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Tobevibart · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Participants will receive treatment with tobevibart + elebsiran up to 240 weeks. |
| Arm 2 | EXPERIMENTAL | Participants will receive Bulevirtide for 24 weeks and switch to receive tobevibart + elebsiran for additional 216 weeks |
| Arm 1 (Tobevibart + Elebsiran) | EXPERIMENTAL | Participants will receive treatment with tobevibart + elebsiran for 240 weeks. |
| Arm 2 (Tobevibart + Elebsiran) | EXPERIMENTAL | Participants will receive tobevibart + elebsiran after an observational period for 240 weeks. |
| Name | Type | Description |
|---|---|---|
| Tobevibart | DRUG | Tobevibart administered by subcutaneous injection |
| Elebsiran | DRUG | Elebsiran administered by subcutaneous injection |
| Bulevirtide | DRUG | Bulevirtide administered by subcutaneous injection |
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...
Tobevibart is an investigational small molecule being developed for the treatment of viral hepatitis, specifically chronic hepatitis D virus (HDV) infection. It is currently in Phase 3 clinical development and has received Fast Track designation from the FDA. Tobevibart is being studied in combination with elebsiran in multiple clinical trials.
Tobevibart is being developed by Vir Biotechnology, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VIR. The company is conducting Phase 3 clinical trials to evaluate the drug in patients with chronic HDV infection, including those who have not achieved virologic suppression with existing therapies.
Tobevibart is in Phase 3 clinical development for chronic hepatitis D virus infection. It has received Fast Track designation from the FDA, which is intended to expedite the development and review of drugs that treat serious conditions and fill unmet medical needs. The drug remains investigational and has not been approved by regulatory authorities.
Tobevibart is being evaluated in three active clinical trials. NCT06903338 is a Phase 3 study in chronic HDV infection with 124 participants. NCT07128550 is a Phase 3 study in patients not virologically suppressed with bulevirtide, enrolling 150 participants. NCT07142811 is a Phase 2 study comparing Tobevibart plus elebsiran versus bulevirtide, with 100 participants.
No, Tobevibart is not FDA approved. It is an investigational drug currently in Phase 3 clinical trials for chronic hepatitis D virus infection. The FDA has granted it Fast Track designation, which facilitates development and review, but the drug has not yet received marketing approval. Its safety and efficacy are still being evaluated in clinical studies.