Overview

Dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids. It is used to treat or manage a variety of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis (AS), and juvenile idiopathic poly-articular arthritis (JIA).

Indication

Etanercept is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults and in chronic moderate to severe plaque psoriasis in patients 4 years of age and older. It is also used to manage signs and symptoms of polyarticular idiopathic arthritis and Juvenile Psoriatic Arthritis in those aged 2 years and older. Etanercept is also used to manage the symptoms of psoriatic arthritis and ankylosing spondylitis.

Associated Conditions

Active Juvenile Psoriatic Arthritis
Ankylosing Spondylitis (AS)
Graft-versus-host Disease (GVHD)
Polyarticular Juvenile Idiopathic Arthritis
Psoriasis Vulgaris (Plaque Psoriasis)
Psoriatic Arthritis
Pyoderma Gangrenosum
Rheumatoid Arthritis
Severe Plaque psoriasis
Stevens-Johnson Syndrome
Chronic, severe Psoriatic Arthritis
Moderate Plaque psoriasis
Moderate, active Rheumatoid arthritis
Severe, active Rheumatoid arthritis

Research Report

Published: Jul 16, 2025

Etanercept (DB00005): A Comprehensive Monograph on a Pioneering TNF Inhibitor

Section 1: Molecular Profile and Bioengineering

Etanercept is a cornerstone biologic agent in the treatment of autoimmune diseases, representing a triumph of rational drug design and recombinant DNA technology. Its structure and production method are intricately linked to its therapeutic efficacy, stability, and clinical utility.

1.1. Structural Characterization: An Engineered Dimeric Fusion Protein

Etanercept is a large, complex biomolecule classified as a dimeric fusion protein.[1] It possesses an apparent molecular weight of approximately 150 kilodaltons (kDa) and is composed of two identical polypeptide chains, with each chain comprising 934 amino acids.[1] The defining characteristic of Etanercept is its engineered structure, which is not found in nature. It is created by fusing two distinct and functionally critical human protein domains using recombinant DNA techniques.[5]

The two key components of each polypeptide chain are:

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty	2025/08/24	NCT07138898	Not Applicable	Not yet recruiting	NYU Langone Health
Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis	2024/11/27	NCT06707194	Phase 4	Recruiting	Nanfang Hospital, Southern Medical University
A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis	2024/09/19	NCT06596772	Phase 3	Recruiting	mAbxience Research S.L.
A Study Investigating the Safety, Absorption, and Elimination of MB04, a New Compound That May Potentially be Used in the Treatment of Autoimmune Disorders	2024/04/30	NCT06392074	Phase 1	Active, not recruiting	mAbxience Research S.L.
Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis	2023/08/29	NCT06016517	N/A	Not yet recruiting	Tufts Medical Center
Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome	2023/08/25	NCT06011889	Phase 2	Recruiting	National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant	2023/07/18	NCT05950724	Early Phase 1	ENROLLING_BY_INVITATION	Northwestern University
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D	2022/03/16	NCT05281614	Early Phase 1	Completed	Benaroya Research Institute
Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging	2021/11/26	NCT05135312	Phase 4	UNKNOWN	OptiSkin Medical
A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants	2021/07/22	NCT04973566	Phase 1	Completed	Janssen Research & Development, LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ENBREL	A-S Medication Solutions	50090-3531	SUBCUTANEOUS	50 mg in 1 mL	4/13/2021
ENBREL	Immunex Corporation	58406-010	SUBCUTANEOUS	25 mg in 0.5 mL	12/6/2023
ENBREL	Immunex Corporation	58406-435	SUBCUTANEOUS	50 mg in 1 mL	12/6/2023
ENBREL	Immunex Corporation	58406-456	SUBCUTANEOUS	50 mg in 1 mL	12/6/2023
ENBREL	Immunex Corporation	58406-032	SUBCUTANEOUS	50 mg in 1 mL	12/6/2023
ENBREL	Immunex Corporation	58406-055	SUBCUTANEOUS	25 mg in 0.5 mL	12/6/2023
ENBREL	Immunex Corporation	58406-446	SUBCUTANEOUS	50 mg in 1 mL	12/6/2023
ENBREL	A-S Medication Solutions	50090-4490	SUBCUTANEOUS	50 mg in 1 mL	6/20/2019
ENBREL	Immunex Corporation	58406-445	SUBCUTANEOUS	50 mg in 1 mL	12/6/2023
ENBREL	Immunex Corporation	58406-044	SUBCUTANEOUS	50 mg in 1 mL	12/6/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Enbrel	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	2/2/2000
Enbrel	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	2/2/2000
Erelzi	Sandoz GmbH,Biochemiestrasse 10,6250 Kundl,Austria	Authorised	6/23/2017
Nepexto	Biosimilar Collaborations Ireland Limited,Unit 35/36,Grange Parade,,Baldoyle Industrial Estate,Dublin 13,DUBLIN,D13 R20R,Ireland	Authorised	5/20/2020
Benepali	Samsung Bioepis NL B.V.,Olof Palmestraat 10,2616 LR Delft,The Netherlands	Authorised	1/13/2016
Benepali	Samsung Bioepis NL B.V.,Olof Palmestraat 10,2616 LR Delft,The Netherlands	Authorised	1/13/2016
Benepali	Samsung Bioepis NL B.V.,Olof Palmestraat 10,2616 LR Delft,The Netherlands	Authorised	1/13/2016
Benepali	Samsung Bioepis NL B.V.,Olof Palmestraat 10,2616 LR Delft,The Netherlands	Authorised	1/13/2016

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Enbrel Solution for Injection in a Pre-Filled Syringe 25mg	Pfizer Manufacturing Belgium NV (Pre-filled Syringe)	SIN13834P	INJECTION, SOLUTION	50mg/mL	7/16/2010
NEPEXTO SOLUTION FOR INJECTION IN PRE-FILLED PEN 50MG/ML	Lupin Limited (Biotech Division)	SIN16533P	INJECTION, SOLUTION	50.0 mg/ml	7/4/2022
NEPEXTO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 25 MG/0.5 ML	Lupin Limited (Biotech Division)	SIN16531P	INJECTION, SOLUTION	25.0 mg/0.5ml	7/4/2022
Enbrel Solution for Injection in a Pre-filled Syringe 50mg	Pfizer Manufacturing Belgium NV (Pre-filled Syringe)	SIN13835P	INJECTION, SOLUTION	50mg/mL	7/16/2010
NEPEXTO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ML	Lupin Limited (Biotech Division)	SIN16532P	INJECTION, SOLUTION	50.0 mg/ml	7/4/2022
Enbrel Solution for Injection in a Pre-filled Pen 50mg	Pfizer Manufacturing Belgium NV (Pre-filled Syringe)	SIN14440P	INJECTION, SOLUTION	50mg/ml	11/15/2013
ENBREL FOR INJECTION 25 mg/vial	Pfizer Manufacturing Belgium NV (Lyophilized Powder), Pfizer Manufacturing Belgium NV (Diluent)	SIN11854P	INJECTION	25 mg/vial	3/23/2002

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ERELZI etanercept (rch) 25 mg in 0.5 mL solution for injection pre-filled syringe	281783	Sandoz Pty Ltd	Medicine	A	11/30/2017
ERELZI etanercept (rch) 50 mg in 1 mL solution for injection auto-injector	281780	Sandoz Pty Ltd	Medicine	A	11/30/2017
ENBREL etanercept (rch) 50 mg solution for injection cartridge	352091	Pfizer Australia Pty Ltd	Medicine	A	3/23/2021
ERELZI etanercept (rch) 50 mg in 1 mL solution for injection pre-filled syringe	281784	Sandoz Pty Ltd	Medicine	A	11/30/2017
ENBREL etanercept (rch) 50 mg solution for injection pre-filled syringe	124422	Pfizer Australia Pty Ltd	Medicine	A	3/6/2007
ENBREL etanercept (rch) 25 mg solution for injection cartridge	352090	Pfizer Australia Pty Ltd	Medicine	A	3/23/2021
ENBREL etanercept (rch) 25 mg powder for injection vial and diluent syringe composite pack	90456	Pfizer Australia Pty Ltd	Medicine	A	3/18/2003
BRENZYS etanercept (rch) 50 mg solution for injection pre-filled syringe	245252	Samsung Bioepis AU Pty Ltd	Medicine	A	7/22/2016
BRENZYS etanercept (rch) 50 mg solution for injection auto-injector	245253	Samsung Bioepis AU Pty Ltd	Medicine	A	7/22/2016
NEPEXTO etanercept 50 mg/1 mL solution for injection auto-injector	386938	Maxx Pharma Pty Ltd	Medicine	A	9/14/2022

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
RYMTI	lupin pharma canada limited	02530309	Solution - Subcutaneous	50 MG / 1 ML	4/5/2024
BRENZYS	Samsung Bioepis Co., Ltd.	02455323	Solution - Subcutaneous	50 MG / ML	9/23/2016
RYMTI	lupin pharma canada limited	02530295	Solution - Subcutaneous	50 MG / 1 ML	4/5/2024
BRENZYS	Samsung Bioepis Co., Ltd.	02455331	Solution - Subcutaneous	50 MG / ML	9/13/2016
ERELZI	Sandoz Canada, Inc.	02462877	Solution - Subcutaneous	25 MG / 0.5 ML	12/8/2017
ENBREL	Immunex Corporation	02274728	Solution - Subcutaneous	50 MG / ML	12/21/2005
ERELZI	Sandoz Canada, Inc.	02462850	Solution - Subcutaneous	50 MG / ML	8/4/2017
ERELZI	Sandoz Canada, Inc.	02462869	Solution - Subcutaneous	50 MG / ML	8/4/2017
ENBREL	Immunex Corporation	02242903	Kit , Powder For Solution , Liquid - Subcutaneous	25 MG / KIT	3/14/2001
RYMTI	lupin pharma canada limited	02530287	Solution - Subcutaneous	25 MG / 0.5 ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NEPEXTO 50 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Biosimilar Collaborations Ireland Limited	1201436005	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Commercialized
ERELZI 50 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Sandoz Gmbh	1171195007	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Commercialized
ENBREL 25 mg SOLUCION INYECTABLE EN JERINGAS PRECARGADAS	Pfizer Europe Ma Eeig	99126013	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Commercialized
ENBREL 25 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	99126003	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
ENBREL 50 mg SOLUCION INYECTABLE EN PLUMAS PRECARGADAS	Pfizer Europe Ma Eeig	99126020	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Commercialized
ENBREL 25 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Pfizer Europe Ma Eeig	199126023	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Commercialized
ERELZI 25 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA	Sandoz Gmbh	1171195003	SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
Benepali 50mg solucion inyectable en pluma precargada	Samsung Bioepis Nl B.V.	1151074002	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Commercialized
ERELZI 50 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA	Sandoz Gmbh	1171195010	SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA	Diagnóstico Hospitalario	Commercialized
ENBREL 10 mg POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE PARA USO PEDIATRICO	Pfizer Europe Ma Eeig	99126022	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Biocon Biologics Expands Nepexto Biosimilar to Australian Market for Autoimmune Disease Treatment

a month ago

Biocon Biologics has launched Nepexto, a biosimilar to Enbrel (etanercept), in Australia through partnership with Generic Health to expand patient access.

Canadian Real-World Study Shows Comparable Remission Rates Between Etanercept Biosimilars and Originator in Rheumatoid Arthritis

a month ago

A Canadian real-world evidence study of 150 rheumatoid arthritis patients found no significant differences in remission outcomes between etanercept biosimilars (Brenzys and Erelzi) and the originator drug Enbrel.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access

Etanercept