Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)

In plain English

National Institutes of Health (Department of Health and Human Services) has announced this as a forecast: an opportunity it expects to post. It is not open for applications yet. Estimated posting date: Mar 1, 2027. Estimated application due date: May 25, 2027.

The listing does not state award amounts or the number of awards.

Eligible applicant types include nonprofits, small businesses, for-profit companies, state governments, local governments, tribal governments & organizations and colleges & universities, plus others described in the listing.

The listing says cost sharing or matching is not required.

Built only from the fields in the Grants.gov listing. Always confirm on the official listing.

Browse similar: Nonprofits · Small businesses · For-profit companies · State governments · Local governments · Tribal governments & organizations · Colleges & universities

• State governments
• County governments
• City or township governments
• Special district governments
• Public and state-controlled institutions of higher education
• Native American tribal governments (federally recognized)
• Native American tribal organizations (other than federally recognized tribal governments)
• Nonprofits with 501(c)(3) status (other than institutions of higher education)
• Nonprofits without 501(c)(3) status (other than institutions of higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others (see the eligibility details in the listing)

Additional eligibility information (excerpt from the listing):

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. …

Excerpt from the official forecast on Grants.gov (shortened; read the full text on the official listing):

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in supporting the conduct of scientific research utilizing data from intermediate-size patient population expanded access protocols for ALS ("intermediate expanded access protocol for ALS", see Expanded Access Categories for Drugs (Including Biologics) ). Eligible intermediate expanded access protocols for ALS should: 1) provide access to an investigational drug or biological product for people with ALS, and 2) generate data to support research on the prevention, diagnosis, mitigation, treatment, or cure of ALS. …

Read the full forecast on Grants.gov →