CS-1103 / Clear Scientific - LARVOL DELTA

A novel drug sequestrant-based therapeutic candidate reverses methamphetamine-induced hyperthermia and hypermetabolism and abates multiorgan toxicity in rats. (PubMed, J Pharmacol Exp Ther) - "SIGNIFICANCE STATEMENT: Methamphetamine is a common drug of abuse associated with broad toxicity and fatality in humans. An animal model that replicates many of these toxicities was developed and this model was used to demonstrate that CS-1103, a methamphetamine-binding sequestrant, has efficacy in preventing toxicity and death."

Journal • Preclinical • CNS Disorders • Psychiatry

A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade (clinicaltrials.gov) - P2 | N=16 | Recruiting | Sponsor: Clear Scientific, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade (clinicaltrials.gov) - P2 | N=16 | Not yet recruiting | Sponsor: Clear Scientific, Inc.

New P2 trial

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 | Recruiting | Sponsor: Clear Scientific, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

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: Feb 2026 ➔ Sep 2026 | Trial primary completion date: Jan 2026 ➔ Sep 2026

Trial completion date • Trial primary completion date

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