FDA Grants Fast Track Designation for CS-1103, a First-in-class Small Molecule to Reverse Acute Intoxication from Methamphetamine
CAMBRIDGE, Mass., Sept. 30, 2025 /PRNewswire/ -- Clear Scientific Inc., a clinical stage biopharmaceutical company focused on the development of first-in-class small molecules to reverse acute intoxication from methamphetamine, announced today that the U.S. Food and Drug Administration (FDA) has granted its lead asset, CS-1103, Fast Track designation for treatment of acute methamphetamine intoxication. The FDA grants investigational medicines Fast Track designation to facilitate the development and expedite the review of medicines that demonstrate the potential to treat serious conditions and fill an unmet medical need.
CS-1103 is an injectable therapeutic that, in non-clinical studies, binds and encapsulates intoxicants in the blood, rapidly reversing their toxic effects. Subsequently, CS-1103 accelerates the clearance of the intoxicants into urine, preventing further harm. CS-1103 was shown to be safe and well tolerated in humans at clinically relevant doses in a Phase 1 clinical trial. Phase 2 trials are expected to begin in Q1 2026.
"Receiving the Fast Track designation for CS-1103 is an important milestone for our company. 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." Shekar Shetty CEO.
About the Methamphetamine Crisis:
Acute methamphetamine intoxication remains a critical public health crisis in the United States, with an estimated 563,000 emergency department visits and over 29,000 deaths involving methamphetamine in 2024 alone. The condition is associated with severe neurological, cardiovascular, and multi-organ complications, including agitation, psychosis, hyperthermia, cardiac distress, and renal failure. Current treatments are limited to supportive care, which often involves medications that carry significant risks such as oversedation, respiratory depression, cardiac complications, and prolonged hospital stay. Notably, amphetamine-related hospitalizations have a 29% higher in-hospital mortality rate compared to other admissions, and patients are 36% more likely to require transfer to additional care facilities, underscoring the inadequacy of existing interventions and the urgent need for targeted therapies
About Clear Scientific
Clear Scientific, co-founded by Prof. George Whitesides of Harvard University focuses on development of highly selective, small molecule sequestrants that bind, immediately inactivate and rapidly clear excess toxic compounds from the body.
Research reported in this press release was supported by the National Institute on Drug Abuse of the National Institutes of Health under award numbers U01DA058548 and U01DA053054. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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SOURCE Clear Scientific, Inc.