access-principles-1access-principles-2access-principles-3backcarrierdevelopmentease_of_administrationexportimplantableinjectablenon-implantablenon_carriernon_injectableother_featuresprintroute_of_administrationtherapeutic_areatype_of_tech

Drug information

Drug's link(s)
Generic name

GS-3242 + lenacapavir

Brand names

investigational

Compound type

Small molecule

Drug class/category

INSTI+capsid inhibitor

Summary

Not provided

Approval status

Unknown

Regulatory authorities

Unknown

Therapeutic area(s)

  • HIV
Use case(s)
  • Treatment

Administration route

Oral, Subcutaneous, Route of administration is being determined in the clinical program

Associated long-acting platforms

Aqueous drug particle suspension, Oral solid form

Use of drug

Ease of administration
  • Administered by a community health worker
  • Administered by a nurse
  • Administered by a specialty health worker
  • To be determined
Frequency of administration
  • Every 6 months
  • Other/Variable/Unknown : To be determined
User acceptance

To be determined

Dosage

Available dose and strength

to be determined

Maximum dose

to be determined

Recommended dosing regimen

to be determined

Additional comments

Not provided

Dosage link(s)

Formulations

Compare
Related formulations

GS-3242
Lenacapavir (LEN)

Associated technologies

Not provided

Comment & 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

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

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