Full Press Release Details
Hyderabad, India; September 17, 2026: Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as "Dr. Reddy's") today announced a royalty -free non-exclusive voluntary licensing agreement with Gilead Sciences for i nvestigational once -yearly lenacapavir for HIV prevention as pre-exposure prophylaxis (PrEP).
The agreement builds on Dr. Reddy's existing voluntary licensing arrangement with Gilead , signed in October 2024, for twice-yearly lenacapavir for HIV prevention and treatment and r eflects the continued confidence between the two companies as they work towards broadening future access to long-acting HIV prevention options in licensed markets.
The agreement aims to facilitate manufacturing readiness, technology tr ansfer and future supply planning for investigational once-yearly lenacapavir while clinical development efforts continue in the licensed territories, primarily low- and lower-middle-income countries.
The collaboration further strengthens Dr. Reddy's Publi c Health Access portfolio, which focuses on improving access to medicines across communicable diseases, reproductive health, and maternal and child health. HIV continues to represent a significant global public health challenge, underscoring the need for innovative long-acting prevention options. “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 .
Investigational once-yearly lenacapavir is currently being evaluated in Gilead's ongoing Phase 3 PURPOSE 365 study.
Once-yearly lenacapavir for HIV prevention is investigational and has not been approved by any regulatory authority. Its safety and efficacy have not been established.
1 Gileads Twice Yearly Lenacapavir for HIV Prevention Reduced HIV Infections by 96 and Demonstrated Superiority to Daily Truvada in Second Pivotal Phase 3 Trial About Lenacapavir:
Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug-resistant HIV in combination with other antiretrovirals. The use of twice-yearly lenacapavir for HIV prevention is also approved by the USFDA and the European Medicines Agency. WHO also recommends twice-yearly lenacapavir in its guidelines for HIV prevention.
The use of once-yearly lenacapavir is investigational, and the safety and efficacy of lenacapavir for this use have not been established.
The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.
Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that h elp address individual needs and preferences of people a nd communities affected by HIV1.
………………………………………………………………………………..…………………………………………………………………………………………………………………… About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded g enerics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to sev eral industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and a ffordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.
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