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Drug information

Drug's link(s)

Not provided

Generic name

GS-4182

Brand names

investigational

Compound type

Small molecule

Summary

GS-4182 is an investigational lenacapavir prodrug with improved bioavailability and potential for oral weekly administration. The chemical structure of GS-4182 is not yet available in the public domain. GS-4182 is studied in combination with GS-1720, a new oral INSTI. Phase II/III WONDERS trials are currently underway using the GS-4182+GS-1720 combination. If successful, a weekly oral HIV treatment could provide a valuable alternative for PLHIV.

Approval status

GS-4182 is currently in clinical development and not yet approved in any jurisdiction.

Regulatory authorities

GS-4182 is currently in clinical development and not yet approved in any jurisdiction.

Therapeutic area(s)

  • HIV
Use case(s)
  • Treatment

Administration route

Oral

Associated long-acting platforms

Oral solid form

Use of drug

Ease of administration
  • Self-administered
User acceptance

Not provided

Dosage

Available dose and strength

300mg is the investigated dose

Frequency of administration

once a week oral dosing with GS-1720 is the investigated schedule

Maximum dose

600mg 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 technologies

Not provided

Comment & Information

Not provided

Developer(s)

Gilead
Originator
United States

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

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

Useful links

There are no additional links

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