Simufilam - Filana Therapeutics
Alternative Names: C0105; C0105M; Filora; PTI-125; PTI-910; Simufilam hydrochloride; Sumifilam - Filana TherapeuticsLatest Information Update: 25 Mar 2026
At a glance
- Originator Pain Therapeutics
- Developer Filana Therapeutics
- Class Antidementias; Antiepileptic drugs; Ketones; Small molecules
- Mechanism of Action FLNA protein modulators
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Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase III Alzheimer's disease
- Preclinical Epilepsy
Most Recent Events
- 12 Mar 2026 Filana Therapeutics plans to submit responses including additional pre-clinical data and protocol design modifications for Epilepsy to the US FDA
- 10 Mar 2026 Cassava Sciences is now called Filana Therapeutics
- 31 Dec 2025 Filana Therapeutics receives Clinical Hold Letter for Epilepsy from the US FDA in December 2025