Vilobelimab

GOHIBIC is a chimeric monoclonal IgG4-kappa antibody that binds to C5a with a dissociation constant of 9.6pM and blocks its interaction with the C5a receptor. C5a is part of the complement system and is activated as part of the innate immune response initiating an inflammatory cascade that includes increased vascular permeability, coagulation, proinflammatory cytokine release, and recruitment and activation of neutrophils and other myeloid cells.

• No contraindications have been identified based on the limited available data for the emergency use of GOHIBIC under this EUA.contraindicated

2.1 Recommended Dosage The recommended dosage of GOHIBIC for the treatment of adults with COVID-19 is 800 mg administered by intravenous infusion after dilution [see Dosage and Administration (2.2) ] for a maximum of 6 (six) doses over the treatment period as described below. Treatment should be started within 48 hours of intubation (Day 1) followed by administration on Days 2, 4, 8, 15 and 22 as long as the patient is hospitalized (even if discharged from ICU). 2.2 Preparation and Administration Preparation Using aseptic technique, dilute and prepare GOHIBIC for intravenous infusion before administration. For the recommended dose of 800 mg GOHIBIC, dilute 80 mL of GOHIBIC in 170 mL of 0.9% Sodium Chloride at room temperature. Use a 250 mL infusion bag of 0.9% Sodium Chloride solution USP and the follow steps below: Withdraw 80 mL of 0.9% Sodium Chloride solution USP from the infusion bag and discard. Withdraw the 80 mL of GOHIBIC from the vials and add slowly to the 0.9% Sodium Chloride solution USP infusion bag to a final concentration of 3.2 mg/mL. To mix the solution, gently invert the bag to avoid foaming. Storage of Diluted GOHIBIC Diluted GOHIBIC must be used within 4 hours when stored at room temperature 20°C to 25°C (68°F to 77°F). Diluted GOHIBIC stored under refrigeration at 2°C to 8°C (36°F to 46°F) must be used within 24 hours. After removal of diluted GOHIBIC from the refrigerator stored at 2°C to 8°C (36°F to 46°F), it must be left to acclimatize to room temperature prior to administration.

There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC use. 5.1 Serious Infections Serious infections due to bacterial, fungal, and viral pathogens have been reported in patients with COVID-19 receiving GOHIBIC. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC. There is limited information regarding the use of GOHIBIC in patients with COVID-19 and concomitant active serious infections. The risks and benefits of treatment with GOHIBIC in COVID-19 patients with other concurrent infections should be considered [see Adverse Reactions (6) ] . 5.2 Hypersensitivity Reactions Hypersensitivity reactions have been observed with GOHIBIC. If a severe hypersensitivity reaction occurs, administration of GOHIBIC should be discontinued and appropriate therapy initiated.

6.1 Clinical Trial Experience The following adverse reactions have been observed in the clinical studies of GOHIBIC that supported the EUA. The adverse reaction rates observed in these clinical studies cannot be directly compared to rates in the clinical studies of other products and may not reflect the rates observed in clinical practice. The safety of GOHIBIC is based on PANAMO, a Phase 3 randomized, placebo-controlled trial in COVID-19 patients requiring IMV or ECMO [see Clinical Studies (14) ] . The analysis of adverse reactions included a total of 364 adult patients who received at least one dose of either GOHIBIC (n=175) or placebo (n=189) plus standard of care. Patients received GOHIBIC 800 mg administered by intravenous infusion on Days 1, 2, 4, 8, 15 and 22 or placebo. During the study, there were 62 deaths in the GOHIBIC arm and 85 deaths in the placebo arm [see Clinical Studies (14) ] . Fatal infections occurred in more placebo patients. Nonfatal serious infections occurred in 58 patients (33.1%) in the GOHIBIC arm and in 55 patients (29.1%) in the placebo arm. The most commonly reported nonfatal serious infections with GOHIBIC were pneumonia (18.9% vs 13.8% in placebo), sepsis (14.9% versus 7.4% in placebo), and septic shock (9.1% versus 7.4% in placebo). Discontinuation of study treatment due to an adverse reaction occurred in 2.9% of the GOHIBIC group and 1.6% of the placebo group. Adverse reactions leading to discontinuation of GOHIBIC included eczema, bronchopulmonary aspergillosis, rash, hemodynamic instability, thrombocytopenia, and multi-organ failure.

8.1 Pregnancy Risk Summary There are no available data on GOHIBIC use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as GOHIBIC is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. In an enhanced pre- and post-natal (ePPND) study conducted in cynomolgus monkeys, placental transport of GOHIBIC was observed but there was no evidence of fetal harm following intravenous administration of GOHIBIC throughout pregnancy at doses 2.5 times the maximum recommended human dose (MRHD) of 800 mg on a mg/kg basis (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk for major birth defects and miscarriage in clinical recognized pregnancies is 2% - 4% and 15% - 20%, respectively.

Metabolism

In healthy subjects, following a single intravenous infusion of GOHIBIC ranging from 2 mg/kg to 4 mg/kg, GOHIBIC C max showed dose proportionality while the AUC showed greater than dose proportionality. The elimination half-life of GOHIBIC following a 4 mg/kg single intravenous dose in healthy subjects was 95 hours.

1. 1Death267%
2. 2Off Label Use133%
3. 3Pyoderma Gangrenosum133%

The 10 most recently updated of 12 ClinicalTrials.gov registrations naming Vilobelimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)
  Recruiting · Phase 2 · Interventional · 600 enrolled · PPD Development, LP
  NCT06703073updated 2026-05-08
• JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
  Recruiting · Phase 2 · Interventional · 200 enrolled · PPD Development, LP
  NCT06701682updated 2026-05-08
• Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
  Terminated · Phase 3 · Interventional · 54 enrolled · InflaRx GmbH
  NCT05964413updated 2025-11-04
• Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.
  Terminated · Phase 2 · Interventional · 30 enrolled · InflaRx GmbH
  NCT04812535updated 2025-02-11
• Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
  Completed · Phase 2 · Interventional · 19 enrolled · InflaRx GmbH
  NCT03971643updated 2023-09-14
• Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
  Completed · Phase 2 · Phase 3 · Interventional · 399 enrolled · InflaRx GmbH
  NCT04333420updated 2023-06-05
• Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
  Completed · Phase 2 · Interventional · 57 enrolled · InflaRx GmbH
  NCT03895801updated 2022-08-25
• Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
  Terminated · Phase 2 · Interventional · 20 enrolled · InflaRx GmbH
  NCT03712345updated 2022-05-26
• Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
  Completed · Phase 2 · Interventional · 179 enrolled · InflaRx GmbH
  NCT03487276updated 2021-04-08
• Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa
  Completed · Phase 2 · Interventional · 12 enrolled · InflaRx GmbH
  NCT03001622updated 2017-09-19

Frequently asked questions

How does Vilobelimab work?

GOHIBIC is a chimeric monoclonal IgG4-kappa antibody that binds to C5a with a dissociation constant of 9.6pM and blocks its interaction with the C5a receptor. C5a is part of the complement system and is activated as part of the innate immune response initiating an inflammatory cascade that includes increased vascular permeability, coagulation, proinflammatory cytokine release, and recruitment and activation of neutrophils and other myeloid cells.

What class of drug is Vilobelimab?

Vilobelimab is classified as Complement inhibitors, Antibody-Receptor Interactions, Cellular Activity Alteration, Decreased Complement Activity, Immunologic Activity Alteration.

What are the brand names for Vilobelimab?

Vilobelimab is marketed under brand names including Gohibic.

What are the contraindications for Vilobelimab?

Vilobelimab labeling lists contraindications including: No contraindications have been identified based on the limited available data for the emergency use of GOHIBIC under this EUA.. Always consult the full prescribing information and a clinician.