Anifrolumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Anifrolumab
- saphnelo
- Saphnelo
- anifrolumab
- Anifrolumab
- Anifrolumab (blinded)
- anifrolumab [INN]
- ANIFROLUMAB [JAN]
- Anifrolumab [MI]
- ANIFROLUMAB [USAN]
- Anifrolumab [WHO-DD]
- Anifrolumab 1000 mg
- Anifrolumab 300 mg
- anifrolumab fnia
- Anifrolumab fnia
- Anifrolumab fnia [WHO-DD]
- anifrolumab fnia who dd
- anifrolumab inn
- Anifrolumab IV infusion (300mg)
- anifrolumab jan
- anifrolumab mi
- anifrolumab usan
- anifrolumab who dd
- Anifrolumab-fnia
- immunoglobulin g1 anti human interferon alpha beta receptor human monoclonal medi 546 heavy chain disulfide with human monoclonal medi 546 kappa chain dimer
- IMMUNOGLOBULIN G1, ANTI-(HUMAN INTERFERON .ALPHA./.BETA. RECEPTOR) (HUMAN MONOCLONAL MEDI-546 HEAVY CHAIN), DISULFIDE WITH HUMAN MONOCLONAL MEDI-546 .KAPPA.-CHAIN, DIMER
- medi 546
- Medi-546
And 1 more, listed on the interactive page.
- ATC classification codes
- L04AG11
Sources for recorded values
- CAS registry numbers
- 1326232-46-5
- ChEMBL ID
- CHEMBL2364653
- FDA ingredient codes (UNII)
- 38RL9AE51Q
- 2565265
- 2565276
- Applicant
- ASTRAZENECA AB
- Approval date
- 30 Jul 2021
- Application number
- BLA761123
- Status
- Authorised
- Status date
- 14 Feb 2022
- Authorisation date
- 14 Feb 2022
- Approved indications
- Saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy.
- Product number
- EMEA/H/C/004975
- Authorisation holder
- AstraZeneca AB
- 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
- No
Therapeutic areas
- Lupus Erythematosus, Systemic
European medicines record
- Patents
- 0
- Designations
- 2
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- anifrolumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Interferon-alpha/beta receptor alpha chain antagonist
- Action type
- Antagonist
- Target
- Interferon alpha/beta receptor 1
- Protein identifier
- P17181
- Action
- Binding
- Action type
- Binding
- Target
- interferon α/β receptor 1
- Gene symbol
- IFNAR1
- Protein identifier
- P17181
- Median affinity
- 10
- Affinity units
- pKd
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- Interferon-alpha/beta receptor alpha chain antagonist
- Action type
- Antagonist
- Target
- Interferon alpha/beta receptor 1
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Sjogren's Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000699
- Subject identifier
- D012859
- Condition
- Lupus Erythematosus, Cutaneous
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003834
- Subject identifier
- D008178
- Condition
- Vitiligo
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004208
- Subject identifier
- D014820
- Condition
- Lupus Nephritis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005761
- Subject identifier
- D008181
- Condition
- Hidradenitis Suppurativa
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000710
- Subject identifier
- D017497
- Condition
- Scleroderma, Localized
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001993
- Subject identifier
- D012594
- Condition
- Lupus Erythematosus, Systemic
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0007915
- Subject identifier
- D008180
- Condition identifier
- EFO_0000685
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000699
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003834
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004208
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005761
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001993
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005100
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005282
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005556
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0006559
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0007915
- Condition identifier
- MONDO_0007915
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0008170
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008383
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008661
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0010030
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0016367
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0019127
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0019340
- Highest recorded phase
- 1
- Condition identifier
- MONDO_8000010
- Highest recorded phase
- 2
- NCT00930683
- NCT01438489
- NCT01559090
- NCT01753193
- NCT02446899
- NCT02446912
- NCT02794285
- NCT02962960
- NCT04726553
- NCT04877691
- NCT04931563
- NCT05001698
- NCT02547922
- NCT05138133
- NCT03435601
- NCT05383677
- NCT05917561
- NCT06015737
- NCT06374212
- Dose
- 300 mg
- Route
- Intravenous
- How often
- Every 4 weeks
Conditions of use
- Administer as an infusion over 30 minutes
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Light chain
- Type
- Protein
- Sequence
- EIVLTQSPGTLSLSPGERATLSCRASQSVSSSFFAWYQQKPGQAPRLLIYGASSRATGIPDRLSGSGSGTDFTLTITRLEPEDFAVYYCQQYDSSAITFGQGTRLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLVQSGAEVKKPGESLKISCKGSGYIFTNYWIAWVRQMPGKGLESMGIIYPGDSDIRYSPSFQGQVTISADKSITTAYLQWSSLKASDTAMYYCARHDIEGFDYWGRGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPEFEGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPASIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- 0310-3040
- 0310-3080
Related records
Trials (78)
- A Clinical Study of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps.
- A Dose Ranging Placebo-controlled Double-blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of 610 in Participants With Severe Eosinophilic Asthma
- A Long-term Study of AK102 in Patients With Hypercholesterolemia
- A Multicenter, Randomized, Double-blind, Parallel Group Study to Determine the Optimal Dose of HL301 After 7 Days Oral Administration in Acute Bronchitis or Acute Exacerbations of Chronic Bronchitis Patients (HL301: Mixed Extract of Rehmannia Glutinosa, Schisandra and so on)
- A Phase II Study of 610 in Participants With Severe Eosinophilic Asthma
- A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
- A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
- A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions
- A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients With Colorectal, Ovarian, and Renal Cancers
- A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus
- A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
- A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects
- A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations
- A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma
- A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults
- A Study to Evaluate the Efficacy and Safety of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
- A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
- A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus
- A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
- A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)
Approved for (1)
In development for (8)
- Cutaneous lupus erythematosus Phase 3
- Hidradenitis suppurativa Phase 2
- Lupus nephritis Phase 3
- Ovarian cancer Phase 2
- Rheumatoid arthritis Phase 2
- Scleroderma Phase 1
- Sjogren syndrome Phase 2
- Vitiligo Phase 2
Targets (1)
- IFNAR1 Interferon-alpha/beta receptor alpha chain antagonist