Announced details
Treatment of narcolepsy type 1 in adults (narcolepsy with cataplexy)
Clinical trials showed statistically significant improvements in excessive daytime sleepiness, cataplexy and health-related quality of life, among other measures.
The estimated number of patients with NT1 in the US is 120,000.
The FDA granted marketing approval for the drug developed and submitted for approval by Takeda, while the DEA is reviewing its drug scheduling.
The FDA is the US food and drug regulatory authority. The DEA is the US drug enforcement authority. Other details are Not disclosed.
No material impact on the full-year consolidated earnings forecast for the fiscal year ending March 2027 (FY2026) is expected.
The company does not address Contract Value / Offering price.
FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) Phase 3 clinical trials
| Item | Details |
|---|---|
| Names of Products / Services Covered | ORZEYFUL (generic name: obeporexton), TAK-861 |
| Counterparty | U.S. Food and Drug Administration (FDA), US Drug Enforcement Administration (DEA) |
| Counterparty overview | The FDA is the US food and drug regulatory authority. The DEA is the US drug enforcement authority. Other details are Not disclosed. |
| Relationship with the Company | The FDA granted marketing approval for the drug developed and submitted for approval by Takeda, while the DEA is reviewing its drug scheduling. |
| Launch date | Availability in the US is planned after the DEA makes its scheduling determination. The scheduling decision is expected within 90 days. The specific availability date is Not disclosed. |
| Applicable area | Treatment of narcolepsy type 1 in adults (narcolepsy with cataplexy) |
| Quantitative Effects | Clinical trials showed statistically significant improvements in excessive daytime sleepiness, cataplexy and health-related quality of life, among other measures. |
| Usage history | The estimated number of patients with NT1 in the US is 120,000. |
| Impact on Business Performance | No material impact on the full-year consolidated earnings forecast for the fiscal year ending March 2027 (FY2026) is expected. |
| Source | FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) Phase 3 clinical trials |
Items this document does not state (8)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The FDA approved ORZEYFUL as a treatment addressing the orexin deficiency that causes NT1. The approval was based on the Phase 3 clinical development program, including FirstLight and RadiantLight.