Drug name
Last update: Aug 2026VRC01 (mAb)
Developer(s)
Drug information
Not provided
VRC-01
Not provided
Biotherapeutic
bNAb targeting gp120 on HIV-1 virus envelope
The crystal structure of VRC01 in complex with the HIV-1 gp120 core has demonstrated that this broadly neutralizing antibody, which targets the CD4 binding site (CD4bs), partially mimics the interaction between gp120 and its primary receptor, CD4. The VRC-01-gp120 interaction has a trimeric viral envelope spike that acts as an aid to gain deeper insights into the antibody’s neutralization mechanism and to identify viral determinants associated with resistance to VRC01-mediated neutralization. The half-life of VRC-01 is estimated to be ~15-20 days with a volume of distribution (Vd) of 3-5 L and a clearance (Cl) of ~0.2–0.3 mL/hr/kg. VRC-01 follows first order of kinetics at 5-30 mg/kg.
Not approved yet
Not approved yet
Therapeutic area(s)
- HIV
- Pre-Exposure Prophylaxis (PrEP)
- Treatment
Administration route
Intravenous, Subcutaneous
Associated long-acting platforms
Solution
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Monthly
- Every 2 months
- Every 3 months
- Every 2 weeks
- Every 6 weeks
Dosage
5 mg/kg; 20mg/kg; 40mg/kg
40 mg/kg
Not provided
Not provided
Not provided
Associated compounds, formulations and regimens
Not provided
Associated technologies
Not provided
Additional information
Developer(s)
NIAID Vaccine Research Center (VRC)
The NIAID Vaccine Research Center (VRC), founded in 1999 at NIH, was established to accelerate vaccine development for infectious diseases like HIV, Ebola, and COVID-19. Located in Bethesda, it includes advanced labs, a vaccine production facility, and clinical trial units, enabling seamless translational research from bench to bedside. Vaccine Production Program (VPP) develops vaccines in-house.
Drug structure
Scale-up and manufacturing prospects
Not provided
Bioreactors, Incubators, filtration units, lyophilizers, formulation vessels,
VRC01 is a monoclonal antibody, and its production involves several key steps: 1. Gene Cloning and Vector Construction: The genes encoding the heavy and light chains of VRC01 are cloned and inserted into suitable expression vectors optimized for antibody production in host cells. 2. Expression Systems: Recombinant VRC01 is expressed in various systems, including human embryonic kidney (HEK) cell lines, plant-based systems (Nicotiana benthamiana or tabacum), and yeast (Pichia pastoris), depending on the desired yield and glycosylation pattern. 3. Protein Purification via affinity chromatography
HPLC, mass spectrometry, spectrophotometers, and sterility tests.
Excipients & delivery device(s)
Not provided
Not provided
Not provided
No delivery device
Safety, Efficacy and Evidence Summary
Not provided
Not provided
Not provided
Not provided
VRC01 antibody and method of treatment of HIV
Monoclonal neutralizing antibodies are disclosed that specifically bind to the CD4 binding site of HIV-I gpl20. Monoclonal neutralizing antibodies also are disclosed that specifically bind to HIV-I gp41. The identification of these antibodies, and the use of these antibodies are also disclosed. Methods are also provided for enhancing the binding and neutralizing activity of any antibody using epitope scaffold probes.
WO2011038290
Compound, MoT
THE UNITED STATES OF AMERICA, as represented by THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Not provided
September 24, 2030
Granted: AU, CA, CN, EP (BE, CH, DE, FR, GB, IT, LI), IN, US