ENBREL (etanercept)
ENBREL is indicated for the treatment of Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Plaque Psoriasis; Polyarticular Juvenile Idiopathic Arthritis; Juvenile Psoriatic Arthritis.
How ENBREL Works
Etanercept is a dimeric soluble form of the p75 TNF receptor that binds to tumor necrosis factor (TNF), a cytokine that drives inflammatory and immune responses. By binding to TNF-alpha and TNF-beta, the drug prevents these molecules from attaching to receptors on the cell surface. This action renders the TNF biologically inactive, thereby interrupting the inflammatory processes that lead to joint pathology and skin symptoms. In vitro studies show that the drug does not cause the lysis of cells expressing transmembrane TNF.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-11-02
- Patent Cliff
- 2029
- Revenue
- $532M (Q4-2025)
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SYRINGE, VIAL
ENBREL Approval History
What ENBREL Treats
6 indicationsENBREL is approved for 6 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Plaque Psoriasis
- Polyarticular Juvenile Idiopathic Arthritis
- Juvenile Psoriatic Arthritis
ENBREL Boxed Warning
SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. SERIOUS INFECTIONS Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. ( 5.1 ) Enbrel should be discontinued if a patient develops a serious infection or sepsis during treatment. ( 5....
WARNING: SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. SERIOUS INFECTIONS Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. ( 5.1 ) Enbrel should be discontinued if a patient develops a serious infection or sepsis during treatment. ( 5.1 ) Perform test for latent TB; if positive, start treatment for TB prior to starting Enbrel. ( 5.1 ) Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 ) MALIGNANCIES Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including Enbrel. ( 5.3 ) SERIOUS INFECTIONS Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Enbrel should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before Enbrel use and during therapy. Initiate treatment for latent infection prior to Enbrel use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infe
ENBREL Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
ENBREL Biosimilars
2 FDA-approved1 can be substituted at the pharmacy without calling the prescriber. The other 1 require prescriber approval to switch.
What are biosimilars? Lower-cost alternatives to ENBREL with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
ENBREL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ENBREL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ENBREL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ENBREL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
99 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03451851 PROTOSTAR results posted | CR108452 CNTO1959PSO3011, 2023-503378-19-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants |
| NCT03997786 | TILD-19-12 | Ph 2, Ph 3 | active not recruiting | A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis |
| NCT06011889 SAPHO | NIGRIR_003SAPHO | Ph 2, Ph 3 | recruiting | Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome |
| NCT02840175 AJIBIOREM | P 150902 2016-000312-15 | Ph 3 | completed | Treatment Tapering in JIA With Inactive Disease |
| NCT04066348 | PR172190 | Ph 2 | recruiting | TNF-α Treatment of Blast-Induced Tinnitus |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT03792841 | 20180101 | Ph 1 | terminated | Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT06707194 | NFEC-2025-283 NFSC-2024-060 | Ph 4 | recruiting | Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis |
| NCT02713997 results posted | PEDS-2016-22934 R01DK109914 | Ph 4 | completed | Anti-inflammatory Therapy to Improve Outcomes After TPIAT |
| NCT04973566 | CR109053 2021-001656-33, 80202135EDI1003 | Ph 1 | completed | A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants |
| NCT04254627 E/M | GWICTIC-EMphase1 CDMRP-PC16GW170044 | Ph 1 | active not recruiting | TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset |
| NCT03976245 | RAJP0001 | Ph 4 | recruiting | Advanced Therapeutics in Rheumatoid Arthritis (RA) |
| NCT02308163 results posted | 015K-CL-RAJ3 | Ph 3 | completed | A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs |
| NCT03728478 STARS | 2018-001931-27 | Ph 3 | recruiting | STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS |
| NCT04485325 AcceleRAte | TMP-0731-2018 | Ph 4 | completed | Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients |
| NCT03182426 | Pro00053082 | Ph 1, Ph 2 | completed | Stem Cell Mobilization (Plerixafor) and Immunologic Reset in Type 1 Diabetes (T1DM) |
| NCT02464878 results posted | Islet after Kidney - AAT | Ph 2 | completed | Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant |
| NCT03636373 results posted | Pro2018000562 | Ph 4 | terminated | Pilot Study Evaluating The Efficacy Of Etanercept In Acute Gout |
| NCT00841789 results posted | SEA-12652 FD003526 | Ph 2 | completed | A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease |
| NCT01421069 CLIPPER2 results posted | B1801023 0881A1-3342, 2010-023802-10 | Ph 3 | completed | Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis |
| NCT02374021 TARGET results posted | 2014P002747 | Ph 4 | completed | Treatments Against RA and Effect on FDG-PET/CT |
| NCT02376790 results posted | 20130207 2014-004869-24 | Ph 3 | completed | Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis |
| NCT03100253 RAFTING | IRFMN-RA-6453 | Ph 4 | terminated | Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation |
| NCT02821026 | Pro00058260 | Ph 1, Ph 2 | completed | Omental Islet Transplant |
| NCT01690299 results posted | CC-10004-PSOR-010 2012-000859-14 | Ph 3 | completed | Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis |
| NCT03073200 Ixora-peds results posted | 16367 I1F-MC-RHCD, 2016-003331-38 | Ph 3 | completed | Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis |
| NCT00837434 results posted | DAIT ARA06 NIAID CRMS ID#: 20001 | Ph 4 | completed | Anti-TNF Agents for the Treatment of Rheumatoid Arthritis |
| NCT02092467 results posted | A3921133 2013-003177-99 | Ph 4 | completed | Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis |
| NCT02346240 CIMPACT results posted | PS0003 2014-003492-36 | Ph 3 | completed | Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) |
| NCT02464033 results posted | EDCR IIa | Ph 2 | completed | EDCR Study - Etanercept Diamyd Combination Regimen -Open Trial to Evaluate Safety in Children With Type 1 Diabetes |
| NCT01358578 FIXTURE results posted | CAIN457A2303 2010-022228-66 | Ph 3 | completed | Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis |
| NCT01865630 | 13-3007-ETP | Ph 1 | withdrawn | Safety and Efficacy Study of Etanercept for Aneurysmal Subarachnoid Hemorrhage |
| NCT00833729 | CA-2008-0008 | Ph 4 | completed | The Safety & Efficacy of Etanercept in Psoriasis Patients Who Have Not Responded to Adalimumab |
| NCT02509026 RE-EMBARK results posted | B1801381 2015-000541-24 | Ph 4 | completed | Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA |
| NCT02749370 results posted | 20150252 | Ph 4 | completed | Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast |
| NCT01971346 results posted | Derm 652 | Ph 4 | completed | The Immunological Basis for Treatment Resistance to Anti-TNF Treatments |
| NCT02433184 VEDERA | RR10/9592 | Ph 4 | completed | Very Early Versus Delayed Etanercept in Patients With RA |
| NCT02481180 | T0001-P2.0 | Ph 1 | terminated | Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis) |
| NCT02134210 results posted | CHS-0214-04 | Ph 3 | completed | Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO) |
| NCT02115750 CHS-0214-02 results posted | CHS-0214-02 | Ph 3 | completed | Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA) |
| NCT02656082 TARGET-DLE | RR15/114 2015-001602-33 | Ph 2 | completed | Targeted Therapy Using Intradermal Injection of Etanercept for Remission Induction in Discoid Lupus Erythematosus |
| NCT03160001 | PRO17050001 | Ph 1, Ph 2 | completed | Niclosamide With Etanercept in Rheumatoid Arthritis |
| NCT03273088 | ARY.ETA.AJ.PH1.2016 | Ph 1 | completed | Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects |
| NCT01934933 | [2013]2-93 | Ph 4 | completed | Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis |
| NCT01927757 ROCkIES results posted | 20120125 | Ph 4 | terminated | Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab |
| NCT01543204 results posted | 20101145 | Ph 4 | terminated | Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab |
| NCT00888628 results posted | IAK | Ph 1, Ph 2 | completed | Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients |
| NCT03332719 GEMENE | GEMENE001 | Ph 3 | completed | Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis |
| NCT03193957 | SB4-G21-RA | Ph 2 | completed | An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis |
Showing 50 of 99 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ENBREL FDA Label Details
Indications & Usage
FDA Label (PDF)ENBREL is indicated for the treatment of Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Plaque Psoriasis; Polyarticular Juvenile Idiopathic Arthritis; Juvenile Psoriatic Arthritis.
WARNING: SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. SERIOUS INFECTIONS Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive ...
Pro Intelligence Preview
Deep insights for ENBREL
Revenue Insights
- • Q4-2025: $532M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • Generic/biosimilar risk
Trial Analysis
- • 108 total trials
- • Stage: Mature
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment