Adalvo today announced the successful outcome of a pivotal fasting bioequivalence (BE) study for Dolutegravir, a WHO-recommended first-line therapy for the treatment of HIV.
This milestone brings Adalvo closer to a potential Day-1 launch of an affordable generic version of this critical therapy, addressing a significant global health need.
As a blockbuster HIV therapy, Dolutegravir is recognised for potent viral suppression, a high barrier to resistance, and a strong safety profile across diverse patient populations.
The study success underscores Adalvo’s technical expertise and strategic focus on complex molecules, supporting broader access to life-saving generic therapies.
With robust regulatory capabilities and a global supplier ecosystem, Adalvo is well placed to support partners looking to add this vital medication to their portfolios.
According to IQVIA, Dolutegravir achieved global sales of $1.92 billion in 2024. With HIV prevalence rising in key regions, including Africa and Southeast Asia, demand for affordable generic alternatives is expected to grow.
To explore licensing opportunities, or to see our full antiviral portfolio, contact our team today.