NIH SBIR

NIH SBIR Phase II (Omnibus)

Funds United States small businesses advancing validated biomedical innovations through substantial full development execution.

The NIH SBIR Phase II Omnibus is the National Institutes of Health's primary non-dilutive R&D execution grant for U.S. small businesses that have completed or can demonstrate Phase I-equivalent feasibility work. Issued under activity code R44, Phase II awards are capped at $2,045,816 in total costs and cover one to three years of full research and development — typically prototype construction, animal studies, clinical-grade manufacturing runs, or pre-clinical validation, depending on the technology modality. NIH disburses approximately $440 million in SBIR Phase II awards per fiscal year, making it the largest single NIH non-dilutive grant mechanism for small businesses.

Eligibility mirrors Phase I requirements: U.S. small business concerns of 500 or fewer employees, majority U.S.-owned, with the company performing at least 50% of the funded research effort (a relaxed threshold from Phase I's 67%). VC-majority ownership is permitted under SBIR rules. Clinical trial applications must use the separate clinical trials NOFO. Standard receipt dates are September 5, January 5, and April 5; the September 2026 cycle is the first expected after the April 2026 reauthorization. Applications from companies with more than 15 Phase II awards in the past ten fiscal years must demonstrate at least $100,000 in average commercialization revenue or investment per award, or at least 0.15 patents per award, to maintain eligibility.

Review follows NIH's standard 1–9 impact-score peer-review process; each participating institute and center sets its own payline, and FY25 Phase II success rates averaged approximately 22% across NIH. Phase II applications must demonstrate completion of Phase I milestones and include a substantive commercialization plan. A Phase IIB renewal mechanism exists for companies requiring additional R&D funding beyond the initial Phase II period. Most applicants apply to continue work from an NIH-funded Phase I, though the Direct-to-Phase II path is available for those who have established feasibility outside the SBIR ladder.