CS-1103 / Clear Scientific - LARVOL DELTA

FDA Grants Fast Track Designation for CS-1103, a First-in-class Small Molecule to Reverse Acute Intoxication from Methamphetamine (PRNewswire) - "Phase 2 trials are expected to begin in Q1 2026."

Fast track • New P2 trial • Substance Abuse

Development of CS-1103 as a First-In-Class Treatment for Methamphetamine Intoxication (CPDD 2025) - P1 | "Sequestration by CS-1103 represents a novel pathway for removing harmful substances from the human body. Successful completion of nonclinical efficacy and clinical safety studies of our therapeutic candidate, CS-1103, clears a significant hurdle toward conducting Phase 2 efficacy trials in humans."

Cardiomyopathy • Cardiovascular • CNS Disorders • Epilepsy • Psychiatry • Renal Disease

A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Clear Scientific, Inc. | Trial completion date: Oct 2025 ➔ Feb 2026 | Initiation date: Mar 2025 ➔ Jun 2025 | Trial primary completion date: Sep 2025 ➔ Jan 2026

Trial completion date • Trial initiation date • Trial primary completion date

A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Clear Scientific, Inc.

New P2 trial

A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Clear Scientific, Inc. | Recruiting ➔ Completed

Trial completion

A Novel Approach to Treat Xylazine and Opioid Intoxication (CPDD 2024) - "CS-1103 is effective in reversing fentanyl and xylazine toxicity."

Anesthesia