Frenelle PBC Completes Pharmacokinetic and Toxicology Study with Promising Results
PLYMOUTH, Minn. – May 4, 2026 – Frenelle PBC, a drug development company specializing in long acting injectables for opioid use disorder (OUD) announced today that it has successfully completed a pharmacokinetic (PK) and toxicology (tox) study for FRN01, its lead 30-day subcutaneous buprenorphine injection for OUD. FRN01 is built in Frenelle Pharma proprietary Faros™ long-acting injectable technology.
The study demonstrated favorable PK profiles with low burst release and sustained drug levels over 30 days and a clean toxicology profile consistent with buprenorphine's established safety record and prior studies with the Faros™ long-acting injectable platform technology. These pre-clinical proof of concept results support advancement into formulation optimization and IND-enabling activities and position FRN01 as a differentiated long-acting injectable option designed to improve patient access to medications for opioid use disorder (MOUD).
"Completing this critical tox study with promising results de-risks our development pathway and demonstrates the Faros™ platform's ability to deliver consistent, month-long exposure," said Jeff Missling, CEO of Frenelle PBC. "Frenelle PBC's progress, in collaboration with Mayo Clinic, reinforces our commitment to addressing the opioid crisis through innovative delivery solutions."
Frenelle PBC continues to advance toward proof-of-concept clinical trials. Frenelle PBC is committed to advancing programs and partnerships that ensure that FRN01 is developed to be accessible, affordable, and integrated into real-world care pathways. The company strives to improve the patient experience by focusing on patient-centric solutions that reduce treatment burden, enhance comfort, and support sustained recovery, particularly in underserved populations. The team at Frenelle PBC is actively building coalitions with groups that provide addiction services, including public health initiatives, not-for-profit groups and government organizations to learn how patients seeking treatment for OUD can more easily get effective care when they need it.
About Frenelle PBC
Frenelle PBC has an exclusive license from Frenelle Pharma to Faros™ applications in substance use disorder. With leadership from Frenelle Pharma, the company was formed to develop FRN01. Frenelle Pharma systematically advances Faros™-enabled therapeutics from discovery through commercialization via its hub-and-spoke model. With micro-sized, spherical, non-porous particles that deliver consistent drug release, Faros™ particles enable injections through very small-gauge needles, minimizing injection-site pain and enhancing the safety of soft-tissue injections. Its aerodynamic properties make it compatible with inhalation as well. Frenelle Pharma has three subsidiaries at this time, SpineThera (sciatica), Frenelle PBC (addiction
medicine), and Anumio (animal health). Headquartered in Minnesota's Medical Alley, the
company is committed to continually improving patient and pet experiences through superior
drug delivery. Learn more at frenellepharma.com.
Media Contact:
Jeff Missling, CEO
Frenelle PBC
info@frenellepharma.com