Clear Scientific Inc. announced that the U.S. Food and Drug Administration has granted Fast Track designation to CS-1103, a first-in-class small molecule therapeutic for treating acute methamphetamine intoxication. The designation facilitates development and expedites regulatory review for medicines addressing serious conditions with unmet medical needs.
Novel Mechanism of Action
CS-1103 represents an innovative approach to treating methamphetamine overdose through its unique mechanism of action. In non-clinical studies, the injectable therapeutic binds and encapsulates intoxicants in the blood, rapidly reversing their toxic effects. The drug subsequently accelerates clearance of the intoxicants into urine, preventing further harm to patients.
The therapeutic demonstrated safety and tolerability in humans at clinically relevant doses during Phase 1 clinical trials. Clear Scientific expects to initiate Phase 2 trials in the first quarter of 2026.
Addressing a Critical Public Health Crisis
Acute methamphetamine intoxication represents a significant public health emergency in the United States. According to the company's data, an estimated 563,000 emergency department visits and over 29,000 deaths involved methamphetamine in 2024 alone. The condition presents with severe complications across multiple organ systems, including neurological, cardiovascular, and multi-organ effects such as agitation, psychosis, hyperthermia, cardiac distress, and renal failure.
Current treatment options remain severely limited, consisting primarily of supportive care measures. These interventions often involve medications that carry substantial risks, including oversedation, respiratory depression, cardiac complications, and prolonged hospital stays. The inadequacy of existing treatments is highlighted by concerning statistics: amphetamine-related hospitalizations show a 29% higher in-hospital mortality rate compared to other admissions, and patients are 36% more likely to require transfer to additional care facilities.
Regulatory Significance
"Receiving the Fast Track designation for CS-1103 is an important milestone for our company," said Shekar Shetty, CEO of Clear Scientific. "This designation facilitates the review process, shortening the clinical development timeline. With no FDA approved treatments available for overdose from stimulants, like methamphetamine, CS-1103 can have a profound impact on the meth overdose epidemic."
The Fast Track designation underscores the urgent need for targeted therapies in this therapeutic area, where no FDA-approved treatments currently exist for methamphetamine overdose.
Company Background and Research Support
Clear Scientific, co-founded by Professor George Whitesides of Harvard University, focuses on developing highly selective, small molecule sequestrants that bind, immediately inactivate, and rapidly clear excess toxic compounds from the body. The research underlying CS-1103 has received support from the National Institute on Drug Abuse of the National Institutes of Health under award numbers U01DA058548 and U01DA053054.
