RegulationFast Track (United States), Emergency Use Authorization (United States), Orphan Drug (United States), Orphan Drug (European Union), Exceptional Circumstances (European Union)

Structure/Sequence

Sequence Code 616722016H

Source: *****

Sequence Code 616722017L

Source: *****

Clinical Trials associated with Vilobelimab

NCT06701682

/ RecruitingPhase 2

Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design.
Cohort A: Participants will be randomized to receive either a placebo or vilobelimab.
This record describes the default procedures and analyses for Cohort A. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.

Start Date21 Jun 2025

Sponsor / Collaborator

PPD Development LP

[+4]

NCT06703073

/ RecruitingPhase 2

Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Participants will be randomized to receive either a placebo or one of the active treatments.
This record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.

Start Date10 Jun 2025

Sponsor / Collaborator

PPD Development LP

[+4]

NCT05964413

/ TerminatedPhase 3

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

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

Start Date01 Nov 2023

Sponsor / Collaborator

InflaRx GmbH

100 Clinical Results associated with Vilobelimab

100 Translational Medicine associated with Vilobelimab

100 Patents (Medical) associated with Vilobelimab

Literatures (Medical) associated with Vilobelimab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

A network meta-analysis study of monotherapies for hidradenitis suppurativa: analyses of the current evidence base

Review

Author: Economopoulos, Vasiliki ; Magalhaes, Renata ; Bamimore, Mary A. ; Talukder, Mesbah ; Piguet, Vincent ; Gupta, Aditya K.

BACKGROUND:

The number of monotherapies for hidradenitis suppurativa (HS) has expanded. However, the efficacy of active comparators has not been determined in head-to-head trials.

AIMS:

We conducted an NMA to determine the relative efficacy and safety of monotherapies for HS.

METHODS:

The literature was systematically reviewed to obtain data from trials that (1) were published in English, (2) investigated a systemically administered monotherapy with an immunomodulatory agent (3) randomized, and (4) quantified efficacy, at 16 weeks, insofar as the Hidradenitis Suppurativa Clinical Response 50 (HiSCR-50), Dermatology Life Quality Index (DLQI) and Numeric Rating Scale 30 (NRS30). For safety, we analyzed the occurrence of treatment-emergent adverse events (TEAEs). For sensitivity analyses, we conducted network meta-regressions adjusted for age and sex.

RESULTS:

We determined the efficacy of numerous regimens including those approved by the United States FDA; for instance, the FDA-approved 'bimekizumab 320 mg every 2 weeks' was more efficacious than 'IFX-1 800 mg every 2 weeks' (odd ratio = 1.99, 95% credible interval: 1.09,3.87, p < 0.05) in terms of HiSCR-50. Sensitivity analyses showed that the main analyses were robust. Overall, risk of bias across studies was low.

CONCLUSIONS:

The current NMA provides comparative evidence on systematic immunomodulatory HS monotherapies from the most up-to-date trial evidence.

29 Apr 2025·AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY

An evaluation of vilobelimab (anti-C5a) as a cost-effective option to treat severely ill mechanically ventilated patients with COVID-19

Article

Author: Oderda, Gary ; Biskupiak, Joseph ; Seheult, Roger ; Brixner, Diana ; Malone, Daniel C

Abstract:

Purpose:

COVID-19 patients in intensive care units (ICUs) requiring invasive mechanical ventilation (IMV) have few available treatment options. PANAMO, a multicenter, double-blind, randomized, placebo-controlled phase 3 study of vilobelimab, which blocks the inflammatory process caused by complement component 5a, demonstrated a significant mortality benefit at 28 and 60 days in these patients. A cost-effectiveness analysis was conducted to assess the incremental cost per quality-adjusted life-year (QALY).

Methods:

A Markov model was used to estimate QALYs and the incremental cost-effectiveness ratio (ICER) of vilobelimab plus standard of care (SOC) versus SOC alone. The model simulated progression from severe COVID-19 to survival or death over a lifetime horizon. Outcomes data (COVID-19 all-cause mortality and renal replacement therapy) were incorporated from the PANAMO trial. COVID-19 mortality estimates were based on Centers for Disease Control and Prevention age-specific survival data. Utility values and hospital costs came from the literature. Vilobelimab cost was obtained from RED BOOK Online.

Results:

For COVID-19 ICU patients, total costs of care were $103,414 (SOC) and $132,247 (SOC plus vilobelimab), respectively, resulting in an incremental cost of $28,833. SOC provided 6.70 QALYs versus 7.99 QALYs for vilobelimab, an additional 1.29 QALYs. The ICER for vilobelimab plus SOC versus SOC alone was $22,287/QALY. Probabilistic sensitivity analysis demonstrated the robustness of the cost-effectiveness result as vilobelimab plus SOC was favored at a willingness-to-pay threshold of $50,000 in over 81% of iterations.

Conclusion:

Vilobelimab provides a cost-effective option to treat ICU patients with severe COVID-19 receiving IMV compared to SOC, at well below the commonly accepted $50,000 US willingness-to-pay threshold.

01 Apr 2025·BMJ Open Respiratory Research

Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients

Article

Author: Rückinger, Simon ; Zerbib, Robert ; Riedemann, Niels C ; Vlaar, Alexander P ; van de Beek, Diederik ; Brouwer, Matthijs C ; Thielert, Claus ; Lim, Endry H T ; de Bruin, Sanne ; Burnett, Bruce P ; Guo, Renfeng ; Chong, Camilla

Background:

Vilobelimab, a first in class C5a-specific monoclonal antibody, improved 28-day and 60-day mortality in intubated COVID-19 patients in PANAMO, a phase 3 randomised, double-blind, placebo-controlled multicentre study. All-cause mortality was pre-specified to be analysed pooling by region (western Europe, South America, South Africa/Russia).

Methods:

Critically ill, invasively mechanically ventilated COVID-19 patients were randomised in a 1:1 ratio within 48 hours of intubation to receive vilobelimab treatment (six, 800 mg intravenous infusions) or placebo on top of standard of care. We analysed the efficacy and safety of vilobelimab based on prespecified geographic regions.

Results:

368 patients were randomised and analysed: 177 in the vilobelimab group and 191 in the placebo group. In western Europe (n=209), 28-day all-cause mortality was significantly lower in the vilobelimab group (21%) compared with placebo (37%) (HR 0.51 (95% CI: 0.30, 0.87), p=0.014). In South America (n=126), mortality was similar between groups (40% vs 37%; HR 0.94 (95% CI: 0.53, 1.67), p=0.83). In South Africa/Russia (n=33), mortality was 69% in the vilobelimab group and 87% in the placebo group (HR 0.62 (95% CI: 0.28, 1.38), p=0.25). Within the Brazilian subpopulation (n=74), a significant age imbalance between the vilobelimab and placebo group was detected (median 53.5 years in the vilobelimab group vs 44.5 years in the placebo group). Occurrence of treatment-emergent adverse events between regions was similar.

Conclusion:

The most apparent 28-day all-cause mortality benefit for vilobelimab was in western Europe. Age imbalance between treatment groups in Brazil may have resulted in a lower efficacy signal for vilobelimab in South America compared with other regions. Overall, vilobelimab demonstrated a favourable safety profile and reduced mortality in critically ill, intubated COVID-19 patients, with regional variations influencing outcomes.

107

News (Medical) associated with Vilobelimab

31 Jul 2025

·www.globenewswire.com

InflaRx to Report Second Quarter 2025 Results on August 7, 2025

JENA, Germany, July 31, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the Company will report its second quarter 2025 financial and operating results on August 7, 2025, before the market opens. No conference call is planned. About InflaRx InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5a receptor technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx has developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies. InflaRx is also developing INF904, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx). Contacts: InflaRx N.V.MC Services AGJan Medina, CFAVice President, Head of Investor RelationsEmail: IR@inflarx.deKatja Arnold, Laurie Doyle, Dr. Regina LutzEmail: inflarx@mc-services.eu Europe: +49 89-210 2280U.S.: +1-339-832-0752 FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses, current expectations and the risks, uncertainties and other factors described under the headings, “Risk factors” and “Cautionary statement regarding forward looking statements”, in our periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

Financial StatementLicense out/in

28 May 2025

·www.fiercepharma.com

InflaRx drops rare skin disease study for COVID med vilobelimab after futility signal

Vilobelimab is a monoclonal antibody designed to block the immune complement factor C5a, which has been implicated in many different inflammatory diseases. After a poor showing of its COVID med vilobelimab in a rare skin disorder trial, German drugmaker InflaRx is going back to the drawing board.The independent data monitoring committee assessing a phase 3 trial of vilobelimab in pyoderma gangrenosum (PG) has urged InflaRx to stop the study early for futility. The committee made the call after analyzing data on the first 30 patients enrolled in the study, InflaRx said in a Wednesday press release. InflaRx noted that it remains blinded to the study results.Given the trial’s outcome, InflaRx plans to stop development of vilobelimab in PG, though the drug will remain available in the U.S. under emergency use authorization to treat critically ill COVID patients, the company clarified.Vilobelimab—which goes by the commercial moniker Gohibic in its authorized COVID indication—is a monoclonal antibody designed to block the immune complement factor C5a, which has been implicated in many different inflammatory diseases.PG is a rare skin condition that causes large, painful sores to form on the skin, most often on the legs. While the exact cause of PG remains elusive, it is believed to be an immune disorder, the Mayo Clinic notes.“While the outcome is not what we had hoped it would be, InflaRx remains committed to its goal of developing new therapies for underserved patients with chronic immune-dermatological conditions,” Niels Riedemann, InflaRx’s chief executive, said in a statement. The company now aims to focus its resources on its oral small molecule candidate INF904—also a C5a inhibitor—which is expected to deliver phase 2a readouts in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) this summer, InflaRx said.Meanwhile, the trial winddown may herald the start of a broader cost-saving effort at the company, InflaRx warned. The drugmaker said it is considering a potential “redirection of resources” to help extend its cash runway.The FDA awarded emergency use authorization to vilobelimab, A.K.A. Gohibic, in April 2023, though the data that supported that sign-off were less-than-ideal.In a randomized late-stage trial, Gohibic failed to deliver statistically significant results on the study’s primary endpoint of curbing the risk of death in the sickest COVID patients. That said, a separate predefined analysis and two post hoc analyses painted the drug in a better light, showing an improvement that was statistically significant. In the U.S., the antibody is specifically cleared for use in hospitalized patients within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). InflaRx noted that it will carry on with a BARDA-funded phase 2 study of Gohibic as a potential treatment for acute respiratory distress syndrome (ARDS).Gohibic has also won marketing authorization under exceptional circumstances in the European Union—a distinction not entirely dissimilar to an FDA emergency use nod—to treat adults with SARS-CoV-2-induced ARDS who are on systemic corticosteroids and receiving IMV with or without ECMO.After the trial update, InflaRx’s share price was down more than 50% in Wednesday morning trading.

Phase 3Drug ApprovalPhase 2Emergency Use Authorization

28 May 2025

·pipelinereview.com

InflaRx Announces Outcome of Interim Analysis for Vilobelimab Phase 3 Trial in Pyoderma Gangrenosum

JENA, Germany I May 28, 2025 I InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today 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. 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. InflaRx as the study sponsor remains blinded to the study results. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said: “We would like to thank the dedicated physicians and pyoderma gangrenosum patients for their participation in this pioneering study targeting a significant unmet need. While the outcome is not what we had hoped it would be, InflaRx remains committed to its goal of developing new therapies for underserved patients with chronic immune-dermatological conditions, including with our oral inhibitor of C5aR, INF904, with data expected this summer.” InflaRx intends to discontinue further development of vilobelimab in the PG indication and to prioritize its resources on INF904, with Phase 2a data readouts in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) anticipated this summer. The Company is also considering additional cost savings and redirection of resources toward the goal of extending the Company’s existing cash runway. GOHIBIC (vilobelimab) remains available in the US where it has been granted Emergency Use Authorization by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). The Company will continue its support of the BARDA-funded Phase 2 clinical platform study. In the EU, GOHIBIC (vilobelimab) has been granted marketing authorization 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 IMV with or without ECMO. About InflaRx N.V. InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx’s lead product candidate, vilobelimab, is a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies in different indications. InflaRx is also developing INF904, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx). About GOHIBIC (vilobelimab) In the U.S., GOHIBIC (vilobelimab) has been granted an Emergency Use Authorization by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). The emergency use of GOHIBIC (vilobelimab) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner. GOHIBIC (vilobelimab) is an investigational drug that has not been approved by the FDA for any indication, including for the treatment of COVID-19. There is limited information known about the safety and effectiveness of using GOHIBIC (vilobelimab) to treat people in the hospital with COVID-19. Please see additional information in the Fact Sheet for Healthcare Providers, Fact Sheet for Patients and Parents/Caregivers and FDA Letter of Authorization on the GOHIBIC website http://www.gohibic.com . In the EU, GOHIBIC (vilobelimab) has been granted marketing authorization 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). The EU approval of GOHIBIC (vilobelimab) is supported by the previously announced results of the multicenter Phase 3 PANAMO trial, one of the largest 1:1 randomized, double-blind, placebo-controlled trials in invasively mechanically ventilated COVID-19 patients in intensive care units. The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in the global data set. The data were published in The Lancet Respiratory Medicine. A marketing authorization under exceptional circumstances is recommended when the benefit/risk assessment is determined to be positive but, due to the rarity of the disease, it’s unlikely that comprehensive data can be obtained under normal conditions of use. Under the terms of GOHIBIC’s (vilobelimab’s) approval in the EC, InflaRx will provide annual updates to EMA on the previously announced clinical platform study planned by the Biomedical Advanced Research and Development Authority (BARDA). Vilobelimab is included in this study as one of three new potential therapies for treating ARDS. The COVID-19 related work described herein was partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx. Important Safety Information about GOHIBIC (vilobelimab) There is limited clinical data available for GOHIBIC (vilobelimab). Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC (vilobelimab) use. GOHIBIC (vilobelimab) has been associated with an increase of serious infections. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC (vilobelimab). Hypersensitivity reactions have been observed with GOHIBIC (vilobelimab). If a severe hypersensitivity reaction occurs, administration of GOHIBIC (vilobelimab) should be discontinued and appropriate therapy initiated. The most common adverse reactions (incidence ≥3%) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash. Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious AEs or deaths that occur during GOHIBIC (vilobelimab) treatment and are considered to be potentially attributable to GOHIBIC (vilobelimab). Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. In addition, side effects can be reported to InflaRx at: pvusa@inflarx.de. For the full prescribing information and additional important safety information, please visit www.GOHIBIC.com. The COVID-19 related work described herein was partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx. About vilobelimab Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. SOURCE: Inflarx

Phase 3Drug ApprovalClinical ResultPhase 2

100 Deals associated with Vilobelimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11838	-	-	DB16416

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Respiratory Distress Syndrome, Acute	European Union	InflaRx GmbH	13 Jan 2025
Respiratory Distress Syndrome, Acute	Iceland	InflaRx GmbH	13 Jan 2025
Respiratory Distress Syndrome, Acute	Liechtenstein	InflaRx GmbH	13 Jan 2025
Respiratory Distress Syndrome, Acute	Norway	InflaRx GmbH	13 Jan 2025
COVID-19	United States	InflaRx NV	04 Apr 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pyoderma Gangrenosum	Phase 3	United States	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Australia	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Belgium	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	France	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Germany	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Hungary	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Italy	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Poland	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Spain	InflaRx GmbH	01 Nov 2023
Pyoderma Gangrenosum	Phase 3	Switzerland	InflaRx GmbH	01 Nov 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05964413 (Biospace) Manual	Phase 3	Pyoderma Gangrenosum	-	vilobelimab	vshxfsrfek(yslffxlxve) = InflaRx’s vilobelimab met the bar for futility in a Phase III trial for the rare skin disease pyoderma gangrenosum. wdzsgoqrei (pxwjukvcqo ) Not Met	Negative	28 May 2025
ATS2025	Not Applicable	Legionellosis \| COVID-19 \| MRSA - Methicillin resistant Staphylococcus aureus infection SARS-CoV-2 PCR+ \| MRSA PCR+ \| Legionella+	1	Vilobelimab 800mg	yocckundse(saciembznq) = ujdsmquxit asdwjryboh (tmfnzexgdl ) View more	Positive	16 May 2025
PANAMO (ATS2025)	Phase 3	Respiratory Distress Syndrome, Acute SARS-CoV-2 infection	-	Vilobelimab 800mg + standard-of-care (SOC)	vxixzinlzv(bntscdfprf): HR = 0.75 (95% CI, 0.48 - 1.16), P-Value = 0.19	Positive	16 May 2025
				Placebo + standard-of-care (SOC)
NCT04812535 (CTgov)	Phase 2	Cutaneous Squamous Cell Carcinoma	30	Vilobelimab (Arm A:)	qgdoddymal = jefzpajrop hqxtosmpwm (ornooakiad, tdmabyqftr - kngxielnfi) View more	-	11 Feb 2025
				Vilobelimab+pembrolizumab (Arm B: Regimen 1:)	swqvcpiitw(ousufskkkg) = ncexgpnkuv rkdujyzmcf (efgjclirvb, ztqdhngenj - rprtxnvzqi) View more
NCT03487276 (SHINE, GlobeNewswire) Manual	Phase 2	Hidradenitis Suppurativa	177	Vilobelimab 1200 mg	suytqvnlpl(eeorcdbcmw) = vcyfsmtpwh rpbkagchnm (ldcetixjzw )	Positive	25 Sep 2024
				Placebo	-
NCT03971643 (CTgov)	Phase 2	Pyoderma Gangrenosum	19	vilobelimab (Vilobelimab 800 mg Q2W)	qwbknvruia = zzaedtvwiv jwmmznulot (olwtfesydj, yebmuzgjri - bkfsddplyn) View more	-	14 Sep 2023
				vilobelimab (Vilobelimab 1600 mg Q2W)	qwbknvruia = ifcnckoqgv jwmmznulot (olwtfesydj, adxezcctkq - qqiylzpdgj) View more
NCT04333420 (PANAMO, Pubmed \| Intensive Care Med Exp)	Phase 3	COVID-19	368	Vilobelimab	vsuustiqov(brvedjoywg) = csnugaacvv xraucgidsk (jhibrziiwp )	Positive	19 Jun 2023
				Placebo	vsuustiqov(brvedjoywg) = jsriampwxm xraucgidsk (jhibrziiwp )
NCT04333420 (PANAMO, FDA) Manual	Phase 3	COVID-19	368	vilobelimab+SoC	ojqxumkvfc(glbmzshxqy) = lnhasdupki zedqemytrm (cyvgwkqftq ) View more	Positive	04 Apr 2023
				Placebo+SoC	ojqxumkvfc(glbmzshxqy) = zncfsbaooz zedqemytrm (cyvgwkqftq ) View more
NCT03895801 (IXCHANGE Trial, ACR2022)	Phase 2	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Add-on	57	Vilobelimab + reduced-dose GC (RDGC)	mdizmwagch(tvbntjeuvl) = vlymtrdvcx dhmndmfrbz (tetrdaclrk ) View more	Positive	12 Nov 2022
				Standard-dose GC (SDGC)	mdizmwagch(tvbntjeuvl) = teyqwmcotx dhmndmfrbz (tetrdaclrk ) View more
NCT04333420 (PANAMO, Literature \| Pubmed \| Lancet Respir Med) Manual	Phase 3	COVID-19	368	Standard of Care+Vilobelimab	dczuiehqng(aksvokvqqn) = wnflzuezti ghescuqadl (xqutkzhrkv, 25 - 39) View more	Positive	07 Sep 2022
				Standard of Care+Placebo	dczuiehqng(aksvokvqqn) = gvyyoafnds ghescuqadl (xqutkzhrkv, 35 - 49) View more

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