This section highlights FDA-related milestones and regulatory updates for drugs developed by InflaRx (IFRX).
Over the past two years, InflaRx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
INF904 and Vilobelimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
INF904 FDA Regulatory Events
INF904 is a drug developed by InflaRx for the following indication: C5aR Inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INF904
- Announced Date:
- December 20, 2024
- Indication:
- C5aR Inhibitor
Announcement
InflaRx N.V announced that the first patient has been dosed in its Phase 2a basket study in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), investigating the Company's oral C5aR inhibitor, INF904.
AI Summary
InflaRx N.V. announced that the first patient has been dosed in its Phase 2a basket study using its oral C5aR inhibitor, INF904. This clinical trial is testing the treatment for two inflammatory conditions: chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS). The study is designed to evaluate the safety, drug levels, and early signs of clinical benefit of INF904.
In this multi-center, open-label trial, approximately 75 patients with moderate-to-severe CSU or HS will participate. The treatment phase will last four weeks, followed by an additional four-week follow-up period. The trial will test various dosing regimens to identify the best exposure, with data expected later next year. InflaRx believes that INF904’s anti-inflammatory properties and best-in-class potential could address significant unmet medical needs in these conditions and possibly other immune-inflammatory disorders.
Read Announcement
Vilobelimab FDA Regulatory Timeline and Events
Vilobelimab is a drug developed by InflaRx for the following indication: Pyoderma Gangraenosum.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Vilobelimab
- Announced Date:
- May 28, 2025
- Indication:
- Pyoderma Gangraenosum
Announcement
InflaRx N.V. announced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase 3 trial for vilobelimab in pyoderma gangrenosum (PG), recommended that the trial be stopped due to futility.
AI Summary
InflaRx N.V. announced that the Independent Data Monitoring Committee (IDMC) recommended stopping its Phase 3 trial for vilobelimab in treating pyoderma gangrenosum (PG) due to futility. The decision came from an unblinded interim analysis of data from the first 30 patients enrolled in the study. Although the committee found no unexpected adverse events, the early evidence indicated that the treatment was unlikely to provide the intended benefit. As a result, InflaRx will discontinue further development of vilobelimab for PG and focus on other projects, such as advancing its oral inhibitor INF904 for chronic immune-dermatological conditions. The company expressed gratitude to the participating physicians and patients for their commitment to the study, underscoring its ongoing commitment to developing innovative therapies for underserved patient populations.
Read Announcement - Drug:
- Vilobelimab
- Announced Date:
- March 7, 2025
- Indication:
- Pyoderma Gangraenosum
Announcement
InflaRx N.V announced the presentation of multiple posters describing the utility of vilobelimab in pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS), including clinical efficacy data, safety assessments, and pharmacokinetic (PK) and pharmacodynamic (PD) analyses.
AI Summary
InflaRx N.V. announced that it is showcasing several posters at the 2025 American Academy of Dermatology Annual Meeting in Orlando, FL. These presentations focus on vilobelimab’s potential in treating pyoderma gangrenosum (PG) and hidradenitis suppurativa (HS). The posters include clinical efficacy data, safety evaluations, and detailed pharmacokinetic (PK) and pharmacodynamic (PD) analyses that highlight the drug’s role in reducing inflammation.
Data from the studies show that vilobelimab is well tolerated among patients suffering from these conditions and is effective in lowering C5a—a key factor in the inflammatory process. In HS patients, promising improvements were observed, such as a significant reduction in draining tunnels. These findings support the idea that targeting the C5a/C5aR pathway may be beneficial in managing these challenging, inflammation-driven diseases and indicate that further research into vilobelimab could lead to promising treatment options.
Read Announcement- Drug:
- Vilobelimab
- Announced Date:
- January 15, 2025
- Indication:
- Pyoderma Gangraenosum
Announcement
InflaRx N.V announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) with or without extracorporeal membrane oxygenation (ECMO).
AI Summary
InflaRx N.V. announced that the European Commission has granted marketing authorization under exceptional circumstances for GOHIBIC® (vilobelimab). This new approval is for treating adult patients with SARS‑CoV‑2-induced acute respiratory distress syndrome (ARDS). The authorized use applies to those receiving systemic corticosteroids as part of standard care while on invasive mechanical ventilation, with or without extracorporeal membrane oxygenation (ECMO).
GOHIBIC is now the first and only treatment approved in the European Union for SARS‑CoV‑2-induced ARDS. The decision follows positive results from the PANAMO study, a large Phase 3 trial that showed improved survival rates among patients. The approval is valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway, marking a significant advancement in the treatment options available for critically ill COVID-19 patients.
Read Announcement- Drug:
- Vilobelimab
- Announced Date:
- November 15, 2024
- Indication:
- Pyoderma Gangraenosum
Announcement
InflaRx N.V. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of GOHIBIC (vilobelimab), under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)).
AI Summary
InflaRx N.V. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion for the marketing authorization of GOHIBIC (vilobelimab). This positive opinion comes under exceptional circumstances and is aimed at treating adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). The treatment is intended for patients already receiving systemic corticosteroids and invasive mechanical ventilation, with or without extracorporeal membrane oxygenation (ECMO).
The EMA’s recommendation reflects significant progress in treating critically ill COVID-19 patients in intensive care. The company expects the European Commission to officially issue the marketing authorization within 67 days. With this positive CHMP opinion, InflaRx is moving closer to making GOHIBIC available for patients in the European market, offering a new potential therapy for those suffering severe respiratory issues due to COVID-19.
Read Announcement- Drug:
- Vilobelimab
- Announced Date:
- September 25, 2024
- Indication:
- Pyoderma Gangraenosum
Announcement
InflaRx N.V. announced the e-poster presentation of a post hoc analysis of the SHINE Phase 2b study of its first-in-class anti-C5a antibody, vilobelimab, in hidradenitis suppurativa (HS) at the 2024 European Academy of Dermatology and Venereology (EADV) Congress being held in Amsterdam, September 25 – 28, 2024.
AI Summary
InflaRx N.V. announced it will present an e-poster at the European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam from September 25 to 28, 2024. The presentation will highlight a post hoc analysis from the SHINE Phase 2b study evaluating its first-in-class anti-C5a antibody, vilobelimab, in patients with hidradenitis suppurativa (HS). The analysis focused on vilobelimab 1200 mg and revealed statistically significant improvements compared to placebo. Notably, the study showed a considerable reduction in draining tunnels, total lesion count, and the International Hidradenitis Suppurativa Score 4, suggesting a promising role for vilobelimab in managing key clinical aspects of HS. This research also examined additional efficacy parameters beyond the standard HiSCR to further understand the potential of vilobelimab in modifying HS by targeting inflammation and reducing difficult-to-treat lesions that impact patient quality of life.
Read Announcement- Drug:
- Vilobelimab
- Announced Date:
- June 24, 2024
- Indication:
- Pyoderma Gangraenosum
Announcement
InflaRx N.V announced today that GOHIBIC (vilobelimab) has been selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as one of three investigational therapies to be assessed in a Phase 2 clinical platform study exploring potential new options for the treatment of acute respiratory distress syndrome (ARDS).
AI Summary
InflaRx N.V. announced that its investigational anti-inflammatory therapy, GOHIBIC (vilobelimab), has been chosen by BARDA for further study in a Phase 2 clinical trial aimed at treating acute respiratory distress syndrome (ARDS). This platform study, which is scheduled to begin later this year, will assess three investigational drugs, each in its own patient cohort of 200 patients. The trial will be randomized, double-blind, and placebo-controlled across about 60 U.S. sites with a total target of 600 adult patients. ARDS is a critical condition with no approved treatments, and the study will focus on assessing vilobelimab’s safety and efficacy by measuring endpoints such as all-cause mortality and other clinical outcomes. InflaRx believes that the drug’s unique mechanism, targeting C5a while preserving immune defense, could offer a promising new treatment option for ARDS patients.
Read Announcement- Drug:
- Vilobelimab
- Announced Date:
- May 21, 2024
- Indication:
- Pyoderma Gangraenosum
Announcement
InflaRx N.V announced data presented at the American Thoracic Society (ATS) 2024 International Conference that is being held from May 17-22, 2024 in San Diego.
AI Summary
InflaRx N.V. presented new data at the American Thoracic Society (ATS) 2024 International Conference in San Diego, held from May 17-22, 2024. The company shared findings from a post-hoc subgroup analysis of the PANAMO Phase III global study, which involved critically ill COVID-19 patients on invasive mechanical ventilation. This analysis focused on the combination of vilobelimab with either tocilizumab or baricitinib, compared to a placebo combined with the same immunomodulators, with all patients receiving standard care.
The data, derived from 71 patients, showed a significant reduction in all-cause mortality. At 28 days, mortality was 6.3% in the treatment group versus 40.9% in the control group, and at 60 days, the figures were 16.4% and 49.3% respectively. Importantly, the co-administration of these therapies raised no safety concerns, highlighting vilobelimab’s potential to improve outcomes in critically ill COVID-19 patients.
Read Announcement
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