GOHIBIC (Vilobelimab)

GOHIBIC (vilobelimab), from InflaRx, was authorised in the EU on 13 January 2025 (under exceptional circumstances) for adults with acute respiratory distress syndrome (ARDS) caused by SARS-CoV-2 who are on invasive mechanical ventilation, with or without ECMO, and receiving systemic corticosteroids as standard care.

Vilobelimab binds and blocks C5a, a powerful inflammatory part of the complement system that drives lung injury in severe COVID-19. In the main study of 369 critically ill adults, 28-day mortality was 32% with GOHIBIC versus 42% with placebo; this difference was not statistically significant, but supporting analyses and an acceptable safety profile led to authorisation.

• The most common side effects (more than 1 in 20) are infections, including pneumonia, herpes simplex, bronchopulmonary aspergillosis and sepsis.
• It is used only in intensive care settings, alongside standard care.
• The authorisation is under exceptional circumstances, with ongoing obligations to provide further data.

Who orders GOHIBIC?

GOHIBIC is used only in intensive care units, so it is ordered by the hospital or the treating ICU team for a specific ventilated patient.

How many vials are needed?

The EU dose is 800 mg by intravenous infusion, given on up to six days (day 1 within 48 hours of intubation, then days 2, 4, 8, 15 and 22 while the patient remains in hospital). Each vial contains 200 mg, so one dose needs 4 vials (one pack), and a full course needs up to 24 vials.

What documents do we need?

• A prescription or requisition from the treating intensive care specialist
• ICU clinical summary confirming SARS-CoV-2 ARDS on invasive mechanical ventilation
• Patient photo ID, or the hospital’s details when the ICU orders directly

ICU requests are urgent, so please send the requisition and clinical summary together; the order is confirmed once both have been checked.

How is GOHIBIC stored?

The EU label asks for vials to be kept in a refrigerator at 2–8 °C, not frozen or shaken, in the original pack to protect them from light. Unopened vials have a shelf life of 24 months.

GOHIBIC is used in urgent ICU situations and must stay refrigerated. Before accepting an order we confirm stock and cold-chain transport, and we source it only through authorised channels.

ICU teams can call +91 96548 60915 or +91 93100 90915, WhatsApp +91 98104 69557, or email info@indianpharmanetwork.in for availability and pricing.

Global Approval Status:

• European Union: Marketing authorisation under exceptional circumstances, granted on 13 January 2025.
• United States: Emergency Use Authorization (EUA) issued in April 2023; not fully FDA-approved.

Sources:

• GOHIBIC – EU product information (EMA EPAR)
• GOHIBIC EUA labeling on DailyMed (US National Library of Medicine)

Information last checked: November 2026.

What is GOHIBIC (Vilobelimab) prescribed for?

GOHIBIC is a first-in-class anti-C5a monoclonal antibody indicated for COVID-19-induced ARDS in ventilated adults.

Who markets GOHIBIC?

GOHIBIC comes from InflaRx.

How does GOHIBIC help?

Vilobelimab binds and blocks C5a, a powerful inflammatory part of the complement system that drives lung injury in severe COVID-19.

Is GOHIBIC used for mild COVID-19?

No. It is only for critically ill adults with COVID-19 ARDS on mechanical ventilation.

How many doses of GOHIBIC are given?

Up to six doses of 800 mg each, on days 1, 2, 4, 8, 15 and 22, for as long as the patient remains in hospital.

What is the FDA status of GOHIBIC?

It is not fully FDA-approved. In April 2023 the FDA issued an Emergency Use Authorization for certain critically ill adults with COVID-19.