GlobeNewswire·Jul 22, 2026, 8:00 AM ET

Monopar Initiates Rolling NDA Submission for ALXN1840 in Wilson Disease

Monopar Therapeutics Inc. initiated a rolling New Drug Application (NDA) submission to the FDA on July 22, 2026, for ALXN1840 (tiomolibdate choline) to treat Wilson disease.
The FDA authorized the rolling submission, allowing Monopar to submit completed sections for review while finalizing remaining parts of the application.
ALXN1840 is a first-in-class albumin tripartite complex (ATC) activator that mobilizes & sequesters excess copper, suppressing redox reactivity & blocking transport across the blood-brain barrier.
If approved, ALXN1840 would be the first therapy with a novel mechanism of action approved in the U.S. for Wilson disease in decades.
ALXN1840 received Rare Pediatric Disease (RPD) designation in June 2026, offering potential eligibility for a pediatric Priority Review Voucher upon NDA approval.
The pivotal Phase 3 trial met its primary endpoint by demonstrating rapid & sustained copper mobilization significantly greater than standard of care over 48 weeks.
Clinical development data covered 266 patients across 645 patient-years, showing durable clinical improvement & a well-characterized safety profile.
Monopar also maintains a portfolio of radiopharmaceutical programs for advanced cancers, including MNPR-101-Zr (Phase 1), MNPR-101-Lu (Phase 1a), & MNPR-101-Ac (late preclinical).