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Hepcludex

Bulevirtide-Gmod
Antiviral
Powder,for Solution Injection

Hepcludex (bulevirtide) is the first approved therapy with an indication specifically for chronic hepatitis D virus (HDV) infection, a severe form of viral hepatitis seen in patients co-infected with hepatitis B virus (HBV). The drug prevents the virus from entering liver cells, which helps prevent further infection and damage to the liver.

Hepcludex is a new treatment for the treatment of hepatitis D and an important unmet medical need for patients at risk of cirrhosis, liver failure and liver cancer. Its selective antiviral activity provides a promising option for slowing disease progression and improving long-term liver health outcomes.

Approval Date
22-May-26
Data Exclusivity Expiry
22-May-30
Market Exclusivity Expiry
22-May-38
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
239
2027
442
2028
514
2029
583
2030
620
2031
636
2032
651
Molecule profile

Details & specifications

Molecule
Bulevirtide-Gmod
Innovator
GILEAD SCIENCES, INC.
Dosage Form
Powder,for Solution Injection
Strength
8.5 mg
Therapeutic Category
Antiviral
Usage
To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis
Good to know

Frequently asked questions

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Intelligence you can file on

Verified regulatory data
Milestones tracked against primary FDA sources and refreshed continuously.
Analyst-built projections
Seven-year sales outlooks modeled by our pharma intelligence team.
First-to-file focus
Exclusivity windows framed around the decisions generics teams actually make.
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