Rezpegaldesleukin (NKTR-358 / RESET T1D)
What it is
A regulatory T-cell-directed IL-2 biologic in a recruiting Phase 2 trial for recent-onset T1D. No T1D outcomes are posted; skin-disease results do not establish diabetes benefit.
Editorial review: . What was checked and what remains uncertain.
Latest dated source in the citation list: 2026-09-08. 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: RESET is testing C-peptide preservation; no T1D result is posted.[1]
- Important harms and treatment burden
- Safety: T1D safety results are unavailable. The protocol uses staged age enrolment and safety review before younger cohorts.[1]
- Approval and country access
- A regulatory T-cell-directed IL-2 biologic in a recruiting Phase 2 trial for recent-onset T1D. No T1D outcomes are posted; skin-disease results do not establish diabetes benefit.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: The protocol includes follow-up after 26 weeks of dosing; lasting T1D benefit remains unknown.[1]
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
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: 12 × 30 + 10 × 20 + 25 × 20 + 25 × 10 + 25 × 20 = 1810; divide by total weight 100. Unrounded weighted result: 18.1.
The protocol includes follow-up after 26 weeks of dosing; lasting T1D benefit remains unknown.[1]
T1D safety results are unavailable. The protocol uses staged age enrolment and safety review before younger cohorts.[1]
Protocol ages are 8–45, within 100 days of diagnosis, with residual C-peptide; current opening of each age band requires site confirmation.[1]
Phase 2, recruiting, with 66 participants planned rather than 66 demonstrated outcomes.[1]
The full picture
What makes this a distinct entry
Rezpegaldesleukin is a specific IL-2 receptor agonist designed to expand regulatory T cells. It is related to the broad low-dose IL-2 approach, but its formulation and T1D trial should be judged separately. The proposed immune effect is the developer's rationale, not an observed diabetes outcome.1
RESET T1D
The 8 September registry update lists RESET as recruiting: 66 participants planned, randomized 2:1, injections every 14 days for 26 weeks, then follow-up. Ages 8–45 are in the protocol, but younger cohorts open only after staged safety review. The registry does not establish which age bands each site accepts today. Primary completion is estimated for May 2028; dates may change.2
No T1D efficacy or adverse-event results are posted. Neither registration nor results in atopic dermatitis demonstrate preserved insulin secretion, safe long-term use, or insulin independence in T1D. This entry concerns research participation, not a commercially available T1D treatment.
Sources
- [1]NCT07142252 — study record · registry · 2026-09-08 — Registry update date; retrieved 16 September 2026. Registry registration is not proof of clinical benefit.
- [2]Nektar pipeline: rezpegaldesleukin in type 1 diabetes · manufacturer