Clear Scientific Inc., a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead asset, CS-1103, for the treatment of acute methamphetamine intoxication.
Fast Track designation is granted to investigational medicines that address serious conditions and unmet medical needs, helping to expedite development and regulatory review.
About CS-1103
CS-1103 is an injectable small-molecule therapeutic designed to bind and encapsulate intoxicants in the bloodstream, rapidly reversing their toxic effects. It also accelerates the clearance of these compounds into urine, preventing further harm.
- Phase 1 results: CS-1103 was safe and well tolerated in humans at clinically relevant doses.
- Next steps: Phase 2 trials are expected to begin in Q1 2026.
“Receiving the Fast Track designation for CS-1103 is an important milestone. With no FDA-approved treatments for methamphetamine overdose, CS-1103 has the potential to significantly impact the ongoing meth crisis.”
- Shekar Shetty, CEO of Clear Scientific.
Methamphetamine Crisis in the U.S.
Acute methamphetamine intoxication is a major public health issue, with:
- 563,000 emergency department visits and over 29,000 deaths in 2024 alone.
- Severe neurological, cardiovascular, and multi-organ complications, including agitation, psychosis, hyperthermia, cardiac distress, and renal failure.
- Existing treatments rely on supportive care, which carries risks such as oversedation, respiratory depression, cardiac complications, and prolonged hospital stays.
Patients with amphetamine-related hospitalizations face a 29% higher in-hospital mortality rate and are 36% more likely to require additional care transfers, highlighting the urgent need for targeted therapies.
About Clear Scientific
Co-founded by Prof. George Whitesides of Harvard University, Clear Scientific focuses on developing highly selective small-molecule sequestrants that immediately inactivate and rapidly clear toxic compounds from the body.
Research reported in this release was supported by the National Institute on Drug Abuse (NIDA) of the NIH under awards U01DA058548 and U01DA053054. The content represents the authors’ responsibility and does not necessarily reflect the official views of the NIH.x
