Etanercept

Generic Name: Etanercept

Brand Names: Enbrel, Eticovo, Benepali, Erelzi, Nepexto

Drug Type: Biotech

CAS Number: 185243-69-0

Unique Ingredient Identifier: OP401G7OJC

Background: 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

Clinical Trials

Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

Phase 4

Not yet recruiting

Conditions: Spondyloarthritis (SpA)
Ankylosing Spondylitis (AS)

Interventions: Biological: Etanercept
Drug: Benzathine Penicillin
Other: Placebo

First Posted Date: 2024-11-27

Last Posted Date: 2024-11-27

Lead Sponsor: Nanfang Hospital, Southern Medical University

Target Recruit Count: 208

Registration Number: NCT06707194

Locations: 🇨🇳
Anhui Provincial Hospital, Hefei, Anhui, China
🇨🇳
The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China
🇨🇳
Nan Fang Hospital, Southern Medical University, Guangzhou, Guangdong, China

and more 2 locations

A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis

Phase 3

Recruiting

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: MB04 (proposed biosimilar to etanercept)
Drug: Enbrel (etanercept)

First Posted Date: 2024-09-19

Last Posted Date: 2025-03-24

Lead Sponsor: mAbxience Research S.L.

Target Recruit Count: 458

Registration Number: NCT06596772

Locations: 🇧🇬
Research site 2007, Haskovo, Bulgaria
🇧🇬
Research site 2005, Plovdiv, Bulgaria
🇧🇬
Research Site 2002, Ruse, Bulgaria

and more 57 locations

A Study Investigating the Safety, Absorption, and Elimination of MB04, a New Compound That May Potentially be Used in the Treatment of Autoimmune Disorders

Phase 1

Active, not recruiting

Conditions: Healthy Volunteers

Interventions: Drug: MB04
Drug: US License Enbrel

First Posted Date: 2024-04-30

Last Posted Date: 2025-05-11

Lead Sponsor: mAbxience Research S.L.

Target Recruit Count: 132

Registration Number: NCT06392074

Locations: 🇳🇱
ICON Clinical Research Unit, Groningen, Netherlands

Application of N-of-1 Rheumatoid Arthritis

Not yet recruiting

Conditions: Arthritis, Rheumatoid

First Posted Date: 2023-08-29

Last Posted Date: 2025-03-04

Lead Sponsor: Tufts Medical Center

Target Recruit Count: 18

Registration Number: NCT06016517

Locations: 🇺🇸
Tufts Medical Center, Boston, Massachusetts, United States

Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome

Phase 2

Recruiting

Conditions: SAPHO Syndrome

Interventions: Drug: Placebo
Drug: Etanercept

First Posted Date: 2023-08-25

Last Posted Date: 2024-11-19

Lead Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Target Recruit Count: 60

Registration Number: NCT06011889

Locations: 🇵🇱
Centrum Wsparcia Badań Klinicznych, Warsaw, Mazowieckie, Poland

RENAL: TNF-alpha Inhibitor for Improving Renal Dysfunction and Primary Graft Dysfunction After Lung Transplant

Early Phase 1

Conditions: Lung Transplant; Complications

Interventions: Drug: Etanercept Injection [Enbrel]

First Posted Date: 2023-07-18

Last Posted Date: 2023-11-13

Lead Sponsor: Northwestern University

Target Recruit Count: 20

Registration Number: NCT05950724

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States

Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D

Early Phase 1

Completed

Conditions: Type 1 Diabetes

Interventions: Drug: Etanercept
Drug: Vedolizumab

First Posted Date: 2022-03-16

Last Posted Date: 2024-05-24

Lead Sponsor: Benaroya Research Institute

Target Recruit Count: 20

Registration Number: NCT05281614

Locations: 🇺🇸
University of California San Diego, La Jolla, California, United States
🇺🇸
Benaroya Research Institute, Seattle, Washington, United States