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NIH SBIR

NIH SBIR Direct-to-Phase II (Omnibus)

Funds United States small businesses moving directly into major development when early biomedical feasibility is already established.

OpenNational Institutes of HealthUnited States

The NIH SBIR Direct-to-Phase II (D2PII) Omnibus allows U.S. small businesses to apply directly for Phase II-level funding without a prior NIH Phase I award, provided the company can demonstrate that Phase I-equivalent feasibility has already been established through other means. Issued under activity code R44 as a "New" application (not a renewal), D2PII awards carry the same cap as standard Phaseโ€ฆ

Phase II-scope biomedical R&D for projects whose feasibility has been established through prior non-SBIR work (e.g. university research, foundation funding, internal R&D).

CycleiHow often this grant runs - e.g. annually, on a rolling basis, or a one-off call.Multiple per year
Next deadlineiThe next date applications are due. Rolling means you can apply any time.5 Jan 2027
Decision timeiTypical time from the deadline to the funder's decision.36 weeks
Project durationiHow long the funded work is expected to run.1โ€“24 months
Award typeiThe form of funding - grant, equity, loan, tax credit, etc.Grant
Match fundingiThe share of project costs you must cover yourself. 0% = fully funded.0%
Funding pooliThe total budget available across all awards in this round.$80M

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Guides for this application

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Open

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๐Ÿ‡บ๐Ÿ‡ธNIH ยท United States

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๐Ÿ‡บ๐Ÿ‡ธNIH ยท United States

Funds the single centre that runs statistics, data and coordination for the consortium testing anti-obesity medication in children.

Oct'26
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Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs)

๐Ÿ‡บ๐Ÿ‡ธNIH ยท United States

Funds work on the methodological problems that make trials of rapid-acting psychotropic drugs hard to interpret, and on sustaining the treatment afterwards.

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Assay Validation of High Quality Markers for Clinical Studies in Cancer

๐Ÿ‡บ๐Ÿ‡ธNIH ยท United States

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Oct'26
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Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3)

๐Ÿ‡บ๐Ÿ‡ธNIH ยท United States

Funds the clinical validation of a cancer biomarker assay whose analytical performance has already been proven.

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