Durham, NC – July 2, 2025 — MAA Laboratories Inc., a specialty pharmaceutical company focused on developing clinically differentiated, value‑added drug products, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its Methotrexate Nanoparticle Tablets. 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.

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 thrilled to receive IND clearance from the FDA for our lead asset,” said Anjani Jha, Founder and CEO of MAA Laboratories. “This milestone validates not only the scientific integrity of our Methotrexate Nanoparticle Tablets but also the broader potential of our NanoCont™ platform. We believe this formulation could significantly improve methotrexate’s safety and tolerability profile—a longstanding unmet need for patients with autoimmune diseases and certain cancers.”

Key Highlights

• IND clearance granted for Methotrexate Nanoparticle Tablets
• 505(b)(2) regulatory pathway confirmed for BA/BE studies in healthy volunteers
• Developed using NanoCont™, an FDA‑recognized Emerging Technology
• Designed to improve safety, tolerability, and systemic exposure
• Potential for label differentiation post‑approval

About Methotrexate Nanoparticle Tablets

This next‑generation formulation is designed to reduce dose‑dependent toxicity and gastrointestinal side effects commonly associated with conventional methotrexate while maintaining therapeutic efficacy. By enhancing absorption and minimizing variability, the nanoformulation aims to improve patient adherence across both autoimmune and oncology indications.

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Corporate Office
MAA Laboratories, Inc.
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Suite# 214
Durham, NC 27709
United States of America
Email: info@maalaboratories.com
Phone: 919.271.7868