Autoimmune disease medicines in Ireland 2026: clinical trials, new EU approvals and who makes them

Which autoimmune conditions this guide covers

This guide covers medicines for autoimmune and immune-mediated inflammatory diseases: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, juvenile idiopathic arthritis, psoriasis, Crohn's disease, ulcerative colitis, lupus, Sjögren's disease and systemic sclerosis. Multiple sclerosis and atopic dermatitis are counted separately, because they are often grouped with neurology and skin medicine.

It reports approval status, trials, manufacturing sites and reimbursement steps. It does not say which medicine suits a patient or compare how well medicines work. Speak to your doctor or pharmacist about treatment.

Autoimmune clinical trials in Ireland: 28 active studies

There are 28 active autoimmune clinical trials with at least one site in Ireland, read 8 November 2026 from the ClinicalTrials.gov file in our Airmid Éireann open data (records processed by ClinicalTrials.gov on 6 November 2026). Nine are recruiting and 19 are active but no longer recruiting. Across all statuses, 146 trials with an Irish site have studied these conditions.

Bowel disease dominates: 20 of the 28 active trials study Crohn's disease, ulcerative colitis or both. Fifteen of the 28 are Phase 3, five are Phase 2, one is Phase 2/3 and seven list no phase. You can browse them on our Crohn's disease trials in Ireland and ulcerative colitis trials in Ireland pages.

Source: ClinicalTrials.gov, via the Airmid Éireann ctgov_ireland file (2,710 studies with an Irish site), read 8 November 2026. "Active" means recruiting, not yet recruiting, active not recruiting or enrolling by invitation. A trial studying two conditions appears in both rows. Rheumatoid arthritis has many completed trials but only one still active.

Which companies lead autoimmune trials in Ireland

AbbVie leads autoimmune trials in Ireland, sponsoring 11 of the 28 active studies, read 8 November 2026. Its studies cover upadacitinib, risankizumab and adalimumab in Crohn's disease, ulcerative colitis, rheumatoid arthritis and psoriatic arthritis. Industry sponsors lead 26 of the 28.

• AbbVie: 11 active trials (see our AbbVie Ireland page).
• Takeda: 3, all on vedolizumab, two in children and teenagers.
• Eli Lilly and Company: 2 in ulcerative colitis (mirikizumab, and eltrekibart with mirikizumab).
• Bristol-Myers Squibb: 2 on deucravacitinib, in psoriatic arthritis and lupus.
• Alfasigma: 2 on filgotinib in ulcerative colitis.
• One each: Sanofi (sarilumab, juvenile arthritis), Janssen (guselkumab, ulcerative colitis), MSD (tulisokibart, Crohn's disease), Abivax (ulcerative colitis), Beeline Medicines (afimetoran, lupus), argenx (efgartigimod, Sjögren's disease), University College Cork (an imaging study in ulcerative colitis) and University College London (a children's Sjögren's cohort).

Over all 146 trials, the most frequent lead sponsors are AbbVie (27), Bristol-Myers Squibb (9), and Hoffmann-La Roche, Shire and University College Cork (6 each). Our trial sponsors directory lists every sponsor.

New autoimmune and immunology medicines authorised in the EU, 2025-2026

Six new active substances for autoimmune or immune-mediated conditions received an EU marketing authorisation between 1 January 2025 and 8 November 2026, according to EMA medicines data. An EU authorisation is valid in Ireland, but it does not mean the HSE pays for the medicine.

Source: EMA medicines data (file dated 8 November 2026) and each product's EPAR page. On 17 September 2026 the EMA's committee also gave positive opinions for Povofortay (povorcitinib, Incyte) in hidradenitis suppurativa and Klygefa (gefurulimab, Alexion Europe) in generalised myasthenia gravis; neither had an EU authorisation in the 8 November file. New approvals appear in our EMA approvals register.

Where autoimmune medicines are made in Ireland

Two Cork plants are named in EU product information as makers of the active substance for six immunology biologics: Janssen Sciences Ireland in Ringaskiddy and Eli Lilly Kinsale. The list comes from Annex II of each EU product information, which names the approved makers of a biological active substance and the sites responsible for batch release. It does not show what share of supply each site makes.

Source: EMA product information PDFs, Annex II, downloaded 8 November 2026. We also checked Humira, Skyrizi, Entyvio, Cosentyx, Bimzelx, Benlysta and Saphnelo: none names an Irish manufacturing or batch release site. See the sites on our Cork pharma map and the Johnson & Johnson Ireland, Eli Lilly Ireland and Regeneron Ireland pages.

Biosimilars are a separate story: 11 ustekinumab biosimilars hold an EU authorisation in the EMA file of 8 November 2026. Their holders and HSE best-value status are in our biosimilars in Ireland guide.

How autoimmune medicines are reimbursed in Ireland

The HSE decides whether to pay for a new autoimmune medicine, after the National Centre for Pharmacoeconomics (NCPE) assesses its value for money. The HSE Corporate Pharmaceutical Unit commissions the NCPE once a company applies. Every medicine gets a rapid review, which the NCPE aims to finish in about four weeks; some then go to a full health technology assessment of about 18 weeks. The HSE Drugs Group makes recommendations, and the HSE decides under the Health (Pricing and Supply of Medical Goods) Act 2013.

Recent NCPE immunology assessments, read 8 November 2026:

• Risankizumab (Skyrizi), ulcerative colitis: the NCPE recommended against reimbursement at the submitted price (August 2024). The HSE approved reimbursement in April 2025 after confidential price talks, as a later line of therapy after a lower cost biologic.
• Guselkumab (Tremfya), ulcerative colitis and Crohn's disease: rapid reviews completed 11 September 2025; the NCPE recommended that guselkumab not be considered for reimbursement for these uses at the submitted price.
• Mirikizumab (Omvoh), Crohn's disease: rapid review completed 18 December 2025, with the same recommendation at the submitted price.
• Teprotumumab (Tepezza), thyroid eye disease: full assessment commissioned 29 October 2025; the NCPE page says it was paused on 29 October 2026.
• Remibrutinib (Rhapsido), chronic spontaneous urticaria: full assessment commissioned 3 July 2026.

An NCPE recommendation is advice, and the price can change in later negotiation. We found no NCPE page for nemolizumab, nipocalimab, icotrokinra or tolebrutinib in a search of ncpe.ie on 8 November 2026.

How we built this guide

Trial counts come from the Airmid Éireann ctgov_ireland CSV, downloaded 8 November 2026 (checksum matched the catalogue). We matched the conditions field, case-insensitively, for: rheumatoid arthritis; psoriatic arthritis; spondyloarthritis or ankylosing spondylitis; juvenile idiopathic or juvenile rheumatoid arthritis; psoriasis; crohn; ulcerative colitis; lupus erythematosus, lupus nephritis, lupus or SLE; Sjögren; systemic sclerosis or scleroderma; and, separately, multiple sclerosis and atopic dermatitis or eczema. Study titles were not searched.

EU approvals come from the EMA medicines file (8 November 2026), filtered to new, non-generic, non-biosimilar medicines; Irish sites come from Annex II; reimbursement from NCPE pages. More on our Ireland trials register and our methodology page; errors are logged on our corrections page.