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Organization (Government)

Food and Drug Administration

ClinicalTrials.gov lists Food and Drug Administration as lead sponsor of 25 trials. It has 20 active development programs and 31 approved assets.

TH Government Investor
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18 0 2002 2027

Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.

2026 is partial: 11 registered with a 2026 start date. The hollow diamonds on the dashed line are a forecast of the full-year count, planned starts included: about 14 in 2026 and about 12 in 2027, the average of the 24 months through September, counted as registered and carried forward. The columns, the lighter one included, count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. This method has not been backtested on organizations. In backtests on conditions with as many trial starts a year as this organization (5 to 20), forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Logo Food and Drug Administration, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.

This page covers Food and Drug Administration: 25 lead-sponsored trials and 1 legal-entity registration.

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Disease areas (145)

Shown in this order: most trials first.

Disease areas
Disease area Trials
Substance-Related Disorders 15
Tobacco Use Disorder 12
Pain 6
Anemia 5
Autism Spectrum Disorder 4

Trials by start year as sponsor or collaborator (25)

Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Show the table of trials by start year as sponsor or collaborator
Trials by start year as sponsor or collaborator
Year Trials started
2026 (partial year) 11
2025 11
2024 15
2023 5
2022 17
2021 18
2020 15
2019 12
2018 11
2017 10

Recruitment duration, a model prediction: none of the 25 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

Active development programs (20)

Shown in this order: max phase, then active trials.

Active development programs
Drug Disease area Max phase Trials
10 mg Dronabinol (Marinol®) + Alcohol Beverage Substance-Related Disorders Phase 1 1
Escitalopram and Oxycodone Hypercapnia Phase 1 1
Escitalopram and Oxycodone Respiratory Insufficiency Phase 1 1
Oxycodone and Midazolam Hypercapnia Phase 1 1
10 mg Dronabinol (Marinol®) + Alcohol Beverage Marijuana Abuse Phase 1 1

Approved assets (31)

Shown in this order: max phase first.

Approved assets
Drug Trials
Moxifloxacin 2
Lamotrigine 2
Ranolazine 2
Dofetilide 2
VERAPAMIL 2

Sponsor delivery record (1)

Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.

Sponsor delivery record
Enrollment Timeline
73% hit target (n=15) 31% on time (n=16)

Journals published in (200)

Shown in this order: most published in first.

Journals published in
Journal Publications
Clinical pharmacology and therapeutics 11
Anesthesiology 9
JAMA 9
Blood 7
Neurology 7

US granted patents (1)

Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.

US granted patents
US patents granted Granted in the last 5 years Most recent grant
1 1 2025-04-15

Organization relationships (34)

Shown in this order: most evidence first.

Organization relationships
Related organization Relationship Evidence
Minnesota Office of Higher Education Co sponsors trial with 1
Department of Health and Human Services Co sponsors trial with 1
Boston University Co sponsors trial with 1
Sumitomo Pharma Switzerland GmbH (Switzerland) Co sponsors trial with 1
Consejo Superior de Investigaciones Científicas Co sponsors trial with 1

Latest dated events (198)

Shown in this order: newest first.

Latest dated events
Date Event Source
2026-09-30 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2026-09-24 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2026-09 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2026-08-20 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2026-08-13 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))

Biomarker capability evidence (238)

Shown in this order: tier desc, then gene symbol.

Biomarker capability evidence
Gene Role Evidence
ABCA4 Trial collaborator Named in trial inclusion criteria
ABCD1 Trial collaborator Named in trial inclusion criteria
ATP12A Trial collaborator Named in trial inclusion criteria
ATP4A Trial collaborator Named in trial inclusion criteria
BSN Trial collaborator Named in trial inclusion criteria

Not on this page

Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda inspection record, fda recalls, fda import refusals, manufacturing and distribution sites, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.