Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Grant Opportunity Analysis
The National Institutes of Health and the National Institute of Neurological Disorders and Stroke are seeking applications to support scientific research utilizing data from intermediate-size patient population expanded access protocols for Amyotrophic Lateral Sclerosis. Funded projects must provide access to an investigational drug or biological product for people with ALS and generate scientific research data on the prevention, diagnosis, mitigation, treatment, or cure of the disease. Eligible applicants must be clinical trial sites participating in a phase 2/3 or phase 3 efficacy clinical trial supported by a U.S.-based small business concern that is the FDA-designated sponsor of the investigational product. Applications are not being solicited at this time, but the estimated synopsis post date is March 1, 2027, with an estimated close date of May 25, 2027. For inquiries, potential applicants can contact the program office at NINDSALSMailbox@mail.nih.gov.
Eligible Applicants
Eligible applicants must be clinical trial sites that participate in a phase 2/3 or phase 3 efficacy clinical trial (designed to provide pivotal data to establish substantial evidence of effectiveness in support of a marketing application) supported by a U.S. based small business concern that is the FDA-designated sponsor of a drug or biological product which is the subject of an IND under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) to prevent, diagnose, mitigate, treat, or cure ALS. The definition of a small business concern can be found in section 3(a) of the Small Business Act (15 U.S.C. 632(a)).Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Grant Documents
No documents available for this grant.