Drug Profile

Leronlimab - CytoDyn

Alternative Names: PA-14; PRO-140; Vyrologix^®

Latest Information Update: 17 Oct 2025

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At a glance

Originator Progenics Pharmaceuticals
Developer CytoDyn; Progenics Pharmaceuticals; Syneos Health
Class Anti-inflammatories; Antidementias; Antineoplastics; Antiretrovirals; Antivirals; Hepatoprotectants; Immunotherapies; Monoclonal antibodies; Vascular disorder therapies
Mechanism of Action CCR5 receptor antagonists; Virus internalisation inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Graft-versus-host disease
New Molecular Entity Yes

Registered Triple negative breast cancer
Preregistration COVID 2019 infections; HIV infections
Phase II Colorectal cancer; Inflammation; Non-alcoholic steatohepatitis; Post acute COVID 19 syndrome; Solid tumours
Phase I Alzheimer's disease
Preclinical Glioblastoma
Suspended COVID-19 pneumonia
Discontinued Graft-versus-host disease; HIV-1 infections; Multiple sclerosis; Stroke; Traumatic brain injuries

16 Oct 2025 CytoDyn completes a phase II/III in HIV-1 infections (Treatment-experienced) in the US (SC, Injection) (NCT03902522)
10 Oct 2025 CytoDyn completes a Phase-II/III clinical trials in COVID-2019 infections in United Kingdom and United States (SC) (NCT04347239)
30 Sep 2025 CytoDyn plans to initiate Data Safety Monitoring Board (DSMB) safety review to commence randomization including the 700 mg dose in phase II trial with Colorectal cancer (Combination therapy, Second-line therapy or greater, Inoperable/Unresectable, Metastatic disease)

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