> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Corrects CytoDyn Misinformation on Leronlimab
- URL: https://www.fdaweb.com/fda-corrects-cytodyn-misinformation-on-leronlimab/
- Published: 2021-05-17T12:00:00.000Z
- Updated: 2026-09-14T16:59:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149337

FDA has taken the rare step of publicly correcting misinformation being disseminated by a drug company about an investigational therapy. In a[ 5/17 notice](https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab?ref=fdaweb.com), FDA says two CytoDyn trials evaluating leronlimab do not support the drug’s clinical benefit in treating Covid-19 despite public company statements suggesting otherwise.

In the CD10 study, FDA says there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints. The primary endpoint for the CD10 trial relied on a measure of participants’ Covid-19 symptoms called a total clinical symptom score. “The CD10 trial results showed no clinically meaningful differences in average change in total clinical symptom score from baseline to Day 14 between study arms (-3.5 in the leronlimab group versus -3.4 in the placebo group),” FDA says. “Additionally, none of the secondary endpoints were met in this study, including mortality, time to symptom resolution, and time to return to normal activity.”

FDA says the other study (CD12) also “failed to find any effect of the drug on the primary study endpoint, with no difference seen in mortality (20.5% in the leronlimab treatment group and 21.6% in the placebo treatment group); or on any of the secondary endpoints, for example, with no difference on the average length of hospitalization (21.4 days in both the leronlimab and the placebo treatment groups).”

The agency also notes that CytoDyn has wrongly communicated differences in small subgroups from the CD12 trial suggesting that the data demonstrated a mortality benefit in certain patients who had received leronlimab. “Subgroup analyses have well-established limitations, especially in the context of a clinical trial that has failed to show a benefit in the overall study population,” it says. “For example, subgroups are often small, and therefore imbalances are common. Here, the data from CD12 illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons.”