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Drug information

Drug's link(s)

Not provided

Generic name

3BNC117; CAS 1412902-17-0. Long-acting variants: 3BNC117-LS (teropavimab, GS-5423) and 3BNC117-LS-J

Brand names

investigational

Compound type

Biotherapeutic

Drug class/category

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

Summary

3BNC117 is a recombinant human IgG1 kappa bNAb cloned from an HIV-infected viraemic controller. It is a second-generation bNAb that binds the CD4 binding site on the HIV-1 envelope and, beyond neutralising virus, can engage Fc receptors to promote clearance of infected cells. It is the parent molecule of teropavimab (3BNC117-LS, GS-5423), the LS-modified long-acting variant that Gilead licensed from Rockefeller in January 2020 and is developing with zinlirvimab (10-1074-LS) and lenacapavir. The LS Fc modification roughly doubled half-life (median 2.8 versus 1.4 weeks in macaques), and teropavimab reached a mean half-life of 63.5 days after a 2,550 mg IV dose in people with HIV, which is what makes the six-monthly regimen feasible.

Approval status

Not approved in any jurisdiction as of September 2026. The parent antibody 3BNC117 has been studied up to phase 2 in treatment and cure research. Its long-acting variant teropavimab (3BNC117-LS) is in phase 3 with zinlirvimab and lenacapavir, and holds US FDA breakthrough therapy designation for that combination (January 2025).

Regulatory authorities

No marketing authorisation application identified for 3BNC117. Developed under US FDA IND 118225 (Rockefeller University); combination trials with albuvirtide conducted in China by Frontier Biotechnologies.

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
  • Other/Variable/Unknown : To be determined
User acceptance
Not provided

Dosage

Available dose and strength

Investigational. Doses studied: 1, 3, 10 and 30 mg/kg IV, single or repeated.

Maximum dose

30 mg/kg IV per infusion

Recommended dosing regimen

No approved or established regimen. Phase 2 treatment-interruption studies used repeated 30 mg/kg IV infusions of 3BNC117, alone or with 10-1074.

Additional comments

Pharmacokinetics are shortened in viraemic individuals (half-life 9.6 days versus 17.6 days without HIV), consistent with antigen-mediated clearance. Pre-screening of participant virus for 3BNC117 sensitivity was used in several trials.

Dosage link(s)

Not provided

Related entries

Not provided

Additional information

Not provided

Developer(s)

Gilead
Originator
United States

Gilead

Frontier Biotechnologies
Originator
China

Frontier Biotechnologies

Rockefeller University
Originator
United States

Rockefeller University

Drug structure

Scale-up and manufacturing prospects

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

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)

Not provided

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