Benuvia Receives Second NIH Award to Advance GMP-Grade Ketanserin Development for Psychedelic Research

Award builds on Benuvia’s ongoing work supporting psychedelic research and addresses the need for high-quality serotonin receptor antagonists in clinical development

ROUND ROCK, Texas, October 21, 2026 – Benuvia Operations, LLC (Benuvia), a global contract development and manufacturing organization, today announced that it has been awarded a contract by the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), for the Good Manufacturing Practice (GMP) development and manufacture of ketanserin tartrate active pharmaceutical ingredient (API).

The award is Benuvia’s second from NIH, following the March 2025 contract for the GMP synthesis of psilocybin and other bulk drug substances. Under the new contract, Benuvia will develop, scale up and manufacture GMP-grade ketanserin tartrate to support IND-enabling studies and future clinical investigation.

Ketanserin is a selective serotonin 5-HT2A receptor antagonist – the same receptor through which psilocybin, LSD and other classic psychedelics produce their effects. In published clinical studies, ketanserin has been shown to block or attenuate the subjective effects of classic psychedelics. Although it has been used internationally for decades, no acceptable serotonin receptor antagonist of this kind is presently available in the United States Pharmacopeia (USP), leaving U.S. investigators and clinicians without a GMP-grade option.

As psychedelic-assisted therapies advance through clinical development, the need for such a tool is growing. GMP ketanserin tartrate has the potential to serve three critical roles:

• A psychedelic rescue medication – a means to rapidly attenuate an overwhelming or adverse psychedelic experience, creating a safety backstop for patients.
•  A clinical investigational tool – enabling researchers to confirm 5-HT2A receptor mechanisms and design placebo-controlled and blinded studies with greater rigor.
• A resource for the practicing psychedelic therapist – a way to bring a prolonged experience to a close when the therapy session ends, so patients can leave in a safe and stable state.

For these reasons, ketanserin is often described within the field as “naloxone for the mind.” Just as naloxone transformed the safety landscape for opioids, a readily available, pharmaceutical-grade 5-HT2A antagonist could become an essential safeguard for psychedelic medicine.

“Receiving a second NIH award is an important milestone for Benuvia and further validates our commitment to supporting the advancement of psychedelic research,” said Terry Novak, CEO of Benuvia. “As psychedelic therapies progress through clinical development, access to high-quality, GMP-grade research materials becomes increasingly important. Ketanserin addresses a critical need by providing researchers with a serotonin receptor antagonist that can support more rigorous clinical investigations. We are proud to continue working with NIH on this important initiative and to help build the scientific foundation for the next generation of psychedelic therapies.”

The program builds on Benuvia’s expertise in the development and manufacture of controlled substances under GMP conditions, including its ongoing work producing psilocybin for NIDA’s preclinical toxicity studies and clinical trials. Benuvia will produce ketanserin tartrate in accordance with FDA requirements, ensuring researchers can access a consistent, pharmaceutical-grade product.

Mr. Novak continued, “Our mission at Benuvia is to provide high-purity, federally compliant substances for scientific research and pharmaceutical development. Psychedelic medicine is only as strong as its safety net. We look forward to helping NIH put that safety net in the hands of the researchers and clinicians who need it.”

About Benuvia Operations, LLC

Benuvia Operations, LLC is a global Contract Development and Manufacturing Organization (CDMO) that helps pharmaceutical and biotech companies deliver life-changing therapies to patients in need. The company provides end-to-end development and manufacturing services for Active Pharmaceutical Ingredients (APIs) and finished dosage products and has extensive experience with cannabinoids, psychedelics, and other controlled substances. Benuvia operates an 83,000 square foot best-in-class manufacturing facility in Round Rock, Texas that can produce Schedule I-V compounds, offering comprehensive solutions for companies throughout the entire drug development lifecycle-from API synthesis and clinical trial supply to commercial production. Learn more at www.benuvia.com.

Research reported in this press release will be supported by the National Institute on Drug Abuse of the National Institutes of Health under contract number 75N95025D00003. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Media Contact

Eric Kizior
Vice President of Commercial Business
Benuvia Operations, LLC
ekizior@benuvia.com