Asset profile
bepirovirsen · Ionis (IONS)
- Indication
- chronic hepatitis B (CHB) in adults without cirrhosis on NrtI therapy ≥6 months with suppressed HBV DNA and HBsAg ≤3000 IU/ml
- Also known as
- Hibsago
Company
IONSIonis
IONSIonisIonis Pharmaceuticals is the leading developer of antisense technology to discover and develop novel drugs. Its broad clinical and preclinical pipeline targets a wide variety of diseases, with an emphasis on cardiovascular, metabolic, neurological, and rare di…
On the calendar
21
Oct 2026
Oct 21, 2026
10 days ago
IONSIonisIonis/GSK: bepirovirsen NDA accepted for Priority Review, PDUFA Oct 26 2026
Rescheduled — was Oct 26, 2026
Timeline
Newest first.
Apr 28, 2026
06:06 AM
IONSIonisRegistered trials
| Registry ID | Phase | Status | Primary completion | Enrollment | Sites |
|---|---|---|---|---|---|
| NCT06537414 | Phase 2 | Active, not recruiting | May 31, 2027 | 283 | 5 of 80 sites in the United States |
| NCT05630820 | Phase 3 | Completed | Nov 3, 2025 | 857 | 12 of 171 sites in the United States |
| NCT04954859 | Phase 2 | Active, not recruiting | Jan 24, 2029 | 360 | 5 of 163 sites in the United States |
| NCT07696520 | Phase 2 | Not yet recruiting | Dec 30, 2027 | 30 | 0 of 1 sites in the United States |
| NCT05330455 | Phase 1/2 | Terminated | May 19, 2025 | 74 | 0 of 14 sites in the United States |
| NCT06497504 | Phase 2 | Active, not recruiting | Apr 22, 2027 | 153 | 7 of 51 sites in the United States |
| NCT05630807 | Phase 3 | Completed | Nov 11, 2025 | 981 | 12 of 177 sites in the United States |
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