Vilobelimab
- Generic Name
- Vilobelimab
- Drug Type
- Biotech
- CAS Number
- 2250440-41-4
- Unique Ingredient Identifier
- F5T0RF9ZJA
- Background
Vilobelimab is a chimeric monoclonal immunoglobulin G4 (IgG4) antibody that binds to the soluble form of human C5a with high affinity. It consists of mouse anti-human complement factor 5a (C5a) monoclonal binding sites (variable regions of heavy and light chain regions) and human gamma 4 heavy chain and light kappa chain constant regions. In April 2023, the FDA issued an emergency use authorization (EUA) for vilobelimab for the treatment of COVID-19 in hospitalized adults requiring mechanical ventilation or artificial life support. The drug is not yet fully approved for this condition.
- Indication
Vilobelimab is used for emergency use to treat coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). However, vilobelimab is not FDA-approved for this use.
- Associated Conditions
- Coronavirus Disease 2019 (COVID‑19)
- Associated Therapies
- Emergency Treatment
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)
- Conditions
- Acute Respiratory Distress Syndrome (ARDS)ARDSARDS (Acute Respiratory Distress Syndrome)Acute Respiratory Distress Syndrome
- First Posted Date
- 2024-11-25
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- PPD Development, LP
- Target Recruit Count
- 600
- Registration Number
- NCT06703073
- Locations
- 🇺🇸
Nova Clinical Research, Bradenton, Florida, United States
🇺🇸St. Luke's Boise Medical Center, Boise, Idaho, United States
🇺🇸Renown Institute for Heart & Vascular Health, Reno, Nevada, United States
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
- Conditions
- Acute Respiratory Distress Syndrome (ARDS)ARDSARDS (Acute Respiratory Distress Syndrome)Acute Respiratory Distress Syndrome
- First Posted Date
- 2024-11-22
- Last Posted Date
- 2025-05-14
- Lead Sponsor
- PPD Development, LP
- Target Recruit Count
- 200
- Registration Number
- NCT06701682
- Locations
- 🇺🇸
Nova Clinical Research, Bradenton, Florida, United States
🇺🇸St. Luke's Boise Medical Center, Boise, Idaho, United States
🇺🇸Renown Institute for Heart & Vascular Health, Reno, Nevada, United States
Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
- First Posted Date
- 2023-07-27
- Last Posted Date
- 2025-03-27
- Lead Sponsor
- InflaRx GmbH
- Target Recruit Count
- 90
- Registration Number
- NCT05964413
- Locations
- 🇪🇸
Hospital Ramón y Cajal, Madrid, Spain
🇺🇸Aby´s New Generation Research, Inc, Hialeah, Florida, United States
🇺🇸Dermatology/University of Miami Hospital, Miami, Florida, United States
Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.
- Conditions
- SCC - Squamous Cell Carcinoma of Skin
- Interventions
- Drug: Vilobelimab + pembrolizumab combination therapy
- First Posted Date
- 2021-03-23
- Last Posted Date
- 2025-02-11
- Lead Sponsor
- InflaRx GmbH
- Target Recruit Count
- 30
- Registration Number
- NCT04812535
- Locations
- 🇺🇸
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
🇺🇸UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸Inova Schar Cancer Institute, Fairfax, Virginia, United States
Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
- Conditions
- Severe COVID-19 Pneumonia
- Interventions
- First Posted Date
- 2020-04-03
- Last Posted Date
- 2023-06-05
- Lead Sponsor
- InflaRx GmbH
- Target Recruit Count
- 399
- Registration Number
- NCT04333420
- Locations
- 🇲🇽
InflaRx Site #0502, Chihuahua, Mexico
🇫🇷InflaRx Site #1004, Paris, France
🇩🇪InflaRx Site #0202, Berlin, Germany
Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
- First Posted Date
- 2019-06-03
- Last Posted Date
- 2023-09-14
- Lead Sponsor
- InflaRx GmbH
- Target Recruit Count
- 19
- Registration Number
- NCT03971643
- Locations
- 🇺🇸
InflaRx Site #08, Miami, Florida, United States
🇨🇦InflaRx Site #01, Richmond Hill, Ontario, Canada
🇺🇸InflaRx Site #07, Sacramento, California, United States
Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
- Conditions
- Granulomatosis With Polyangiitis (GPA)Microscopic Polyangiitis (MPA)
- Interventions
- First Posted Date
- 2019-03-29
- Last Posted Date
- 2022-08-25
- Lead Sponsor
- InflaRx GmbH
- Target Recruit Count
- 57
- Registration Number
- NCT03895801
- Locations
- 🇬🇧
Clinical Site, Sheffield, United Kingdom
🇪🇸Clinical site, Barcelona, Spain
Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
- Conditions
- Granulomatosis With Polyangiitis (GPA)Microscopic Polyangiitis (MPA)
- Interventions
- First Posted Date
- 2018-10-19
- Last Posted Date
- 2022-05-26
- Lead Sponsor
- InflaRx GmbH
- Target Recruit Count
- 20
- Registration Number
- NCT03712345
- Locations
- 🇺🇸
Texas Health Resources, Dallas, Texas, United States
🇺🇸Rush University Medical Center, Chicago, Illinois, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
- First Posted Date
- 2018-04-04
- Last Posted Date
- 2021-04-08
- Lead Sponsor
- InflaRx GmbH
- Target Recruit Count
- 179
- Registration Number
- NCT03487276
- Locations
- 🇵🇱
InflaRX Investigational Site, Łódź, Poland
🇺🇸InflaRx Investigational Site, Goodlettsville, Tennessee, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.