Drugs / SPN-817
last change Jul 2025 re-read 3 minutes ago

SPN-817

Developed for
focal epilepsy · epilepsy
Investigated by
Supernus Pharmaceuticals, Inc.

Trials 3

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 23 trials
Phase 2 NCT07141329 Jul 2025 → Dec 2027 expected focal epilepsy Supernus Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 2 NCT06798896 Dec 2024 → Aug 2027 expected focal epilepsy Supernus Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 2 NCT05518578 Feb 2023 → Dec 2027 expected epilepsy Supernus Pharmaceuticals, Inc. Recruiting No outcome recorded
Comparator or background therapy1 trial
Phase 0 NCT05102552 Comparator Oct 2021 → Mar 2022 — Supernus Pharmaceuticals, Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2024-11-04 Supernus Pharmaceuticals, Inc. Results Supernus Announces Third Quarter 2024 Financial Results supernus.com ↗
The Company has now completed enrollment of Stage A and is reporting topline data from all subjects with focal seizures who received the 3mg and 4mg twice daily doses, completed the maintenance period (n=10), and enrolled in the post-maintenance extension period (n=6).
2024-08-06 Supernus Pharmaceuticals, Inc. Results Supernus Announces Second Quarter 2024 Financial Results supernus.com ↗
We also advanced our product pipeline, announcing interim results from our open-label Phase 2a clinical study of SPN-817 for treatment-resistant seizures, and continued to progress SPN-820 through two Phase 2 studies in patients with depression," said Jack Khattar, President and CEO of Supernus.
2024-05-23 Supernus Pharmaceuticals, Inc. Results Supernus Announces Promising Interim Data from Ongoing Open-Label Phase 2a Study of SPN-817 in Epilepsy supernus.com ↗
75% median focal seizure reduction at the 3mg to 4mg twice daily doses in the maintenance period.

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

FieldValueCited text
Known as SPN-817 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05518578 ↗
3

NCT07141329 ↗

NCT06798896 ↗

NCT05102552 ↗

Action Inhibit “an acetylcholinesterase inhibitor” NCT05102552 ↗
Route Oral “0.25 mg to 4 mg SPN-817 taken orally twice daily” NCT05518578 ↗