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Drug information

Drug's link(s)

Not provided

Generic name

GS-0415 (investigational)

Brand names

Not applicable (investigational; no brand name assigned)

Compound type

Biotherapeutic

Drug class/category

Not disclosed

Summary

GS-0415 is an investigational agent from Gilead Sciences for the treatment of HIV-1. Its structure and mechanism of action have not been disclosed. A first-in-human phase 1 study (NCT07719491), recruiting in the United States since July 2026, evaluates single and multiple ascending subcutaneous or intravenous doses in virologically suppressed adults on stable ART.

Approval status

Not approved. Phase 1 (recruiting).

Regulatory authorities

Unknown

Therapeutic area(s)

  • HIV
Use case(s)
  • Treatment

Administration route

Subcutaneous, Intravenous

Associated long-acting platforms

Monoclonal antibodies and antibody drug conjugates

Use of drug

Ease of administration
  • To be determined
Frequency of administration
  • Other/Variable/Unknown : To be determined based on clinical development
User acceptance
Not provided

Dosage

Available dose and strength

Not disclosed

Maximum dose

Not disclosed

Recommended dosing regimen

Not established. Phase 1 (NCT07719491): single ascending doses SC or IV versus placebo; multiple ascending doses SC/IV (five administrations up to Day 57) versus placebo.

Additional comments

Not provided

Dosage link(s)

Not provided

Related entries

Not provided

Additional information

Not provided

Developer(s)

Gilead
Originator
United States

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

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