Vilobelimab
Highest phase reached
Phase 3
Drug type
Antibody
- Listing at source
- Listed
- Highest phase reached
- Phase 3
- Drug type
- Antibody
- Drug name
- Vilobelimab
- 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
- ATC classification codes
- L04AJ10
Sources for recorded values
- CAS registry numbers
- 2250440-41-4
- ChEMBL ID
- CHEMBL2109636
- RxNorm IDs (RxCUI)
- 2639620
- FDA ingredient codes (UNII)
- F5T0RF9ZJA
- 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
- 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
- European Union (EMA)
- Authorised
- 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
- 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
- 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
- NCT02246595
- NCT02866825
- NCT03001622
- NCT03487276
- NCT03712345
- NCT03895801
- NCT03971643
- NCT05964413
- NCT04333420
- NCT04812535
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 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''
- 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)
- 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)
In development for (11)
- Acute respiratory distress syndrome Phase 2
- Anti-neutrophil cytoplasmic antibody-associated vasculitis Phase 1
- COVID-19 Phase 2
- Granulomatosis with polyangiitis Phase 2
- Hidradenitis suppurativa Phase 2
- Microscopic polyangiitis Phase 2
- Pneumonia Phase 2
- Pyoderma Phase 3
- Pyoderma gangrenosum Phase 1
- Skin carcinoma Phase 2
- Toxic shock syndrome Phase 2
Targets (1)
- C5 Complement C5 inhibitor