New Delhi: Generic versions of lenacapavir, a twice-yearly injectable drug that can prevent Human Immunodeficiency Virus (HIV) infection, have moved a step closer to becoming available in India after an expert panel under the country’s drug regulator recommended waiving local Phase 3 clinical trials for two Indian manufacturers.
The Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic Drugs, under the Central Drugs Standard Control Organisation (CDSCO), recommended the waiver for applications from Dr Reddy’s Laboratories and Emcure Pharmaceuticals at its 11 August meeting.
Lenacapavir is an HIV drug developed by US-based pharma company, Gilead Sciences. It is marketed as Sunlenca for treating people with multidrug-resistant HIV and as Yeztugo for HIV prevention, or pre-exposure prophylaxis (PrEP), in the US. PrEP is medication taken by people who do not have HIV to reduce their risk of being infected.
Gilead entered voluntary licensing agreements with six generic manufacturers, including India’s Dr Reddy’s Laboratories and Emcure Pharmaceuticals, to produce and supply lenacapavir in 120 mainly low- and middle-income countries. However, the generic versions still require regulatory approval in individual countries.
The recommendation covers lenacapavir injection 463.5 mg/1.5 mL for PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35 kg who are at increased risk of acquiring HIV.
However, the recommendation does not amount to final marketing approval. The SEC said lenacapavir PrEP addresses an “unmet medical need” and recommended waiving both the bioequivalence and local Phase III trial requirements. Bioequivalence studies check whether a generic drug behaves in the body in the same way as the original drug, while Phase III trials test the drug’s safety and effectiveness in a large group of people.
Once marketing authorisation is granted, both the companies will have to submit their Phase IV study protocols to CDSCO within three months for review by the committee.
Why the waiver matters
The recommendation could substantially shorten the time Indian manufacturers would otherwise have needed to bring the drug to the domestic market. Chetali Rao, senior scientific and legal researcher at Third World Network, said that without the waiver, Indian manufacturers would likely have had to conduct local Phase III trials, which she estimated could have taken around “one-and-a-half, two years”.
“With the waiver coming, they will be able to, as soon as the product is there, they will immediately be able to launch it,” Rao said.
The development follows an earlier appeal by people living with HIV, vulnerable communities, health organisations and public-health experts to Drugs Controller General of India (DCGI) Rajeev Raghuvanshi, urging the regulator to expedite approval of generic lenacapavir and waive local Phase III trial requirements.
In the appeal, the group argued that lenacapavir had already shown strong results in global Phase III trials and had been approved by major regulators. It called for local Phase III trials to be waived and for Phase IV studies to be conducted instead.
The group also highlighted the need for affordable generic versions, citing a target price of $40 per person per year.
Rao said the waiver was particularly significant because Indian manufacturers have been able to supply lenacapavir to other countries, while access to the drug for HIV prevention has not yet been available in India.
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What happens after approval
The SEC has made Phase IV studies a condition of the regulatory pathway. These studies will generate post-marketing evidence among people who need PrEP, rather than requiring the companies to repeat local Phase III trials before marketing authorisation.
The committee has also specified that individuals must have a negative HIV-1 test before starting lenacapavir.
Lenacapavir, developed by Gilead Sciences, is a long-acting HIV drug that targets the virus’s capsid, or outer shell. For HIV prevention, it is given as an injection twice a year after an initial oral dose.
The US Food and Drug Administration approved lenacapavir for PrEP in June 2025 under the brand name Yeztugo, making it the first twice-yearly injectable HIV prevention option approved in the US.
The drug’s effectiveness for prevention was demonstrated in the Phase III PURPOSE trials. In PURPOSE 1, no HIV infections were recorded among women receiving twice-yearly lenacapavir. In PURPOSE 2, lenacapavir reduced HIV incidence by 96 percent compared with estimated background incidence.
Existing oral PrEP requires regular dosing, which can make adherence difficult for some people because of stigma, privacy concerns and difficulties accessing healthcare.
Waiver only for prevention, not treatment
The SEC’s recommendation applies only to lenacapavir for HIV prevention and does not cover its use as a treatment. For Emcure’s application to use lenacapavir in heavily treatment-experienced people with multidrug-resistant HIV-1, the committee said there was not enough evidence on how the drug behaves in the body and whether its effects could differ across ethnic groups.
It therefore did not recommend waiving the local Phase III trial requirement for the treatment indication.
Price and access
The move could also open the door to a substantially cheaper version of the drug in India. The earlier appeal by patient groups to the DCGI had specifically called for affordable generic lenacapavir. It also warned that delays in India’s approval could affect access in other low- and middle-income countries by pushing up prices and slowing scale-up.
The innovator version is currently priced at around $28,000 per year, but under Gilead’s voluntary licensing arrangement, generic manufacturers can supply lenacapavir to 120 low- and middle-income countries at about $40 per year.
The eventual price of generic lenacapavir in India is not yet clear and will depend on the manufacturers and their pricing decisions.
Regulatory approval is also only one part of making the drug accessible. Unlike daily oral PrEP, lenacapavir is an injectable that has to be administered twice a year.
Rao said that its inclusion in public HIV-prevention programmes, availability through healthcare facilities and the infrastructure required to administer an injectable drug will determine how widely it reaches people who need it.
HIV testing will also remain important because lenacapavir as PrEP is intended for people who do not have HIV.
(Edited by Nardeep Singh Dahiya)