Ustekinumab (IL-12/23 p40 blocker)
Janssen / Johnson & Johnson (Stelara; repurposed)
What it is
Ustekinumab blocks the IL-12/IL-23 p40 subunit. A randomized trial in adolescents with recent-onset T1D met its 52-week C-peptide endpoint; this did not establish insulin independence or prevention of stage 3 disease. An adult phase 2/3 trial remains listed as active, not recruiting, without posted results. T1D is not an indication in the checked US label.
Editorial review: .
Most recent recorded citation date: 2026-09-08. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Delay of onset: The adolescent trial found greater stimulated C-peptide at 52 weeks after diagnosis. It did not test prevention of stage 3 onset.[1]
- Important harms and treatment burden
- Safety: No increase in adverse events was observed in the small adolescent trial. The US label includes serious infection and other warnings; this study cannot exclude uncommon harms.[3]
- Approval and country access
- Investigational for T1D. Ages 12–35 summarize the reviewed adolescent and adult trial populations, not an approved T1D age range.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: The primary result covers 52 weeks; it does not establish durable benefit after treatment stops.[1]
Research status alone does not establish approval, clinical benefit or local availability.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 45 × 30 + 35 × 20 + 70 × 20 + 30 × 15 + 20 × 15 = 4200; divide by total weight 100. Unrounded weighted result: 42.
The adolescent trial found greater stimulated C-peptide at 52 weeks after diagnosis. It did not test prevention of stage 3 onset.[1]
The primary result covers 52 weeks; it does not establish durable benefit after treatment stops.[1]
No increase in adverse events was observed in the small adolescent trial. The US label includes serious infection and other warnings; this study cannot exclude uncommon harms.[3]
The reviewed T1D trial concerns recent-onset stage 3 disease. Its findings cannot establish stage 1 or stage 2 prevention.[1]
The checked US label lists immune-disease indications, not T1D. The adult T1D study is listed as active, not recruiting; no routine T1D access is established.[3]
Editor’s take
A positive beta-cell function result after diagnosis warrants further study. It is not proof of prevention or a replacement for insulin. Ratings are editorial judgments about this limited evidence, not treatment recommendations.
The full picture
What was tested
Ustekinumab targets the shared p40 subunit of IL-12 and IL-23. The adolescent T1D trial tested preservation of remaining beta-cell function after diagnosis, rather than prevention of stage 3 onset.1
The study randomized 72 adolescents aged 12–18. Its prespecified primary analysis included 62 with complete baseline and week-52 data. Stimulated C-peptide was 49% higher with ustekinumab: geometric mean ratio 1.49 (95% CI 1.08–2.06; P=0.02). Adverse-event rates did not increase. The paper did not find significant improvement in other metabolic measures, including HbA1c and time in range. Immune-cell associations were exploratory.1
This result does not establish a cure, insulin independence or durable benefit after treatment. A small trial cannot rule out uncommon harms. The current US label lists immune-disease indications and includes warnings about infections and other serious risks; it does not list T1D.3
Adult study and access
The separate adult UST1D2 registry record remains active, not recruiting, with estimated enrollment of 66 adults aged 18–35. Its last posted update was 24 February 2025. It estimates primary completion on 1 February 2026 and study completion on 1 November 2026; no results are posted in the record checked on 17 September 2026. Passed estimates do not prove completion or an overdue publication.2
The age range shown here combines the two reviewed trial populations; it is not an approved T1D label. See the adolescent trial record for its evidence and eligibility.
Coming soon
ETA · Adult study completion estimated November 2026 in a registry last updated February 2025; no results-publication date established
- →Adult UST1D2 study completion · Estimated 1 November 2026 in the registry; not a promised readout date
Sources
- [1]Ustekinumab for type 1 diabetes in adolescents: a multicenter, double-blind, randomized phase 2 trial · Peer-reviewed study · 2024-07-30 — 72 randomized; 62 with complete data in the prespecified primary analysis. C-peptide ratio 1.49 at 52 weeks (95% CI 1.08–2.06).
Tatovic D, et al. Ustekinumab for type 1 diabetes in adolescents. Nature Medicine, 2024.
- [2]Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2) · Trial registry · 2025-02-24 — Checked 17 September 2026: active, not recruiting; enrollment estimated at 66, ages 18–35. Estimated primary completion 1 February 2026 and completion 1 November 2026. No results posted; estimates are not publication deadlines.
ClinicalTrials.gov. NCT03941132; live record checked 17 September 2026.
- [3]STELARA (ustekinumab): current US prescribing information · Regulatory decision · 2026-09-08 — DailyMed update date. Sections 1 and 5: approved indications and warnings; no T1D indication.
STELARA US prescribing information, DailyMed update 8 September 2026, sections 1 and 5.