Opportunity Information: Apply for PAR 25 129
The National Institutes of Health (NIH) is offering an R01 grant opportunity titled "Biology of Bladder Cancer (R01 Clinical Trial Optional)" (Funding Opportunity Number: PAR-25-129). This Notice of Funding Opportunity is focused on supporting research that explains the fundamental biology of bladder cancer and the underlying mechanisms that drive how it starts, progresses, and becomes malignant. The main idea is to move beyond lists of mutations and molecular profiles and instead build a clearer, mechanism-based understanding of what those changes do in cells and tissues over time, and how they translate into tumor behavior, recurrence, and clinical outcomes. Clinical trials are optional under this announcement, meaning applicants may propose studies that include clinical trial components, but they are not required.
A central motivation for the program is that bladder cancer remains a major public health problem in the United States and worldwide, with an especially heavy medical burden due to its high incidence and frequent recurrence. Even though the field has made meaningful strides in identifying mutated genes and characterizing tumor subtypes through molecular profiling, NIH emphasizes that key biological questions remain unanswered. The NOFO highlights a gap between descriptive datasets and true biological understanding: relatively little is known about the molecular and cellular mechanisms that actually cause bladder tumors to form, evolve, invade, resist treatment, or recur. The opportunity is therefore aimed at studies that can explain cause-and-effect relationships, such as how specific molecular events reshape signaling pathways, cell states, tissue organization, microenvironment interactions, or immune responses in ways that enable cancer development and progression.
Another major priority is strengthening the knowledge base for the normal bladder itself. The NOFO explicitly notes that basic understanding of normal bladder biology at the molecular, cellular, and organ levels is limited, and that this limitation slows progress in cancer research. By encouraging projects that investigate both normal and cancer processes, NIH is signaling that strong proposals may compare normal urothelial biology to malignant transformation, define baseline cell types and functions, characterize normal regeneration and injury responses, or map how normal bladder tissues respond to stressors that may contribute to carcinogenesis. The broader purpose is to establish fundamental reference points so researchers can more precisely identify what changes in cancer, when it changes, and why those changes matter.
The solicitation encourages multidisciplinary research teams and approaches, reflecting the complexity of bladder cancer biology. Competitive applications may integrate expertise across cancer biology, urology, pathology, genomics, epigenetics, immunology, computational biology, systems biology, bioengineering, and other fields. The NOFO also encourages the use of clinical specimens, which can include patient-derived tissues and biospecimens that anchor mechanistic work to real disease biology and improve translational relevance. Projects that connect observations from human samples to functional experiments, or that bridge normal bladder biology with tumor biology, align closely with the program's stated interests.
This is a discretionary grant mechanism using the NIH R01 funding instrument, which typically supports substantial, multi-year investigator-initiated research projects. The opportunity falls under health and education activity categories and lists CFDA numbers 93.393 and 93.396. The original closing date is 2025-09-07, and the opportunity was created on 2024-11-19. An award ceiling and the expected number of awards are not specified in the provided source information, which usually means applicants should consult the full announcement for budget parameters and funding expectations.
Eligibility is broad and includes many organization types commonly able to apply for NIH funding. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as listed); for-profit organizations other than small businesses; and small businesses. The NOFO also explicitly calls out additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-domestic (non-U.S.) entities (foreign organizations). This wide eligibility reflects an intent to draw strong bladder cancer biology proposals from diverse institutional settings and to support broad participation, including from institutions serving historically underrepresented communities and from international research organizations.
Overall, this NOFO is aimed at advancing bladder cancer research from descriptive characterization to deeper mechanistic insight, while also building a stronger foundation in normal bladder biology. The expected payoff is more precise understanding of the biological processes that drive initiation, progression, and recurrence, which in turn can inform better prevention strategies, improved biomarkers, and more effective interventions for patients.Apply for PAR 25 129
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Biology of Bladder Cancer (R01 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393, 93.396.
- This funding opportunity was created on 2024-11-19.
- Applicants must submit their applications by 2025-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: Biology of Bladder Cancer (R01 Clinical Trial Optional) - PAR-25-129
What is the name of this NIH funding opportunity?
The opportunity is titled "Biology of Bladder Cancer (R01 Clinical Trial Optional)".
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PAR-25-129.
Which federal agency is offering this grant?
The grant opportunity is offered by the National Institutes of Health (NIH).
What is the main purpose of this NOFO?
This Notice of Funding Opportunity supports research that explains the fundamental biology of bladder cancer, including the mechanisms that drive how bladder cancer starts, progresses, becomes malignant, invades, resists treatment, and recurs.
What kind of research is NIH trying to encourage through this program?
NIH is encouraging research that moves beyond descriptive findings (such as lists of mutations or molecular subtypes) and instead provides a mechanism-based, cause-and-effect understanding of what molecular and cellular changes do over time in cells and tissues, and how those changes translate into tumor behavior, recurrence, and clinical outcomes.
Is this opportunity focused only on tumor profiling and mutation cataloging?
No. The NOFO specifically emphasizes a gap between descriptive datasets and true biological understanding. The focus is on studies that explain how molecular events reshape signaling pathways, cell states, tissue organization, microenvironment interactions, or immune responses to enable cancer development and progression.
Are clinical trials required under this funding opportunity?
No. Clinical trials are optional. Applicants may propose studies that include clinical trial components, but clinical trials are not required under this announcement.
Why is NIH prioritizing bladder cancer biology through this NOFO?
The NOFO notes that bladder cancer remains a major public health problem in the U.S. and worldwide, with a heavy medical burden due to its high incidence and frequent recurrence. NIH highlights that key biological questions about how bladder tumors form and evolve remain unanswered.
What specific scientific gaps does the NOFO highlight?
NIH highlights that, despite advances in identifying mutated genes and tumor subtypes, relatively little is known about the molecular and cellular mechanisms that cause bladder tumors to form, evolve, invade, resist treatment, or recur. The NOFO aims to close the gap between descriptive molecular characterization and mechanism-driven biological understanding.
Does the NOFO encourage research on normal bladder biology as well?
Yes. A major priority is strengthening the knowledge base for the normal bladder. The NOFO states that basic understanding of normal bladder biology at molecular, cellular, and organ levels is limited and that this limitation slows progress in bladder cancer research.
What are examples of normal bladder biology topics that may align with the NOFO priorities?
Based on the NOFO description, aligned projects may include studies that compare normal urothelial biology to malignant transformation, define baseline bladder cell types and functions, characterize normal regeneration and injury responses, and map how normal bladder tissues respond to stressors that may contribute to carcinogenesis.
Does NIH encourage comparing normal bladder processes to cancer processes?
Yes. The NOFO signals that strong proposals may bridge normal bladder biology with tumor biology to establish reference points for identifying what changes in cancer, when it changes, and why those changes matter.
Are multidisciplinary research teams encouraged?
Yes. The solicitation encourages multidisciplinary research teams and approaches to address the complexity of bladder cancer biology.
What disciplines or areas of expertise are mentioned as relevant?
The NOFO indicates that competitive applications may integrate expertise across fields such as cancer biology, urology, pathology, genomics, epigenetics, immunology, computational biology, systems biology, bioengineering, and other related disciplines.
Does the NOFO encourage the use of clinical specimens?
Yes. The NOFO encourages the use of clinical specimens, including patient-derived tissues and biospecimens, to anchor mechanistic work to real disease biology and improve translational relevance.
What kinds of approaches seem especially aligned with this NOFO?
Approaches that connect observations from human samples to functional experiments, and projects that bridge normal bladder biology with tumor biology, align closely with the program's stated interests in moving from descriptive characterization to mechanistic insight.
What is the funding mechanism for this opportunity?
This opportunity uses the NIH R01 funding instrument, which typically supports substantial, multi-year, investigator-initiated research projects.
What activity categories are associated with this opportunity?
The opportunity is listed under health and education activity categories.
What CFDA numbers are associated with this opportunity?
The opportunity lists CFDA numbers 93.393 and 93.396.
When was this opportunity created?
The opportunity was created on 2024-11-19.
What is the original closing date?
The original closing date is 2025-09-07.
Is there an award ceiling listed?
No award ceiling is specified in the provided information. This typically means applicants should consult the full announcement for budget parameters.
Is the expected number of awards listed?
No. The expected number of awards is not specified in the provided information, which commonly indicates that applicants should review the full announcement for funding expectations.
Who is eligible to apply for this NIH R01 opportunity?
Eligibility is broad. Eligible applicants include many organization types commonly able to apply for NIH funding, including various levels of government, eligible educational institutions, nonprofit and for-profit organizations, small businesses, tribal entities, U.S. territories, regional organizations, eligible federal agencies, and non-U.S. (foreign) organizations.
Are higher education institutions eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are nonprofit organizations eligible?
Yes. Eligible applicants include nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as listed in the provided information).
Are for-profit organizations eligible?
Yes. Eligibility includes for-profit organizations other than small businesses, and also includes small businesses.
Are government entities eligible to apply?
Yes. Eligible applicants include state, county, city, township, and special district governments, as well as independent school districts.
Are tribal entities eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments and tribal organizations other than federally recognized tribal governments, as well as Tribally Controlled Colleges and Universities (TCCUs).
Are U.S. territories or possessions eligible?
Yes. The NOFO includes eligibility for U.S. territories or possessions.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The NOFO explicitly includes non-domestic (non-U.S.) entities (foreign organizations) as eligible applicants.
Does the NOFO mention eligibility for institutions that serve underrepresented communities?
Yes. The NOFO calls out additional eligible categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. The NOFO explicitly includes faith-based or community-based organizations among eligible applicant categories.
Are public housing authorities eligible?
Yes. Eligibility includes public housing authorities and Indian housing authorities.
What is the overall expected payoff or impact described for this NOFO?
The NOFO aims to advance the field from descriptive characterization to deeper mechanistic insight, while also building a stronger foundation in normal bladder biology. The expected payoff is more precise understanding of initiation, progression, and recurrence, which can inform better prevention strategies, improved biomarkers, and more effective interventions for patients.
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Apply for PAR 25 129
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| Biology of Bladder Cancer (R21 Clinical Trial Optional) Apply for PAR 25 128 Funding Number: PAR 25 128 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Chemical Countermeasures Research Program (CCRP) Initiative: Basic Research on The Deleterious Effects of Acute Exposure to Ultra-Potent Synthetic (UPS) Opioids (R01 Clinical Trial Not Allowed) Apply for RFA DA 26 034 Funding Number: RFA DA 26 034 Agency: National Institutes of Health Category: Education, Health Funding Amount: $300,000 |
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| Utilizing the PLCO Biospecimens Resource to Bridge Gaps in Cancer Etiology and Early Detection Research (U01 Clinical Trial Not Allowed) Apply for PAR 25 248 Funding Number: PAR 25 248 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Innovative Approaches to Studying Cancer Communication in the New Information Ecosystem (R21 Clinical Trial Optional) Apply for PA 25 295 Funding Number: PA 25 295 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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| Advancing Learning Health Care Research in Outpatient Mental Health Treatment Settings (R34 Clinical Trial Optional) Apply for PAR 25 278 Funding Number: PAR 25 278 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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