Adalimumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2002
- First approval year
- 2002
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Adalimumab
- amgevita
- Amgevita
- amsparity
- Amsparity
- cyltezo
- Cyltezo
- halimatoz
- Halimatoz
- hefiya
- Hefiya
- hulio
- Hulio
- humira
- Humira
- idacio
- Idacio
- imraldi
- Imraldi
- kromeya
- Kromeya
- libmyris
- Libmyris
- solymbic
- Solymbic
- trudexa
And 1 more, listed on the interactive page.
- 40 mg msb11022
- 40 mg MSB11022
- abp 501
- ABP 501
- Abp-501
- abrilada
- Abrilada
- adalimumab
- Adalimumab
- ADALIMUMAB
- Adalimumab (40 mg sc every other week)
- Adalimumab (40 mg)
- Adalimumab (abbvie)
- adalimumab (ADA)
- Adalimumab (ADA)
- Adalimumab (BCD-057)
- adalimumab (D2E7)
- Adalimumab (D2E7)
- Adalimumab (genetical recombination)
- ADALIMUMAB (GENETICAL RECOMBINATION) [JAN]
- adalimumab (Humira)
- Adalimumab (humira)
- Adalimumab (Humira)
- adalimumab (HUMIRA®)
- Adalimumab (Humira®)
And 240 more, listed on the interactive page.
- CAS registry numbers
- 331731-18-1
- ChEMBL ID
- CHEMBL1201580
- FDA ingredient codes (UNII)
- FYS6T7F842
- L04AA17
- L04AB04
Sources for recorded values
- 327361
- 2640849
- Applicant
- AMGEN INC
- Approval date
- 23 Sept 2016
- Application number
- BLA761024
- Status
- Authorised
- Status date
- 8 Sept 2003
- Authorisation date
- 8 Sept 2003
- Approved indications
- Please refer to the product information document.
- Product number
- EMEA/H/C/000481
- Authorisation holder
- AbbVie Deutschland GmbH & Co. KG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 10
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthritis, Juvenile Rheumatoid
- Arthritis, Psoriatic
- Arthritis, Rheumatoid
- Colitis, Ulcerative
- Crohn Disease
- Psoriasis
- Spondylitis, Ankylosing
- Uveitis
European medicines record
- Patents
- 0
- Designations
- 1
- Earliest recorded loss of exclusivity
- 24 Feb 2028
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- adalimumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- tumour necrosis factor shed form
- Gene symbol
- tumour necrosis factor shed form
- Median affinity
- 8
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- TNF-alpha inhibitor
- Action type
- Inhibitor
- Target
- Tumor necrosis factor
- Protein identifier
- P01375
Open Targets mechanisms
- Mechanism
- TNF-alpha inhibitor
- Action type
- Inhibitor
- Target
- Tumor necrosis factor
- Condition
- Prostatic Hyperplasia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000284
- Subject identifier
- D011470
- Condition
- Crohn Disease
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Psoriasis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000676
- Subject identifier
- D011565
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Spondylarthropathies
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000706
- Subject identifier
- D025242
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Macular Degeneration
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001365
- Subject identifier
- D008268
- Condition
- Arthritis, Juvenile
- Highest recorded phase
- 4
- Condition identifier
- EFO:0002609
- Subject identifier
- D001171
- Condition
- Inflammatory Bowel Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003767
- Subject identifier
- D015212
- Condition
- Arthritis, Psoriatic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003778
- Subject identifier
- D015535
- Condition
- Behcet Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003780
- Subject identifier
- D001528
- Condition
- Colitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003872
- Subject identifier
- D003092
- Condition
- Spondylitis, Ankylosing
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003898
- Subject identifier
- D013167
- Condition
- Dupuytren Contracture
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004229
- Subject identifier
- D004387
- Condition
- Glomerulosclerosis, Focal Segmental
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004236
- Subject identifier
- D005923
- Condition
- Osteoarthritis, Knee
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004616
- Subject identifier
- D020370
- Condition
- Arthritis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005856
- Subject identifier
- D001168
- Condition
- Cystitis, Interstitial
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008507
- Subject identifier
- D018856
- Condition
- Arthritis, Juvenile
- Highest recorded phase
- 4
- Condition identifier
- EFO:0009733
- Subject identifier
- D001171
- Condition
- Hidradenitis Suppurativa
- Highest recorded phase
- 4
- Condition identifier
- EFO:1000710
- Subject identifier
- D017497
- Condition
- Bursitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000941
- Subject identifier
- D002062
- Condition
- Giant Cell Arteritis
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001209
- Subject identifier
- D013700
- Condition
- Uveitis
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001231
- Subject identifier
- D014605
- Condition
- Psoriasis
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001494
- Subject identifier
- D011565
And 12 more, listed on the interactive page.
- Condition identifier
- EFO_0000284
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000384
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000676
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0000706
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000729
- Condition identifier
- EFO_0001365
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002609
- Condition identifier
- EFO_0003767
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003778
- Condition identifier
- EFO_0003898
- Condition identifier
- EFO_0004229
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004236
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004616
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005856
- Condition identifier
- EFO_0007462
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008507
- Highest recorded phase
- 3
- Condition identifier
- EFO_0700108
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000710
- Condition identifier
- EFO_1000941
- Condition identifier
- EFO_1001082
- Condition identifier
- EFO_1001209
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001231
- Condition identifier
- EFO_1001494
And 69 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Warning
- Black Box Warning
- Effect
- infectious disease
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Event
- abdominal discomfort
- Reports
- 4,024
- Reporting signal score
- 2,999.68
- Event
- alopecia
- Reports
- 4,727
- Reporting signal score
- 4,100.75
- Event
- anti-cyclic citrullinated peptide antibody positive
- Reports
- 1,298
- Reporting signal score
- 3,245
- Event
- arthralgia
- Reports
- 32,168
- Reporting signal score
- 16,039.5
- Event
- arthropathy
- Reports
- 3,686
- Reporting signal score
- 4,721.36
- Event
- c-reactive protein abnormal
- Reports
- 1,253
- Reporting signal score
- 2,815.55
- Event
- crohn's disease
- Reports
- 9,375
- Reporting signal score
- 8,491.65
- Event
- drug intolerance
- Reports
- 6,655
- Reporting signal score
- 7,535.19
- Event
- glossodynia
- Reports
- 2,124
- Reporting signal score
- 3,988.7
- Event
- hand deformity
- Reports
- 1,994
- Reporting signal score
- 4,394.96
- Event
- infection
- Reports
- 3,792
- Reporting signal score
- 2,231.8
- Event
- injection site bruising
- Reports
- 10,144
- Reporting signal score
- 9,004.63
- Event
- injection site erythema
- Reports
- 28,046
- Reporting signal score
- 30,429.7
- Event
- injection site pain
- Reports
- 36,582
- Reporting signal score
- 33,558.3
- Event
- injection site pruritus
- Reports
- 15,404
- Reporting signal score
- 17,113.1
- Event
- injection site reaction
- Reports
- 14,682
- Reporting signal score
- 13,838.5
- Event
- injection site swelling
- Reports
- 15,132
- Reporting signal score
- 15,546.7
- Event
- injection site warmth
- Reports
- 7,246
- Reporting signal score
- 8,837.08
- Event
- joint swelling
- Reports
- 14,124
- Reporting signal score
- 10,393
- Event
- loss of personal independence in daily activities
- Reports
- 2,016
- Reporting signal score
- 2,825.71
- Event
- nasopharyngitis
- Reports
- 13,404
- Reporting signal score
- 6,696.15
- Event
- pain
- Reports
- 28,914
- Reporting signal score
- 8,203.82
- Event
- pemphigus
- Reports
- 2,549
- Reporting signal score
- 6,003.06
- Event
- psoriasis
- Reports
- 17,665
- Reporting signal score
- 12,206
- Event
- rheumatoid arthritis
- Reports
- 26,240
- Reporting signal score
- 31,700
And 8 more, listed on the interactive page.
- NCT00048542
- NCT00690573
- NCT00775437
- NCT02840175
- NCT05540743
- NCT00049751
- NCT00195650
- NCT00195663
- NCT00195702
- NCT00216177
- NCT00233558
- NCT00233571
- NCT00234234
- NCT00234845
- NCT00234897
- NCT00234936
- NCT00235833
- NCT00235859
- NCT00235872
- NCT00291915
- NCT00298272
- NCT00420927
- NCT00448383
- NCT00480272
- NCT00538902
And 316 more, listed on the interactive page.
- Dose
- 40 mg
- Route
- Subcutaneous
- How often
- Every other week
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 55513-399
- 55513-400
- 55513-410
- 55513-411
- 55513-413
- 55513-479
- 55513-480
- 55513-481
- 55513-482
- 61314-325
- 61314-327
- 61314-332
- 61314-391
- 61314-454
- 61314-473
- 61314-476
- 61314-509
- 61314-517
- 61314-531
- 70114-210
- 70114-220
- 71288-815
- 71288-816
- 72511-399
- 72511-400
And 20 more, listed on the interactive page.
Related records
Trials (575)
- "Comparison of the Efficacy and Safety of Adalimumab to That of Tocilizumab in Severe Uveitis of Behçet's Disease"
- A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
- A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis
- A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions
- A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis
- A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM)
- A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis
- A Clinical Study With Adalimumab Biosimilar
- A Clinical Trail of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis
- A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
- A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis
- A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants
- A Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 Extended Release Capsules
- A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab
- A Dose Response Study to Evaluate the Efficacy and Safety of Oral AP1189 Administered in Disease-Modifying Anti-Rheumatic Drug (DMARD) naïve Participants Participants With Early Rheumatoid Arthritis
- A Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma
- A Double Blind Study in Pediatric Subjects With Chronic Plaque Psoriasis, Studying Adalimumab vs. Methotrexate
- A Multicenter, Open-label Study on the Efficacy and Safety of Tebiovio® (Adalimumab) in Treating Chinese Children With Severe Plaque Psoriasis
- A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients Who Are Overtreated
- A Pharmacokinetic Study Comparing MB02 And EU Avastin® In Healthy Male Volunteers
Approved for (13)
- Ankylosing spondylitis
- Arthritic joint disease
- Crohn disease
- Hidradenitis suppurativa
- Immune system disorder
- Juvenile idiopathic arthritis
- Palmoplantar pustulosis
- Psoriasis
- Psoriasis-related juvenile idiopathic arthritis
- Psoriatic arthritis
- Rheumatoid arthritis
- Ulcerative colitis
- Uveitis
In development for (24)
- Age-related macular degeneration Phase 2
- Asthma Phase 2
- Behcet disease Phase 3
- Benign prostatic hyperplasia Phase 2
- Choroidal neovascularization Phase 2
- Colitis Phase 2
- COVID-19 Phase 3
- Familial Dupuytren contracture Phase 2
- Focal segmental glomerulosclerosis Phase 2
- Frozen shoulder Phase 2
- Inflammatory bowel disease Phase 3
- Interstitial cystitis Phase 3
- Mucopolysaccharidosis type 2 Phase 1
- Mucopolysaccharidosis type 6 Phase 1
- Netherton syndrome Phase 2
- Osteoarthritis Phase 3
- Osteoarthritis, knee Phase 2
- Pyoderma Phase 3
- REM sleep behavior disorder Phase 2
- Sarcoidosis Phase 2
Other linked conditions (2)
- Panuveitis
- Pustular psoriasis
Targets (1)
- TNF TNF-alpha inhibitor