Drug Profile

Leronlimab - CytoDyn

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

Latest Information Update: 31 May 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

11 May 2025 Phase-II clinical trials in Colorectal cancer (Combination therapy, Second-line therapy or greater, Inoperable/Unresectable, Metastatic disease) in USA (Parenteral) (NCT06699836)
07 Feb 2025 Pharmacodynamics data from a preclinical studies in Non-alcoholic steatohepatitis released by CytoDyn
17 Dec 2024 CytoDyn in collaboration with Syneos Health plans a phase II trial for Colorectal cancer (Combination therapy, Second-line therapy or greater, Inoperable/Unresectable, Metastatic disease) in February 2025 (NCT06699836)

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