PharmaTher Achieves Historic Ketamine FDA Approval After Third Attempt
PharmaTher Holdings Ltd. has secured FDA approval for its ketamine product KETARx, marking the first time the agency has approved a ketamine therapy specifically for surgical pain management. The Toronto based company received approval on August 8, 2025, following two previous rejections that cited minor deficiencies in their application.
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| Key Takeaway | Details |
|---|---|
| Historic Approval | First ketamine product approved for surgical pain management |
| Market Position | Joins only Spravato as the second FDA approved ketamine therapy |
| Financial Impact | Company stock gained 148% in six months |
| Market Size | Global ketamine market projected to reach $3.42 billion by 2034 |
Breaking the Ketamine Shortage Barrier
Since February 2018, ketamine has been regularly listed on the FDA drug shortage list, creating a significant gap in medical supply. This shortage has forced healthcare providers to rely on compounded ketamine products, which carry safety concerns. The FDA published a compounding risk alert on October 10, 2023, warning about potential risks of compounded ketamine products for psychiatric disorders.
The approval positions PharmaTher to address this critical shortage. CEO Fabio Chianelli emphasized the company’s goal of becoming a leading supplier to fill the U.S. market demand gap.
Market Dynamics and Future Potential
The global ketamine market is currently valued at $3 billion and projected to reach $7.42 billion by 2034, representing a compound annual growth rate of 16.4%. KETARx now competes with Spravato, which analysts estimate will generate $1.4 billion in 2025.
Ketamine stands out among psychedelic drugs as the only one included on the World Health Organization’s Model List of Essential Medicines. This designation underscores its medical importance beyond traditional anesthesia applications.
PharmaTher plans to expand KETARx development into mental health conditions including depression, neurological disorders like Parkinson’s disease, and chronic pain management. The approval provides a foundation for pursuing these additional therapeutic areas through clinical trials, potentially transforming treatment options for patients with complex medical needs.
