India Pharma Outlook Team | Thursday, 17 September 2026
Gilead just raised the bar in the long-acting HIV prevention race with a bold move on once-yearly lenacapavir.
The company expanded royalty-free licensing deals to prepare a global supply of the investigational annual shot while Phase 3 testing continues.
This step targets high-incidence countries and aims to close access gaps that still limit PrEP use. A single yearly dose, if approved, would offer longer protection than existing options and could reset expectations across the field.
The timing matters because rivals have faced their own hurdles in the same long-acting space.
Gilead Sciences expanded the scope of its six existing royalty-free voluntary licensing agreements for lenacapavir. The new terms now include investigational once-yearly lenacapavir for HIV prevention as PrEP.
These agreements cover 120 high-incidence countries, primarily low- and lower-middle-income nations. They support manufacturing readiness, technology transfer, and future supply planning while the Phase 3 PURPOSE 365 trial continues.
The six partners already produce twice-yearly lenacapavir for prevention. They include Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan Laboratories, a subsidiary of Viatris. Gilead chose these manufacturers for their proven ability to handle complex sterile injectables and their established history as voluntary licensing partners.
Dr. Reddy’s Laboratories entered a royalty-free, non-exclusive voluntary licensing agreement for the once-yearly version. The deal builds on the companies’ existing October 2024 arrangement that already covers twice-yearly lenacapavir for prevention and treatment.
“At Dr. Reddy's, we are committed to improving patient access to innovative medicines across the world. 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,” said Deepak Sapra, Chief Executive Officer, API and Services, Dr. Reddy's Laboratories Ltd.
Key elements of the expanded program stand out:
PURPOSE 365 is an ongoing Phase 3 open-label study. It evaluates the pharmacokinetics, safety, and tolerability of investigational once-yearly intramuscular lenacapavir for HIV prevention.
The trial checks whether a single annual dose can maintain drug concentrations linked to protection across a full 52-week interval. The broader PURPOSE program already delivered strong results with the twice-yearly version.
Gilead frames the annual option as a way to expand choice. Barriers such as stigma, limited clinic access, and the burden of more frequent dosing still hold many people back from starting or staying on PrEP.
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The main competitors in the long-acting PrEP space currently stand as follows:
A once-yearly shot, if PURPOSE 365 confirms the needed levels, safety, and tolerability, would reset the competitive clock. And the success would give users a full year of protection from a single dose and force every other player to rethink their dosing calendars. By preparing generic manufacturing this early, Gilead aims to shorten the path from potential approval to wider availability in the places that need it most.
Gilead Sciences is a global biopharmaceutical company that runs an Indian subsidiary and partners with local generic manufacturers to provide affordable access to critical medicines. Gilead has effectively contributed to discovering and developing medicines for life-threatening diseases like HIV, viral hepatitis, cancer, and inflammation.
