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Leronlimab FDA Approval Status

Last updated by Judith Stewart, BPharm on Aug 31, 2021.

FDA Approved: No
Generic name: leronlimab
Company: CytoDyn Inc.

Leronlimab is an investigational CCR5 antagonist in development for the treatment of HIV infection, metastatic triple-negative breast cancer, and severe respiratory complications associated with COVID-19.

  • Leronlimab is thought to calm the aggressive immune response called the ‘cytokine storm’ that occurs in severely ill COVID-19 patients.
  • Leronlimab has been granted Emergency Investigational New Drug (EIND) status by the FDA for use in COVID-19 patients.
  • Leronlimab has been granted Fast Track Designation by the FDA for use as a combination therapy with HAART for HIV-infected patients, and as a treatment of patients with CCR5-positive metastatic triple-negative breast cancer (mTNBC).
  • From early clinical trials studying leronlimab in the treatment of HIV, it is thought that possible side effects may include diarrhea, headache, swollen lymph nodes, high blood pressure, and injection site reactions.

Development timeline for leronlimab

Oct  7, 2021CytoDyn Announces Study to Evaluate Potential Synergistic Effects of Leronlimab with Immune Checkpoint Blockade (ICB)
Aug 25, 2021CytoDyn’s Final mTNBC Report Indicates as Much as 980% Increase in 12-Month Overall Survival and Up to 660% in 12-Month Modified Progression Free Survival
Jun 21, 2021CytoDyn Inc. Announces Positive Preliminary Results of Unblinded Data from Long-Haulers Trial Showing Greater Improvement in Leronlimab Group over Placebo in 18 of 24 Symptoms
Mar 30, 2021CytoDyn’s Leronlimab Decreased Mortality at 14 Days by 82% With Statistically Significant P-Value of 0.0233 Amongst Critically Ill COVID-19 Patients
Mar  5, 2021CytoDyn’s Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients Treated with Leronlimab
Nov 17, 2020CytoDyn Files Protocol with U.S. FDA for Phase 2 Clinical Trial for COVID-19 Patients with Long-Hauler Symptoms
Oct 26, 2020Leronlimab Shows Early, but Promising Clinical Responses in First Two Patients Recovering from Stroke
Oct 20, 2020CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial
Aug 25, 2020CytoDyn Reaches Enrollment of 195 Patients in its Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms
Aug 17, 2020CytoDyn Submits its Top-line Report from its Phase 2 COVID-19 Trial to the U.S. FDA and Requests Emergency Use Approval
Jul 21, 2020CytoDyn Reports Results From CytoDyn’s Phase 2 COVID-19 Trial for Leronlimab
Jun 11, 2020CytoDyn Initiates Phase 2 Clinical Trial With Leronlimab for Treatment of NASH
May  7, 2020Novant Health Initiates Phase 2b/3 Trial with CytoDyn’s Leronlimab for Severely and Critically Ill COVID-19 Patients
May  4, 2020FDA Approves 54 Emergency INDs for Leronlimab Treatment of Coronavirus – CytoDyn Requests Compassionate Use from FDA for COVID-19 Patients Not Eligible for Participation in Two Ongoing Clinical Trials in U.S. – CytoDyn Targets Enrollment Completion for its 75 Patient, Phase 2 Trial by End of May
Apr 30, 2020CytoDyn Reports Strong Results from eIND COVID-19 Patients Treated with Leronlimab; Majority of Patients Have Demonstrated Remarkable Recoveries
Apr 27, 2020CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients
Apr 15, 2020First Patient Treated with Leronlimab in Phase 2b/3 Trial for COVID-19
Apr  7, 2020CytoDyn Collaborating with U.K.’s Department of Health to Provide Emergency Access to Leronlimab for Severe and Critically Ill COVID-19 Patients
Apr  6, 2020First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency IND and Two Patients Have Already Extubated
Apr  2, 2020Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients
Mar 30, 2020Three Additional Patients with Severe COVID-19 Treated with Leronlimab in New York Medical Center Bringing the Total to 10 Patients
Mar 27, 2020Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise with Two Intubated Patients in ICU, Removed from ICU and Extubated with Reduced Pulmonary Inflammation
Mar 23, 2020Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn’s Leronlimab, Bringing the Total to Four Patients
Mar 19, 2020U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab
Mar  9, 2020CytoDyn Files IND and Protocol for Phase 2 Clinical Trial for Treatment of Coronavirus Patients with Leronlimab (PRO 140)
Mar  4, 2020CytoDyn Treats First Patient with Leronlimab in Phase 2 Trial for GvHD under Modified Trial Protocol
Jan 31, 2020CytoDyn Announces Stunning Results from Clinical Trials Evaluating mTNBC and MBC with Leronlimab and will Request an Emergency Type C Meeting with FDA to Enroll 50 Awaiting Patients with a Serious Solid Tumor Cancer Condition
Jan 28, 2020Leronlimab Under Evaluation for Potential Treatment of Coronavirus
Jan 22, 2020Impressive Results Continue from CytoDyn’s Clinical Trials Evaluating Two Patients with Leronlimab, One in mTNBC and One in MBC
Jan 13, 2020CytoDyn Files for Breakthrough Therapy Designation with the FDA for the Use of Leronlimab for the Treatment of Metastatic Triple-Negative Breast Cancer
Dec 17, 2019CytoDyn Signs Definitive Agreements with Vyera Pharmaceuticals to Commercialize Leronlimab in the U.S. for the Treatment of HIV
Dec  3, 2019CytoDyn Reports Early Results from First Patient in its Phase 1b/2 CCR5+ Metastatic Triple-Negative Breast Cancer Trial of Leronlimab
Nov 21, 2019CytoDyn Reports Strong Positive Preclinical Data to Demonstrate Potential of Leronlimab in Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Humanized Mouse Model
Nov 19, 2019CytoDyn's Lead Product Candidate Leronlimab (PRO 140) Inhibits Colon Carcinoma Metastases to Liver and Lung in Preclinical Studies
Nov 12, 2019CytoDyn Receives IRB Approval To Proceed With Compassionate Use Of Leronlimab For Patients With Triple-Negative Breast Cancer
Oct  1, 2019CytoDyn Announces FDA Clearance to Proceed with Phase 2 Clinical Trial of Leronlimab (PRO 140) for Treatment of NASH
Sep 27, 2019CytoDyn Treats First Patient in Phase 1b/2 Clinical Trial with Leronlimab (PRO 140) for Patients with Treatment-Naïve, Metastatic Triple-Negative Breast Cancer
May  8, 2019CytoDyn Provides Updated Pre-Clinical Data Showing Leronlimab (PRO 140) Continues to Suppress Breast Cancer Metastatic Burden >98% Compared with Untreated Animals
May  7, 2019FDA Grants CytoDyn Fast Track Designation for Leronlimab (PRO 140) in metastatic Triple-Negative Breast Cancer, an Unmet Medical Need

Further information

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