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

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)
  • Pre-Exposure Prophylaxis (PrEP)
  • Treatment

Administration route

Oral, To be determined

Associated long-acting platforms

Oral solid form

Use of drug

Ease of administration
  • Self-administered
Frequency of administration
  • Monthly
User acceptance

Not provided

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 technologies

Not provided

Comment & Information

Not provided

Developer(s)

Gilead Sciences, Inc.
Originator

Gilead Sciences, Inc.

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

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

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

Publications

There are no publication

Additional documents

No documents were uploaded

Useful links

There are no additional links

Collaborate for development

Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology

Share technical information for match-making assessment

Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit

Work with MPP to expand access in LMICs

In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing