LAPaL

Developer(s)

Gilead

Originator

https://www.gilead.com/

Drug structure

Placeholder for GS-1614

Drug information

Associated long-acting platforms

Prodrug (long-acting injectable)

Administration route

Subcutaneous, Intramuscular

Therapeutic area(s)

HIV

Use case(s)

Treatment

Use of drug

Ease of administration

To be determined

Frequency of administration

Every 3 months

User acceptance

Product development was discontinued by the company

Dosage

Available dose and strength

Not provided

Maximum dose

Not provided

Recommended dosing regimen

Every 3 months injection (IM or SC) was the development target

Additional comments

Not provided

Dosage link(s)

Not provided

Drug information

Drug's link(s)

Not provided

Generic name

GS-1614 (islatravir prodrug)

Brand name

Not applicable (investigational; no brand name assigned)

Compound type

Small molecule

Drug class/category

Nucleoside reverse transcriptase translocation inhibitor (NRTTI) prodrug

Summary

GS-1614 is a prodrug of islatravir developed by Calibr-Skaggs (Scripps Research) and licensed to Gilead in January 2024, when Gilead exercised its option in connection with its Merck collaboration. It was being evaluated as a long-acting injectable partner for lenacapavir, with potential for quarterly dosing, in a phase 1b study in people with HIV alongside the integrase inhibitor GS-6212. Gilead discontinued the quarterly regimen with GS-1614 after evaluating the phase 1 data, as stated in its fourth-quarter 2025 prepared remarks of 10 February 2026, prioritising GS-3242 as the twice-yearly partner for lenacapavir.

Approval status

Development discontinued (Gilead Q4 2025 update, 10 February 2026).

Regulatory authorities

Not approved.

Safety

Not provided

Efficacy

Not provided

Evidence Summary

Not provided

Delivery device(s)

No delivery device

Scale-up and manufacturing prospects

Scale-up prospects

Not applicable (discontinued).

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

Clinical trials

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

No documents were uploaded

Useful links

The long-acting HIV treatment era is just beginning — HIV drug Therapy - Glasgow, 2024-11-19

Calibr announces license agreement with Gilead to develop a long-acting HIV antiviral agent for treatment in combination with lenacapavir — Scripps Research, 2024-01-04

Additional information

Not provided