Recent Updates
Recently added Catalysts

Tobevibart

Phase 3

Viral Hepatitis | Small molecule | Infectious Disease |Vir Biotechnology, Inc.|Last Updated: May 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment374
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07128550A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With BulevirtidePHASE3 RECRUITING 150 — — Jul 30, 2025Jul 1, 2031May 6, 202638 Austria, France +5
NCT06903338A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV InfectionPHASE3 ACTIVE NOT_RECRUITING 124 — — Mar 12, 2025May 1, 2031Apr 8, 202639 United States, Canada +8
NCT07142811A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV InfectionPHASE2 ACTIVE NOT_RECRUITING 100 — — Aug 5, 2025Jul 1, 2030Jan 16, 202631 Belgium, Bulgaria +9
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24
Week 24
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment.
24 Weeks after End of Treatment
HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and alanine aminotransferase (ALT) normalization (ALT </= Upper Limit of Normal [ULN]) at Week 48 for Arm 1 vs at Week 12 for Arm 2
Up to 48 weeks
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12
Up to 12 weeks
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48
Week 48
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment
24 Weeks after End of Treatment
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 48
Week 48
Secondary Endpoints
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48, Week 96, Week 120, Week 144, Week 192 and Week 240
Week 48 , Week 96, Week 120, Week 144, Week 192 and Week 240
Change from baseline in ALT at Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALParticipants will receive treatment with tobevibart + elebsiran up to 240 weeks.
Arm 2EXPERIMENTALParticipants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks
Arm 1 (Tobevibart + Elebsiran)EXPERIMENTALParticipants will receive treatment with tobevibart + elebsiran for 240 weeks.
Arm 2 (Tobevibart + Elebsiran)EXPERIMENTALParticipants will receive tobevibart + elebsiran after an observational period for 240 weeks.
Interventions
NameTypeDescription
TobevibartDRUGTobevibart administered by subcutaneous injection
ElebsiranDRUGElebsiran administered by subcutaneous injection
BulevirtideDRUGBulevirtide administered by subcutaneous injection
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: 1. Male or female ages 18 to 70 years at screening 2. HDV RNA ≥ 500 IU/mL at screening 3. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1 4. Noncirrhotic or compensated cirrhotic liver disease at screening 5. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or h...

Countries:AustriaFranceGermanyItalyRomaniaSpainUnited KingdomUnited StatesCanadaGeorgiaMoldovaNew ZealandPakistanUkraineBelgiumBulgariaNetherlands
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07128550primaryCompletionDate: changed
LOWMay 26, 2026NCT06903338primaryCompletionDate: changed
LOWMay 26, 2026NCT07142811primaryCompletionDate: changed
LOWMay 24, 2026NCT07128550studyFirstPostDate: changed
LOWMay 24, 2026NCT06903338studyFirstPostDate: changed
LOWMay 24, 2026NCT07142811studyFirstPostDate: changed