lepetegravir (GS-1720)

Drug information

Drug's link(s)

Not provided

Generic name

GS-1720

Brand names

investigational

Compound type

Small molecule

Drug class/category

integrase strand transfer inhibitor (INSTI)

Summary

GS-1720 is an oral integrase strand transfer inhibitor (INSTI) with potent anti-HIV-1 activity. GS-1720 is an investigational candidate in a once-weekly oral treatment regimen in both treatment-naïve and switch populations of people living with HIV.

Approval status

GS-1720 is currently in clinical development and not yet approved in any jurisdiction.

Regulatory authorities

GS-1720 is currently in clinical development and not yet approved in any jurisdiction.

Therapeutic area(s)

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

Other/Variable/Unknown : once a week is the investigated schedule

User acceptance

Not provided

Dosage

Available dose and strength

650mg is the investigated dose

Maximum dose

1300mg is the investigated loading dose (2 tablets)

Recommended dosing regimen

In the phase 2/3 study (NCT06613685), participants will receive a 1-day loading dose of GS-1720 (1300 mg) and GS-4182 (600 mg) on Day 1.Thereafter, participants will take weekly doses of single agent GS-1720 (650 mg) and GS-4182 (300 mg) co-administered for at least 48 weeks.

Additional comments

Not provided

Dosage link(s)

Not provided

Associated compounds, formulations and regimens

Main compound

Compare

Lenacapavir pacfosacil (GS-4182)

Related compounds

lepetegravir (GS-1720)

Associated formulations and regimens

Compare

lepetegravir + lenacapavir pacfosacil (GS-1720+GS-4182)

Associated technologies

Not provided

Additional information

GS-1720 is on the priority list of MPP since March 2025, as a candidate for which voluntary licensing and technology transfer through MPP would lead to expanded access, significant health benefits, and substantial public health impact compared to available standards of care (https://medicinespatentpool.org/progress-achievements/prioritisation#pills-hiv)

Developer(s)

Originator

Gilead

Drug structure

Scale-up and manufacturing prospects

Scale-up prospects

Detailed manufacturing information is not currently available for this compound.

Tentative equipment list for manufacturing

Detailed manufacturing information is not currently available for this compound.

Manufacturing

Detailed manufacturing information is not currently available for this compound.

Specific analytical instrument required for characterization of formulation

Detailed manufacturing information is not currently available for this compound.

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