{"id":"vilobelimab","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":["7 DRUG INTERACTIONS No drug interaction studies have been conducted with GOHIBIC."],"commonSideEffects":["6 ADVERSE REACTIONS 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. The most common adverse reactions occurring in at least 3% of GOHIBIC-treated patients and at least 1% more frequently than observed in the placebo arm are summarized in Table 1. Table 1. Adverse Reactions that Occurred in ≥3% of Patients Treated with GOHIBIC and at least 1% More Frequently than Observed in the Placebo Arm through Day 60 Adverse Reactions GOHIBIC + SoC (N=175) Placebo + SoC (N=189) n (%) n (%) SoC = standard of care. A patient is only listed once (regardless of event numbers) but one patient can be listed in different categories with one or additional reactions Pneumonia \"Pneumonia\" includes preferred terms containing the term \"pneumonia\"; does not include \"COVID-19 pneumonia\" 55 (31.4%) 44 (23.3%) Sepsis \"Sepsis\" includes preferred terms containing the term \"sepsis\". 38 (21.7%) 30 (15.9%) Delirium \"Delirium includes the following preferred terms: Delirium, Intensive care unit delirium 22 (12.6%) 20 10.6%) Pulmonary embolism 19 (10.9%) 17 (9.0%) Hypertension 16 (9.1%) 13 (6.9%) Pneumothorax 14 (8.0%) 11 (5.8%) Deep vein thrombosis 11 (6.3%) 9 (4.8%) Herpes simplex 11 (6.3%) 5 (2.6%) Enterococcal infection 10 (5.7%) 8 (4.2%) Bronchopulmonary aspergillosis 10 (5.7%) 7 (3.7%) Hepatic enzyme increased 9 (5.1%) 7 (3.7%) Urinary tract infection 9 (5.1%) 6 (3.2%) Hypoxia 8 (4.6%) 6 (3.2%) Thrombocytopenia 8 (4.6%) 2 (1.1%) Pneumomediastinum 8 (4.6%) 0 (0.0%) Respiratory tract infection 7 (4.0%) 5 (2.6%) Supraventricular tachycardia 7 (4.0%) 1 (0.5%) Constipation 6 (3.4%) 3 (1.6%) Rash 6 (3.4%) 0 (0.0%) 6.3 Required Reporting for Serious Adverse Events and Medication Errors The prescribing healthcare provider and/or the provider's designee is/are responsible for mandatory reporting of all serious adverse events (SAEs) SAEs are defined as: Death;A life-threatening AE;Inpatient hospitalization or prolongation of existing hospitalization;A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;A congenital anomaly/birth defect;Other important medical event, which may require a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly and medication errors potentially related to GOHIBIC within 7 calendar days from the healthcare provider's awareness of the event, using FDA Form 3500 (for information on how to ac"],"contraindications":["4 CONTRAINDICATIONS No contraindications have been identified based on the limited available data for the emergency use of GOHIBIC under this EUA."]},"status":"discontinued","trials":["NCT03895801","NCT06703073","NCT04333420","NCT04812535","NCT02246595","NCT05964413","NCT03001622","NCT06701682","NCT03712345","NCT03971643","NCT02866825","NCT03487276"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"aiSummary":"","brandName":"VILOBELIMAB","companyId":"unknown","ecosystem":[],"mechanism":{"drugClass":"","explanation":"","oneSentence":"12.1 Mechanism of Action 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."},"commercial":null,"references":[],"biosimilars":[],"companyName":"","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"VILOBELIMAB","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03895801","phase":"Phase 2","title":"A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Pol","status":"COMPLETED","sponsor":"InflaRx GmbH","isPivotal":false,"enrollment":57,"indication":"Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA)","completionDate":"2021-06-08"},{"nctId":"NCT06703073","phase":"Phase 2","title":"Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)","status":"RECRUITING","sponsor":"PPD Development, LP","isPivotal":false,"enrollment":600,"indication":"Acute Respiratory Distress Syndrome (ARDS), ARDS","completionDate":"2028-09"},{"nctId":"NCT04333420","phase":"Phase 2","title":"A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia","status":"COMPLETED","sponsor":"InflaRx GmbH","isPivotal":true,"enrollment":399,"indication":"Severe COVID-19 Pneumonia","completionDate":"2021-12-01"},{"nctId":"NCT04812535","phase":"Phase 2","title":"Open Label, Multicenter Phase II Study of the C5a Antibody IFX-1 Alone or IFX-1 + Pembrolizumab in Patients With PD-1 or PD-L1 Resistant/Refractory Locally Advanced or Metastatic Cutaneous Squamous Ce","status":"TERMINATED","sponsor":"InflaRx GmbH","isPivotal":false,"enrollment":30,"indication":"SCC - Squamous Cell Carcinoma of Skin","completionDate":"2024-06-04"},{"nctId":"NCT02246595","phase":"Phase 2","title":"A Phase II Randomized, Placebo-controlled, Double-blind, Dose Controlled Trial in Patients Suffering From Early, Newly Developing Abdominal or Pulmonary Derived Septic Organ Dysfunction to Evaluate Sa","status":"COMPLETED","sponsor":"InflaRx GmbH","isPivotal":false,"enrollment":72,"indication":"Severe Sepsis, Septic Shock","completionDate":"2015-12"},{"nctId":"NCT05964413","phase":"Phase 3","title":"A Randomized, Double-blind, Placebo-controlled, Multicenter, Adaptive Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in the Treatment of Ulcerative Pyoderma Gangrenosum","status":"TERMINATED","sponsor":"InflaRx GmbH","isPivotal":true,"enrollment":54,"indication":"Pyoderma Gangrenosum","completionDate":"2025-07-11"},{"nctId":"NCT03001622","phase":"Phase 2","title":"An Open Label Phase II Trial to Evaluate the Safety of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa","status":"COMPLETED","sponsor":"InflaRx GmbH","isPivotal":false,"enrollment":12,"indication":"Hidradenitis Suppurativa","completionDate":"2017-07"},{"nctId":"NCT06701682","phase":"Phase 2","title":"Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)","status":"RECRUITING","sponsor":"PPD Development, LP","isPivotal":false,"enrollment":200,"indication":"Acute Respiratory Distress Syndrome (ARDS), ARDS","completionDate":"2028-09"},{"nctId":"NCT03712345","phase":"Phase 2","title":"Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Efficacy and Safety Study of IFX-1 in Add-On to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyang","status":"TERMINATED","sponsor":"InflaRx GmbH","isPivotal":false,"enrollment":20,"indication":"Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA)","completionDate":"2021-05-03"},{"nctId":"NCT03971643","phase":"Phase 2","title":"Open Label Exploratory Phase IIa Trial to Investigate the Safety and Efficacy of IFX-1 in Treating Patients With Pyoderma Gangrenosum (OPTIMA)","status":"COMPLETED","sponsor":"InflaRx GmbH","isPivotal":false,"enrollment":19,"indication":"Pyoderma Gangrenosum","completionDate":"2022-01-03"},{"nctId":"NCT02866825","phase":"Phase 2","title":"A Phase II Randomized, Placebo-controlled, Double-blind, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamic Dose Response Relationship of IFX-1 in Patients Undergoing Compl","status":"COMPLETED","sponsor":"InflaRx GmbH","isPivotal":false,"enrollment":116,"indication":"Systemic Inflammatory Response Syndrome, C.Surgical Procedure; Cardiac","completionDate":"2017-01"},{"nctId":"NCT03487276","phase":"Phase 2","title":"A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Determine Efficacy and Safety of IFX-1 in Subjects With Moderate to Severe Hidradenitis Suppurativa","status":"COMPLETED","sponsor":"InflaRx GmbH","isPivotal":false,"enrollment":179,"indication":"Hidradenitis Suppurativa (HS)","completionDate":"2020-01-27"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"INTRAVENOUS","dosage_text":"2 DOSAGE AND ADMINISTRATION 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. Administration Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if discoloration or visible particles are present. Administer diluted GOHIBIC via intravenous infusion over 30 - 60 minutes. Avoid concomitant administration of GOHIBIC with other drugs in the same intravenous line."},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Monoclonal antibody","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"AU","regulator":"TGA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"CH","regulator":"Swissmedic","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"NO","regulator":"NoMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"IS","regulator":"IMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"NZ","regulator":"Medsafe","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"AT","regulator":"AGES","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"BE","regulator":"FAMHP","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":"EMEA/H/C/006123"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"BG","regulator":"BDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"HR","regulator":"HALMED","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"CY","regulator":"PHS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"CZ","regulator":"SUKL","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"DK","regulator":"DKMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"EE","regulator":"SAM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"FI","regulator":"Fimea","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"FR","regulator":"ANSM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"DE","regulator":"BfArM","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"GR","regulator":"EOF","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"HU","regulator":"OGYEI","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"IE","regulator":"HPRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"IT","regulator":"AIFA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"LV","regulator":"ZVA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"LT","regulator":"VVKT","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"LU","regulator":"MS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"MT","regulator":"MMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"NL","regulator":"MEB","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"PL","regulator":"URPL","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"PT","regulator":"Infarmed","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"RO","regulator":"ANMDMR","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"SK","regulator":"SIDC","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"SI","regulator":"JAZMP","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"ES","regulator":"AEMPS","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Gohibic","application_number":null},{"country_code":"SE","re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