Pharmaceutical companies are intensifying efforts to bring ketamine-based treatments to market, seeking to capitalize on growing interest in the drug’s potential for mental health disorders. Ketamine, originally developed as an anesthetic in the 1960s, has gained attention in recent years for its rapid antidepressant effects, especially in cases resistant to traditional therapies. Johnson & Johnson currently leads the market with Spravato, a ketamine-like nasal spray approved by the U.S. Food and Drug Administration (FDA) for major depressive disorder and suicidal ideation, projected to generate $2.3 billion in revenue this year.
With ketamine’s original patent long expired, many companies are pursuing drug repurposing strategies, which involve modifying or re-packaging existing drugs to secure exclusive marketing rights, thus shortening development timelines and lowering costs. NRx Pharmaceuticals, for example, is developing Ketafree, a formulation of ketamine without the preservative benzethonium chloride (BZT). The company simultaneously petitioned the FDA to ban all ketamine containing BZT, arguing the preservative poses health risks, while seeking approval for Ketafree in a preservative-free vial. NRx claims its application is progressing quickly and has already ordered five million doses ahead of potential approval.
This strategy has drawn criticism from healthcare professionals who express concern that restricting ketamine supply could raise prices significantly and disrupt access to a staple anesthetic and emerging psychiatric treatment. Generic ketamine typically costs about one dollar per dose, while Spravato sessions can reach $1,200. The drug is primarily produced in China and India and has experienced supply shortages.
Other companies are also developing new ketamine-based products, including Solvonis Therapeutics’ oral thin film for alcohol-use disorder, Freedom Biosciences’ combination treatment intended to prolong antidepressant effects, and Tasman Therapeutics’ extended-release oral formulation designed for at-home use. Meanwhile, major pharmaceutical firms like Eli Lilly and AbbVie have entered the psychedelic medicine space through acquisitions and partnerships focused on novel compounds for depression and other mental health conditions.
Some industry executives emphasize the potential benefits of newer ketamine derivatives that may offer improved efficacy, fewer side effects, and greater convenience. For instance, Gilgamesh Pharmaceuticals is testing blisexprodil, designed to minimize the dissociative experiences linked to ketamine and Spravato and to be safely taken at home without the need for lengthy clinical observation. Such advances could expand insurance coverage for ketamine treatments, which currently is limited mainly to FDA-approved indications.
The safety of BZT as a preservative is debated. NRx CEO Jonathan C. Javitt cited evidence that the FDA banned BZT in over-the-counter hand sanitizers in 2019 and noted its phase-out in some ophthalmic products due to toxicity concerns. However, critics argue that BZT has been used safely in pharmaceutical products for decades without documented health problems, and that ketamine doses used in mental health treatments are too limited to cause harm from the preservative.
The surge in ketamine-based pharmaceuticals accompanies a broader expansion of psychedelics in medicine, with the FDA reviewing dozens of psychedelic compounds, many engineered to reduce psychoactive effects and the need for adjunct psychotherapy. Some practitioners caution that removing the therapeutic context from ketamine treatments risks diminishing their long-term benefits, as psychological support remains central to effective care. Raquel Bennett, a veteran ketamine therapist, warns that rapid commercialization and the drive for more accessible products could undermine patient outcomes by bypassing necessary psychological work.
As ketamine transitions from a niche therapy to a mainstream pharmaceutical category, stakeholders are watching closely how regulatory decisions and market dynamics will shape its future role in mental health care.