Pozelimab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2023
- First approval year
- 2023
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Pozelimab
- veopoz
- Veopoz
- pozelimab
- Pozelimab
- pozelimab [INN]
- Pozelimab [MI]
- POZELIMAB [USAN]
- Pozelimab [WHO-DD]
- pozelimab bbfg
- Pozelimab bbfg [WHO-DD]
- pozelimab bbfg who dd
- pozelimab cemdisiran
- pozelimab inn
- pozelimab mi
- pozelimab usan
- pozelimab who dd
- Pozelimab-bbfg
- regn 3918
- REGN-3918
- regn3918
- Regn3918
- REGN3918
- ATC classification codes
- L04AJ11
Sources for recorded values
- CAS registry numbers
- 2096328-94-6
- ChEMBL ID
- CHEMBL4298086
- FDA ingredient codes (UNII)
- 0JJ21K6L2I
- 2663938
- 2663939
- Applicant
- REGENERON PHARMACEUTICALS
- Approval date
- 18 Aug 2023
- Application number
- BLA761339
- Patents
- 0
- Designations
- 4
- Earliest recorded loss of exclusivity
- 18 Aug 2030
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- United States (FDA)
- Approved
- Pharmacology name
- pozelimab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- complement C5
- Gene symbol
- complement C5
- Median affinity
- 9.59
- Affinity units
- pKd
- 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
- Myasthenia Gravis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004991
- Subject identifier
- D009157
- Condition
- Protein-Losing Enteropathies
- Highest recorded phase
- 4
- Condition identifier
- HP:0002243
- Subject identifier
- D011504
- Condition
- Hemoglobinuria
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0100244
- Subject identifier
- D006456
- Condition
- Hemoglobinuria, Paroxysmal
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0100245
- Subject identifier
- D006457
- Condition identifier
- EFO_0004991
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001492
- Highest recorded phase
- 3
- Condition identifier
- HP_0002243
- Condition identifier
- HP_0002243
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005150
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0007827
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0009688
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0100244
- Highest recorded phase
- 3
- Warning
- Black Box Warning
- Effect
- infectious disease
- Warning
- Black Box Warning
- Effect
- neurotoxicity
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Warning
- Black Box Warning
- Effect
- neurotoxicity
- Country
- United States
- NCT03946748
- NCT04162470
- NCT04811716
- NCT04888507
- NCT05131204
- NCT05133531
- NCT05744921
- NCT04209634
- NCT05070858
- Dose
- 30 mg/kg
- Route
- Intravenous
- How often
- Once weekly starting on Day 8
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLQESGPGLVKPSETLSLTCTVSGDSVSSSYWTWIRQPPGKGLEWIGYIYYSGSSNYNPSLKSRATISVDTSKNQFSLKLSSVTAADTAVYYCAREGNVDTTMIFDYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Light chain
- Type
- Protein
- Sequence
- AIQMTQSPSSLSASVGDRVTITCRASQGIRNDLGWYQQKPGKAPKLLIYAASSLQSGVPSRFAGRGSGTDFTLTISSLQPEDFATYYCLQDFNYPWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Glycosylation sites (N)
- Sequence
- Asn-297 $ Asn-297'
- Component
- Disulfide bridges
- Sequence
- 22-95 $ 22''-95'' $ 23'-88' $ 23'''-88''' $ 134'-194' $ 134'''-194'''' $ 134-214' $ 134''-214''' $ 147-203 $ 147''-203'' $ 226-226'' $ 229-229'' $ 261-321 $ 261''-321' $ 367-425 $ 367''-425''
- Component
- Glycosylation sites (N)
- Sequence
- Asn-297 $ Asn-297''
- 61755-014
Related records
Trials (21)
- A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works
- A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
- A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Whose Current Treatment is Not Working Efficiently
- A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment
- A Study to Examine the Safety, Tolerability and Biological Effects of Single Doses of Subcutaneously and Intravenously Administered Pozelimab as Monotherapy and in Combination With Single Doses of Subcutaneously Administered Cemdisiran in Adult Japanese Healthy Volunteers
- A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis
- A Study to Test the Safety of Pozelimab in Pediatric Participants 1 to 5 Years of Age With a Rare Disease Called CHAPLE (Complement Hyperactivation, Angiopathic Thrombosis, Protein-losing Enteropathy) Disease
- Compassionate Use of Pozelimab
- Compassionate Use of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria
- Compassionate Use of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy
- Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Sporadic Inclusion Body Myositis
- Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria
- Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants
- Open-Label Efficacy and Safety Study of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy (CHAPLE Disease)
- Pozelimab and Cemdisiran Combination Therapy in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy
- Pozelimab and Cemdisiran Combination Treatment in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy
- REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers
- Study of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Adult Participants
- Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN3918 in Healthy Volunteers
Approved for (1)
- Protein-losing enteropathy
In development for (5)
- Age-related macular degeneration Phase 3
- Inclusion body myositis Phase 1
- Myasthenia gravis Phase 3
- Obsolete acquired paroxysmal nocturnal hemoglobinuria Phase 1
- Paroxysmal nocturnal hemoglobinuria Phase 3
Targets (1)
- C5 Complement C5 inhibitor