Drug name
Last update: Sep 2026Developer(s)
Not provided
Teropavimab; TAB; GS-5423; 3BNC117-LS; 3BNC117-LS-J (variant produced for IAVI/ACTG studies); CAS No.: 2417213-72-8
Not applicable (investigational; no brand name assigned)
Biotherapeutic
bNAb targeting the CD4 binding site of gp120 on HIV-1 envelope
Teropavimab (GS-5423) is the long-acting LS variant of the broadly neutralising antibody 3BNC117, discovered at The Rockefeller University and licensed to Gilead Sciences in January 2020. It is a human IgG1 targeting the CD4 binding site of the HIV-1 envelope; the LS substitutions (M428L/N434S) in the Fc region increase FcRn binding and extend serum half-life without changing the antigen-binding region. In phase 2, a single 2,550 mg IV infusion gave a mean half-life of 63.5 days in people with HIV; in viraemic participants, the mean half-life was 41.6 days, consistent with antigen-mediated clearance. Teropavimab is developed exclusively as part of a twice-yearly regimen with zinlirvimab (10-1074-LS) and subcutaneous lenacapavir.
Not approved in any jurisdiction as of September 2026. Phase 3 (Daybreak 1 and 2) registered in 2026 as part of the lenacapavir + teropavimab + zinlirvimab regimen;
Unknown
Intravenous
Monoclonal antibodies and antibody drug conjugates
No formal acceptability data published. In the phase 2 study there were no infusion-related reactions to teropavimab; the most common adverse events in the regimen were injection site reactions to subcutaneous lenacapavir.
Investigational: 2,550 mg IV infusion (phase 2 and phase 3 regimen).
2,550 mg IV (regimen dose)
No approved regimen. Phase 2/3 regimen: teropavimab 2,550 mg IV + zinlirvimab 2,550 mg IV on day 1 with lenacapavir 927 mg SC (two 1.5 mL injections) plus oral lenacapavir loading (600 mg on days 1 and 2), repeated every 6 months.
Viral susceptibility to both bNAbs is a protocol eligibility requirement.
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Not reported for this product. Generic mAb scale-up considerations apply: formulation stability at high concentration, pharmacokinetic suitability, and maintenance of critical quality attributes.
Not reported for this product. Standard therapeutic mAb train may be assumed: production bioreactors, disc-stack centrifugation and depth/membrane filtration for harvest clarification, Protein A and polishing chromatography, viral inactivation and filtration, ultrafiltration/diafiltration, sterile fill-finish.
Recombinant human IgG1 produced in mammalian cell culture by Gilead. Process details not published.
Not reported for this product. Standard mAb characterisation applies: ion-exchange chromatography and capillary isoelectric focusing (charge variants), size-exclusion chromatography (aggregates), DSC (thermal stability), subvisible particle counting, ELISA for serum concentrations, TZM.bl neutralisation assays for susceptibility.
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No delivery device
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There are either no relevant patents or these were not yet submitted to LAPaL