specified timepoints
Area Under the Plasma Concentration Time Curve (AUC) of ABI-6250
From enrollment to 10 days after the last dose, at pre-specified timepoints
Maximum Observed Plasma Concentration (Cmax) of ABI-6250
From enrollment to 10 days after the last dose, at pre-specified timepoints
Time to Cmax (Tmax) of ABI-6250
From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250
From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Systemic Clearance (CL/F) of ABI-6250
From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Volume of Distribution (Vz/F) of ABI-6250
From enrollment to 10 days after the last dose, at pre-specified timepoints
Dose normalized AUCs and Cmax of ABI-6250
From enrollment to 10 days after the last dose, at pre-specified timepoints

Secondary Endpoints

Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs and abnormal laboratory results.
Through study completion, an average of 1.5 years.
Proportion of participants with undetectable HDV RNA or ≥2 log10 IU/mL reduction in HDV RNA
Through study completion, an average of 1.5 years.
In participants with abnormal baseline ALT, the proportion of participants with normal ALT
Through study completion, an average of 1.5 years.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Arm 1EXPERIMENTAL -
Treatment Arm 2EXPERIMENTAL -
Treatment Arm 3EXPERIMENTAL -
Treatment Arm 4EXPERIMENTAL -
Part A: SAD Cohorts 1-5, ABI-6250EXPERIMENTAL -
Part A: SAD Cohorts 1-5, PlaceboPLACEBO_COMPARATOR -
Part A: SAD Food Effect Cohort 6 or 7: ABI-6250EXPERIMENTAL -
Part A: SAD Food Effect Cohort 6 (if applicable): PlaceboPLACEBO_COMPARATOR -
Part B: MAD Cohorts 1-4, ABI-6250EXPERIMENTAL -
Part B: MAD Cohorts 1-4, PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ABI-6250DRUGOnce daily tablet dosing for 48 weeks starting at Day 1 visit
PlaceboDRUGSingle dose (SAD) or once or twice daily dosing over 10 days (MAD)
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Participant has a body mass index ≥18.0 and \<35.0 kg/m2 at Screening * Other than HBV and HDV infection, the participant is in good health (as determined by the Investigator) based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and cli...

Countries:FranceGeorgiaGermanyItalyMoldovaNew ZealandPakistanRomaniaSpainUkraineUnited Kingdom
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07762027NEW_TRIAL: changed
LOWAug 14, 2026NCT07762027NEW_TRIAL: changed
LOWAug 14, 2026NCT07762027NEW_TRIAL: changed

Frequently asked questions about ABI-6250

What is ABI-6250 used for?

ABI-6250 is an investigational small molecule being developed for chronic hepatitis D virus infection, including hepatitis delta virus and chronic hepatitis D infection. It is currently in Phase 2 clinical development and is not yet approved by the FDA.

Who makes ABI-6250?

ABI-6250 is being developed by Assembly Biosciences, Inc. (NASDAQ: ASMB). The company is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the drug in healthy participants and in patients with chronic hepatitis D virus infection.

What phase is ABI-6250 in?

ABI-6250 is in Phase 2 clinical development for chronic hepatitis D infection. A Phase 1 study in healthy participants has been completed, and a Phase 2 trial in patients with chronic hepatitis D virus infection is planned but has not yet started recruiting.

What clinical trials is ABI-6250 in?

ABI-6250 has two clinical trials. NCT06740474 is a completed Phase 1 study in healthy participants in New Zealand. NCT07762027 is a planned Phase 2 study in patients with chronic hepatitis D infection across multiple countries, including France, Germany, Italy, and the United Kingdom.

Is ABI-6250 the same as any other drug?

No alternative names for ABI-6250 have been disclosed. It is identified solely by its code name ABI-6250 in clinical trial registrations and by its developer, Assembly Biosciences.