Key takeaways:

• The FDA granted Fast Track designation to Lu AH69593 to expedite its development and review.
• The investigational compound is a small-molecule orexin 2 receptor agonist designed to enhance wake-promoting signaling.
• Lundbeck is currently evaluating the drug’s safety, tolerability, and pharmacokinetic profile in an ongoing phase 1b clinical program.

The US Food and Drug Administration (FDA) granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist in development by Lundbeck for the treatment of narcolepsy.

Discovered by Lundbeck, the small-molecule compound is currently in phase 1b clinical development. Lu AH69593 targets the orexin pathway, which plays a central role in stabilizing sleep and wakefulness. By activating the orexin 2 receptor (OX2R), the drug is intended to enhance wake-promoting signaling and restore sleep-wake regulation in individuals with narcolepsy.

“Fast Track designation is an important milestone for Lu AH69593 and for our ambition to translate compelling orexin biology into a new treatment approach for narcolepsy and other sleep-wake disorders,” says Johan Luthman, executive vice president R&D at Lundbeck, in a release. “For people living with narcolepsy, the ability to sustain wakefulness can shape almost every part of daily life. Fast Track designation underscores the urgent need for innovative therapies for narcolepsy and recognizes the potential of Lu AH69593.”

The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill unmet medical needs.

Lundbeck is continuing to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of Lu AH69593 in its ongoing phase 1b program. The compound is not currently approved for marketing by any regulatory authority.