CAMBRIDGE, Mass., Sept. 30, 2025 — Clear Scientific, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CS-1103, its first-in-class small molecule therapy to reverse acute methamphetamine intoxication. This milestone underscores the urgent medical need for a targeted solution to one of the fastest-growing drivers of overdose deaths in the United States.
Science Significance
Methamphetamine intoxication is a critical health threat, often presenting with agitation, cardiovascular dysfunction, hyperthermia, and multi-organ failure. According to recent data, over 563,000 emergency department visits and more than 29,000 deaths in 2024 were associated with methamphetamine use.
CS-1103 introduces a novel scientific approach by directly binding and encapsulating methamphetamine molecules in the bloodstream, neutralizing their toxic effects and promoting renal excretion. Unlike current management, which relies on purely supportive care, CS-1103 aims to actively remove the drug from circulation. Preclinical models demonstrated rapid reversal of toxicity, and Phase 1 studies confirmed the drug was safe and well-tolerated at clinically relevant doses.
Regulatory Significance
By granting Fast Track designation, the FDA acknowledged the high unmet medical need and potential of CS-1103 to address a life-threatening condition. The program provides Clear Scientific with closer FDA guidance, eligibility for rolling review, and the possibility of priority review upon submission of pivotal data. These regulatory efficiencies may significantly shorten the time to market, accelerating patient access to the first approved therapy for methamphetamine overdose.
Advertisement
Business Significance
For Clear Scientific, this designation represents a defining moment. The company now advances a pipeline asset positioned at the intersection of toxicology, addiction medicine, and emergency care. The stimulant overdose treatment market is largely untapped, and with methamphetamine use continuing to rise globally, CS-1103 could establish Clear Scientific as a leader in developing novel antidote-like therapies. Investors and potential partners are likely to see this milestone as validation of the company’s platform technology and long-term commercial promise.
Patients’ Significance
Today, patients presenting with methamphetamine intoxication are treated only with supportive measures such as sedation, fluids, and cooling, with no antidote available. This leaves clinicians limited in their ability to prevent complications or save lives. CS-1103 offers the possibility of a targeted, fast-acting therapy that could reduce morbidity, shorten hospital stays, and lower mortality rates. For patients and families affected by stimulant misuse, such an option would represent a transformative change in outcomes and hope in a setting where little exists today.
Policy Significance
The Fast Track designation aligns with broader federal strategies to combat the overdose epidemic. Stimulant-related deaths now account for a growing share of U.S. overdose fatalities, making new treatment pathways a public health priority. CS-1103 could influence not only emergency care protocols but also reimbursement frameworks and addiction policy, setting a precedent for treating substance-use emergencies with dedicated pharmaceutical interventions rather than supportive care alone.
Transaction Highlights
Clear Scientific secured FDA Fast Track designation for CS-1103, the company’s first-in-class small molecule designed to reverse acute methamphetamine intoxication. CS-1103 works by encapsulating methamphetamine in the bloodstream and promoting its excretion through urine, thereby reducing systemic toxicity. The molecule has shown safety and tolerability in Phase 1 human studies and demonstrated efficacy in reversing intoxication in preclinical models. With no approved therapies available for stimulant overdose, CS-1103 is poised to fill a critical treatment gap. The FDA designation enables expedited communication, rolling submissions, and potential priority review, thereby shortening the regulatory pathway. For Clear Scientific, this milestone validates its scientific approach, strengthens its development pipeline, and enhances its positioning in addiction medicine and emergency toxicology.
Source: Clear Scientific, Inc. Press Release
