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# CytoDyn Promoting Unapproved Drug: OPDP
- URL: https://www.fdaweb.com/cytodyn-promoting-unapproved-drug-opdp/
- Published: 2022-02-22T12:00:00.000Z
- Updated: 2026-09-14T17:33:35.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5151207

The CDER Office of Prescription Drug Promotion (OPDP) says a 9/22/21 video interview with the then-CEO of CytoDyn, Vancouver, WA, represented in a promotional context that leronlimab, an investigational new drug, is safe and effective for the purpose for which it is being investigated. Specifically, according to a 2/11 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cytodyn-inc-626957-02112022?ref=fdaweb.com), the video suggests that leronlimab provides a clinical benefit to individuals with Covid-19.

OPDP says the drug is misbranded because the video makes conclusory representations in a promotional context regarding the safety and efficacy of leronlimab, which has not been approved or authorized by FDA and whose safety and efficacy have not been established.

The letter notes that a 5/17/21 agency communication reviewed the results of two clinical trials and said, “it has become clear that the data currently available do not support the clinical benefit of leronlimab for the treatment of Covid-19.”

CytoDyn was told to respond by addressing the agency’s concerns and listing all other company promotional communications for leronlimab that contain the violative representations, with a plan for discontinuing the use of such communications or for ceasing distribution of the drug.

The company also was told to submit a comprehensive plan to disseminate truthful, non-misleading, and complete corrective communications about the concerns discussed in the letter to audiences that received the promotional video.