Drugs / Leronlimab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn multidrug-resistant tuberculosis 2 milestones | |||||
| Withdrawn | US (FDA) | — | multidrug-resistant tuberculosis | 2022-10-28 | “it has voluntarily withdrawn its pending Biologics License Application (BLA) for leronlimab” cytodyn.com ↗ |
| Rejected (CRL) | US (FDA) | — | multidrug-resistant tuberculosis | — | “In July 2020, the Company received a Refusal to File letter from the FDA regarding its BLA submission for leronlimab” cytodyn.com ↗ |
| Clinical hold HIV infectious disease 1 milestone | |||||
| Clinical hold | US (FDA) | — | HIV infectious disease | 2024-02-29 | “the FDA has lifted the clinical hold on leronlimab.” cytodyn.com ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00110591 | Apr 2004 → Nov 2005 | HIV infectious disease | CytoDyn, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03838367 | Apr 2019 → Jul 2022 | triple-negative breast carcinoma | CytoDyn, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 213 trials · 1 missed | ||||||
| Phase 2 | NCT07553338 | Apr 2026 → Nov 2027 expected | Alzheimer disease | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 2 | NCT06699836 | Jun 2025 → Jan 2028 expected | colorectal cancer | CytoDyn, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05730673 | Sep 2022 → May 2023 | colorectal cancer, metastatic malignant neoplasm | CytoDyn, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04678830 | Mar → Jun 2021 | COVID-19 | CytoDyn, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04521114 | Dec 2020 → Dec 2021 | metabolic dysfunction-associated steatohepatitis | CytoDyn, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04504942 | May 2020 → Nov 2021 | cancer | CytoDyn, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04347239 | Apr 2020 → Oct 2021 | COVID-19 | CytoDyn, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04343651 | Apr → Jul 2020 | COVID-19 | CytoDyn, Inc. | Completed | Missed primary |
| Phase 2 | NCT02737306 | May 2017 → Apr 2021 | acute graft versus host disease | CytoDyn, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT02355184 | Nov 2014 → Jun 2022 | HIV infectious disease | CytoDyn, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02175680 | Apr 2014 → Feb 2015 | HIV infectious disease | CytoDyn, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01272258 | Dec 2013 → Jan 2017 | HIV infectious disease | CytoDyn, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00613379 | Dec 2007 → Aug 2008 | HIV infectious disease | CytoDyn, Inc. | Completed | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT03902522 | Jun 2018 → May 2020 | HIV infectious disease | CytoDyn, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT05271370 | Aug 2017 → Jun 2022 | HIV infectious disease | CytoDyn, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT02859961 | Dec 2016 → Sep 2020 | HIV infectious disease | CytoDyn, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT02990858 | Nov 2016 → Jun 2022 | HIV infectious disease | CytoDyn, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 32 trials | ||||||
| Phase 3 | NCT04901689 | Oct 2021 → Feb 2023 | pneumonia | Hospital Israelita Albert Einstein | Suspended | No outcome recorded |
| Phase 3 | NCT04901676 | Sep 2021 → Jan 2023 | pneumonia | Hospital Israelita Albert Einstein | Suspended | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT07536815 | — | triple-negative breast carcinoma | CytoDyn, Inc. | Available | No outcome recorded |
| — | NCT04313075 | — | triple-negative breast carcinoma | CytoDyn, Inc. | No longer available | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT02257788 Comparator | Sep 2014 → Feb 2015 | HIV infectious disease | Drexel University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02438345 Comparator | Nov 2012 → Feb 2015 | HIV infectious disease | Drexel University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00642707 Comparator | Mar → Nov 2008 | HIV infectious disease | CytoDyn, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT02483078 Comparator | Oct 2015 → Feb 2018 | HIV infectious disease | CytoDyn, Inc. | Completed | No outcome recorded |
| — | NCT02759042 Background | — | HIV infectious disease | CytoDyn, Inc. | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2026-04-22 | CytoDyn, Inc. | Results CytoDyn Presents New Leronlimab Data in Metastatic Colorectal Cancer at AACR Annual Meeting 2026 cytodyn.com ↗
Results presented at AACR demonstrate that CCR5 inhibition with leronlimab may enhance anti-tumor activity by modulating the tumor microenvironment and improving immune engagement. |
| 2026-04-20 | CytoDyn, Inc. | Results CytoDyn Presents New Leronlimab Data in Metastatic Triple-Negative Breast Cancer at AACR Annual Meeting 2026 cytodyn.com ↗
The presentation highlighted emerging evidence supporting CCR5 inhibition with leronlimab as a strategy to modulate the tumor microenvironment, enhance immune responsiveness, and improve outcomes in metastatic triple-negative breast cancer (mTNBC). |
| 2026-03-24 | CytoDyn, Inc. | Results CytoDyn Presents at AACR Special Conference in Cancer Research: Brain Cancer cytodyn.com ↗ |
| 2026-02-20 | CytoDyn, Inc. | Results CytoDyn Presents Novel CCR5 Inhibition Mechanisms and Long-Term Survival Signals for Leronlimab in Metastatic Breast Cancer at AACR Immuno-Oncology Conference cytodyn.com ↗ |
| 2025-12-08 | CytoDyn, Inc. | Results CytoDyn to Showcase PD-L1 Upregulation and Improved Survival in Metastatic Triple Negative Breast Cancer at the San Antonio Breast Cancer Symposium cytodyn.com ↗
Leronlimab treatment is associated with upregulation of PD-L1 in circulating tumor cells and cancer-associated macrophage-like cells |
| 2025-09-25 | CytoDyn, Inc. | Results CytoDyn to Present on Leronlimab Induction of PD-L1 and Immune Checkpoint Inhibitor Responses in Metastatic Triple-Negative Breast Cancer at the AACR Special Conference: Mechanisms of Cancer Immunity and Cancer-related Autoimmunity cytodyn.com ↗ |
| 2025-09-16 | CytoDyn, Inc. | Results CytoDyn to Present at the AACR Special Conference: Mechanisms of Cancer Immunity and Cancer-related Autoimmunity cytodyn.com ↗ |
| 2025-07-01 | CytoDyn, Inc. | Results CytoDyn Announces Encouraging Survival Data in Patients with Metastatic Colorectal Cancer Previously Treated with Leronlimab cytodyn.com ↗
The final results indicate that 3/5 patients treated with leronlimab had at least a partial response, as measured by radiologic criteria, including one patient with a complete response who remains alive five years later. |
| 2025-05-13 | CytoDyn, Inc. | Results CytoDyn Announces Data Suggesting Novel Mechanism of Action of Leronlimab for the Treatment of Solid Tumors cytodyn.com ↗
CytoDyn’s results indicate that 15/17 (88%) of patients who received a weekly dose of 525 mg or higher experienced a significant increase in PD-L1 expression on their CTCs over a 30-to-90-day period after starting leronlimab. |
| 2025-04-29 | CytoDyn, Inc. | Results CytoDyn Leadership Team To Attend ESMO Breast Cancer Meeting in Munich, Germany cytodyn.com ↗
The Company has also now confirmed survival outcomes in a group of patients with mTNBC and four prior lines of treatment who are alive more than 48 months after receiving leronlimab. |
| 2025-02-24 | CytoDyn, Inc. | Results CytoDyn Announces Promising Survival Observations in mTNBC Patients Treated with Leronlimab cytodyn.com ↗
CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced encouraging survival outcomes among a group of patients with metastatic triple-negative breast cancer (“mTNBC”) treated with leronlimab. |
| 2025-02-06 | CytoDyn, Inc. | Results CytoDyn Announces Findings of Statistically Significant Fibrosis Reversal Across Studies with SMC Laboratories cytodyn.com ↗
The three studies demonstrated statistically significant reversal of liver fibrosis with leronlimab monotherapy (compared to an isotype IgG4 control arm with p-values across all 3 studies < 0.01). |
| 2024-11-04 | CytoDyn, Inc. | Regulatory CytoDyn Announces FDA Clearance of Its Phase II Oncology Trial cytodyn.com ↗
CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that it has received clearance from the FDA to commence its Phase II oncology trial. |
| 2024-10-07 | CytoDyn, Inc. | Results CytoDyn Announces Abstract that Highlights Leronlimab’s Potential in Mediating ART-Free Viral Control in Infant Rhesus Macaques cytodyn.com ↗
The combination of ART, bNAbs, and leronlimab showed promising results, with no virus rebound observed in any of the treated animals, suggesting a potential for durable viral control and a significant advancement towards minimizing or eliminating the need for ongoing ART. |
| 2024-09-24 | CytoDyn, Inc. | Results CytoDyn Announces Preliminary Findings in Study with SMC Laboratories cytodyn.com ↗
CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today a preliminary review of results from its preclinical study with SMC Laboratories. |
| 2024-02-29 | CytoDyn, Inc. | Regulatory CytoDyn Announces FDA Has Lifted Clinical Hold cytodyn.com ↗
CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the FDA has lifted the clinical hold on leronlimab. |
| 2024-02-01 | CytoDyn, Inc. | Regulatory CytoDyn Announces Submission of Clinical Protocol to FDA and Initiation of Pre-Clinical Study in Glioblastoma cytodyn.com ↗
CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the Company has submitted its revised HIV clinical trial protocol to the FDA. |
| 2022-10-28 | CytoDyn, Inc. | Regulatory CytoDyn Announces Voluntary Withdrawal of BLA for HIV-MDR Due to CRO Data Management Issues cytodyn.com ↗ |
| 2022-04-12 | CytoDyn, Inc. | Results CytoDyn Announces Publication of Peer-Reviewed Paper, “Suppression of Human and Simian Immunodeficiency Virus Replication with the CCR5-Specific Antibody Leronlimab in Two Species” cytodyn.com ↗
All five long-term participants successfully maintained HIV suppression via leronlimab monotherapy for over seven years, with no evidence of viral escape. |
| 2022-03-30 | CytoDyn, Inc. | Regulatory CytoDyn Announces Partial Clinical Hold of HIV Program and Full Clinical Hold of COVID-19 Program cytodyn.com ↗
The partial clinical hold on the HIV program impacts patients currently enrolled in extension trials. |
All press releases naming this drug 29 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Leronlimab | “The CCR5-specific antibody Leronlimab is being investigated as a novel immunotherapy that can suppress HIV replication with minimal side effects.” PMID 35358290 ↗ Mar 2022 |
| Known as | PRO 140 | “Leronlimab (PRO 140) will be administered subcutaneously as weekly dose of 525 mg until disease progression or intolerable toxicity.” NCT04504942 ↗19“Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the C-C chemokine receptor type 5 (CCR5).” NCT04901689 ↗ “Leronlimab (PRO 140) is a humanized IgG4,k monoclonal antibody (mAb) that recognizes the C-C chemokine receptor type 5 (CCR5).” NCT04901676 ↗ “Leronlimab, also known as PRO 140, is a humanized IgG4κ monoclonal antibody to Chemokine Receptor type 5 (CCR5).” NCT07553338 ↗ “Leronlimab (PRO 140) SC” NCT05730673 ↗ “leronlimab (PRO 140)” NCT07536815 ↗ |
| Action | Inhibit | “broadly and potently blocks CCR5-mediated HIV entry” NCT00110591 ↗ |
| Modality | Monoclonal antibody | “man-made monoclonal antibody” NCT00110591 ↗ |
| Route | Intravenous | “administered via intravenous infusion” NCT00110591 ↗ |
| Target | CCR5 | “Monoclonal antibody to CCR5” NCT00110591 ↗ |