Etanercept
Highest phase reached
Approved
Drug type
Protein
First approval year
1998
- First approval year
- 1998
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Etanercept
- benepali
- Benepali
- enbrel
- Enbrel
- erelzi
- Erelzi
- lifmior
- Lifmior
- nepexto
- Nepexto
- 1 235 tumor necrosis factor receptor human fusion protein with 236 467 immunoglobulin g1 human gamma 1 chain fc fragment dimer
- 1-235-TUMOR NECROSIS FACTOR RECEPTOR (HUMAN) FUSION PROTEIN WITH 236-467-IMMUNOGLOBULIN G1 (HUMAN .GAMMA.1-CHAIN FC FRAGMENT), DIMER
- 25mg etanercept
- 50 mg etanercept
- 50 mg Etanercept
- 50mg etanercept
- Benepali
- chs 0214
- Chs-0214
- CHS-0214
- davictrel
- Davictrel
- dwp 422
- Dwp-422
- Enbrel
- Enbrel (Etanercept 25mg)
- Enbrel (etanercept)
- Enbrel (Etanercept)
- ENBREL [PURPLE BOOK CDER]
- enbrel purple book cder
- Enbrel®
- ENBREL®
- Enbrel® (Etanercept)
- enia 11
- Enia-11
And 107 more, listed on the interactive page.
- ATC classification codes
- L04AB01
Sources for recorded values
- CAS registry numbers
- 185243-69-0
- ChEMBL ID
- CHEMBL1201572
- FDA ingredient codes (UNII)
- OP401G7OJC
- 214555
- 2462511
- Applicant
- IMMUNEX
- Approval date
- 2 Nov 1998
- Application number
- BLA103795
- Status
- Authorised
- Status date
- 2 Feb 2000
- Authorisation date
- 2 Feb 2000
- Approved indications
- Rheumatoid arthritis Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Treatment of polyarthritis (rheumatoid-factor-positive or -negative) and extended oligoarthritis in children and adolescents from the age of two years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Enbrel has not been studied in children aged less than two years. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritis Ankylosing spondylitis (AS) Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Non-radiographic axial spondyloarthritis Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). Plaque psoriasis Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric plaque psoriasis Treatment of chronic severe plaque psoriasis in children and adolescents from the age of six years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
- Product number
- EMEA/H/C/000262
- Authorisation holder
- Pfizer Europe MA EEIG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 4
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthritis, Juvenile Rheumatoid
- Arthritis, Psoriatic
- Arthritis, Rheumatoid
- Psoriasis
- Spondylitis, Ankylosing
European medicines record
- Patents
- 0
- Designations
- 4
- Earliest recorded loss of exclusivity
- 27 May 2006
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- etanercept
- Type
- Peptide
- Drug name stem
- -cept
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- tumour necrosis factor shed form
- Gene symbol
- tumour necrosis factor shed form
- 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
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Metabolic Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000195
- Subject identifier
- D024821
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Dermatomyositis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000398
- Subject identifier
- D003882
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- 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
- Sjogren's Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000699
- Subject identifier
- D012859
- Condition
- Spondylarthropathies
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000706
- Subject identifier
- D025242
- Condition
- Subarachnoid Hemorrhage
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000713
- Subject identifier
- D013345
- Condition
- HIV Infections
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Arthritis, Juvenile
- Highest recorded phase
- 4
- Condition identifier
- EFO:0002609
- Subject identifier
- D001171
- Condition
- Reperfusion Injury
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002687
- Subject identifier
- D015427
- Condition
- Pneumonia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003106
- Subject identifier
- D011014
- Condition
- Arthritis, Psoriatic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003778
- Subject identifier
- D015535
- Condition
- Lupus Erythematosus, Cutaneous
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003834
- Subject identifier
- D008178
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Spondylitis, Ankylosing
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003898
- Subject identifier
- D013167
- Condition
- Vitiligo
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004208
- Subject identifier
- D014820
- Condition
- Mucocutaneous Lymph Node Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004246
- Subject identifier
- D009080
- Condition
- Stevens-Johnson Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004276
- Subject identifier
- D013262
- Condition
- Pemphigus
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004719
- Subject identifier
- D010392
And 30 more, listed on the interactive page.
- Condition identifier
- EFO_0000095
- Condition identifier
- EFO_0000195
- Condition identifier
- EFO_0000195
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000198
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000398
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000565
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000621
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000676
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0000699
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000706
- Condition identifier
- EFO_0000713
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002609
- Condition identifier
- EFO_0002687
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002950
- Condition identifier
- EFO_0003106
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003778
- Condition identifier
- EFO_0003884
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003898
- Condition identifier
- EFO_0004208
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004246
- Highest recorded phase
- 2
And 103 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
- arthralgia
- Reports
- 32,254
- Reporting signal score
- 15,993
- Event
- arthropathy
- Reports
- 5,705
- Reporting signal score
- 5,525.09
- Event
- crohn's disease
- Reports
- 9,339
- Reporting signal score
- 8,378.8
- Event
- drug intolerance
- Reports
- 7,675
- Reporting signal score
- 4,572.34
- Event
- hand deformity
- Reports
- 2,486
- Reporting signal score
- 4,125.23
- Event
- injection site bruising
- Reports
- 10,119
- Reporting signal score
- 8,907.37
- Event
- injection site erythema
- Reports
- 28,046
- Reporting signal score
- 30,268.8
- Event
- injection site haemorrhage
- Reports
- 5,395
- Reporting signal score
- 6,107.99
- Event
- injection site pain
- Reports
- 36,582
- Reporting signal score
- 33,354.4
- Event
- injection site pruritus
- Reports
- 15,404
- Reporting signal score
- 17,025.4
- Event
- injection site rash
- Reports
- 4,672
- Reporting signal score
- 6,083.68
- Event
- injection site reaction
- Reports
- 14,682
- Reporting signal score
- 13,757.9
- Event
- injection site swelling
- Reports
- 15,132
- Reporting signal score
- 15,462
- Event
- injection site urticaria
- Reports
- 3,581
- Reporting signal score
- 4,819.4
- Event
- injection site warmth
- Reports
- 7,246
- Reporting signal score
- 8,795.39
- Event
- joint swelling
- Reports
- 14,107
- Reporting signal score
- 10,294.4
- Event
- mobility decreased
- Reports
- 5,262
- Reporting signal score
- 5,194.35
- Event
- musculoskeletal stiffness
- Reports
- 6,833
- Reporting signal score
- 5,265.68
- Event
- nasopharyngitis
- Reports
- 13,404
- Reporting signal score
- 6,634.45
- Event
- pain
- Reports
- 28,949
- Reporting signal score
- 8,122.63
- Event
- pain in extremity
- Reports
- 14,368
- Reporting signal score
- 7,508.66
- Event
- psoriasis
- Reports
- 17,688
- Reporting signal score
- 12,149.9
- Event
- rheumatoid arthritis
- Reports
- 26,299
- Reporting signal score
- 31,670.4
- Event
- sinusitis
- Reports
- 8,497
- Reporting signal score
- 7,391.02
- Event
- synovitis
- Reports
- 4,272
- Reporting signal score
- 6,328.09
And 1 more, listed on the interactive page.
- NCT00001901
- NCT00005007
- NCT00001954
- NCT00001955
- NCT00006070
- NCT00121615
- NCT00031551
- NCT00034060
- NCT00094341
- NCT00099554
- NCT00110903
- NCT00115219
- NCT00132418
- NCT00195494
- NCT00244556
- NCT00249041
- NCT00252668
- NCT00259610
- NCT00298272
- NCT00317538
- NCT00346294
- NCT00356590
- NCT00357903
- NCT00361634
- NCT00393471
And 227 more, listed on the interactive page.
- Dose
- 50 mg
- Route
- Subcutaneous
- How often
- Once weekly
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Sequence
- Type
- Protein
- Sequence
- LPAQVAFTPYAPEPGSTCRLREYYDQTAQMCCSKCSPGQHAKVFCTKTSDTVCDSCEDSTYTQLWNWVPECLSCGSRCSSDQVETQACTREQNRICTCRPGWYCALSKQEGCRLCAPLRKCRPGFGVARPGTETSDVVCKPCAPGTFSNTTSSTDICRPHQICNVVAIPGNASMDAVCTSTSPTRSMAPGAVHLPQPVSTRSQHTQPTPEPSTAPSTSFLLPMGPSPPAEGSTGDEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPQVKFNWYVDGVQVHNAKTKPREQQYNSTYRVVSVLTVLHQNWLDGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- 58406-010
- 58406-021
- 58406-032
- 58406-044
- 58406-055
Related records
Trials (415)
- 16.0040 Ankylosing Spondylitis Study
- 2 Regimens of Lactulose for Colonoscopy Preparation in Adults
- A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy
- A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)
- A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA
- A Long Term Safety Extension Study (CHS-0214-05)
- A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis
- A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years
- A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)
- A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
- A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 RH5 Alone and With MVA RH5
- A Pilot Study of Etanercept in Dermatomyositis
- A Pilot Study of MSCs Iufusion and Etanercept to Treat Ankylosing Spondylitis
- A Pilot Study to Examine the Feasibility and Effect of Tumor Necrosis Factor (TNF) Inhibition on HIV Disease
- A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg
- A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis
- A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
- A Prospective, With One Site, Open-label Not Controled Trial, for the Observation of Treatment With CIDOFOVIR 1%, 3 Nights Per Week, During 4 Weeks, of Anal Intraepithelial Neoplasia, High Level, in HIV+ Patients
- A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease
- A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Approved for (9)
- Ankylosing spondylitis
- Immune system disorder
- Juvenile idiopathic arthritis
- Palmoplantar pustulosis
- Psoriasis
- Psoriatic arthritis
- Rheumatoid arthritis
- Spondylitis
- Spondyloarthropathy
In development for (46)
- Acute graft versus host disease Phase 3
- Alzheimer disease Phase 2
- Asthma Phase 2
- B-cell chronic lymphocytic leukemia Phase 1
- Chronic idiopathic urticaria Phase 2
- Chronic kidney disease Phase 2
- Chronic obstructive pulmonary disease Phase 2
- Cutaneous lupus erythematosus Phase 2
- Dermatomyositis Phase 2
- Fanconi anemia Early phase 1
- Graft versus host disease Phase 2
- Granulomatosis with polyangiitis Phase 2
- Hidradenitis suppurativa Phase 2
- Histiocytosis Phase 2
- HIV infectious disease Phase 1
- Inclusion body myositis Early phase 1
- Ischemia reperfusion injury Phase 2
- Kawasaki disease Phase 2
- Leukemia Phase 2
- Lichen planus Phase 2
Other linked conditions (3)
Targets (1)
- TNF TNF-alpha inhibitor