Arcato’s Non-Opioid Dental Analgesic Gel Achieves Success in Phase I Clinical Trial and Completes First Round of Fully Subscribed Financing

DentalGoodNews｜August 19, 2026, Arcato Laboratories (hereinafter referred to as "Arcato") announced that its non-opioid dental analgesic gel ARC-001 has successfully met the primary safety endpoint in Phase I clinical trial, and the company has completed its first round of fully subscribed financing.

The proceeds from this financing round will primarily be used to advance the ARC-001 gel into subsequent Phase II/III clinical development. As the company's core product, ARC-001 gel is a sustained-release, single-dose gel formulation combining three anesthetic components: benzocaine, lidocaine, and bupivacaine. Administered locally, it is injected directly into the tooth socket after extraction surgery without the need for needle injection. Pharmacokinetic analysis indicates its potential to provide analgesic effects lasting up to 7 days.

Currently, the primary safety endpoint of the Phase I clinical study has been achieved, providing support for subsequent development. Exploratory efficacy endpoints suggest that the drug helps reduce pain within 24 hours post-surgery, and patients in the placebo group reported needing opioids twice as frequently as those in the ARC-001 group.

Dr. Thomas E. Van Dyke, Vice President of Clinical and Translational Research at the ADA Forsyth Institute, noted that over 3 million patients in the United States undergo wisdom tooth extraction surgery each year, and the industry urgently needs new non-opioid pain management solutions. According to the company, Arcato is currently in communication with the U.S. FDA, and its development pathway aligns with the draft "Non-Opioid Analgesic Drug Development Guidance" issued by the FDA in May 2026. As of press time, the company has not disclosed the specific amount of this financing round or post-investment valuation.