Clinical Trials

Numerous clinical trials evaluate bulevirtide across Phase 1 through Phase 3 studies, observational registries, and expanded access protocols for conditions including chronic hepatitis D, hepatitis B co-infection, hepatic impairment, portal hypertension, and liver cirrhosis. Ranging from pharmacokinetic assessments to long-term outcome evaluations, these trials are sponsored by pharmaceutical entities—such as Gilead Sciences, Mirum Pharmaceuticals, and Vir Biotechnology—alongside academic medical centers like Hannover Medical School. Recruitment statuses across the portfolio vary, encompassing completed, actively recruiting, and active not recruiting studies, as well as protocols approved for marketing.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07454837 RECRUITING
Chronic Hepatitis D
Mirum Pharmaceuticals, Inc.
 2026-02-26 PHASE2; PHASE3
NCT07200908 RECRUITING
Chronic Hepatitis D Infection
Mirum Pharmaceuticals, Inc.
 2025-08-27 PHASE3
NCT07128550 ACTIVE_NOT_RECRUITING
Viral Hepatitis
Vir Biotechnology, Inc.
 2025-07-30 PHASE3
NCT07142811 ACTIVE_NOT_RECRUITING
Viral Hepatitis
Vir Biotechnology, Inc.
 2025-08-05 PHASE2
NCT06603311 ACTIVE_NOT_RECRUITING
Compensated Liver Disease (Disorder); Hepatitis D, Chronic
Hannover Medical School
 2024-09-30
NCT05765344 COMPLETED
Hepatic Impairment; Healthy
Gilead Sciences
 2023-03-15 PHASE1
NCT05760300 COMPLETED
Chronic Hepatitis D Infection
Gilead Sciences
 2023-03-15 PHASE1
NCT03852433 COMPLETED
Chronic Hepatitis Delta
Gilead Sciences
 2019-05-31 PHASE2
NCT03852719 COMPLETED
Chronic Hepatitis Delta
Gilead Sciences
 2019-04-17 PHASE3
NCT02888106 COMPLETED
Chronic Viral Hepatitis B With Delta-agent
Hepatera Ltd.
 2016-04 PHASE2
NCT03546621 COMPLETED
Chronic Hepatitis D Infection With Hepatitis B
Hepatera Ltd.
 2016-02-16 PHASE2
NCT02637999 COMPLETED
Chronic Hepatitis D Infection
Hepatera Ltd.
 2014-02-13 PHASE1; PHASE2
NCT02881008 COMPLETED
Chronic Hepatitis B
Hepatera Ltd.
 2012-11-14 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-25)

Check the Bulevirtide (Myrcludex B) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bulevirtide selectively binds to the sodium-taurocholate co-transporting polypeptide (NTCP) receptor with high affinity, effectively blocking viral interaction with hepatocytes and inhibiting host cell entry. By halting viral entry and cell-to-cell spread across liver tissue, this targeted inhibition disrupts the viral infection cycle, providing clinical efficacy in patients with chronic hepatitis D and hepatitis B infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.