Gilead Sciences Prepares for Summer 2025 Launch of Long-Acting HIV Prevention Drug Lenacapavir

Gilead Sciences is planning to launch lenacapavir, a long-acting HIV prevention drug, in the summer of 202512.

Lenacapavir is administered as an injection every six months, making it the first twice-yearly PrEP option15.

The drug showed 100% efficacy in preventing HIV infections in cisgender women during the PURPOSE 1 clinical trial12.

In the PURPOSE 2 trial, lenacapavir demonstrated a 96% risk reduction against HIV infection in cisgender men, transgender individuals, and gender non-binary people2.

Gilead's HIV product sales rose 16% in the fourth quarter of 2024, contributing to the company's overall revenue increase34.

The FDA granted Breakthrough Therapy designation for lenacapavir in October 2024, potentially accelerating its review process2.

Gilead expects to achieve about 75% market access for lenacapavir within six months of launch and 90% by 12 months2.

The company is positioning lenacapavir as a way to "redefine the PrEP market as a whole" and address challenges with daily oral pill compliance1.

Gilead's 2025 financial outlook is positive, with projected product sales between $28.2 billion and $28.6 billion4.

The launch of lenacapavir is expected to strengthen Gilead's leadership in the HIV market into the late 2030s10.

Sources:

1. https://www.fiercepharma.com/pharma/gilead-looks-redefine-hiv-prep-market-2025-long-acting-sunlenca-launch

2. https://www.biospace.com/business/anticipating-approval-gilead-gears-up-for-mid-year-launch-for-lenacapavir-prep

3. https://www.cafepharma.com/boards/posts/6938711/

4. https://www.morningstar.com/news/dow-jones/2025021110724/gilead-sciences-4q-profit-up-on-hiv-product-sales-dividend-raised

5. https://www.nih.gov/news-events/news-releases/us-clinical-trials-begin-twice-yearly-hiv-prevention-injection

10. https://www.benzinga.com/general/biotech/25/02/43673047/gilead-ups-2025-outlook-eyes-lenacapavir-launch-for-hiv-prevention