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Drug information

Drug's link(s)

Not provided

Generic name

Teropavimab; TAB; GS-5423; 3BNC117-LS; 3BNC117-LS-J (variant produced for IAVI/ACTG studies); CAS No.: 2417213-72-8

Brand names

Not applicable (investigational; no brand name assigned)

Compound type

Biotherapeutic

Drug class/category

bNAb targeting the CD4 binding site of gp120 on HIV-1 envelope

Summary

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.

Approval status

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;

Regulatory authorities

Unknown

Therapeutic area(s)

  • HIV
Use case(s)
  • Treatment

Administration route

Intravenous

Associated long-acting platforms

Monoclonal antibodies and antibody drug conjugates

Use of drug

Ease of administration
  • Administered by a nurse
  • Administered by a specialty health worker
Frequency of administration
  • Every 6 weeks
User acceptance

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.

Dosage

Available dose and strength

Investigational: 2,550 mg IV infusion (phase 2 and phase 3 regimen).

Maximum dose

2,550 mg IV (regimen dose)

Recommended dosing regimen

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.

Additional comments

Viral susceptibility to both bNAbs is a protocol eligibility requirement.

Dosage link(s)

Not provided

Associated compounds, formulations and regimens

Main compound
Compare
Zinlirvimab (ZAB)
Related compounds

Teropavimab (TAB)

Associated formulations and regimens
Compare

Teropavimab + Zinlirvimab

Associated technologies

Not provided

Additional information

Not provided

Developer(s)

Gilead
Originator

Gilead

Drug structure

Scale-up and manufacturing prospects

Scale-up prospects

Not reported for this product. Generic mAb scale-up considerations apply: formulation stability at high concentration, pharmacokinetic suitability, and maintenance of critical quality attributes.

Tentative equipment list for manufacturing

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.

Manufacturing

Recombinant human IgG1 produced in mammalian cell culture by Gilead. Process details not published.

Specific analytical instrument required for characterization of formulation

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.

Excipients & delivery device(s)

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredient Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

Delivery device(s)

No delivery device

Safety, Efficacy and Evidence Summary

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

References and relevant studies

Not provided

There are either no relevant patents or these were not yet submitted to LAPaL