Adalvo is preparing to initiate its pivotal bioequivalence study for Voclosporin Soft Gel Capsules in April 2026. It’s a major step towards expanding access for patients in need.
Based on the reference brand, Lupkynis®, Voclosporin is a novel calcineurin inhibitor used to treat adult patients with active lupus nephritis.
To discuss partnership opportunities or to learn more about Adalvo’s immunology portfolio, please contact one of the team.
Lupus is a chronic autoimmune disorder in which the body's immune system attacks its own cells and organs. Lupus nephritis occurs when lupus starts affecting parts of the kidneys that filter out waste.
The disease is heavily skewed towards women, with 90% of lupus patients being female. Many face ongoing, unmet needs around relapse prevention and long-term renal protection.
A growing patient population
While incidences of lupus remain stable globally, prevalence is rising due to improvements in diagnosis and treatment.
Through its focus on specialty formulation capability and global supplier collaboration, Adalvo aims to improve the availability of this established therapy for patients and healthcare systems worldwide.
New guidelines and clinician practices advocate multi-agent strategies involving immunosuppressive and biologic therapies, and reflect a shift towards earlier, more comprehensive disease control. Generic Voclosporin could meaningfully broaden access to treatment, particularly in markets where the branded product remains out of reach.
In 2025, sales of Voclosporin reached $271.3 million in the US alone, representing a 25% year on year growth and accelerating demand.
To discuss licensing opportunities, or to see our full range of immunology therapies, contact us today.