Ladarixin (CXCR1/CXCR2 blockade)
What it is
An oral immune-pathway inhibitor tested soon after T1D diagnosis. The latest Phase 2 trial stopped for futility; results posted in August 2026 did not establish beta-cell preservation.
Editorial review: . What was checked and what remains uncertain.
Latest dated source in the citation list: 2026-08-31. This is the source’s date, not a new review of every claim.
Trial status, labels and access can change between reviews.
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
- Beta-cell preservation: The latest primary analysis included 140 participants and did not show a significant C-peptide advantage (P=0.19582).[1]
- Important harms and treatment burden
- Safety: Serious events affected 1/94 drug recipients and 1/46 placebo recipients; investigators considered neither related. This small comparison cannot exclude rare harms.[1]
- Approval and country access
- An oral immune-pathway inhibitor tested soon after T1D diagnosis. The latest Phase 2 trial stopped for futility; results posted in August 2026 did not establish beta-cell preservation.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: The study stopped for futility; a durable preservation benefit has not been established.[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: 10 × 30 + 10 × 20 + 50 × 20 + 25 × 10 + 35 × 20 = 2450; divide by total weight 100. Unrounded weighted result: 24.5.
The latest primary analysis included 140 participants and did not show a significant C-peptide advantage (P=0.19582).[1]
The study stopped for futility; a durable preservation benefit has not been established.[1]
Serious events affected 1/94 drug recipients and 1/46 placebo recipients; investigators considered neither related. This small comparison cannot exclude rare harms.[1]
The later study selected ages 14–45 within 180 days of first insulin, with autoantibodies and residual insulin production.[1]
Randomized Phase 2 results are available, but the latest trial terminated for futility.[1]
The full picture
What was tested
Ladarixin blocks the CXCR1/CXCR2 receptors in the IL-8 inflammatory pathway. An earlier randomized trial assigned 76 adults to drug or placebo. Its 13-week primary C-peptide comparison was not statistically significant (P=0.122). A transient secondary finding does not reverse that primary result.1
The August 2026 result
NCT04628481 is marked terminated for protocol-defined futility, with results posted on 31 August. The registry's total enrolment of 289 includes the run-in population; it is not the randomized treatment analysis denominator. The primary analysis used 94 ladarixin and 46 placebo recipients. The adjusted difference in change in log(AUC + 1) for meal-stimulated C-peptide at six months was −0.133 (95% CI −0.334 to 0.068; P=0.19582). This is a transformed measure, not a percentage difference or an untransformed C-peptide concentration.2
The safety table reports no deaths in either treatment group and one participant with a serious event in each. It does not establish long-term safety. These are sponsor-posted registry results, distinct from the peer-reviewed earlier trial. Neither study supports using ladarixin as a proven cure or an insulin replacement.
Sources
- [1]NCT04628481 — study record · registry · 2026-08-31 — Registry update date; retrieved 16 September 2026. Registry registration is not proof of clinical benefit.
- [2]Ladarixin in new-onset type 1 diabetes: randomized placebo-controlled trial · peer-reviewed · 2022-07-04