Development of Biomarkers or Composite Biomarkers for Neurological and Neuromuscular Disorders (R61/R33 - Clinical Trial Optional)
Funding for developing biomarkers to aid in clinical development of neurotherapeutics for neurological and neuromuscular disorders.
Funder: National Institutes of Health
Due Dates: May 21, 2025 (Letter of Intent) | June 20, 2025 (Application) | September 7, 2025 (AIDS) | October 20, 2025 (Application) | January 7, 2026 (AIDS) | February 20, 2026 (Application) | May 7, 2026 (AIDS) | June 22, 2026 (Application) | September 7, 2026 (AIDS) | October 20, 2026 (Application) | January 7, 2027 (AIDS) | February 22, 2027 (Application) | May 7, 2027 (AIDS) | June 21, 2027 (Application) | September 7, 2027 (AIDS) | October 20, 2027 (Application) | January 7, 2028 (AIDS) | January 8, 2028 (Expiration)
Funding Amounts: No budget cap; budgets must reflect actual needs. Project period: up to 5 years (R61: 1–3 years, R33: 1–3 years).
Summary: Supports phased development and initial clinical validation of biomarkers or composite biomarkers for neurological and neuromuscular disorders to improve clinical trials and clinical care.
Key Information: Animal studies are not allowed; preliminary human evaluation is required. Contact NIH if requesting ≥$500,000 direct costs in any year.
Description
This NIH opportunity funds the discovery, development, and initial clinical validation of candidate biomarkers or composite biomarker signatures for neurological and neuromuscular disorders. The goal is to deliver biomarkers that are ready for definitive analytical and clinical validation, enabling more efficient clinical trials and improved clinical decision-making in neurotherapeutics. The mechanism is a phased R61/R33 award: the R61 phase supports proof-of-concept and method optimization using human samples or datasets, while the R33 phase supports preliminary clinical validation for one or two defined contexts of use.
Projects must address an unmet clinical need, provide a strong biological rationale, and demonstrate how the biomarker would improve upon current standards. Multidisciplinary teams are encouraged, and leveraging existing biospecimen/data repositories is recommended.
