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

GS-1219

Brand names

Not applicable (investigational; no brand name assigned)

Compound type

Small molecule

Drug class/category

INSTI (Integrase strand transfer inhibitor)

Lifecycle status

Not provided

Summary

https://www.fiercebiotech.com/biotech/gilead-ends-ph-1-trial-after-settling-twice-yearly-treatment-partner-lenacapavir development paused as of July 2026: Deprioritised by Gilead as partner for LEN (NCT07115368) in favour of GS-3242

Approval status

In phase 1, development terminated (last checked 18 Sept. 2026)

Regulatory authorities

not yet approved.

Therapeutic area(s)

  • HIV
Use case(s)
  • Treatment

Administration route

Oral

Associated long-acting platforms

Not provided

Use of drug

Ease of administration
  • To be determined
Frequency of administration
  • Weekly
User acceptance
Not provided

Dosage

Available dose and strength

to be determined

Maximum dose

to be determined

Recommended dosing regimen

to be determined

Additional comments

Development reported as paused by Gilead (https://www.gilead.com/science/pipeline; accessed Sep, 18, 2026)

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