> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/vilobelimab-29c7e656-93c5-41f6-9ff0-98e01ff7f32d
> Record changed: 2026-11-04

# Vilobelimab

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109636)

Drug type

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109636)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109636)

## Names and chemistry

**Drug type**

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109636)

**Drug name**

Vilobelimab

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109636)

### Other names (18)

- cacp 29
- CACP 29
- cacp29
- CaCP29
- CACP29
- ifx 1
- ifx 1 bsc
- IFX-1
- immunoglobulin g4 kappa anti homo sapiens c5 complement 5 anaphylatoxin c5a c5 pr678 751 chimeric monoclonal antibodygamma4 heavy chain chimeric 1 446 vh mus musculus ighv1 61 01 81 6 ighd ighj3 01 92 9 homo sapiens ighv1 46 01 62 2 ighd ighj4 01 92 9 8 8 13 1 119 homo sapiens ighg4 01 ch1 120 217 hinge 1 12 218 229 ch2 230 339 ch3 340 444 chs 445 446 120 446 133 218 disulfide with kappa light chain chimeric 1 218 v kappa mus musculus igkv3 4 01 98 0 igkj2 01 100 homo sapiensigkv3d 11 02 69 1 igkj2 01 91 7 10 3 9 1 111 homo sapiensigkc 01 100 km3 a45 1 157 v101 195 112 218 dimer 225 225 228 228 bisdisulfide produced in chinese hamster ovary cho cells glycoform alfa
- IMMUNOGLOBULIN G4-KAPPA, ANTI-(HOMO SAPIENS C5 (COMPLEMENT 5) ANAPHYLATOXIN (C5A, C5 PR678-751)), CHIMERIC MONOCLONAL ANTIBODYGAMMA4 HEAVY CHAIN CHIMERIC (1-446) (VH (MUS MUSCULUS IGHV1-61\*01 (81.6%)-(IGHD)-IGHJ3\*01 (92.9%)/HOMO SAPIENS IGHV1-46\*01 (62.2%)-(IGHD)-IGHJ4\*01 (92.9%)) (8.8.13) (1-119)-HOMO SAPIENS IGHG4\*01 (CH1 (120-217), HINGE 1-12 (218-229), CH2 (230-339), CH3 (340-444), CHS (445-446)) (120-446)), (133-218')-DISULFIDE WITH KAPPA LIGHT CHAIN CHIMERIC (1'-218') (V-KAPPA (MUS MUSCULUS IGKV3-4\*01 (98.0%)-IGKJ2\*01 (100%)/HOMO SAPIENSIGKV3D-11\*02 (69.1%)-IGKJ2\*01 (91.7%)) (10.3.9) (1'-111')-HOMO SAPIENSIGKC\*01 (100%), KM3 A45.1 (157), V101 (195) (112'-218'))DIMER (225-225'':228-228'')-BISDISULFIDE, PRODUCED IN CHINESE HAMSTER OVARY (CHO) CELLS, GLYCOFORM ALFA
- vilobelimab
- Vilobelimab
- vilobelimab \[INN\]
- VILOBELIMAB \[USAN\]
- Vilobelimab \[WHO-DD\]
- vilobelimab inn
- vilobelimab usan
- vilobelimab who dd

## Identifiers

**ATC classification codes**

- L04AJ10

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109636)

**CAS registry numbers**

- 2250440-41-4

**ChEMBL ID**

CHEMBL2109636

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2109636)

**RxNorm IDs (RxCUI)**

- 2639620

**FDA ingredient codes (UNII)**

- F5T0RF9ZJA

## Regulatory information

### European Union

**Status**

Authorised

**Status date**

13 Jan 2025

**Authorisation date**

13 Jan 2025

**Approved indications**

Gohibic is indicated for the treatment of adult patients with SARS-CoV2-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)).

**Product number**

EMEA/H/C/006123

**Authorisation holder**

InflaRx GmbH

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

Yes

**Accelerated assessment**

No

**Exceptional circumstances**

Yes

#### Therapeutic areas

- COVID-19 virus infection
- Respiratory Distress Syndrome, Adult

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/gohibic)

### Other regulatory facts

**Patents**

0

**Designations**

1

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

## Approval status

**European Union (EMA)**

Authorised

## Pharmacology

### Drug classification

**Pharmacology name**

vilobelimab

**Type**

Antibody

**Drug name stem**

\-mab

**Approval recorded by Guide to Pharmacology**

Yes

### Mechanisms of action

- **Mechanism**  
Complement C5 inhibitor

**Action type**  
Inhibitor

**Target**  
Complement C5

**Protein identifier**  
P01031

### Open Targets mechanisms

- **Mechanism**  
Complement C5 inhibitor

**Action type**  
Inhibitor

**Target**  
Complement C5

### Investigated indications (11)

- **Condition**  
Granulomatosis with Polyangiitis

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005297

**Subject identifier**  
D014890
- **Condition**  
Shock, Septic

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0006834

**Subject identifier**  
D012772
- **Condition**  
Pyoderma Gangrenosum

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0006835

**Subject identifier**  
D017511
- **Condition**  
Skin Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0009259

**Subject identifier**  
D012878
- **Condition**  
Hidradenitis Suppurativa

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000710

**Subject identifier**  
D017497
- **Condition**  
Microscopic Polyangiitis

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000784

**Subject identifier**  
D055953
- **Condition**  
Pyoderma

**Highest recorded phase**  
3

**Condition identifier**  
HP:0000999

**Subject identifier**  
D011711
- **Condition**  
Sepsis

**Highest recorded phase**  
2

**Condition identifier**  
HP:0100806

**Subject identifier**  
D018805
- **Condition**  
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0015492

**Subject identifier**  
D056648
- **Condition**  
Severe Acute Respiratory Syndrome

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0100096

**Subject identifier**  
D045169
- **Condition**  
Inflammation

**Highest recorded phase**  
2

**Condition identifier**  
MP:0001845

**Subject identifier**  
D007249

### Open Targets indications (19)

- **Condition identifier**  
EFO\_0005297

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0006834

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0006835
- **Condition identifier**  
EFO\_1000710

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1000784

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001927

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0000999

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0100806

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005249

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0006502

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0006559

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0012105

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0015492
- **Condition identifier**  
MONDO\_0019124

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0100096
- **Condition identifier**  
MONDO\_0100130
- **Condition identifier**  
MONDO\_0100130

**Highest recorded phase**  
4
- **Condition identifier**  
MP\_0001845
- **Condition identifier**  
MP\_0001845

**Highest recorded phase**  
2

### Trial references (10)

- NCT02246595  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02246595)
- NCT02866825  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02866825)
- NCT03001622  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03001622)
- NCT03487276  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03487276)
- NCT03712345  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03712345)
- NCT03895801  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03895801)
- NCT03971643  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03971643)
- NCT05964413  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05964413)
- NCT04333420  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04333420)
- NCT04812535  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04812535)

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

### Sequences (5)

- **Component**  
Light chain

**Type**  
Protein

**Sequence**  
DIVLTQSPASLAVSLGQRATISCKASQSVDYDGDSYMKWYQQKPGQPPKLLIYAASNLQSGIPARFSGSGSGTDFTLNIHPVEEEDAATYYCQQSNEDPYTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- **Component**  
Heavy chain

**Type**  
Protein

**Sequence**  
QVQLQQSGPQLVRPGTSVKISCKASGYSFTTFWMDWVKQRPGQGLEWIGRIDPSDSESRLDQRFKDRATLTVDKSSSTVYMQLSSPTSEDSAVYYCARGNDGYYGFAYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPSCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- **Component**  
Glycosylation sites (N)

**Sequence**  
Asn-296 $ Asn-296''''
- **Component**  
Disulfide bridges

**Sequence**  
22-96 $ 22''-96'' $ 23'-92' $ 23'''-92''' $ 133-218' $ 133''-218''' $ 138'-198' $ 138'''-198''' $ 146-202 $ 146''-202'' $ 225-225'' $ 228-228'' $ 260-320 $ 260''-320'' $ 366-424 $ 366''-424''
- **Component**  
Glycosylation sites (N)

**Sequence**  
Asn-296 $ Asn-296''

## National Drug Codes

- 83000-110

## Related records

### Trials (12)

- Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
- Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
- [JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)](https://trialight.com/data/trial/just-breathe-breathing-life-into-innovative-therapies-for-b9153690-ceb2-4470-888a-92b70ddd73e7.md)
- JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
- Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.
- Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
- Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
- Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
- Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
- Studying Complement Inhibition in Complex Cardiac Surgery
- Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction
- Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa

### Approved for (1)

- [Adult acute respiratory distress syndrome](https://trialight.com/data/condition/adult-acute-respiratory-distress-syndrome-52101d99-65d3-54cf-b5da-f664febc6a7e.md)

### In development for (11)

- Acute respiratory distress syndrome Phase 2
- [Anti-neutrophil cytoplasmic antibody-associated vasculitis](https://trialight.com/data/condition/anti-neutrophil-cytoplasmic-antibody-associated-vasculitis-a59f9899-4e99-54af-98e3-b03dbdb0192e.md) Phase 1
- [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 2
- Granulomatosis with polyangiitis Phase 2
- [Hidradenitis suppurativa](https://trialight.com/data/condition/hidradenitis-suppurativa-c1030a8d-4971-5d31-b030-aa19715eb7a2.md) Phase 2
- Microscopic polyangiitis Phase 2
- [Pneumonia](https://trialight.com/data/condition/pneumonia-d2f12d4d-57c5-5c54-881e-1efe392849eb.md) Phase 2
- Pyoderma Phase 3
- Pyoderma gangrenosum Phase 1
- Skin carcinoma Phase 2
- Toxic shock syndrome Phase 2

### Targets (1)

- [C5](https://trialight.com/data/target/c5-8ddb191a-5536-5177-83c7-578f41e4de55.md) Complement C5 inhibitor

---

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