On August 13, 2025 MAA Laboratories Inc., a specialty pharmaceutical company focused on developing clinically differentiated, value-added drug products, reported that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Dasatinib Nanoparticle Tablets (Press release, MAA Laboratories, AUG 13, 2025, View Source [SID1234655200]). This novel oral formulation was developed using MAA’s proprietary NanoCont technology platform, which was accepted into the FDA’s Emerging Technology Program in August 2024.
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This regulatory milestone paves the way for MAA Laboratories to initiate its Phase I clinical study in healthy volunteers under the 505(b)(2) regulatory pathway.
"We are extremely pleased to receive IND clearance from the FDA for our third consecutive clinical-stage asset, following Methotrexate and Nintedanib," said Anjani Jha, Founder and CEO of MAA Laboratories. "This achievement is a testament to the versatility and potential of our NanoCont platform to deliver advanced oral drug formulations with meaningful clinical, regulatory, and development advantages."
Key Highlights
IND clearance granted for Dasatinib Nanoparticle Tablets
505(b)(2) regulatory pathway confirmed for a Phase I BA/BE study in healthy volunteers
Developed using NanoCont, an FDA-recognized Emerging Technology
Designed to optimize systemic exposure and patient experience across both oral and subcutaneous reference formulations
Marks MAA’s third consecutive IND approval utilizing NanoCont technology
About Dasatinib Nanoparticle Tablets
MAA’s next-generation Dasatinib Nanoparticle Tablets are designed to address pharmacokinetic and patient-experience limitations associated with conventional Dasatinib formulations. By leveraging the NanoCont platform, the product aims to enhance absorption, achieve consistent dose proportionality across multiple strengths, and improve systemic exposure—supporting a modernized, patient-friendly approach to oral oncology formulation development.