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Hepcludex (BULEVIRTIDE)
Hepcludex (Bulevirtide) is a small molecule developed by MYR GmbH, targeting the sodium/bile acid cotransporter. It is approved to treat chronic infections caused by the Hepatitis D virus and chronic viral hepatitis B with hepatitis D. The commercial status of Hepcludex is patented, with MYR GmbH being the current owner. Key safety considerations are not specified. Hepcludex works by inhibiting the sodium/bile acid cotransporter, which is involved in the replication of the Hepatitis D virus.
At a glance
| Generic name | BULEVIRTIDE |
|---|---|
| Sponsor | MYR GmbH |
| Target | Sodium/bile acid cotransporter |
| Modality | Recombinant protein |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Approved indications
- Chronic infection caused by Hepatitis D virus
- Chronic viral hepatitis B with hepatitis D
Common side effects
Key clinical trials
- A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) (PHASE3)
- Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D
- Expanded Access for Bulevirtide
- Phase 2b/3 Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide (PHASE2,PHASE3)
- A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (PHASE3)
- Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection (NA)
- Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide
- Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hepcludex CI brief — competitive landscape report
- Hepcludex updates RSS · CI watch RSS
- MYR GmbH portfolio CI