A new, potentially multibillion-dollar market is emerging in the global pharmaceutical industry for drugs that target the orexin system in the brain. The first drug in this new class has already received approval from the U.S. regulatory agency for the treatment of narcolepsy, while pharmaceutical companies are beginning to explore the same mechanism for other sleep disorders, attention disorders, cognitive disorders, and neurological diseases.
On August 11, 2026, *The Economist* described these developments as a potential “Ozempic moment” for the brain—drawing an analogy with GLP-1 drugs, which were initially developed primarily to treat diabetes but later radically transformed the obesity treatment market and began to be investigated for a whole range of other diseases.
In the case of brain disorders, the orexin system could become such a universal mechanism.
A key milestone occurred on August 5, 2026, when the U.S. Food and Drug Administration (FDA) approved Takeda’s drug Orzeyful (oveporexton) for adults with type 1 narcolepsy.
This is the first approved drug that directly targets the biological mechanism of this disease.
Type 1 narcolepsy is associated with the death of brain cells that produce orexin—a neuropeptide that regulates wakefulness, sleep, and muscle tone. When orexin is deficient, the brain has a harder time maintaining a stable state of wakefulness and distinguishing between sleep and wakefulness.
Traditional therapies have primarily targeted individual symptoms—for example, by promoting alertness or reducing cataplexy. Oveporexton works differently: the drug activates the orexin receptor OX2R, thereby partially restoring the missing signal.
This is precisely what makes this new approach particularly interesting for the pharmaceutical industry.
The FDA’s decision was based, in particular, on two 12-week randomized, double-blind, placebo-controlled trials involving 273 adult patients with type 1 narcolepsy.
Patients who received oveporestone showed improved ability to remain alert during the day, as well as reduced subjective sleepiness and frequency of cataplexy episodes. Improvements were also observed in other symptoms of the disease.
However, the drug is not without side effects. The FDA lists insomnia, frequent urination, urinary urgency, and increased salivation among the most common side effects.
So, for now, we’re not talking about a “brain-boosting pill,” but rather a medication with a specific medical indication and known risks.
However, the pharmaceutical industry’s interest extends far beyond type 1 narcolepsy.
A good illustration of the scale of these expectations is Eli Lilly’s deal with the British company Centessa Pharmaceuticals.
On June 24, 2026, Lilly completed its acquisition of Centessa, gaining a portfolio of experimental OX2R receptor agonists.
When announcing the deal on March 31, Lilly estimated the initial purchase price at approximately $6.3 billion, with up to an additional $1.5 billion potentially payable depending on the achievement of certain regulatory milestones. Thus, the potential value of the deal reaches about $7.8 billion.
Centessa’s lead drug—cleminorexton, formerly known as ORX750—has already completed a Phase 2a trial in patients with Type 1 and Type 2 narcolepsy and idiopathic hypersomnia. Lilly notes that other drugs in this platform could potentially be studied for a broader range of neurological, neurodegenerative, and neuropsychiatric disorders.
In fact, one of the world’s largest pharmaceutical companies paid billions of dollars for the opportunity to secure a position in a new class of drugs even before most of its potential applications had been proven.
Takeda and Lilly are not the only players in the market.
Alkermes is developing its own OX2R agonist, alixorexton. By 2026, it will already be in Phase 3 trials for narcolepsy types 1 and 2 and in Phase 2 trials for idiopathic hypersomnia.
At the same time, the company is beginning to explore other molecules in this class. ALKS 7290 is in the early stages of development for the treatment of attention-deficit/hyperactivity disorder, and ALKS 4510 is being studied as a potential treatment for fatigue associated with multiple sclerosis and Parkinson’s disease. For now, both programs are still in the early clinical stages.
It is precisely the potential to extend the application of a single biological mechanism to numerous diseases that explains the comparison with GLP-1.
Orexin was discovered relatively recently—in the late 1990s. It is produced by a small group of neurons in the hypothalamus, but their signals spread throughout numerous areas of the brain.
The orexin system is involved in more than just maintaining alertness. It is linked to attention, motivation, energy balance, mood, and other functions of the central nervous system.
Takeda explicitly views orexin as a system linked to sleep and wakefulness, attention, mood, metabolism, and respiration.
This means that pharmacological intervention targeting orexin receptors could theoretically be beneficial not only in cases where there is a direct deficiency of this neuropeptide.
Following the approval of oveporexton, *Nature Reviews Drug Discovery* also noted that the pharmaceutical industry is already exploring broader indications for drugs in this class.
The history of GLP-1 has shown pharmaceutical companies just how valuable a mechanism can be that targets not a single symptom but a fundamental system of the body.
GLP-1 drugs have expanded from treating diabetes to a global market for obesity therapy and are now being studied for a multitude of comorbidities.
Orexin-based drugs may follow a similar trajectory: a rare and well-studied disease serves as the first proof of concept for a new mechanism, after which developers begin testing it for much more common conditions.
This is precisely why the FDA’s approval of oveporexton is important not only for patients with narcolepsy.
It marked the first time a major regulatory agency confirmed that restoring a specific neurochemical signal can directly influence the fundamental mechanism of a brain disorder.
The comparison is interesting, but it’s important not to take it literally.
Proven efficacy currently exists primarily for type 1 narcolepsy. For type 2 narcolepsy and idiopathic hypersomnia, other drugs are in the clinical trial phase, while the use of orexin agonists for ADHD, Parkinson’s disease, multiple sclerosis, and other conditions is still in much earlier stages.
There is no evidence that these drugs will become universal cognitive stimulants or will be able to treat a wide range of mental and neurodegenerative disorders.
Therefore, the main significance of these developments lies not in the emergence of an “Ozempic for the brain” as a single miracle drug, but in the emergence of a new pharmacological platform.
And if further research confirms the ability to safely regulate wakefulness, attention, and other brain functions through the orexin system, this class of drugs could indeed become one of the most important new areas in global neurology and psychiatry.
The combination of the first FDA approval, several competing clinical programs, and multibillion-dollar investments from the largest pharmaceutical companies indicates that the industry is already placing a serious bet on this mechanism.
