Clear Scientific Reports Positive Phase 2 Results for Fentanyl Removal Therapeutic

Clear Scientific, Inc. has reported positive results from the Phase 2 trial of its investigational drug CS-1103. The small-molecule therapeutic is designed to bind and inactivate fentanyl in the body, accelerating its removal through urine.

The study met all its endpoints, demonstrating that CS-1103 significantly increased the excretion of fentanyl compared to a placebo. Crucially, the drug did not interfere with the action of naloxone, an opioid overdose reversal medication, which was administered to all participants. The treatment also showed a favorable safety profile in the 16 healthy adult participants.

"By removing fentanyl from the plasma and brain rather than replacing it, as with receptor antagonists, CS-1103 could help prevent potentially fatal re-narcotization and reduce or eliminate precipitated withdrawal," stated Shekar Shetty, CEO of Clear Scientific. He added that this mechanism could enable faster and safer transitions to addiction treatment.

Clear Scientific plans to advance CS-1103 into Phase 3 clinical trials in the first half of 2027. The company is developing the therapeutic to address the ongoing opioid crisis exacerbated by fentanyl. The U.S. Centers for Disease Control and Prevention has reported tens of thousands of fentanyl-related deaths annually.