Drugs / Bulevirtide
Bulevirtide
also known as
BLV · 915207G · Bulevirtida · BULEVIRTIDE ACETATE · Hepcludex · Hepcludextm · Myrcludex
Protein / enzyme biologic targets SLC10A1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | hepatitis D virus infection | 2025-09-22 | “A Biologics License Application (BLA) for bulevirtide 10 mg was submitted to the U.S. Food and Drug Administration (FDA) on September 22, 2025” gilead.com ↗ |
| Filed | US (FDA) | — | hepatitis D virus infection | 2021-11-19 | “announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for bulevirtide” gilead.com ↗ |
| Approved | EU (EMA) | Hepcludex | — | 2020-07-31 | europa.eu ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05765344 | Mar 2023 → Jan 2025 | — | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT05760300 | Mar 2023 → Jul 2024 | hepatitis D virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT07142811 | Aug 2025 → Nov 2026 expected | viral hepatitis | Vir Biotechnology, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03852433 | May 2019 → Apr 2022 | hepatitis D virus infection | Gilead Sciences | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT07128550 | Jul 2025 → Dec 2026 expected | viral hepatitis | Vir Biotechnology, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03852719 | Apr 2019 → Nov 2020 | hepatitis D virus infection | Gilead Sciences | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT06780579 | — | hepatitis D virus infection | Gilead Sciences | Approved for marketing | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2/3 | NCT07454837 Background | Feb 2026 → Aug 2027 expected | hepatitis D virus infection | Mirum Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07200908 Comparator | Aug 2025 → Jun 2027 expected | hepatitis D virus infection | Mirum Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-05-22 | Gilead Sciences | Regulatory FDA Grants Accelerated Approval to Gilead’s Hepcludex® (bulevirtide-gmod), the First and Only Approved Treatment for Chronic Hepatitis Delta Virus (HDV) gilead.com ↗
The FDA granted accelerated approval to Hepcludex based on reductions in HDV RNA and normalization of alanine aminotransferase (ALT), supported primarily by data from the pivotal, controlled Phase 3 MYR301 study. |
| 2025-10-23 | Gilead Sciences | Results Gilead to Showcase Interim Long-Term Efficacy Data for Livdelzi® (Seladelpar) in Primary Biliary Cholangitis (PBC) and Investigational Bulevirtide in Chronic Hepatitis Delta gilead.com ↗
Elevations in Total Serum Bile Acids During Bulevirtide Treatment are Asymptomatic and Not Associated with Adverse Events of Interest in Patients with Chronic Hepatitis Delta |
| 2025-05-07 | Gilead Sciences | Results Final Data From the Phase 3 MYR301 Study Demonstrated Longer Treatment With Bulevirtide Was Associated With Sustaining Undetectability After Stopping Treatment gilead.com ↗
In participants who sustained undetectability for one year after end of therapy, no relapses occurred in the second year of follow-up. |
| 2025-04-29 | Gilead Sciences | Results Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis gilead.com ↗
Additional presentations will showcase the potential for maintained virologic response following treatment with investigational bulevirtide in people with hepatitis delta virus (HDV) |
| 2024-06-06 | Gilead Sciences | Results Gilead Announces New England Journal of Medicine Publication of Data that Demonstrate Bulevirtide with PegIFN Achieved Post-Treatment Undetectable HDV RNA gilead.com ↗
Data Published in NEJM Demonstrate 46% of Patients Taking Bulevirtide 10 mg with PegIFN Achieved Post-Treatment Undetectable HDV RNA at Week 24 |
| 2024-05-22 | Gilead Sciences | Results Gilead to Present Latest Research Across Key Liver Disease Indications at the European Association for the Study of the Liver Congress 2024 gilead.com ↗
Bulevirtide in combination with pegylated interferon alfa-2a shows a sustained off-treatment response in the liver |
| 2023-11-03 | Gilead Sciences | Results Gilead to Present Late Breaking Data and Real World Evidence Highlighting Key Hepatitis Indications at The Liver Meeting® 2023 gilead.com ↗
No detectable resistance to bulevirtide monotherapy through 96 weeks treatment in patients with chronic hepatitis D |
| 2023-06-23 | Gilead Sciences | Results Hepcludex® (Bulevirtide) Demonstrates Sustained Efficacy and Safety Profile in People With Chronic Hepatitis Delta Virus at 96 Weeks gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced Week 96 results from the pivotal MYR301 Phase 3 clinical trial evaluating the first-in-class entry inhibitor Hepcludex ® (bulevirtide) for the treatment of adults with chronic hepatitis delta (HDV) infection. |
| 2023-05-04 | Gilead Sciences | Regulatory CHMP Adopts Positive Opinion Recommending Hepcludex® (Bulevirtide) for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus (HDV) gilead.com ↗
The CHMP recommendation for full Marketing Authorisation of bulevirtide follows the submission of the Phase 3 MYR301 Week 48 study data, which reinforces the efficacy and safety profile of bulevirtide for the treatment of HDV. |
| 2022-06-23 | Gilead Sciences | Results Treatment With Hepcludex® (Bulevirtide) Meets Primary Endpoint and Achieves Significant Response in Chronic Hepatitis Delta Virus at 48 Weeks gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced Week 48 results from the Pivotal Phase 3 clinical trial evaluating the first-in-class entry inhibitor Hepcludex ® (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection. |
| 2022-06-21 | Gilead Sciences | Results Gilead to Present Latest Data From Across Liver Disease Development Programs at the International Liver Congress™ 2022 gilead.com ↗
over five years, treatment with Epclusa ® (sofosbuvir/velpatasvir) significantly reduced morbidity and mortality (Poster 3201). |
| 2021-11-19 | Gilead Sciences | Regulatory Gilead Submits Biologics License Application to U.S. Food and Drug Administration for Bulevirtide, an Investigational Treatment for People Living With Chronic Hepatitis Delta gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for bulevirtide for injection (2 mg) |
| 2021-11-09 | Gilead Sciences | Results Gilead to Present Data From Liver Disease Development Programs at The Liver Meeting® gilead.com ↗
We’re excited to share data from our robust clinical development programs at AASLD’s The Liver Meeting ® ,including the latest data demonstrating the positive impacts of bulevirtide for people living with HDV. |
| 2021-06-24 | Gilead Sciences | Results Treatment With Hepcludex® (Bulevirtide) Was Shown to Achieve Significant Response in Chronic Hepatitis Delta Virus After 24 Weeks gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced interim results from the Phase 2b and Phase 3 clinical trials evaluating the first-in-class entry inhibitor Hepcludex ® (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV). |
All press releases naming this drug 14 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bulevirtide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07128550 ↗ |
| Known as | 915207G | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297711 ↗ |
| Known as | BLV | “The safety and tolerability of bulevirtide (BLV), a novel entry inhibitor of hepatitis delta virus, were evaluated” PMID 39648559 ↗ Dec 20242“Bulevirtide (BLV) is a HDV/HBV entry inhibitor” PMID 37120031 ↗ Apr 2023 “Bulevirtide (BLV)” NCT05760300 ↗ |
| Known as | Bulevirtida | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297711 ↗ |
| Known as | BULEVIRTIDE ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297711 ↗ |
| Known as | Hepcludex | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297711 ↗ |
| Known as | Hepcludextm | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297711 ↗ |
| Known as | Myrcludex | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297711 ↗ |
| Action | Inhibit | “a novel entry inhibitor of hepatitis delta virus” PMID 39648559 ↗ Dec 20241“Bile acid transporter inhibitor” CHEMBL4297711 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL4297711 ↗ |
| Route | Subcutaneous | “Administered via subcutaneous injections” NCT03852433 ↗ |
| Target | SLC10A1 | “Bile acid transporter inhibitor” CHEMBL4297711 ↗ |