Drugs / vilobelimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Gohibic | — | 2025-01-13 | europa.eu ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01319903 | Mar → Oct 2011 | — | InflaRx GmbH | Completed | No outcome recorded |
| Phase 28 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06701682 | Jun 2025 → Jul 2028 expected | adult acute respiratory distress syndrome | PPD Development, LP | Recruiting | No outcome recorded |
| Phase 2 | NCT06703073 | Jun 2025 → Jul 2028 expected | acute respiratory distress syndrome | PPD Development, LP | Recruiting | No outcome recorded |
| Phase 2 | NCT04812535 | Mar 2021 → Jun 2024 | skin squamous cell carcinoma | InflaRx GmbH | Terminated | No outcome recorded |
| Phase 2 | NCT03971643 | May 2019 → Jan 2022 | pyoderma gangrenosum | InflaRx GmbH | Completed | Met primary |
| Phase 2 | NCT03895801 | Apr 2019 → Apr 2021 | granulomatosis with polyangiitis, microscopic polyangiitis | InflaRx GmbH | Completed | No outcome recorded |
| Phase 2 | NCT03712345 | Oct 2018 → Sep 2020 | granulomatosis with polyangiitis, microscopic polyangiitis | InflaRx GmbH | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03487276 | Feb 2018 → May 2019 | hidradenitis suppurativa | InflaRx GmbH | Completed | Missed primary |
| Phase 2 | NCT03001622 | Dec 2016 → Jul 2017 | hidradenitis suppurativa | InflaRx GmbH | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04333420 | Mar 2020 → Oct 2021 | — | InflaRx GmbH | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT05964413 | Nov 2023 → Jul 2025 | pyoderma gangrenosum | InflaRx GmbH | Terminated | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT02866825 Comparator | May → Dec 2016 | autoinflammatory syndrome | InflaRx GmbH | Completed | No outcome recorded |
| Phase 2 | NCT02246595 Comparator | Apr 2014 → Dec 2015 | infectious disease with sepsis | InflaRx GmbH | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2026-03-30 | InflaRx GmbH | Results InflaRx Highlights Clinical Activity of Vilobelimab in Pyoderma Gangrenosum in Late-Breaker Oral Presentation at 2026 American Academy of Dermatology Annual Meeting inflarx.de ↗
Complete disease remission occurred more frequently with vilobelimab (20.8%) than placebo (5.1%) (95% CI: -4.1%, 34.7%). |
| 2025-12-30 | InflaRx GmbH | Results InflaRx Provides Update on Phase 3 Data Analyses for Vilobelimab in Pyoderma Gangrenosum inflarx.de ↗
Our in-depth data analysis reveals signals of efficacy, particularly regarding ulcer volume reduction, which further supports the potential role of the C5a/C5aR pathway in certain neutrophilic skin diseases, such as PG. |
| 2025-05-28 | InflaRx GmbH | Results InflaRx Announces Outcome of Interim Analysis for Vilobelimab Phase 3 Trial in Pyoderma Gangrenosum inflarx.de ↗
This recommendation was based on data analysis of the first 30 patients enrolled in the study, with no unexpected adverse events noted by the IDMC. |
| 2025-03-07 | InflaRx GmbH | Results InflaRx Showcases Vilobelimab’s Role in Immuno-Dermatology at the 2025 AAD Annual Meeting inflarx.de ↗
Multiple safety analyses showed vilobelimab to be well-tolerated in HS, and in the rare and devastating disease of PG, in which patients are often very ill and have co-morbidities. |
| 2025-01-15 | InflaRx GmbH | Regulatory InflaRx Receives European Commission Approval for GOHIBIC® (vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome (ARDS) inflarx.de ↗
GOHIBIC is the first and only treatment approved in the European Union for the treatment of SARS-CoV-2-induced ARDS. |
| 2024-11-15 | InflaRx GmbH | Regulatory InflaRx Receives Positive CHMP Opinion for GOHIBIC® (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome inflarx.de ↗ |
| 2024-09-25 | InflaRx GmbH | Results InflaRx Presents Post Hoc Analysis of SHINE Trial of Vilobelimab in Hidradenitis Suppurativa at the 2024 European Academy of Dermatology and Venereology Congress inflarx.de ↗
Vilobelimab demonstrates significant improvement in reduction of draining tunnels, total lesion count, International Hidradenitis Suppurativa Score 4 and the newly introduced modified-HiSCR: a post hoc analysis of the Phase IIb SHINE study |
| 2024-05-21 | InflaRx GmbH | Results InflaRx Presents New Analysis of PANAMO Phase III Trial in Severe COVID-19 at ATS 2024 Showing Potential Synergy With Vilobelimab When Used in Combination with Other Immunomodulators inflarx.de ↗
The poster is titled, “Vilobelimab in Combination with Tocilizumab or Baricitinib Dramatically Improves Mortality in Critically Ill COVID-19 Patients” and is being presented during the “ARDS and Acute Respiratory Failure: Mechanism, Risk, and Outcomes” thematic poster session. |
| 2023-08-30 | InflaRx GmbH | Regulatory InflaRx’s Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA) inflarx.de ↗
InflaRx submitted the MAA to EMA in July 2023 following interactions with the rapporteur and co-rapporteur teams of the CHMP. |
| 2023-04-04 | InflaRx GmbH | Regulatory InflaRx Receives FDA Emergency Use Authorization for Gohibic (vilobelimab) for Treatment of Critically Ill COVID-19 Patients inflarx.de ↗
FDA granted EUA based on Phase III clinical trial results showing a significant relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in critically ill invasively mechanically ventilated COVID-19 patients |
| 2022-09-29 | InflaRx GmbH | Regulatory InflaRx Submits Request for Emergency Use Authorization to US FDA for Vilobelimab for Treatment of Critically Ill COVID-19 Patients inflarx.de ↗
Jena, Germany, September 29 , 2022 – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today submitted a request for Emergency Use Authorization (EUA) following encouraging interactions with the US Food and Drug Administration (FDA) at a Type B meeting held this summer. |
| 2022-07-06 | InflaRx GmbH | Regulatory InflaRx Receives FDA Fast Track Designation for Treatment of Ulcerative Pyoderma Gangrenosum inflarx.de ↗ |
| 2022-06-29 | InflaRx GmbH | Regulatory InflaRx Provides Development Update for Vilobelimab in Pyoderma Gangrenosum and Severe COVID-19 inflarx.de ↗
Vilobelimab has been granted orphan drug designation for the treatment of PG by both the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) in Europe. |
| 2022-03-31 | InflaRx GmbH | Results InflaRx Announces Encouraging Phase III Topline Results from PANAMO Trial of Vilobelimab in Severe COVID-19 Patients inflarx.de ↗ |
| 2022-03-17 | InflaRx GmbH | Regulatory InflaRx Receives Corrected Advice Letter from FDA Related to Phase III Program for Vilobelimab in Hidradenitis Suppurativa inflarx.de ↗
In this corrected letter, FDA no longer recommends that the Company use the Hidradenitis Suppurativa Clinical Response Score (“HiSCR”) as the primary endpoint for the chosen patient population but gives recommendations related to implementation of the modified HiSCR (m-HiSCR). |
| 2022-02-28 | InflaRx GmbH | Regulatory InflaRx Provides Update on Development Plans for Vilobelimab in Hidradenitis Suppurativa inflarx.de ↗
The feedback indicates that the FDA recommends using the Hidradenitis Suppurativa Clinical Response Score (“HiSCR”) as the primary endpoint in the Phase III trial. |
| 2022-02-16 | InflaRx GmbH | Results InflaRx Reports Progress in Ongoing Phase II Clinical Trial with Vilobelimab in Cutaneous Squamous Cell Carcinoma inflarx.de ↗
“We are pleased to see the progress in our first oncology study with vilobelimab and that there are to date no safety concerns in either arm,” said Dr. Korinna Pilz, Global Head of Clinical Research and Development at InflaRx. |
| 2021-10-27 | InflaRx GmbH | Results InflaRx Announces Positive Data from Third Cohort of Phase IIa Open-Label Study with Vilobelimab in Pyoderma Gangraenosum inflarx.de ↗
6 out of 7 patients (85.7%) showed clinical remission (PGA score ≤ 1) and closure of target ulcer in the highest dose cohort |
| 2021-08-10 | InflaRx GmbH | Results InflaRx Announces Positive Data from Second Interim Analysis of Ongoing Phase IIa Open Label Study with Vilobelimab in Pyoderma Gangraenosum inflarx.de ↗
Four out of 10 evaluable patients showed clinical response (PGA score ≤ 3), three of whom achieved complete closure of target lesion |
| 2021-02-11 | InflaRx GmbH | Results InflaRx Announces Presentation of New C5a and Vilobelimab (IFX-1) Data from Phase IIB SHINE Study at the 2021 Virtual European Hidradenitis Suppurativa Foundation Conference inflarx.de ↗
InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the presentation of new data with vilobelimab (IFX-1), a first-in-class anti-C5a antibody, demonstrating significantly elevated baseline C5a levels in moderate and severe Hurley Stage II and III hidradenitis suppurativa (HS) patients compared to healthy volunteers. |
| 2020-07-21 | InflaRx GmbH | Results InflaRx Announces Decision to Enter Phase III Development of IFX-1 in Severe COVID-19 Induced Pneumonia inflarx.de ↗
50% lower all-cause mortality rate and other efficacy trends were shown with IFX-1 in initial data from the randomized exploratory Phase II part of the Phase II/III trial |
| 2020-06-17 | InflaRx GmbH | Results InflaRx Reports Encouraging Topline Results from the Exploratory Phase II Part of the Adaptive Randomized Phase II/III Trial of IFX-1 in COVID-19 inflarx.de ↗ |
| 2020-02-26 | InflaRx GmbH | Results InflaRx Announces Positive Initial Data from Ongoing Phase IIa Open Label Study with IFX-1 in Patients Suffering from Pyoderma Gangraenosum inflarx.de ↗
InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive initial data from the first 5 patients in the Phase IIa open label study with IFX-1 in patients suffering from Pyoderma Gangraenosum (PG). |
| 2019-11-06 | InflaRx GmbH | Results InflaRx Reports Positive Results from the Open Label Extension Part of the SHINE Study for IFX-1 in Hidradenitis Suppurativa inflarx.de ↗
The data announced today are from a snapshot analysis at the end of the overall 9-month study treatment period (week 40). |
| 2019-08-23 | Staidson (Beijing) Biopharmaceuticals Co., Ltd | Results IFRX最新报告：IFX-1治疗化脓性汗腺炎（HS）临床IIb结果的深度分析 staidson.com ↗
在第16周，与安慰剂组相比，IFX-1高剂量组的引流瘘（“DF”）相对于基线有统计学意义的减少（图1-所有患者，与基线至少1DF）。 |
| 2019-07-18 | InflaRx GmbH | Results InflaRx Reports Additional Analysis of the SHINE Phase IIb Results for IFX-1 in Hidradenitis Suppurativa inflarx.de ↗ |
| 2019-02-27 | InflaRx GmbH | Regulatory InflaRx Receives Approval to Initiate Phase IIa Clinical Trial with Lead Candidate IFX-1 in Pyoderma Gangraenosum inflarx.de ↗
InflaRx N.V. (Nasdaq: IFRX), an innovative biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the approval of a Clinical Trial Application by Health Canada for a phase IIa clinical trial evaluating the Company’s lead product candidate, IFX-1, in Pyoderma Gangraenosum. |
| 2019-02-06 | InflaRx GmbH | Results InflaRx Announces Presentation of New Clinical Data with Lead Candidate IFX-1 in Hidradenitis Suppurativa inflarx.de ↗
Retrospective long-term results from phase IIa trial indicate sustained remission post IFX-1 treatment |
All press releases naming this drug 50 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | vilobelimab | “with the monoclonal antibody IFX-1 (vilobelimab)” PMID 33015643 ↗ Sep 2020 |
| Known as | CaCP29 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01319903 ↗ |
| Known as | IFX-1 | “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...” NCT04812535 ↗ |
| Action | Inhibit | “the resulting nearly complete blockade of C5a-induced biological effects may be effective in the treatment of subjects with AAV.” NCT03712345 ↗1“Complement C5 inhibitor” CHEMBL2109636 ↗ |
| Modality | Monoclonal antibody | “novel humanized monoclonal antibody CaCP29” NCT01319903 ↗ |
| Route | Intravenous | “CaCP29 or placebo single i.v. infusion” NCT01319903 ↗ |
| Target | C5 | “Complement C5 inhibitor” CHEMBL2109636 ↗ |