Golimumab clinical trials
Golimumab is named as an intervention in 6 current clinical trials in our South Korea, USA, France, Spain, Italy, Netherlands, Belgium, Poland, Norway, Canada, Brazil, Taiwan, Israel, UK, India, China, Germany, Sweden, Denmark, Switzerland, Austria, Czechia, Portugal, Japan, Australia and Singapore registers. 2 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Janssen Research & Development, LLC (3). The most-studied condition is Colitis, Ulcerative. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.
Where Golimumab is approved
All regulators →Of the three regulators tracked here, the first to approve Golimumab was Canada, on 7 Apr 2009. It is approved in 3 of the 3 regulators tracked here.
- 1 FDA-approved biosimilar, 1 interchangeable: Immgolis
- 1 EU safety letter (DHPC), latest: quality defect for Simponi, 9 Aug 2023
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Golimumab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Golimumab works
All drug targets →- TNF-alpha inhibitor InhibitorTarget: TNF tumor necrosis factorChEMBL only
- Psoriasis-related juvenile idiopathic arthritisPhase 3
- Inflammatory bowel diseasePhase 2/3
- Behcet diseasePhase 2
- Crohn diseasePhase 2
- AsthmaPhase 2
- Prostate cancerPhase 2
- SarcoidosisPhase 2
- Type 1 diabetes mellitusPhase 2
- UveitisPhase 2
- Autoimmune inner ear diseasePhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201833, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6776, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Golimumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 8 technology appraisals of Golimumab. 6 are current, and 6 of these recommend it for at least some patients. 2 older appraisals were replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Golimumab for treating active non-radiographic axial spondyloarthritis NICE TA497 | Recommended | 10 Jan 2018 | Current |
| TNF-alpha inhibitors for treating active ankylosing spondylitis and non-radiographic axial spondyloarthritis NICE TA383 | Recommended | 1 Feb 2016 | Current |
| Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed NICE TA375 | Optimised | 26 Jan 2016 | Current |
| Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy NICE TA329 | Recommended | 25 Feb 2015 | Current |
| Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying anti-rheumatic drugs NICE TA225 | Optimised | 22 Jun 2011 | Current |
| Golimumab for the treatment of psoriatic arthritis NICE TA220 | Recommended | 27 Apr 2011 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Golimumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 9 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Golimumab
- ATC code
- L04AB06
- ChEMBL
- CHEMBL1201833
- DrugBank
- DB06674
- CAS number
- 476181-74-5
- FDA UNII
- 91X1KLU43E
- Wikidata
- Q413879
- Wikipedia
- Golimumab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Golimumab
6 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Golimumab in the EU trials register (CTIS)
3 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Golimumab. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Golimumab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
9 single-substance products containing Golimumab on the HPRA medicines list.
- GOBIVAZ 100 mg solution for injection in pre-filled penAdvanz Pharma Limited · EU/1/25/1988/005-006
- GOBIVAZ 100 mg solution for injection in pre-filled syringeAdvanz Pharma Limited · EU/1/25/1988/007-008
- GOBIVAZ 50 mg solution for injection in pre-filled penAdvanz Pharma Limited · EU/1/25/1988/001-002
- GOBIVAZ 50 mg solution for injection in pre-filled syringeAdvanz Pharma Limited · EU/1/25/1988/003-004
- Gotenfia 100 mg solution for injection in pre-filled syringeStada Arzneimittel AG · EU/1/25/2009/003-004
Supply shortages
- GotenfiaGermany (BfArM) · Production problem · 1 Mar 2026 to 3 May 2027
- GotenfiaGermany (BfArM) · Production problem · 1 Mar 2026 to 3 May 2027
- GotenfiaGermany (BfArM) · Production problem · 1 Mar 2026 to 3 May 2027
- GotenfiaGermany (BfArM) · Production problem · 1 Mar 2026 to 3 May 2027
Recent approvals
Conditions studied with Golimumab
6 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Janssen Research & Development, LLC | 3 |
| Oslo University Hospital | 1 |
| Marie Hudson, MD | 1 |
| Seoul National University Hospital | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Golimumab trials
How many clinical trials are testing Golimumab?
6 current trials in our South Korea, USA, France, Spain, Italy, Netherlands, Belgium, Poland, Norway, Canada, Brazil, Taiwan, Israel, UK, India, China, Germany, Sweden, Denmark, Switzerland, Austria, Czechia, Portugal, Japan, Australia and Singapore registers name Golimumab as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Golimumab trials recruiting patients?
Yes. 2 of the 6 trials are recruiting: 1 with sites in South Korea and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Golimumab clinical trials?
Janssen Research & Development, LLC (3), Oslo University Hospital (1), Marie Hudson, MD (1) and Seoul National University Hospital (1). The number in brackets is how many trials each organisation leads.
Is Golimumab licensed in Ireland?
Yes. The HPRA medicines list includes 9 single-substance products containing Golimumab, for example GOBIVAZ 100 mg solution for injection in pre-filled pen (Advanz Pharma Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Golimumab shortage?
The registers we track list 4 entries for Golimumab: 4 German notices. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Golimumab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Golimumab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Golimumab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.