Challenge Summary:
The National Institute on Drug Abuse (NIDA), one of the components of the National Institutes of Health (NIH), announces the annual “$100,000 Start an SUD Startup” Challenge. The Challenge goal is to support research ideas in the areas of drug use, misuse, and substance use disorder (SUD) that are intended to be the foundation for developing successful new startups. NIDA expects that the Challenge will enable the winning Teams to test the premise that their research idea can be fostered into a biotech startup, and that eventually the newly created startups will contribute to the pool of innovative small business companies that can successfully compete for NIDA’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding.
The Challenge is to be administered in two stages. In Stage 1, up to 12 winning Teams (Teams must be comprised of no less than 3 and no more than 5 individuals) will be offered a non-cash prize of a 6-month-long biomedical product development mentorship from NIDA entrepreneurship experts. In Stage 2, the Teams that put in the required time and effort to successfully complete the training process will be selected to deliver a Team startup presentation and awarded a cash prize of up to $10,000 each. The Challenge total cash prize purse available to distribute across all winning Teams is up to $100,000.
Subject of the Challenge:
NIDA is reissuing this Challenge because of its continued success and strong popularity within the community. The Challenge is a competition for Teams of participants with research ideas in the areas of drug use, misuse, and substance use disorder (SUD). These research ideas are purposefully intended to be the foundation for developing new successful biomedical startups. NIDA will award up to 12 Teams (Teams must be comprised of no less than 3 and no more than 5 individuals) with dedicated one-on-one technical mentoring from NIDA entrepreneurship experts and up to $10,000 in cash for each Team that completes all requirements of the mentoring process. NIDA expects this Challenge will inspire and enable the winning Teams to test the premise that their SUD research idea can be fostered into a biotech startup. This Challenge is unique because NIDA intends to provide dedicated entrepreneurial assistance and prize money to the “would-be” startup founders much earlier than most investors, incubators, or traditional models of research funding, such as small business grants. NIDA anticipates that the newly created startups will eventually contribute to the pool of innovative small business companies that can successfully compete for NIDA’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding.
What does it take to participate in the Challenge? The participants must have a research idea directly related to the research areas of drug use, misuse, or SUD, or an idea that could be extended or adapted to be useful in those research areas. For a platform technology, the research idea must be broad enough to address multiple conditions, or indications, including SUD. For example, if the idea would only work for cancer or diabetes, entering this Challenge is not appropriate. However, if the plan is to test an idea for a research tool that would further an understanding of neurobiology relevant to SUD, drug use, or misuse to advance the field faster and with greater fidelity, entering this Challenge is appropriate.
The participants must intend to create a startup around their research idea to bring a startup product to the target customers. Here, the term “product” is used in its broadest definition. Product is any source of value for the people who become customers. Services, subscriptions, software as a service (SaaS), physical/tangible products (biomedical devices, drugs, etc.), aggregations, etc. could all provide value and thus be considered startup products. The startup product could be the result of novel scientific discoveries, repurposing existing technology for a new use, extending a research observation or discovery made in a different scientific field into the SUD area, devising a new business model or distribution/delivery channel that unlocks new value, or simply bringing a product or service to a previously underserved customer.
Potential startup founders must have passion, drive, discipline, and the ability to work collaboratively to push forward under conditions of business uncertainty and must be eager to be coached. The Teams must also have time to dedicate to the 6-month product development mentorship and the work involved. The Team must include no less than 3 and no more than 5 Team members, and the Team must commit to the mentorship process, including attendance at five scheduled monthly 90-minute lectures, attendance at five monthly office hours of 60-90 minutes with their assigned mentor, and timely completion of required homework (five monthly assignments). The amount of time the Teams will need to dedicate is approximately 25 hours per month. In addition, each Team is required to identify a Team Leader who is a citizen or permanent resident of the United States, registers and submits a required Submission Package on behalf of the Team, and is responsible for accepting any prize money in full and distributing it to the other Team members. To reiterate, NIH/NIDA will pay the prize in full to the Team Leader and NIH/NIDA is not responsible for any distribution of the prize among the Team members.
The winners of this Challenge are offered training and encouraged to use the prize money to develop a minimum viable product (MVP), to obtain customer feedback to discover if the MVP meets customer needs, to assess the feasibility of science-based small business creation, and to develop key concepts in support of a NIDA SBIR/STTR application. Post Challenge, as it does with all interested applicants to NIH grant opportunities, NIDA staff will provide technical assistance and guidance about the grant submission process, including how to submit an SBIR/STTR application to NIDA’s small business programs.
Dates:
- Challenge Launch: July 25, 2025
- Submission Start: August 11, 2025 9:00 AM ET
- Submission End: February 4, 2026 06:00 PM ET
- Judging Period: February 9, 2026 to February 27, 2026
- Stage 1, Winners Announced: March 9, 2026
- Stage 2, Winners Announced: September 2026
Statutory Authority to Conduct the Challenge
NIDA is conducting this Challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, as amended [15 U.S.C. § 3719]. The general purpose of NIDA is to conduct and support biomedical and behavioral research, health-services research, research training, and health information dissemination with respect to the prevention of drug use and the treatment of substance use disorders. This Challenge is consistent with and advances the mission of NIDA as described in 42 U.S.C. 285o in that it supports biotech startups in the development of research ideas that would further an understanding and management of SUD. As this Challenge is consistent with and advances the mission of NIDA in that it seeks to identify novel biomedical products to prevent and treat drug use, misuse, and addiction, any submissions pursuing ideas in the areas of alcohol use disorder and pain will not be accepted.
Prizes
Amount of the Prize:
The total cash prize purse for this Challenge is up to $100,000, and up to 12 non-cash prizes will be awarded as well. The Challenge is to be administered in two stages. In Stage 1, up to 12 winning Teams will be awarded a non-cash prize of a 6-month long product development mentorship from NIDA entrepreneurship experts. To successfully complete the training program, the entire Team must be deeply committed and dedicated to the time-intensive mentorship curriculum. Each Team member should plan to spend at least 25 hours per month on mentoring seminars and learning exercises for the entire duration of the 6-month program. In Stage 2, the Teams that put in the required time and effort to successfully complete the training process, culminating in each Team’s startup presentation, will be awarded up to $10,000 per Team. The names of both Stage 1 and 2 winners and the titles of their submissions will be posted on the NIDA website.
Award Approving Official:
The Award Approving Official for this Challenge will be the Director of NIDA.
Payment of the Prize:
Prizes awarded under this Challenge will be paid by electronic funds transfer and may be subject to Federal income taxes. HHS/NIH will comply with Internal Revenue Service withholding and reporting requirements, where applicable. Winners must be able to provide bank account and routing information in order to receive the cash prize funds and must be prepared to obtain additional documentation or funds transfer information from their financial institution as needed. NIDA will pay the cash prize directly and in full to the Team Leader who registers and submits on behalf of a Team. NIDA is not responsible for any distribution of the prize among the Team members.
NIH reserves the right, in its sole discretion, to (a) cancel, suspend, or modify the Challenge, or any part of it for any reason, and/or (b) not award any prizes if no submissions are deemed worthy.
Rules
Eligibility Rules:
The Challenge is open to Teams of participants 18 years of age or older. No prior startup experience is necessary. A Team is defined as a group of individuals assembled with the purpose of participating in this Challenge. Each Team must be a group of no less than three and no more than five individual participants. Each Team is required to identify a Team Leader who is a citizen or permanent resident of the United States, registers and submits a required Submission Package on behalf of the Team, and is responsible for accepting any prize money in full and distributing it to the other Team members. Teams may be a newly formed group of founders, may be part of an entity (e.g., academic institution, non-profit organization), or may have applied to past “Start an SUD Startup” Challenge competitions. If the Team applied to a past Challenge and was not selected for a prize, they may apply again with the same or a new idea, and if the Team applied to a past Challenge and was selected for a prize, they may apply again with a new idea. SBIR and STTR grantees with currently active grants and SBIR/STTR applicants with grant applications currently under review are not eligible to participate in this Challenge.
To be eligible to win a cash or non-cash prize under this Challenge, individuals participating as part of a Team —
- Shall have registered to participate in the Challenge under the rules promulgated by the National Institutes of Health (NIH) as published in this announcement;
- Shall have complied with all the requirements set forth in this announcement;
- In the case of a Team, the Team Leader shall be a citizen or permanent resident of the United States. However, non-U.S. citizens and non-permanent residents can participate as a member of a Team that otherwise satisfies the eligibility criteria. Non-U.S. citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning Team, if applicable, may be recognized when the results are announced.
- Shall not be a federal entity or federal employee acting within the scope of their employment;
- Shall not be an employee of the Department of Health and Human Services (HHS, or any other component of HHS) acting in their personal capacity;
- Who are employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency ethics official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this Challenge;
- Shall not be a judge of the Challenge, or any other party involved with the design, production, execution, or distribution of the Challenge or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child).
- Must have an intention to form a United States-based startup or be a United States-based new startup (i.e., in the early stage of formation and growth).
- Shall be 18 years of age or older at the time of submission.
Participation Rules:
(1) Participants (participating as a group of individuals) may not use federal funds from a grant award or cooperative agreement to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.
(2) Federal contractors may not use federal funds from a contract to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.
(3) By participating in this Challenge, each Participant (participating as a group of individuals) agrees to assume any and all risks and waive claims against the federal government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise.
(4) Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage, or loss potentially resulting from Challenge participation, no Participant (participating as a group of individuals) participating in the Challenge is required to obtain liability insurance, or demonstrate financial responsibility, or agree to indemnify the federal government against third party claims for damages arising from or related to Challenge activities in order to participate in this Challenge.
(5) A Participant (participating as a group of individuals) shall not be deemed ineligible because the Participant used federal facilities or consulted with federal employees during the Challenge if the facilities and employees are made available to all Participants participating in the Challenge on an equitable basis.
(6) By participating in this Challenge, each Participant (participating as a group of individuals) warrants that they are sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original with the Participant (or is an improved version of an existing work that the Participant has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which the Participant is aware.
(7) By participating in this Challenge, each Participant (participating as a group of individuals) grants to the NIH an irrevocable, paid-up, royalty-free nonexclusive worldwide license to publish, post, link to, share, and display publicly the Participants’ names and the title and/or summary of their submission on the web or elsewhere. Each Participant will retain all other intellectual property rights in their submissions, as applicable. To participate in the Challenge, each Participant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of the Participant’s rights to the federal government. To receive an award, Participants will not be required to transfer their intellectual property rights to NIH, but Participants must grant to the federal government the nonexclusive licenses recited herein.
(8) Each Participant (participating as a group of individuals) agrees to follow all applicable federal, state, and local laws, regulations, and policies.
(9) Each Participant (participating as a group of individuals) participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such Participant’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein.
Disqualification:
Submissions may be disqualified for plagiarism, falsification of any information submitted, use of copyrighted material without permission, and use of profanity, violent images, or nudity. NIDA is not responsible for lost, late, incomplete, invalid, unintelligible, or misdirected entries, which will be disqualified. As this Challenge is consistent with and advances the mission of NIDA, in that it seeks to identify novel biomedical products to combat drug addiction, any submissions pursuing ideas in the areas of alcohol use disorder and pain will not be accepted.
Judging Criteria
Basis Upon Which Stage 1 Winners Will be Selected. The judging panel, comprised of federal employee scientists, will consider the following 4 criteria and make recommendations to the award approving official based upon their assessments of the criteria.
- Team/Founders Aptitudes (0-20 points). Does the Team demonstrate a high level of ability and dedication? Is the passion, drive, discipline, ability to work collaboratively, and willingness to push forward under conditions of extreme business uncertainty successfully demonstrated? Is the commitment to participate in the 6-month mentorship process documented? Is the eagerness for coaching demonstrated?
- Validation of Unmet Need (0-10 points). Is there a significant need for the proposed product or service? Does the project address an important problem or a critical barrier to progress in the field of SUD/drug use/misuse research? How was the presence of the need established and validated? Is there any evidence of market research?
- Idea Novelty (0-5 points). Does the proposed idea utilize novel theoretical concepts, approaches, methodologies, instrumentation, service, or interventions for SUD/drug use/misuse research? Will the resulting product successfully differentiate from the currently used approaches and practices to address this same validated need?
- Commercialization (0-10 points). Are the product end-users and purchasers clearly identified? Is there evidence of market research or analysis of competitors? Is there a clear regulatory path for the product/service to reach the market? Is there a clear reimbursement path for the product/service to reach the market?
Submissions that are responsive and comply with the entry requirements will be reviewed by a panel of judges consisting of federal employees. The responsive and compliant submissions will be scored in accordance with the judging criteria outlined above. Failure to meet a minimum standard for any one criterion may disqualify a submission. The score for each submission will be the sum of the scores from each of the voting judges. The scores will be listed in order, from highest to lowest. Challenge contenders with sufficiently high scores may then be contacted via tele- or videoconference. Those meetings will be used to gather more details about the information provided in the Submission Package and to determine the up-to-date level of participants’ availability, interest, and commitment. Final winners of Stage 1 will be determined based on the judges’ scoring and tele- or videoconference meetings.
Basis Upon Which Stage 2 Winners Will be Selected. It is anticipated that Stage 2 winners will be selected based upon their successful completion of the mentorship process, which includes attending all lectures and meetings, timely completion of all exercises assigned to the Team, the quality of the work completed by the Team, nomination from the Team’s coach, and the quality of their presentation during the Peer Board Meeting. The Peer Board Meeting is a final meeting where all Teams present their progress and a summary of the work they have completed throughout the mentorship process.
How to Enter
Registration Process:
Participants must be a group of individuals (i.e., a Team of no less than three and no more than five individuals assembled with the purpose of participating in this Challenge). Each Team is required to identify a Team Leader who registers and submits a required Submission Package on behalf of the Team. To be eligible to win a prize in this challenge, the Team Leader shall be a citizen or permanent resident of the United States. The Team Leader must submit via email the completed registration form and all submission materials to NIDAChallenge@nih.gov by the specified submission deadline date and time. You can download the registration form.
Submission Requirements:
Stage 1
Each submission for this Challenge requires a complete Submission Package. The Submission Package includes the registration form, a 5-minute video introducing the Team, and a 4-page written proposal describing the idea (see requirements below for the video and proposal). Both the 5-minute video and the proposal will be evaluated. Submissions that do not follow the format described below will be disqualified and removed from the prize considerations.
- Video. A 5-minute video must be posted to YouTube and the link to the video provided. In contrast to the proposal, the video is intended to introduce the Team, not the research idea. The Team and its commitment to the mentorship process are evaluated under the “Team/Founders Aptitudes” judging criterion, which allows for the most points.
In the YouTube video:- In one minute or less, tell NIDA who on your Team is the lead “hacker,” also known as technical lead, with the skills to develop your product and to focus on the available technology options and requirements.
- In one minute or less, tell NIDA who on your Team is the lead “hipster,” also known as the end-user/customer need lead, the person concerned with the customer experience and design. This Team member understands the end-user of your product and focuses on the medical and healthcare delivery issues (most often, a practicing SUD physician, clinical department manager, etc.).
- In one minute or less, tell NIDA who on your Team is the lead “hustler,” also known as the business or entrepreneurial lead, with the skills or aspirations to focus on the overall business objectives, customer discovery, business plan, etc.
- Tell NIDA how long you have known each other and relay something that can illustrate the drive or the desire of each Team member to become a startup founder. What unique skill set, background, or experience does this Team have that has led them to pursue this idea?
- Most importantly, convince NIDA of the Team’s commitment to entrepreneurship and the product development mentorship. Tell NIDA something about each Team member that demonstrates a high level of perseverance, commitment, and grit. Tell NIDA how all members of the Team understand the significant time commitment that is required to participate in the Challenge. Describe how each member of the Team is planning to manage the time commitment of approximately 25 hours per month.
- Proposal. The proposal must consist of a PDF file with at least 1-inch margins and be no more than four (4) pages long. Font size must be no smaller than 11-point Arial. All submissions must be in English. The participants must not use the HHS logo or official seal or the logo of NIH or NIDA in the submissions and must not claim federal government endorsement.
In the proposal:- Need Validation. Explain the methods you used (how, when, where, whom) to determine whether the product the Team aspires to develop is needed by the target customer and whether that end-user/customer would be willing to pay for the product. Include calculation of market size and analysis of competing products or current standard of care. (1 page)
- Idea Description. Describe how your research idea would address the identified (clinical) need, further an understanding of drug use, misuse, and/or SUD and be the foundation for a successful startup. The research idea must be defendable and evidence-based. Include references as needed. (1 page)
- Prototype Description and Step-by-Step Use of Final Product, as Envisioned. Describe, in as many details as possible, what the prototype of your envisioned product would look like. Then, walk the Challenge judges through the typical use of the product, using simple terms and instructions. (1.5 pages)
- Team Technical Competence and Research Experience. Convince the Challenge judges of your technical competence, commitment to engaging in the 6-month mentorship program, and willingness to be coached. Be brief and persuasive. Only present the relevant information. Do not use the NIH Bibliographic Sketch format. (0.5 page)
Stage 2
Each Stage 1 winning Team will be required to submit a startup package, produced as a result of the 6-month mentorship, and a presentation for the Peer Board Meeting. Further details on the Submission Package for Stage 2 will be provided to Stage 1 winners during the mentorship process.
- Startup package (5 pages)
- Peer Board Presentation (5 slides)
Additional Information
For Further Information Contact:
Challenge email: NIDAChallenge@nih.gov
Sara Lioi, PhD
NIDA Challenge Administrator
Office of Translational Initiatives and Program Innovations (OTIPI)
National Institute on Drug Abuse (NIDA)
Building 31 Room 1B59
Bethesda, MD 20814
Phone: (301) 827-5829
Email: sara.lioi@nih.gov
Elena Koustova, PhD, MBA
NIDA Challenge Manager
Director, Office of Translational Initiatives and Program Innovations (OTIPI)
National Institute on Drug Abuse (NIDA)
Building 31 Room 1B47B
Bethesda, MD 20814
Phone: (301) 496-8768
Email: elena.koustova@nih.gov