The U.S. FDA awarded Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for treating individuals with narcolepsy
The orexin 2 receptor sits at a key point in the core biological route that controls wakefulness and sleep-wake cycles
Lu AH69593 is now advancing through Phase 1b trials for narcolepsy patients
This designation represents a key regulatory step as Lundbeck progresses its collection of programs aimed at sleep-wake conditions

/PRNewswire/ - Lundbeck announced today that the U.S. Food and Drug Administration has awarded Fast Track designation to Lu AH69593, the firm's primary oral orexin 2 receptor agonist among multiple candidates in its sleep-wake disorder pipeline. Lundbeck discovered Lu AH69593, which is currently progressing through phase 1b trials for narcolepsy treatment.

Narcolepsy represents a long-term neurological condition that impairs the brain's control over sleep and alertness cycles. Individuals with this disorder often face intense daytime drowsiness, abrupt sleep episodes, broken nighttime rest, sleep paralysis, and sensory hallucinations. In type 1 narcolepsy, cataplexy also occurs as a sudden drop in muscle strength frequently set off by strong feelings. These issues can interfere with routine activities, schooling, employment, social interactions, and overall well-being.

Orexin functions as a neuropeptide that promotes wakefulness and helps stabilize transitions between sleep and alertness. Neurons producing orexin reside in the lateral hypothalamus and extend widely through brain areas tied to arousal and REM sleep management. Orexin acts via orexin 1 and orexin 2 receptors, with the latter viewed as central to wake-promoting effects and sleep-wake balance. Interference with orexin pathways thus offers a direct treatment focus for narcolepsy and related conditions marked by daytime sleepiness.

Lu AH69593 aims to deliver a top-tier agent that stimulates the OX2R and boosts wake-promoting signals along the orexin route. By engaging a pathway closely connected to wakefulness mechanisms, the compound seeks to rebuild alertness and sleep-wake stability in narcolepsy patients, where existing options ease symptoms yet leave substantial daily challenges for many.

"Fast Track designation marks a significant step for Lu AH69593 and our goal to turn strong orexin science into fresh treatment options for narcolepsy and similar sleep-wake issues," noted Johan Luthman, Executive Vice President of R&D at Lundbeck. "For those living with narcolepsy, maintaining wakefulness influences nearly every aspect of everyday routines. This designation highlights the pressing demand for new therapies and affirms the promise of Lu AH69593. The effort reflects Lundbeck's shift of its R&D pipeline toward breakthrough neurology, neuroendocrine, and rare disease projects that may gain regulatory support. We welcome closer collaboration with the FDA as development continues."

Fast Track designation serves as an FDA mechanism to speed development and review of therapies for serious conditions with unmet medical needs.

About Lu AH69593

Lu AH69593 is an investigational small-molecule orexin 2 receptor agonist under development at Lundbeck for narcolepsy. Orexin, also called hypocretin, is a neuropeptide linked to arousal, wakefulness, and sleep-wake stability. Lu AH69593 targets activation of OX2R to support wake-promoting orexin signals. The agent is under evaluation in a Phase 1b program, where Lundbeck continues to examine its safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics.

Lu AH69593 remains an investigational agent without marketing approval from any regulatory body, and its efficacy and safety profile have not been confirmed.

About narcolepsy

Narcolepsy is a persistent neurological sleep-wake disorder defined by excessive daytime sleepiness and poor regulation of sleep and alertness. Common features include sudden sleep episodes, disrupted nighttime rest, sleep paralysis, hallucinations, and cataplexy in type 1 cases. In type 1 narcolepsy, reduced hypocretin or orexin levels form a central biological marker. Existing therapies can ease symptoms, yet many patients still encounter notable effects on daily function, education, work, and life quality.

Contacts

Anders Crillesen	Jens Hoyer
Senior Director, External and Internal Relations	Vice President, Head of Investor Relations
email protected	email protected
+45 27 79 12 86	+45 30 83 45 01

About H. Lundbeck A/S

Lundbeck operates as a biopharmaceutical firm dedicated solely to brain health. With over 70 years in neuroscience, the company works to enhance outcomes for those affected by neurological and psychiatric conditions.

Brain disorders impact a substantial share of the global population, with effects felt across society. Through advancing knowledge of brain biology, Lundbeck focuses on driving brain health via exploration of new treatment possibilities.

As a targeted innovator, the company directs its research and development toward some of the toughest neurological problems. It creates transformative medicines for patients with limited or no options, extending from a solid base in psychiatry and neurology into neuro-specialty and neuro-rare areas.

Lundbeck commits to reducing stigma and advancing health equity. It seeks lasting value for shareholders through meaningful contributions to patients, families, and communities.

Lundbeck employs more than 5,000 people across over 20 countries, with products reaching more than 80 nations. Additional details are available on the corporate site www.lundbeck.com and via LinkedIn.

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U.S. Food and Drug Administration. Fast Track Designation Requests.
U.S. Food and Drug Administration. Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review.

CONTACT: H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Denmark +45 3630 1311 email@lundbeck.com