Introduction of ZX008 and Phase 3 study
First written in FY2019. 13 of 20 entries say "Restated". Latest entry: 2026-11-13.
No other company in this theme has enough history to compare yet.
- FY2025-H1RestatedAnnual report
「ZX008 (product name: Fintepla® oral solution 2.2 mg/mL; generic name: fenfluramine hydrochloride) is currently undergoing a Phase 3 trial in patients with CDKL5 deficiency.」
The Phase 3 trial of ZX008 for CDKL5 deficiency is ongoing. - FY2024AdvancedAnnual report
「For ZX008 (product name: Fintepla Oral Solution 2.2 mg/mL, generic name: fenfluramine hydrochloride), UCB (Belgium) submitted an application for partial approval modification for the indication of Lennox-Gastaut syndrome in June 2023 and obtained approval in March 2024. A Phase 3 study in CDKL5 deficiency disorder is also ongoing.」
ZX008 progressed from a supplemental approval application for Lennox-Gastaut syndrome to approval in March 2024, while the Phase 3 trial for CDKL5 deficiency is ongoing. - FY2024-Q3RestatedAnnual report
「• For ZX008 (product name: Fintepla Oral Solution 2.2 mg/mL, generic name: fenfluramine hydrochloride), UCB (Belgium) submitted an application for partial approval modification for the indication of Lennox-Gastaut syndrome in June 2023. A Phase 3 study in CDKL5 deficiency disorder is also ongoing.」
For ZX008, the partial approval modification application for Lennox-Gastaut syndrome and the Phase 3 study for CDKL5 deficiency disorder are ongoing. - FY2024-Q2RestatedAnnual report
「• For ZX008 (product name: Fintepla Oral Solution 2.2 mg/mL, generic name: fenfluramine hydrochloride), UCB (Belgium) submitted an application for partial approval modification for the indication of Lennox-Gastaut syndrome in June 2023. A Phase 3 study in CDKL5 deficiency disorder is also ongoing.」
For ZX008, the partial approval modification application for Lennox-Gastaut syndrome and the Phase 3 study for CDKL5 deficiency disorder are ongoing. - FY2024-Q1AdvancedAnnual report
「• For ZX008 (product name: Fintepla Oral Solution 2.2 mg/mL, generic name: fenfluramine hydrochloride), UCB (Belgium) submitted an application for partial approval modification for the indication of Lennox-Gastaut syndrome in June 2023. A Phase 3 study in CDKL5 deficiency disorder is also ongoing.」
For ZX008, the status of the partial approval modification application for Lennox-Gastaut syndrome and the Phase 3 study for CDKL5 deficiency disorder was stated. - FY2023RestatedAnnual report
「For ZX008 (product name: Fintepla Oral Solution 2.2 mg/mL, generic name: fenfluramine hydrochloride), we licensed the product from UCB (formerly Zogenix) (Belgium) in 2019, and UCB is conducting a Phase 3 study in Lennox-Gastaut syndrome.」
For ZX008, the Phase 3 study for Lennox-Gastaut syndrome has continued following approval for Dravet syndrome. - FY2023-Q2AdvancedAnnual report
「• For ZX008 (generic name: fenfluramine hydrochloride), a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from UCB (formerly Zogenix) (Belgium) in 2019. In December 2021, UCB Japan Co., Ltd. submitted an application for approval for the indication of Dravet syndrome and obtained approval in September 2022. For Lennox-Gastaut syndrome, UCB is conducting a Phase 3 study.」
ZX008 progressed to approval for Dravet syndrome. Meanwhile, the Phase 3 study for Lennox-Gastaut syndrome is ongoing. - FY2022-Q3AdvancedAnnual report
「For ZX008 (generic name: fenfluramine hydrochloride), a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from Zogenix (US) in 2019. In December 2021, Zogenix submitted an application for approval for the indication of Dravet syndrome. For Lennox-Gastaut syndrome, Zogenix is conducting a Phase 3 study.」
For ZX008, the licensor submitted an application for approval for the indication of Dravet syndrome in December 2021 and is continuing the Phase 3 study for Lennox-Gastaut syndrome. - FY2022-Q2RestatedAnnual report
「• For ZX008 (generic name: fenfluramine hydrochloride), a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from Zogenix (US) in 2019, and Zogenix is conducting a Phase 3 study.」
The licensing of ZX008 and the ongoing Phase 3 study conducted by the licensor are restated. - FY2022-Q1RestatedAnnual report
「• For ZX008, a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from Zogenix (US) in 2019, and Zogenix is conducting a Phase 3 study.」
The licensing of ZX008 and the ongoing Phase 3 study conducted by the licensor are restated. - FY2021RestatedAnnual report
「For ZX008, a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from Zogenix (US) in 2019, and Zogenix is conducting a Phase 3 study.」
The licensing of ZX008 and the ongoing Phase 3 study conducted by the licensor are restated. - FY2021-Q3RestatedAnnual report
「• For ZX008, a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from Zogenix (US) in 2019, and Zogenix is conducting a Phase 3 study.」
The licensing of ZX008 and the ongoing Phase 3 study conducted by the licensor are restated. - FY2021-Q2RestatedAnnual report
「• For ZX008, a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from Zogenix (US) in 2019, and Zogenix is conducting a Phase 3 study.」
The licensing of ZX008 and the ongoing Phase 3 study conducted by the licensor are restated. - FY2021-Q1RestatedAnnual report
「• For ZX008, a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from Zogenix (US) in 2019, and Zogenix is conducting a Phase 3 study.」
The licensing of ZX008 and the ongoing Phase 3 study conducted by the licensor are restated. - FY2020-Q3RestatedAnnual report
「For ZX008, a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from Zogenix (US) in March 2019, and Zogenix is conducting a Phase 3 study.」
The licensing of ZX008 in March 2019 and the ongoing Phase 3 study conducted by the licensor are restated. - FY2020-Q2RestatedAnnual report
「• For ZX008, a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from Zogenix (US) in March this year, and Zogenix is conducting a Phase 3 study.」
The licensing of ZX008 in March 2019 and the ongoing Phase 3 study conducted by the licensor are restated. - FY2020-Q1RestatedAnnual report
「• For ZX008, a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from Zogenix (US) in March this year, and Zogenix is conducting a Phase 3 study.」
The licensing of ZX008 in March 2019 and the ongoing Phase 3 study conducted by the licensor are restated. - FY2019First statedAnnual report
「For ZX008, a treatment for refractory epilepsy (Dravet syndrome and Lennox-Gastaut syndrome), we licensed the product from Zogenix (US) in March this year, and Zogenix is conducting a Phase 3 study.」
It was stated for the first time that ZX008 was licensed from Zogenix in March 2019 and that the licensor was conducting a Phase 3 study.