Oveporexton (TAK-861-2001) is a Takeda Pharmaceutical Co Ltd program in Narcolepsy type 1 (NT1). The FDA approved it on Aug 5, 2026. 1 FDA decision on record below. Every date links its source.
Oveporexton (TAK-861-2001) is marketed as ORZEYFUL (oveporexton); the events below include those tracked under the brand name. Indication under review: Narcolepsy type 1 (NT1). Sponsor: Takeda Pharmaceutical Co Ltd (TAK). Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
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