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IMPORTANT CORRECTION OF INVESTIGATIONAL DRUG INFORMATION
On February 11, 2022, CytoDyn, Inc. received a Warning Letter from the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion in which FDA asserted that statements made in a video created a misleading impression regarding the safety and efficacy of leronlimab. Leronlimab is an investigational drug that has not been approved (or authorized) by the U.S. FDA for the treatment of COVID-19 or for any indication. For more information, click here to access a Dear Healthcare Provider (DHCP) Letter: View Here.
Pipeline
Building a Broad Pipeline of
Indications
Mechanism of Action: Leronlimab as a CCR5 antagonist
| Program | Indication | Pre-clinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|---|---|
| HIV | |||||
|
Combination Therapy (Fast Track designation) |
Pre-clinical Phase complete
|
Phase 1 Phase complete
|
Phase 2 Phase complete
|
Phase 3 Phase in progress
|
|
| Monotherapy |
Pre-clinical Phase complete
|
Phase 1 Phase complete
|
Phase 2 Phase in progress
|
Phase 3 Phase not started
|
|
| Pre-exposure prophylaxis (PrEP) |
Pre-clinical Phase in progress
|
Phase 1 Phase not started
|
Phase 2 Phase not started
|
Phase 3 Phase not started
|
|
| Oncology | |||||
|
Triple-Negative Breast (Fast Track designation) |
Pre-clinical Phase complete
|
Phase 1 Phase complete
|
Phase 2 Phase in progress
|
Phase 3 Phase not started
|
|
| Basket trial for 22 solid tumors |
Pre-clinical Phase complete
|
Phase 1 Phase complete
|
Phase 2 Phase in progress
|
Phase 3 Phase not started
|
|
| NASH | |||||
| Non-alcoholic steatohepatitis (NASH) |
Pre-clinical Phase complete
|
Phase 1 Phase complete
|
Phase 2 Phase in progress
|
Phase 3 Phase not started
|
|
| COVID-19 | |||||
| COVID-19 Acute Severe |
Pre-clinical Phase complete
|
Phase 1 Phase complete
|
Phase 2 Phase complete
|
Phase 3 Phase in progress
|
|
| COVID-19 Acute Critical |
Pre-clinical Phase complete
|
Phase 1 Phase complete
|
Phase 2 Phase complete
|
Phase 3 Phase in progress
|
|
| COVID-19 Post-Acute (long haulers) |
Pre-clinical Phase complete
|
Phase 1 Phase complete
|
Phase 2 Phase in progress
|
Phase 3 Phase not started
|
|
| MS | |||||
| Multiple Sclerosis (MS) |
Pre-clinical Phase in progress
|
Phase 1 Phase not started
|
Phase 2 Phase not started
|
Phase 3 Phase not started
|
Leronlimab for HIV Treatment
Our lead product, leronlimab (PRO 140), is a subcutaneous injection for HIV that prevents healthy cells from viral entry.
Read More on LeronlimabLeronlimab for Cancer Metastasis
Recent research demonstrates the potential importance of the CCR5 receptor as a therapeutic target in oncology.
Read More on CCR5Coronavirus Disease 2019
CytoDyn is coordinating with several healthcare partners to provide access to leronlimab for COVID-19 patients through two clinical trials, a Phase 2 trial for those with mild-to-moderate indications and a Phase 2b/3 trial for severe and critically ill patients.
Read More on COVID-19Get In Touch
For more information on leronlimab, our science, or our new developments, please reach out to us using the link provided.
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