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Drug information

Drug's link(s)

Not provided

Generic name

Not provided

Brand names

Not provided

Compound type

Small molecule

Drug class/category

Capsid inhibitor

Summary

GS-3107 is an investigational long-acting capsid inhibitor. It is an oral prodrug of lenacapavir. This capsid inhibitor is designed to convert to lenacapavir after oral administration, but with a pharmacokinetic profile engineered to increase oral bioavailability and support once-monthly oral dosing. The approach of using prodrug to optimise bioavailability is being used when parent molecules have limited oral absorption. By increasing oral bioavailability, lower doses are needed, which means smaller pills (including in fixed-dose combinations). Phase 1 data (expected in 2026) will indicate safety and whether monthly oral dosing achieves and sustains protective concentrations.

Approval status

Investigational

Regulatory authorities

The product is still in development.

Therapeutic area(s)

  • HIV
Use case(s)
  • Treatment

Administration route

Oral

Associated long-acting platforms

Oral solid form

Use of drug

Ease of administration
  • Self-administered
Frequency of administration
  • Monthly
User acceptance
to be determined

Dosage

Available dose and strength

Not provided

Maximum dose

Not provided

Recommended dosing regimen

Not provided

Additional comments

Not provided

Dosage link(s)

Not provided

Associated compounds, formulations and regimens

Not provided

Associated technologies

Not provided

Additional information

Not provided

Developer(s)

Gilead
Originator

Gilead

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