NIH STTR

NIH STTR Phase II (Omnibus)

Funds United States small-business and research-partner teams advancing biomedical projects already proven in early studies.

The NIH STTR Phase II Omnibus funds the full R&D execution phase of a technology that has cleared STTR Phase I feasibility review, issued under activity code R42 with the same $2,045,816 total-cost cap and one-to-three-year performance period as its SBIR Phase II counterpart. NIH disburses approximately $65 million per fiscal year in STTR Phase II awards. The program continues the formal collaboration between the small business and a non-profit research-institution partner that was established at Phase I: the small business must still perform at least 40% of the funded effort, and the research institution must still perform at least 30%. This sustained collaboration structure distinguishes STTR Phase II from SBIR Phase II throughout the full development arc.

Eligibility requirements carry forward from Phase I: U.S. small business concern of 500 or fewer employees, majority U.S.-owned, with VC-majority ownership explicitly disallowed. The partnering research institution must be a non-profit U.S. entity, typically a university or federal research facility. Clinical trial applications use the separate STTR Clinical Trials NOFO. Standard receipt dates are September 5, January 5, and April 5. As with all NIH SBIR/STTR mechanisms, successor NOFOs following the April 2026 reauthorization are expected before the September 2026 cycle. Participating ICs span the full NIH enterprise plus CDC and FDA under the shared omnibus parent announcement.

FY25 STTR Phase II success rates were approximately 27%, materially higher than SBIR Phase II (22%), reflecting the more selective and smaller STTR applicant pool. Phase II applications must demonstrate Phase I milestone completion, include a detailed commercialization plan, and maintain the documented research-institution partnership. Companies exceeding NIH's commercialization benchmarks — specifically those with more than 15 Phase II awards in the past ten fiscal years — must demonstrate at least $100,000 in average revenue or investment per award to maintain eligibility. STTR Phase II represents the primary non-dilutive development vehicle for university spinouts working in biomedical, behavioral, or health-services innovation.