PharmaTher receives FDA approval for ketamine product KETARx

Published 11/08/2025, 14:58
PharmaTher receives FDA approval for ketamine product KETARx

TORONTO - PharmaTher Holdings Ltd. (OTCQB:PHRRF) (CSE:PHRM) received U.S. Food and Drug Administration approval for its ketamine product KETARx on Friday for surgical pain management applications, the company announced Monday. The stock, currently valued at $33.09 million in market capitalization, has seen remarkable momentum with a 148% price return over the past six months, according to InvestingPro data.

The approval represents a significant milestone for the specialty pharmaceutical company, which focuses on developing ketamine-based treatments.

"With FDA approval for ketamine now in hand, we are closer to realizing our goal of becoming a global leader in ketamine-based pharmaceuticals," said Fabio Chianelli, Founder, Chairman and CEO of PharmaTher, in a press release statement.

Ketamine is included on the World Health Organization’s Model List of Essential Medicines. The global ketamine market is currently valued at $750 million and projected to reach $3.42 billion by 2034, representing a compound annual growth rate of 16.4%.

The FDA approval provides a foundation for PharmaTher to expand development of ketamine across various therapeutic areas within its product pipeline, including depression, Parkinson’s disease, Amyotrophic Lateral Sclerosis, and complex pain conditions. While the company is not yet profitable, investors seeking detailed analysis of PharmaTher’s growth potential can access comprehensive financial metrics and expert insights through InvestingPro.

Since February 2018, ketamine has been regularly listed on the FDA drug shortage list. In October 2023, the FDA issued a compounding risk alert detailing potential risks associated with compounded ketamine products used for psychiatric disorders.

The Veterans Health Administration currently approves and funds ketamine infusions for retired military personnel with depression, PTSD, and chronic pain, according to the company’s statement.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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