Drugs / ABI-4334
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05569941 | Nov 2022 → Apr 2023 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT06384131 Comparator | Jun 2024 → Apr 2025 | chronic hepatitis B virus infection | Assembly Biosciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2025-11-07 | Assembly Biosciences | Results Assembly Biosciences Presents Positive Phase 1b Data for Next-Generation Capsid Assembly Modulator ABI-4334 at AASLD The Liver Meeting® assemblybio.com ↗ |
| 2025-06-25 | Assembly Biosciences | Results Assembly Biosciences Reports Positive Topline Results from Phase 1b Clinical Trial of Next-Generation Investigational Capsid Assembly Modulator ABI-4334 in Chronic Hepatitis B assemblybio.com ↗
today announced positive topline efficacy, safety and pharmacokinetic (PK) results from a Phase 1b study evaluating ABI-4334, an investigational next-generation capsid assembly modulator (CAM), in participants with chronic hepatitis B virus (HBV) infection. |
| 2025-05-07 | Assembly Biosciences | Results New Preclinical Data for Assembly Biosciences’ Oral Hepatitis D Virus Entry Inhibitor ABI-6250 and Next-Generation Hepatitis B Virus Capsid Assembly Modulator ABI-4334 Presented at the EASL Congress 2025 assemblybio.com ↗
Additionally, in vitro data presented for ABI-4334 provide further insights into the potential for next-generation capsid assembly modulators to impact markers of chronic HBV infection. |
| 2024-12-26 | Assembly Biosciences | Results Assembly Biosciences Reports Interim Phase 1b Results from Clinical Trial Evaluating Next-Generation Capsid Assembly Modulator Candidate ABI-4334 in Chronic Hepatitis B assemblybio.com ↗
A mean decline in HBV DNA of 2.9 log 10 IU/mL was observed in a population of predominately hepatitis B e antigen (HBeAg) negative participants. |
| 2023-09-19 | Assembly Biosciences | Results Assembly Biosciences to Highlight Pipeline Progress in HBV and HDV at the 2023 International HBV Meeting assemblybio.com ↗
A second oral presentation reports new data for ABI-4334 (4334), Assembly Bio’s most potent capsid assembly modulator (CAM) with a potential best-in-class profile, describing the prevention of HBV DNA integration in vitro . |
| 2023-06-21 | Assembly Biosciences | Results Assembly Biosciences Presents New Data Highlighting Entry Inhibitor and Core Inhibitor Programs at EASL’s International Liver Congress™ 2023 assemblybio.com ↗ |
| 2023-06-07 | Assembly Biosciences | Results Assembly Biosciences to Present Data at Upcoming International Herpesvirus Workshop and EASL International Liver Congress™ 2023 assemblybio.com ↗
Next generation core inhibitors ABI-H3733 and ABI-4334 have significantly improved potency and target coverage for both antiviral and cccDNA formation activities compared to first-generation core inhibitors |
| 2023-04-18 | Assembly Biosciences | Results Assembly Biosciences Announces Additional Promising Data from Phase 1a Clinical Trial Evaluating Highly Potent Next-Generation Core Inhibitor Candidate ABI-4334 and Provides Pipeline Update assemblybio.com ↗
Phase 1a clinical data for remaining 200 mg multiple dose cohort for ABI-4334 continue to demonstrate encouraging clinical profile with strong projected activity against both viral replication and cccDNA formation |
| 2023-03-22 | Assembly Biosciences | Results Assembly Biosciences Provides Update on its Core Inhibitor Pipeline, Reports Fourth Quarter and Year End 2022 Financial Results and Recent Highlights assemblybio.com ↗
Based on the data from our ongoing clinical and nonclinical studies, we are focusing on 4334 given its greater potency and encouraging clinical profile emerging from the initial cohorts in the Phase 1a study. |
| 2022-12-19 | Assembly Biosciences | Results Assembly Biosciences Announces Promising Interim Results from Two Clinical Trials Evaluating Highly Potent Next-Generation Core Inhibitor Candidates ABI-H3733 and ABI-4334 assemblybio.com ↗
Initial ABI-4334 Phase 1a single-dose 30 mg cohort demonstrated pharmacokinetic profile supportive of once-daily oral dosing and provides early indication that ABI-4334's very high potency seen preclinically can be accessed clinically |
| 2022-11-08 | Assembly Biosciences | Regulatory Assembly Biosciences Reports Third Quarter 2022 Financial Results and Recent Highlights and Announces Upcoming Conference Participation assemblybio.com ↗
Phase 1a Trial of Next-Generation Core Inhibitor, ABI-4334, Now Underway Following Clinical Trial Application (CTA) Clearance |
| 2022-11-04 | Assembly Biosciences | Results Assembly Biosciences Presents New Data at AASLD The Liver Meeting® Highlighting Breadth of Virology Portfolio and Potential of Next-Generation Core Inhibitors in HBV assemblybio.com ↗
Data demonstrating nanomolar potency of core inhibitor ABI-4334 to disrupt the hepatitis B virus (HBV) life cycle at multiple points supports advancement into clinical studies |
| 2022-10-24 | Assembly Biosciences | Results Assembly Biosciences to Present Data in Four Poster Presentations at Upcoming AASLD The Liver Meeting® assemblybio.com ↗
Data demonstrating preclinical activity of next-generation core inhibitor ABI-4334 against hepatitis B virus supports planned advancement into clinical studies before year end |
| 2022-06-22 | Assembly Biosciences | Results Assembly Biosciences Presents New Data Highlighting Clinical Progress of Core Inhibitor Programs at EASL’s International Liver Congress™ 2022 assemblybio.com ↗
Additionally, preclinical data presented for 4334, with its best-in-class potential, demonstrates the candidate's potent activity against both cccDNA formation and pre-genomic RNA (pgRNA) encapsidation, supporting our plans to initiate a Phase 1a trial later this year. |
| 2021-11-12 | Assembly Biosciences | Results Assembly Biosciences Presents New Data at AASLD The Liver Meeting™ Highlighting the Progress of its HBV Core Inhibitor Portfolio assemblybio.com ↗
Newly selected preclinical core inhibitor candidate, ABI-4334, demonstrates single-digit nanomolar potency against both pgRNA encapsidation and cccDNA formation |
All press releases naming this drug 17 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ABI-4334 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05569941 ↗ |
| Route | Oral | “10 mg or 50 mg tablets for oral administration” NCT06384131 ↗ |