access-principles-1access-principles-2access-principles-3backcarrierdevelopmentease_of_administrationexportimplantableinjectablenon-implantablenon_carriernon_injectableother_featuresprintroute_of_administrationtherapeutic_areatype_of_tech

Drug information

Drug's link(s)

Not provided

Generic name

VH4527079; VH079

Brand names

Not applicable (investigational; no brand name assigned)

Compound type

Biotherapeutic

Drug class/category

mAb (Monoclonal antibody) — Human monoclonal antibody for HIV

Lifecycle status

Active / In Development (Phase 1/2/3)

Summary

VH4527079 (VH-079) is an investigational human bispecific broadly neutralizing antibody (bNAb) in development by ViiV Healthcare for the treatment and prevention of HIV-1. It is in first-in-human evaluation under NCT06652958, a phase 1 open-label study of single subcutaneous or intravenous dosing in healthy adults, and multiple intravenous dosing in healthy adults and in people with HIV. It might be a bispecific antibody with an anticipated target of every-6-month dosing interval by subcutaneous or intravenous administration. The targeted epitopes are not yet disclosed, nor the half-life extension strategy.

Approval status

Not approved in any jurisdiction as of September 2026. Investigational; phase 1 (first-in-human), active and not recruiting.

Regulatory authorities

No marketing authorisation application identified. Developed under a US FDA IND held by ViiV Healthcare.

Therapeutic area(s)

  • HIV
Use case(s)
  • Treatment

Administration route

Subcutaneous, Intravenous

Associated long-acting platforms

Monoclonal antibodies and antibody drug conjugates

Use of drug

Ease of administration
  • Administered by a nurse
  • To be determined
Frequency of administration
  • Every 6 months
User acceptance
Not provided

Dosage

Available dose and strength

to be determined

Maximum dose

to be determined

Recommended dosing regimen

to be determined

Additional comments

Not provided

Dosage link(s)

Not provided

Related entries

Not provided

Additional information

Not provided

Developer(s)

ViiV Healthcare
Originator
United Kingdom

ViiV Healthcare

ViiV Healthcare is a pharmaceutical company that specializes in the development of therapies for HIV infection. The company is headquartered in Brentford in the United Kingdom and was initially formed in November 2009 as a part of a joint venture between GlaxoSmithKline and Pfizer. Shionogi joined in October 2012

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