Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional) | PAR 20 111

Opportunity Information: Apply for PAR 20 111

The Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional) is an NIH cooperative agreement funding opportunity (PAR-20-111) aimed specifically at small businesses that are trying to move promising small-molecule therapeutics for nervous system disorders closer to, or into, human testing. It is a reissue of an earlier announcement (PAR-18-541) and is structured to help companies bridge the costly, technical gap between early discovery work and the set of studies needed to begin clinical evaluation. While the program is focused on small-molecule drug candidates, it is broadly framed around disorders of the nervous system, supporting projects that can credibly progress toward clinical readiness.

A central feature of this opportunity is its hybrid support model. Awardees continue to run the disease- and target-specific science themselves, meaning the applicant company remains responsible for the specialized biology and pharmacology that depends on proprietary know-how, custom assays, disease models, biomarkers, or other internal research tools. The award provides funding for the work performed in the companys own labs, but it also plugs participants into NIH-supported expertise and infrastructure. In practice, this means awardees collaborate with NIH-funded consultants and may also leverage NIH contract research organizations (CROs) to carry out key drug development tasks that often require specialized capabilities, regulated processes, or scale that early-stage companies may not have in-house.

The CRO-enabled support spans many of the expensive and execution-heavy parts of small-molecule development. This includes medicinal chemistry support for optimization, pharmacokinetics work to understand exposure and drug behavior in vivo, toxicology studies required for regulatory filings, formulation development to produce a drug product suitable for dosing, and chemical synthesis that can include Good Manufacturing Practices (GMP) manufacturing. The program can also support Phase I clinical testing, allowing projects that reach readiness to move into first-in-human evaluation. This structure is designed to increase the odds that promising science is translated into a real development candidate with the data package regulators and investors expect.

BPN accommodates projects at different maturity levels by allowing entry at either a Discovery stage or a Development stage. Discovery-stage entry is for groups that have initial hit compounds and need medicinal chemistry and iterative optimization to improve potency, selectivity, exposure, and overall drug-like properties, with the goal of selecting a development candidate. If a project starts at Discovery and meets its milestones, it may continue forward into Development within the program. Development-stage entry is for projects that already have a more advanced candidate (or are close to one) and want to move more directly toward the IND-enabling track, including the toxicology and other studies needed to support an Investigational New Drug (IND) application and subsequent Phase I clinical testing. In other words, the program is built to support a pipeline from hits to candidates to IND-enabling studies and potentially to early clinical trials, with milestone-driven progression.

Because this is a cooperative agreement, NIH is not simply providing funds and stepping back; there is an expectation of active collaboration and coordinated project execution. The NIH role includes providing access to consultants and contractors and aligning work with program expectations, timelines, and milestone-based decision points. For applicants, this typically means planning a development strategy that can be broken into clear stages with measurable go/no-go criteria, since continued support is tied to meeting defined objectives.

Intellectual property terms are another major draw. The opportunity states that BPN awardee institutions keep their own IP rights and also receive assignment of IP rights from BPN contractors for drug candidates developed through the program. Practically, that means the small business retains control over patent prosecution and licensing negotiations for candidates that emerge from the collaboration, rather than losing leverage to outside vendors or fragmented ownership. For commercialization-focused applicants, that IP structure can reduce downstream friction and make the resulting assets cleaner for partnering or investment.

Eligibility is limited to small businesses, reflecting the programs purpose of accelerating industry-led translation rather than funding basic academic discovery. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, foreign components as defined in NIH policy may be allowed, which typically means certain discrete elements of a project could be performed abroad when strongly justified and compliant with NIH rules, even though the applicant organization itself must be domestic.

Administratively, the opportunity is offered by the National Institutes of Health under a discretionary funding category using the U44 mechanism, with clinical trials listed as optional, meaning a project can be proposed with or without a clinical trial component depending on its stage and readiness. The original closing date listed in the provided data is 2023-09-07, and the opportunity is associated with multiple CFDA numbers, reflecting that it draws on NIH institutes and programs that support neuroscience and neurological disorder research. Overall, the BPN U44 is positioned as a practical, translational pathway for small businesses to turn nervous-system small-molecule leads into IND-ready candidates and, when appropriate, into early human testing using a mix of company-driven biology and NIH-enabled development capabilities.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.213, 93.242, 93.273, 93.279, 93.853, 93.865, 93.866, 93.867.
• This funding opportunity was created on 2020-03-03.
• Applicants must submit their applications by 2023-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 20 111

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