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.
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Funder: National Institutes of Health
Due Dates: February 22, 2027 (Applications) | June 21, 2027 (Applications) | October 20, 2027 (Applications) | January 7, 2028 (Closing date)
Funding Amounts: No budget cap; R61 and R33 phases each last 1–3 years, with 5 years maximum overall
Summary: Supports discovery, early evaluation, and preliminary clinical validation of biomarkers for neurological and neuromuscular disorders.
Key Information: Projects must include preliminary human evaluation using standardized human samples or datasets.
Description
This NIH phased R61/R33 program, administered by the National Institute of Neurological Disorders and Stroke (NINDS), supports candidate biomarkers and composite biomarker signatures that could improve neurotherapeutic development, clinical trials, or clinical care decisions. The goal is to deliver candidates ready for definitive analytical and clinical validation, rather than research primarily aimed at understanding disease mechanisms.
The R61 phase establishes proof of concept and may optimize the detection method. The R33 phase tests preliminary clinical utility in an independent retrospective or prospective clinical cohort for one or two defined Contexts of Use. Proposals should explain the unmet clinical need, biological rationale, and advantage over existing tools. Supported modalities include molecular, imaging, behavioral, physiological, and digital measures. Applications may propose clinical trials, but trials are not required.
