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Drug information

Drug's link(s)

Not provided

Generic name

GS-3107 (oral lenacapavir prodrug)

Brand names

Not applicable (investigational; no brand name assigned)

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). It is intended as the oral component of a once-monthly oral treatment regimen with an integrase inhibitor partner still to be defined; a paediatric HIV-1 treatment study is also planned according to the company pipeline.

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

Once-monthly oral dosing is the development target.

Maximum dose

Not provided

Recommended dosing regimen

Not provided

Additional comments

Not provided

Dosage link(s)

Not provided

Related entries

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