LAPaL

Developer(s)

Gilead

Originator

https://www.gilead.com/

Drug structure

GS-3107 Structure Placeholder

Drug information

Associated long-acting platforms

Oral solid form

Administration route

Oral

Therapeutic area(s)

HIV

Use case(s)

Treatment

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

Drug information

Drug's link(s)

Not provided

Generic name

Not provided

Brand name

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.

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

Delivery device(s)

Not provided

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

Clinical trials

ACTRN12626000118303

Identifier

GS-US-756-7894

Link

https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12626000118303

Phase

Phase I

Status

Not yet recruiting

Sponsor

Gilead Sciences

More details

This Phase 1 study will evaluate the safety, tolerability, and PK of oral GS 3107 in combination with oral encequidar (ECD) in healthy participants. The results from this study will inform the feasibility of long interval dosing of GS 3107 with ECD for the prevention of HIV 1 infection, or to be used in combination with other antiretroviral agents for HIV 1 treatment. This study provides comparisons of PK and generates safety data for the expected therapeutic range of drug exposures planned for evaluation in subsequent studies. This is an open label study with adaptive dose selection in healthy adult participants to evaluate the effect of coadministration of GS 3107 and ECD on the PK of LEN (administered as LEN prodrug, GS-3107)

Purpose

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GS-3107 Coadministered with Encequidar in Healthy Participants

Interventions

Intervention 1

GS-3107 + encequidar methanesulfonate (ECD)

Dosage: up to 5600 mg GS-3107 oral tablets coadministered with up to 360 mg ECD oral tablets

Countries

New Zealand

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2026-02-10

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
2026-09-12

Estimated Completion Date
Not provided

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

Adults

Genders

All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

18 year(s) to 55 year(s) ; BMI between 19 and 32 kg/m 2; non-smokers

Health status

Considered at low risk of : HIV

Negative to : HIV, HBV, HCV

Study type

Interventional (clinical trial)

Enrollment

16

Allocation

Non-randomized

Intervention model

Sequential assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Once

Studied LA-formulation(s)

Tablet

Studied route(s) of administration

Oral

Use case

Unspecified

Key resources

Not provided

Excipients

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

Patent info

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

Supporting material

Publications

There are no publication

Additional documents

UNIADS- Beyond 2025 – Long acting antiretrovirals: potential to close HIV prevention and treatment gaps

TAG-Pipeline report 20255 - Antiretroviral Therapy

Useful links

There are no additional links

Additional information

Not provided