Xspray Pharma has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for its product candidate XS003, an improved formulation of nilotinib for treating chronic myeloid leukemia (CML). The Swedish pharmaceutical company announced the submission on August 19, 2025, marking its second product candidate under FDA review.
Enhanced Formulation Addresses Key Treatment Challenges
XS003 represents a significant advancement over the reference product Tasigna®, demonstrating the lowest documented food interaction within the nilotinib class. The improved formulation, developed using Xspray's proprietary HyNap™ technology, shows enhanced dose linearity that provides physicians with greater predictability when adjusting doses.
The most notable improvement is XS003's reduced food interaction profile. While the reference product shows 82% food interaction as reflected in its labeling, XS003 demonstrates only 28% interaction when taken with food. This substantial reduction may eliminate the need for the three-hour fasting requirement currently included in Tasigna's boxed warning, potentially simplifying treatment and improving patient adherence.
Clinical Data Supports Bioequivalence at Lower Doses
Registration studies demonstrate bioequivalence with Tasigna despite XS003 being administered at less than half the dose of the reference product. The studies confirm clearly improved dose linearity, which may provide physicians with better predictability when adjusting doses and thereby enable improved treatment outcomes.
"Patients with chronic leukemia live not only with their disease—but also with side effects from medications, often related to food interaction and concomitant treatments," said Per Andersson, CEO of Xspray Pharma. "Our proprietary HyNap technology addresses these challenges and may help improve treatment outcomes and quality of life for this patient group."
Regulatory Timeline and Market Opportunity
Xspray expects the FDA to initiate its review within 60 days, with a regulatory decision anticipated approximately eight months thereafter. The company now has two product candidates under FDA review with strong clinical potential, addressing a total U.S. market worth $2.7 billion.
The global nilotinib market reached $1.67 billion in 2024, with $850 million coming from the U.S. market alone. XS003's improved profile positions it to capture a significant portion of this established market by addressing key limitations of current nilotinib formulations.
Technology Platform Enables Next-Generation PKI Development
The HyNap™ technology platform underlying XS003 represents Xspray's broader strategy to develop next-generation protein kinase inhibitor products with stable absorption, low variability, and minimal food interaction. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies.
The improved control and potentially lower risk of side effects when XS003 is taken with food may indicate better therapeutic management for patients with chronic myeloid leukemia, a condition requiring long-term treatment adherence.
