Monepantel - PharmAust
Alternative Names: NUZ-001; PPL-1; S-MonepantelLatest Information Update: 01 Sep 2025
At a glance
- Originator Pitney Pharmaceuticals
- Developer Neurizon Therapeutics; PharmAust
- Class Acetonitriles; Anthelmintics; Antineoplastics
- Mechanism of Action Cyclin-dependent kinase 2 modulators; Cyclin-dependent kinase 4 modulators; TDP-43 protein inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase I/II Solid tumours
- Phase I Motor neuron disease
- Preclinical Amyotrophic lateral sclerosis; Huntington's disease
Most Recent Events
- 20 Aug 2025 Efficacy and adverse events data from a phase I trial in Motor neuron disease released by PharmAust
- 15 Aug 2025 The US FDA decision on the Clinical Hold Complete Response (CHCR) to the IND application for NUZ 001, for Amyotrophic lateral sclerosis is expected by October 3, 2025
- 28 Jul 2025 No recent reports of development identified for phase-I development in Amyotrophic-lateral-sclerosis in Australia (PO, Tablet)