Takeda’s Oveporexton Succeeds in Two Phase III Trials, Paving Way for Narcolepsy Drug Filings

Takeda's orexin receptor 2 agonist, oveporexton (TAK-861), met all primary and secondary endpoints in two pivotal Phase III trials (FirstLight and RadiantLight) for narcolepsy Type 1, demonstrating significant improvements in wakefulness, daytime sleepiness, cataplexy, attention, quality of life, and daily functioning compared to placebo135.

Both trials registered statistically significant outcomes with p-values below 0.001 for all efficacy endpoints15.

Oveporexton is a potential first-in-class, oral, selective orexin receptor 2 agonist and represents a novel mechanism directly addressing the orexin neuron deficiency in narcolepsy Type 113.

The drug displayed a safety profile consistent with earlier studies and was generally well tolerated4.

Peak sales of oveporexton are projected at around $3 billion, with potential to exceed this figure as part of a broader orexin-targeted drug franchise15.

Takeda plans to file for regulatory approval of oveporexton by March 202615.

Sources:

1. https://www.pharmiweb.com/pwtoday-story/takeda-s-first-in-class-orexin-agonist-oveporexton-posts-stellar-phase-iii-results

3. https://www.thepharmaletter.com/pharmaceutical/positive-phase-iii-results-for-takedas-oveporexton

4. https://www.bioworld.com/articles/722137-takeda-phase-iiis-win-street-still-wants-a-visual-on-narcolepsy

5. https://www.biospace.com/drug-development/takeda-establishes-lead-in-narcolepsy-race-with-back-to-back-phase-iii-wins