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Usona Institute

Full company profile

uuid000r9na

Namestring
Usona Institute
Legal namestring
Usona Institute
Company typeenum
Private
Founded yearint
2014
Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersMadison, United States
HQ citystring
Madison
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Keyword5 values
psilocybin research, clinical trials, depression treatment, psychedelic therapy, medical research
Industry2 codes
1Clinical Development (Phase I–III Trial Design & Execution)
CodeHLAIALAEPrimaryYes
2Regulatory Strategy & IND/NDA/BLA Submissions Support
CodeHLAIALAHPrimaryNo
NAICS code2 codes
  • Research and Development in Biotechnology (except Nanobiotechnology)541714
  • Scientific Research and Development Services5417
SIC code2 codes
  • Services-Commercial Physical & Biological Research8731
  • Pharmaceutical Preparations2834
Product category
Psychedelic Therapeutics Research
Social media profiles1 record
GTM motion2 records

Each record includes

Type, Description, Source

Revenue model1 record
1Nonprofit Research Model
TypeLicensing Royalties
Description

Usona Institute operates as a nonprofit organization developing psychedelic therapies. As a nonprofit pharmaceutical research entity, the revenue model would involve potential licensing of treatments or partnership arrangements post-approval rather than traditional commercial revenue generation.

fiercebiotech.com
Marketing channels2 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components4 values
Technology or R&D, Personnel, Operations, Infrastructure
GTM typeB2B
B2B
Offering typeServices
Services
Core offering1 text field

Usona Institute is a nonprofit medical research organization conducting clinical research on psilocybin as a potential therapeutic for mental illness, with a primary focus on major depressive disorder. The organization is currently running Phase 3 trials and has received FDA Breakthrough Therapy Designation and a Commissioner's National Priority Voucher to accelerate regulatory review timelines. As a nonprofit pharmaceutical research entity, Usona operates through clinical development and eventual licensing/partnership arrangements rather than direct commercialization.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 value
  • Accelerated FDA review timeline from 6-10 months to 1-2 months with priority voucher
Product overview1 text field

Usona Institute is a nonprofit medical research organization conducting clinical trials on psilocybin-based therapy for major depressive disorder. The organization is in the research and development phase with Phase 3 trials underway, having received Breakthrough Therapy Designation and FDA Commissioner's National Priority Voucher. The company does not have a commercial software product or service offering at this time.

Product and service1 record
1Psilocybin Therapy for Major Depressive Disorder
CategoryPsychiatric Drug Development
Scale indicator3 records

Each record includes

Type, Value, Description, Source

Partnership1 partner
Strategic tierCoreTypeOthersAnnounced on2026-04-01
Description

The FDA awarded Usona Institute a Commissioner's National Priority Voucher following President Trump's executive order directing the agency to accelerate research and approval of psychedelic therapies for mental health. This voucher provides priority communication with the FDA and accelerated 1- to 2-month review timelines (compared to standard 6-10 months) for approval applications.

Recent move3 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight4 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Compass Pathways is the most direct peer to Usona: a clinical-stage psychedelic therapy company also in Phase 3 trials of psilocybin for treatment-resistant depression, also holder of an FDA Commissioner's National Priority Voucher, and the other most-cited scientific source on psilocybin for depression alongside Usona.

TypeDirect peer
Description

Transcend Therapeutics was the third co-recipient of the FDA Commissioner's National Priority Voucher alongside Usona, also focused on psychedelic-derived therapies for mental illness, making it a closely comparable regulatory-stage peer.

TypeDirect peer
Description

MindMed is a clinical-stage psychedelic medicine company developing psychedelic-inspired therapies for mental health and addiction, including MDD-adjacent indications, with publicly traded capital access — a direct competitor in the same therapeutic and regulatory category.

TypeDirect peer
Description

Atai Life Sciences is a clinical-stage biopharmaceutical company developing psychedelic and complementary therapies for mental health disorders including depression, with multiple psychedelic programs and a publicly listed platform comparable in scope to Usona's MDD focus.

TypeDirect peer
Description

GH Research is a clinical-stage company developing mebufotenin and other 5-HT2A agonist psychedelic therapies for treatment-resistant depression — directly comparable to Usona's MDD psychedelic approach and patient population.

TypeDirect peer
Description

Cybin is a clinical-stage psychedelic therapeutics company developing deuterated psilocybin analogs for depression and other psychiatric indications, representing a direct pipeline-level peer to Usona's psilocybin MDD program.

TypeEmerging player
Description

Beckley Psytech is a private clinical-stage psychedelic medicine company developing psilocybin and 5-MeO-DMT-based therapies for depression and other CNS indications, overlapping with Usona's therapeutic area at an earlier stage of development.

TypeDirect peer
Description

MAPS (Multidisciplinary Association for Psychedelic Studies) is a nonprofit psychedelic research organization pursuing MDMA-assisted therapy through FDA approval — directly comparable to Usona as a mission-driven nonprofit advancing psychedelic therapy through the regulatory pathway.

TypeEmerging player
Description

Filament Health is a botanical psychedelic drug development company focused on naturally-derived psilocybin, comparable to Usona as a potential manufacturing/development peer for psilocybin-based therapies.

TypeRegional player
Description

Johns Hopkins Center for Psychedelic and Consciousness Research is a leading academic research center conducting clinical trials of psilocybin for depression and other indications — a nonprofit scientific peer whose research underpins much of the field, including Usona's evidence base.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses3 records

Each record includes

Headline, Details, Source

Competitive moat3 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment1 record

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile2 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature1 record

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Usona Institute

Psychedelic Therapeutics Researchusonainstitute.org

Usona Institute firmographics

Firmographics
Name
Usona Institute
Legal name
Usona Institute
Website
https://usonainstitute.org
Company type
Private
Founded year
2014
Operating status
Operating
Headcount range
11–50 employees
Ownership category
akta.pro rank

Usona Institute industry classification

Industry
Product category
Psychedelic Therapeutics Research
NAICS
Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)
SIC
Services-Commercial Physical & Biological Research (8731), Pharmaceutical Preparations (2834)
akta.pro primary industry
Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE)
akta.pro secondary industry
Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

Keywords

  • Psilocybin research
  • Clinical trials
  • Depression treatment
  • Psychedelic therapy
  • Medical research

Where Usona Institute is headquartered

Location

Headquarters

HQ city
Madison
HQ country
United States
HQ region
North America

Markets served

Usona Institute business model

Business model
GTM type
B2B
Offering type
Services
Cost components
Technology or R&D, Personnel, Operations, Infrastructure

Revenue model

  1. Nonprofit Research Model: Usona Institute operates as a nonprofit organization developing psychedelic therapies. As a nonprofit pharmaceutical research entity, the revenue model would involve potential licensing of treatments or partnership arrangements post-approval rather than traditional commercial revenue generation.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels2 records

Usona Institute product offering

Product offering

Core offering

Usona Institute is a nonprofit medical research organization conducting clinical research on psilocybin as a potential therapeutic for mental illness, with a primary focus on major depressive disorder. The organization is currently running Phase 3 trials and has received FDA Breakthrough Therapy Designation and a Commissioner's National Priority Voucher to accelerate regulatory review timelines. As a nonprofit pharmaceutical research entity, Usona operates through clinical development and eventual licensing/partnership arrangements rather than direct commercialization.

Product overview

Usona Institute is a nonprofit medical research organization conducting clinical trials on psilocybin-based therapy for major depressive disorder. The organization is in the research and development phase with Phase 3 trials underway, having received Breakthrough Therapy Designation and FDA Commissioner's National Priority Voucher. The company does not have a commercial software product or service offering at this time.

Differentiator

Problem solved

Functional benefit

Products and services

  • Psilocybin Therapy for Major Depressive Disorder

Quantifiable outcome

  • Accelerated FDA review timeline from 6-10 months to 1-2 months with priority voucher

Companies that use Usona Institute

Customer profile

Segments1 record

Ideal customer profiles2 records

Usona Institute technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature1 record

Usona Institute partnerships and signals

Strategic signal

Partnerships

One partnership is on record.

  • FDA (U.S. Food and Drug Administration)coreOthers · 1 April 2026The FDA awarded Usona Institute a Commissioner's National Priority Voucher following President Trump's executive order directing the agency to accelerate research and approval of psychedelic therapies for mental health. This voucher provides priority communication with the FDA and accelerated 1- to 2-month review timelines (compared to standard 6-10 months) for approval applications.

Scale indicators3 records

Recent moves3 records

Expansion highlights4 records

Usona Institute competitors and assessment

Company assessment

Direct peers

  • Compass Pathways: Compass Pathways is the most direct peer to Usona: a clinical-stage psychedelic therapy company also in Phase 3 trials of psilocybin for treatment-resistant depression, also holder of an FDA Commissioner's National Priority Voucher, and the other most-cited scientific source on psilocybin for depression alongside Usona.
  • Transcend Therapeutics: Transcend Therapeutics was the third co-recipient of the FDA Commissioner's National Priority Voucher alongside Usona, also focused on psychedelic-derived therapies for mental illness, making it a closely comparable regulatory-stage peer.
  • MindMed: MindMed is a clinical-stage psychedelic medicine company developing psychedelic-inspired therapies for mental health and addiction, including MDD-adjacent indications, with publicly traded capital access — a direct competitor in the same therapeutic and regulatory category.
  • Atai Life Sciences: Atai Life Sciences is a clinical-stage biopharmaceutical company developing psychedelic and complementary therapies for mental health disorders including depression, with multiple psychedelic programs and a publicly listed platform comparable in scope to Usona's MDD focus.
  • GH Research: GH Research is a clinical-stage company developing mebufotenin and other 5-HT2A agonist psychedelic therapies for treatment-resistant depression — directly comparable to Usona's MDD psychedelic approach and patient population.
  • Cybin: Cybin is a clinical-stage psychedelic therapeutics company developing deuterated psilocybin analogs for depression and other psychiatric indications, representing a direct pipeline-level peer to Usona's psilocybin MDD program.
  • MAPS / MAPS PBC: MAPS (Multidisciplinary Association for Psychedelic Studies) is a nonprofit psychedelic research organization pursuing MDMA-assisted therapy through FDA approval — directly comparable to Usona as a mission-driven nonprofit advancing psychedelic therapy through the regulatory pathway.

Emerging players

  • Beckley Psytech: Beckley Psytech is a private clinical-stage psychedelic medicine company developing psilocybin and 5-MeO-DMT-based therapies for depression and other CNS indications, overlapping with Usona's therapeutic area at an earlier stage of development.
  • Filament Health: Filament Health is a botanical psychedelic drug development company focused on naturally-derived psilocybin, comparable to Usona as a potential manufacturing/development peer for psilocybin-based therapies.

Regional players

  • Johns Hopkins Center for Psychedelic and Consciousness Research: Johns Hopkins Center for Psychedelic and Consciousness Research is a leading academic research center conducting clinical trials of psilocybin for depression and other indications — a nonprofit scientific peer whose research underpins much of the field, including Usona's evidence base.

Market position

Strengths5 records

Weaknesses3 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Usona Institute social profiles

Digital presence

Usona Institute financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Usona Institute leadership team

Management profile

Number of profiles

Usona Institute funding detail

Funding detail

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Usona Institute M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Usona Institute

What does Usona Institute do?

Usona Institute is a nonprofit medical research organization conducting clinical research on psilocybin as a potential therapeutic for mental illness, with a primary focus on major depressive disorder. The organization is currently running Phase 3 trials and has received FDA Breakthrough Therapy Designation and a Commissioner's National Priority Voucher to accelerate regulatory review timelines. As a nonprofit pharmaceutical research entity, Usona operates through clinical development and eventual licensing/partnership arrangements rather than direct commercialization.

Is Usona Institute a public or private company?

Usona Institute is a private company. It is classified as nonprofit foundation owned and is currently operating.

When was Usona Institute founded?

Usona Institute was founded in 2014. It employs 11 to 50 people.

Where is Usona Institute based?

Usona Institute is headquartered in Madison, United States, in the North America region.

How does Usona Institute make money?

One revenue line is on record: nonprofit Research Model.

Who are Usona Institute's main competitors?

Direct peers on record are Compass Pathways, Transcend Therapeutics, MindMed, Atai Life Sciences, GH Research, Cybin and MAPS / MAPS PBC. Emerging players are Beckley Psytech and Filament Health. Johns Hopkins Center for Psychedelic and Consciousness Research is listed as a regional player.

Does Usona Institute have an API?

No public API is recorded for Usona Institute.

What industry is Usona Institute in?

Usona Institute's product category is Psychedelic Therapeutics Research. Its primary akta.pro industry code is HLAIALAE, Clinical Development (Phase I–III Trial Design & Execution), with a secondary code of HLAIALAH, Regulatory Strategy & IND/NDA/BLA Submissions Support. Its NAICS code is 541714 and its SIC code is 8731.

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Live signals
CNBCWhy Trump is encouraging psychedelics for mental healthIn April 2026, President Donald Trump signed an executive order to accelerate research into psychedelic drugs for mental illness, simultaneously issuing priority review vouchers to Compass Pathways, Usona Institute, and Transcend Therapeutics to expedite FDA review of their psychedelic or MDMA-like therapies. Investors responded positively, driving shares of psychedelic drug developers higher as the order marked a notable policy shift from Trump's first-term stance on controlled substances. Researchers, however, warn that political momentum could outpace scientific evidence, noting that the FDA previously rejected an MDMA-assisted therapy application in 2024 over safety and study design concerns.CNBCWhy Trump is pushing psychedelics research to treat mental illnessThe Trump administration issued an executive order fast-tracking psychedelic drug review, bringing psilocybin, MDMA, and ibogaine closer to FDA approval for mental illness treatment. Published research from Compass Pathways and Usona Institute provides some of the strongest evidence yet for psilocybin as a depression treatment. Scientists, however, have raised concerns that accelerating the approval process could compromise research standards and scientific rigor.Deccan HeraldHow Trump’s Executive Order Boosted Hopes for Psychedelic Drug StartupsPresident Trump's executive order to accelerate psychedelic drug development has raised hopes among companies in the sector that it could attract more institutional capital by reducing regulatory uncertainty. The FDA recently granted expedited review to Compass Pathways, Usona Institute, and Transcend Therapeutics, while investors estimate faster regulatory engagement could save clinical-stage companies tens of millions of dollars. However, researchers caution that most psychedelic drugs remain in early development stages and are still years from market, with funding and insurance reimbursement challenges persisting.Healthcare BrewWhat Trump’s psychedelics order means for healthcarePresident Donald Trump issued an executive order on April 18 to accelerate psychedelic therapy research, granting priority review vouchers to Compass Pathways, Usona Institute, and Transcend Therapeutics. The administration also allocated $50 million to state programs and directed the FDA and DEA to facilitate access under the Right to Try Act, leading to significant stock gains for involved pharmaceutical companies.FierceBiotech‘Real momentum’ or ‘completely absurd’? How Trump’s support has shaken up psychedelicsThe Trump administration directed the FDA to fast-track reviews of psychedelic drug candidates for mental health conditions, leading the agency to grant priority review vouchers to three biotech companies: Compass Pathways, Transcend Therapeutics, and the nonprofit Usona Institute. Medical ethicists and Democratic lawmakers have criticized the process, arguing it was improperly influenced by political factors, including a text from podcaster Joe Rogan, rather than following traditional regulatory procedures. Compass Pathways expects to be launch-ready for its COMP360 psilocybin therapy by the end of the year and anticipates the voucher will accelerate its approval timeline.GenengnewsStockWatch: Trump Order Lifts Psychedelic Drug SharesPresident Trump signed an executive order accelerating psychedelic drug research, and the FDA issued three CNPVs to Compass Pathways, Usona Institute, and Otsuka. Compass shares rose 42% on the first trading day after the order, with COMP360 expected to be the first psychedelic approved in 2027.ReutersUS FDA moves to fast-track psychedelic drugs after Trump orderThe U.S. FDA awarded priority review vouchers to three companies developing psychedelic treatments for serious mental illness, days after President Trump signed an executive order on April 18 directing the agency to accelerate review of breakthrough psychedelic therapies. Compass Pathways confirmed receiving a voucher for its synthetic psilocybin candidate COMP360 for treatment-resistant depression, while Usona Institute and Transcend Therapeutics are developing psilocybin and methylone treatments respectively. The vouchers can cut review time from 6-10 months to 1-2 months, with Compass aiming to be launch-ready by year-end.BioSpaceFDA awards priority vouchers to 3 undisclosed companies for investigational psychedelicsThe FDA awarded Commissioner’s National Priority Vouchers to three companies developing psychedelic therapies for treatment-resistant depression, major depressive disorder, and PTSD, following President Trump’s executive order directing the agency to accelerate psychedelic drug development. While the FDA did not publicly disclose the recipients, Compass Pathways confirmed receipt of a voucher for its psilocybin-based candidate COMP360, with Transcend Therapeutics and Usona Institute identified as matching the agency’s product descriptions. The priority voucher program aims to shorten FDA review timelines from 10–12 months to 1–2 months for products with Breakthrough Therapy designation.FierceBiotechCompass, Usona score FDA national priority vouchers amid Trump administration’s psychedelic pushThe FDA awarded three Commissioner's National Priority Vouchers to Compass Pathways, Usona Institute, and Transcend Therapeutics for their psychedelic treatments targeting treatment-resistant depression, major depressive disorder, and PTSD, respectively, following President Trump's executive order to accelerate mental health treatment access. The vouchers entitle recipients to benefits including priority communication with the FDA and accelerated 1- to 2-month review timelines for approval applications. Separately, the FDA cleared DemeRx NB to conduct the first U.S. clinical study of noribogaine hydrochloride, a derivative of ibogaine, following an Investigational New Drug submission.UsnewsUS FDA Moves to Fast-Track Psychedelic Drugs After Trump OrderThe U.S. Food and Drug Administration said on Friday it is taking steps to accelerate the development of psychedelic-based treatments for serious mental illness, following an executive order signed by President Trump last week. The agency will issue national priority review vouchers to three companies developing such treatments — two studying psilocybin for treatment-resistant depression and major depressive disorder, and one studying methylone for post-traumatic stress disorder — potentially cutting review time to one to two months from the usual six to ten months. Compass Pathways, Usona Institute, and Transcend Therapeutics are the named developers, while the FDA also cleared the first human trial in the United States of noribogaine, a derivative of ibogaine.