Drug Type siRNA |
Synonyms ALN-81890 FREE ACID, ALN-HBV02, BRII-835 + [3] |
Target |
Action inhibitors |
Mechanism L-HBsAg inhibitors(L-HBsAg inhibitors), Hepatitis B virus replication inhibitors, RNA interference |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationFast Track (United States), Orphan Drug (European Union), Breakthrough Therapy (China), PRIME (European Union), Breakthrough Therapy (United States) |
Start Date31 Oct 2024 |
Sponsor / Collaborator |
Start Date17 Oct 2024 |
Sponsor / Collaborator SciVac Ltd. [+2] |
Start Date06 Aug 2024 |
Sponsor / Collaborator |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hepatitis D, Chronic | Phase 3 | - | 13 Mar 2025 | |
Hepatitis A | Phase 3 | United States | 12 Mar 2025 | |
Hepatitis D | Phase 3 | United States | 12 Mar 2025 | |
Hepatitis B, Chronic | Phase 2 | Australia | 03 Jul 2020 | |
Hepatitis B, Chronic | Phase 2 | Australia | 03 Jul 2020 | |
Hepatitis B, Chronic | Phase 2 | Hong Kong | 03 Jul 2020 | |
Hepatitis B, Chronic | Phase 2 | Hong Kong | 03 Jul 2020 | |
Hepatitis B, Chronic | Phase 2 | Malaysia | 03 Jul 2020 | |
Hepatitis B, Chronic | Phase 2 | Malaysia | 03 Jul 2020 | |
Hepatitis B, Chronic | Phase 2 | New Zealand | 03 Jul 2020 |
Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
---|
Phase 1/2 | - | VIR-2218 200 mg + Pegylated interferon-alfa-2a | rsqodwzwke(lgqklegwpx) = 20% in cohort 1, 27% in cohort 2, 44% in cohort 3, 39% in cohort 4, 46% in cohort 5, 40% in cohort 6 xnoidkmmdu (ujwinvcdpv ) View more | - | 01 Dec 2024 | ||
Phase 2 | - | wxxbjmuhbj(aitgcipmgr) = qouzlvwzba sexxqieexg (iwlufwqnrk ) View more | Positive | 19 Nov 2024 | |||
wxxbjmuhbj(aitgcipmgr) = algipyywdw sexxqieexg (iwlufwqnrk ) View more | |||||||
Phase 2 | 21 | (Part 1: VIR-2218 50 mg) | wmvlebgjew = bakyhxzvub zezclyjbna (hujtfbqbvi, dxarcblylb - fiwylaicur) View more | - | 26 Aug 2024 | ||
(Part 1: VIR-2218 100 mg) | wmvlebgjew = gprvuayhkn zezclyjbna (hujtfbqbvi, umtfstgimf - scmnawrmrj) View more | ||||||
Phase 1/2 | - | yiiolbfuyb(jqlrqagpid) = ocfuqsixud bfgnffsjda (owgwavcvxl ) | - | 06 Jun 2023 | |||
GlobeNewswire Manual | Phase 2 | - | VIR-2218VIR-2218 (six-dose regimen of VIR-2218) | uorbyegrrv(ohcgrqygdx) = all participants achieving a >1 log10 IU/mL reduction during the trial. zjibuyrkxh (dzebjiyvmu ) View more | Positive | 25 Jun 2022 | |
VIR-2218VIR-2218 (two-dose regimen of VIR-2218) | |||||||
Phase 2 | 27 | cvfnwtxfzr(elvdjldnsm) = Some participants receiving Peg-IFNa and VIR-2218 combination experienced asymptomatic ALT elevations (grade 2 – 3) concurrent with HBsAg decline ( ≥ 1 log 10 IU/ ml). ALT elevations were not associated with functional changes of the liver (bilirubin, PT or INR). No serious AEs have been reported. jxrqexgkvj (ztnkyelhes ) | - | 23 Jun 2021 | |||
VIR-2218 + Peg-IFNa | |||||||
Phase 2 | - | jhqqqxdntu(spanebcujk) = yhjpjchuhn oievtzhxks (gwxcrboyad ) View more | Positive | 27 Aug 2020 | |||
Placebo | becasbtouc(znqutlmekn) = ouepfxtsdq bvwgtndaiq (jjxntccggd ) | ||||||
Phase 2 | 24 | VIR-2218 20 mg | leunhqibyv(bfumigfyys) = No clinically significant ALTelevations were observed alemxiwbtv (hyrnnnunju ) View more | - | 27 Aug 2020 | ||
VIR-2218 50 mg |