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Organization (Industry)

CytoDyn Inc.

ClinicalTrials.gov lists CytoDyn Inc. as lead sponsor of 24 trials. It has 33 active development programs.

US Industry Manufacturer CIK 0001175680
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4 0 2004 2026

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: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.6 trial starts a year over the five years to September, under the 5 a year the method needs.

This page covers CytoDyn Inc.: 24 lead-sponsored trials and 2 legal-entity registrations.

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Disease areas (10)

Shown in this order: most trials first.

Disease areas
Disease area Trials
HIV Infections 7
COVID-19 5
Acquired Immunodeficiency Syndrome 3
Breast Neoplasms 3
Triple Negative Breast Neoplasms 3

Trials by start year as sponsor or collaborator (15)

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
2025 1
2022 1
2021 3
2020 4
2019 1
2018 1
2017 2
2016 2
2015 1
2014 2

Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

Active development programs (33)

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

Active development programs
Drug Disease area Max phase Trials
PRO 140 HIV Infections Phase 2/3 5
PRO 140 Acquired Immunodeficiency Syndrome Phase 2/3 2
700 mg leronlimab Colorectal Neoplasms Phase 2 1
350 mg leronlimab Colorectal Neoplasms Phase 2 1
200 mg Pembrolizumab Colorectal Neoplasms Phase 2 1

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
50% hit target (n=14) 23% on time (n=13)

Journals published in (13)

Shown in this order: most published in first.

Journals published in
Journal Publications
Medical hypotheses 2
Alimentary pharmacology & therapeutics 1
Clinical and experimental immunology 1
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 1
Clinical medicine (London, England) 1

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
8 2 2023-02-21

SEC-reported annual financials (12)

Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.

SEC-reported annual financials
Fiscal year Revenue (USD) Net income (USD) R&D (USD)
2026 not reported -42,699,000 not reported
2025 not reported 3,745,000 not reported
2024 not reported -49,841,000 7,240,000
2023 0 -79,824,000 2,632,000
2022 266,000 -210,820,000 27,043,000
2021 0 -176,465,000 53,403,000
2020 not reported -139,936,000 52,640,000
2019 not reported -56,187,000 42,490,000
2018 not reported -50,149,681 38,222,580
2017 not reported -25,763,801 20,205,743

Financing and grant events (129)

Shown in this order: most recent first.

Financing and grant events
Date Round type Amount (USD) Source
2026-03-25 Other financing not disclosed Edgar offerings
2026-03-24 Debt financing not disclosed Sec extracted
2026-03-09 Other financing not disclosed Edgar offerings
2026-02-28 Other financing not disclosed Sec extracted
2026-02-27 Private placement 18,800,000 Sec extracted

FDA warning letters (1)

FDA warning letters
Issue date Letter
2022-02-11 cytodyn-inc-626957-02112022

Climate targets, as filed (1)

Climate targets, as filed
Reporting year Net-zero target
2025 not disclosed

Workforce and board diversity, as filed (1)

Workforce and board diversity, as filed
Reporting year Workforce % women Board % women
2025 not disclosed not disclosed

Organization relationships (3)

Shown in this order: most evidence first.

Organization relationships
Related organization Relationship Evidence
Amarex Clinical Research, LLC (United States) Co sponsors trial with 2
Syneos Health (United States) Uses vendor 1
Government of the United States of America Co sponsors trial with 1

Latest dated events (162)

Shown in this order: newest first.

Latest dated events
Date Event Source
2026-03-25 Financing Funding rounds and grants (NIH RePORTER + SEC EDGAR)
2026-03-24 Debt facility Funding rounds and grants (NIH RePORTER + SEC EDGAR)
2026-03-09 Financing Funding rounds and grants (NIH RePORTER + SEC EDGAR)
2026-02-28 Financing Funding rounds and grants (NIH RePORTER + SEC EDGAR)
2026-02-27 Private placement Funding rounds and grants (NIH RePORTER + SEC EDGAR)

Biomarker capability evidence (128)

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

Biomarker capability evidence
Gene Role Evidence
ALK Trial sponsor Named in trial inclusion criteria
CCR5 Trial sponsor Named in trial inclusion criteria
CCR5 Trial sponsor Named in trial inclusion criteria
CCR5 Trial sponsor Named in trial inclusion criteria
CCR5 Trial sponsor 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, approved assets, fda untitled letters, fda inspection record, fda recalls, fda import refusals, manufacturing and distribution sites, clia clinical laboratory certificates, and biomarkers this organization publishes on.