Dr Reddy’s Laboratories has entered into a royalty-free, non-exclusive voluntary licensing agreement with Gilead Sciences for investigational once-yearly lenacapavir for HIV prevention through pre-exposure prophylaxis (PrEP).

The agreement builds on the companies’ existing voluntary licensing arrangement signed in October 2024 covering twice-yearly lenacapavir for HIV prevention and treatment. 

The latest agreement is intended to support preparations for potential future access to once-yearly lenacapavir in licensed territories, primarily low- and lower-middle-income countries.

Under the agreement, Dr Reddy’s will work towards manufacturing readiness, technology transfer and future supply planning for once-yearly lenacapavir while clinical development continues in the licensed markets.

“At Dr. Reddy's, we are committed to improving patient access to innovative medicines across the world,” said Deepak Sapra, Chief Executive Officer, API and Services, Dr. Reddy's Laboratories Ltd. 

“This agreement builds on our existing collaboration with Gilead and reflects our continued commitment to supporting global HIV prevention efforts. If approved, investigational once-yearly lenacapavir may offer an additional long-acting HIV prevention option for people at risk of HIV acquisition, particularly in regions where access and adherence remain significant challenges.”

The agreement expands Dr Reddy’s Public Health Access portfolio, which focuses on improving access to medicines across communicable diseases, reproductive health, and maternal and child health.

Once-yearly lenacapavir is currently being evaluated in Gilead’s ongoing Phase 3 PURPOSE 365 study. The product remains investigational and has not been approved by any regulatory authority. Its safety and efficacy have not yet been established.