Alkermes and Takeda are Leading a Revolution in Narcolepsy Treatment
- Sep 8
- 2 min read
Updated: Sep 28
The biopharmaceutical industry is at a high point with the promise of a new era in the treatment of sleep disorders. Alkermes and Takeda Pharmaceuticals are leading the race in the development of an innovative class of therapies for narcolepsy, poised to be a game-changer in sleep medicine.
Alkermes' Alixorexton, an orexin 2 receptor (OX2R) agonist, has entered Phase 3 trials for narcolepsy type 1 (NT1). Its Phase 2 Vibrance-1 trial yielded statistically significant and clinically relevant results across all evaluated doses (4, 6, and 8 mg). The drug significantly improved wakefulness, leading patients to achieve normative wakefulness (mean sleep latency ≥20 minutes) by the sixth week. Furthermore, the 6 mg dose significantly reduced cataplexy episodes. The safety results were robust, with no serious adverse events reported, and over 95% of participants chose to continue in an open-label extension study. Its once-daily oral formulation and multi-symptom efficacy (addressing wakefulness, fatigue, and cataplexy) position it as a comprehensive solution in the market. Alkermes, with $1.2 billion in cash reserves, aims to secure FDA and EMA approvals. Analysts project peak sales of $2 billion for Alixorexton.
In parallel, Takeda has unveiled promising data from its Phase 3 trials (FirstLight and RadiantLight) for Oveporexton, another OX2R agonist. This drug, administered twice daily, demonstrated increases in wakefulness of 20 and 17 minutes more than placebo in the two studies, with patients achieving between 22 and 25 minutes of wakefulness by the end of the studies. Oveporexton also showed a remarkable improvement in reducing days with cataplexy, increasing from zero days at baseline to 4-5 days per week by Week 12. The most common adverse events were insomnia and urinary issues, considered "worthwhile trade-offs" by experts, though no serious drug-related adverse events were reported. Takeda plans to submit its approval applications to regulators this fiscal year, projecting peak revenue potential of $2 billion to $3 billion for NT1.
The global narcolepsy treatment market, valued at $3.15 billion in 2023, is expected to reach $7 billion by 2031. Although existing drugs, such as sodium oxybate-based treatments (e.g., Xyrem), dominate with a 70% market share, they come with regulatory restrictions and complex dosing regimens. The arrival of OX2R agonists like Alixorexton and Oveporexton represents a significant disruption. While Takeda’s Oveporexton might have a "first-mover advantage", Alixorexton’s once-daily formulation could be a key differentiator. Both companies are exploring the expansion of their drugs' use to other orexin-related disorders, which could drive sustained long-term revenue growth in neurological medicine.
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