Patent allowances cover proprietary crystalline form and manufacturing processes for Ceruvia's clinical-stage, non-hallucinogenic LSD analog

GREENWICH, Conn., Aug. 27, 2026 /PRNewswire/ -- Ceruvia Lifesciences, a leading neurotransformational biopharmaceutical company, today announced that it has received Notices of Allowance from the U.S. Patent and Trademark Office for three patent applications covering the proprietary pharmaceutical form and manufacturing of BOL-148, the company's non-hallucinogenic LSD analog being developed for the treatment of cluster headache.

The allowances include patent claims covering a crystalline form of 2-bromolysergic acid diethylamide hydrobromide (2-Br-LSD HBr), the form of BOL-148 Ceruvia intends to advance through clinical development and potential commercialization. Two additional U.S. allowances cover high-purity BOL-148 produced by distinct manufacturing processes, including routes beginning with bromocriptine that tightly control LSD and other process-related impurities.

Together, the allowances and grant add important layers of protection around both the drug product and its manufacture and form part of Ceruvia's broader intellectual property portfolio covering BOL-148. For example, Ceruvia is pursuing patent protection for its proprietary form of 2-Br-LSD HBr in Europe and Canada. Ceruvia has obtained a European Unitary Patent directed to Ceruvia's preferred salt form, and the Canadian Patent Office has indicated that Ceruvia's corresponding application is allowable.

The allowances strengthen Ceruvia's composition-of-matter protection around the highly pure crystalline form of BOL-148 it intends to advance through clinical development and potential commercialization.

The salt form selected by Ceruvia was discovered through pharmaceutical development work conducted with Curia and offers characteristics important to producing a reliable commercial drug product. The highly crystalline material is non-hygroscopic, meaning it does not absorb moisture, supporting formulation reproducibility, stability, and shelf life. Ceruvia's manufacturing processes are also designed to produce high-purity BOL-148 while tightly controlling unwanted impurities.

"BOL-148 has been known scientifically for decades, but developing a known molecule into a commercially viable pharmaceutical requires considerably more than demonstrating that it can be synthesized," said Carey Turnbull, Founder and CEO of Ceruvia Lifesciences. "Our work has focused on developing a stable, reproducible, pharmaceutical-grade form of BOL-148 that can be manufactured at scale, while building meaningful intellectual property protection around the product we intend to take through clinical development and, ultimately, to patients."

Ceruvia's broader intellectual property portfolio includes patent rights covering the use of BOL-148 in the treatment of cluster headache, as well as additional pending applications covering other crystalline forms, dosing regimens, and potential therapeutic applications. The company has also filed divisional applications seeking protection for additional crystalline forms of BOL-148.

The recently allowed patents arising from Ceruvia's pharmaceutical development and manufacturing work are expected to provide potential protection through 2042. Depending on the final approved product and claims, patents covering the commercial drug product may also be eligible for listing in the FDA's Orange Book and, following regulatory approval, patent-term extension to compensate for regulatory review time.

"The combination of our clinical progress, manufacturing readiness, intellectual property portfolio, and financing puts Ceruvia in a strong position to advance BOL-148," Turnbull continued. "Our immediate focus is cluster headache, where there remains a significant unmet need, but we also believe BOL-148 may ultimately have potential across a broader range of neurological and psychiatric conditions."

Earlier this month, Ceruvia announced an $8 million investment that fully funds its planned integrated Phase 1/2 clinical program for BOL-148. The company expects to submit a Clinical Trial Application in Germany in September 2026, with first participant enrollment expected in the fourth quarter of 2026. The study is designed to progress from dose escalation in healthy volunteers directly into a randomized, placebo-controlled Phase 2 proof-of-concept evaluation in patients with cluster headache.

BOL-148 is a proprietary, non-hallucinogenic LSD analog being developed as a potential treatment for cluster headache. The program builds on encouraging preliminary clinical observations reported in a trial conducted by Harvard Medical School involving patients with cluster headache, as well as Ceruvia's clinical safety experience in healthy volunteers.

About Ceruvia Lifesciences

Founded in 2017, Ceruvia Lifesciences is a clinical-stage biopharmaceutical company with a mission to improve the lives of underserved patients suffering from neurological and psychiatric disorders. Founded by Carey Turnbull, Ceruvia is relentlessly focused on the development and commercialization of neurotransformational medicines to deliver meaningful relief to patients suffering from hard-to-treat headache disorders, OCD and substance abuse disorder. For too long, these communities have been poorly understood and under-served. At Ceruvia, we believe they no longer have to live this way. With a long history of partnership with leading researchers at Yale University School of Medicine, NYU School of Medicine and Harvard Medical School, Ceruvia is undertaking clinical research in order to help patients return to living their lives to the fullest.

For more information, please visit www.ceruvialifesciences.com

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