Drugs / Rezpegaldesleukin
Rezpegaldesleukin
also known as
LY3471851 · Il-2 peg conjugate (nktr-358) · NKTR-358 · REZPEG · Rezpegaldesleukina · Rezpegaldesleukine
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT05565729 | Oct 2022 → Feb 2023 | — | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04998487 | Aug 2021 → Jul 2022 | — | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04119557 | Nov 2019 → Jul 2021 | psoriasis | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04133116 | Oct 2019 → Mar 2020 | — | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03556007 | Apr 2018 → Aug 2019 | systemic lupus erythematosus | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04380324 | Mar 2017 → Jan 2019 | — | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 25 trials · 2 met primary · 2 missed | ||||||
| Phase 2 | NCT07142252 | May 2026 → May 2028 expected | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting | No outcome recorded |
| Phase 2 | NCT06340360 | Apr 2024 → Nov 2025 | alopecia areata | Nektar Therapeutics | Completed | Met primary |
| Phase 2 | NCT06136741 | Nov 2023 → May 2025 overdue | atopic eczema | Nektar Therapeutics | Active not recruiting | Met primary |
| Phase 2 | NCT04677179 | Mar 2021 → Aug 2022 | ulcerative colitis | Nektar Therapeutics | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT04433585 | Aug 2020 → Jan 2023 | systemic lupus erythematosus | Nektar Therapeutics | Completed | Missed primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT07711418 | Aug 2026 → Jun 2028 expected | atopic eczema | Nektar Therapeutics | Recruiting | No outcome recorded |
| Phase 3 | NCT07690371 | Jun 2026 → May 2028 expected | atopic eczema | Nektar Therapeutics | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT04081350 Comparator | Dec 2019 → Jun 2022 | atopic eczema | Nektar Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | Nektar Therapeutics | Results New Rezpegaldesleukin Data Supporting Long-term Durability and Disease Improvement in Patients with Alopecia Areata and Atopic Dermatitis at EADV Congress 2026 nektar.com ↗
Rezpegaldesleukin demonstrated durability and deepening of response through one year of treatment in two dermatological indications, reinforcing the differentiated properties of this novel Treg mechanism |
| 2026-09-30 | Nektar Therapeutics | Results New Biomarker Data Presented in a Late Breaking Oral Presentation at EADV Congress 2026 Showing Early Molecular Responses to Rezpegaldesleukin Across Multiple Immune Pathways Dysregulated in Patients with Atopic Dermatitis nektar.com ↗
Rezpegaldesleukin-associated improvements were detected as early as Week 2 and were significantly correlated with subsequent clinical response |
| 2026-08-25 | Nektar Therapeutics | Results Nektar Announces Publication in The Lancet of Positive Phase 2b REZOLVE-AD 16-Week Induction Results of Rezpegaldesleukin in Moderate-to-Severe Atopic Dermatitis nektar.com ↗
REZOLVE-AD study met all primary and key secondary endpoints, including EASI -75, EASI -90, Itch NRS, vIGA-AD and BSA, on rezpegaldesleukin 24 µg/kg q2w |
| 2026-04-20 | Nektar Therapeutics | Results 52-Week Topline Results from 16-Week Blinded Treatment Extension of REZOLVE-AA Demonstrate Deepening of Responses in Severe-to-Very-Severe Alopecia Areata with Rezpegaldesleukin nektar.com ↗
29% and 31% of patients in the 18 µg/kg and 24 µg/kg extension arms, respectively, achieved new SALT Score ≤20 from week 36 to week 52 with continued twice-monthly treatment |
| 2026-03-28 | Nektar Therapeutics | Results Data from Phase 2b REZOLVE-AD and REZOLVE-AA Studies of Rezpegaldesleukin Presented at 2026 American Academy of Dermatology Annual Meeting nektar.com ↗
During the 16-week induction period, patients also achieved comparable EASI -75 (at least a 75% improvement in EASI score from baseline) and EASI -90 response (at least a 90% improvement in EASI score from baseline). |
| 2026-02-10 | Nektar Therapeutics | Results New REZOLVE-AD Maintenance Data in Atopic Dermatitis Demonstrate Rezpegaldesleukin Resulted in Durable and New Responses Across Key Disease Measurements with Both Monthly and Quarterly Dosing nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, today announced positive results from the 36-week blinded maintenance period of the 52-week REZOLVE-AD study of rezpegaldesleukin, a novel regulatory T-cell (Treg) biologic, in patients with moderate-to-severe atopic dermatitis (AD). |
| 2025-12-16 | Nektar Therapeutics | Results REZOLVE-AA Phase 2b Study of Rezpegaldesleukin Establishes Proof-of-Concept in Patients with Severe-to-Very-Severe Alopecia Areata nektar.com ↗
Achieved target product profile on the primary endpoint, with a mean percent reduction in SALT score at 36 weeks of 28.2% in the 24 µg/kg arm versus 11.2% in placebo |
| 2025-11-08 | Nektar Therapeutics | Results New Data from REZOLVE-AD Study of Rezpegaldesleukin Presented in Late-Breaking Oral Abstract Presentation at ACAAI 2025 Annual Scientific Meeting nektar.com ↗
Statistically significant and clinically meaningful improvements in mean ACQ-5 scores were reported at week 16 versus placebo in patients who had atopic dermatitis and a history of asthma |
| 2025-09-18 | Nektar Therapeutics | Results Nektar Presents New Data from REZOLVE-AD Phase 2b Study for Rezpegaldesleukin in Late-Breaker Oral Presentation at EADV 2025 nektar.com ↗
In the Phase 2b study, rezpegaldesleukin achieved statistical significance on the primary endpoint of mean improvement in Eczema Area and Severity Index (EASI) at week 16 over baseline for all rezpegaldesleukin arms versus placebo. |
| 2025-07-29 | Nektar Therapeutics | Regulatory Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Severe-to-Very Severe Alopecia Areata nektar.com ↗
SAN FRANCISCO , July 29, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms. |
| 2025-06-24 | Nektar Therapeutics | Results REZOLVE-AD Phase 2b Study of Rezpegaldesleukin Meets Primary and Key Secondary Endpoints in Patients with Moderate-to-Severe Atopic Dermatitis nektar.com ↗
Across all three dose arms, translational blood biomarker data demonstrate robust on-target and dose-dependent pharmacological activity with an increase in total Tregs of up to 6-fold in the high dose arm. |
| 2025-02-10 | Nektar Therapeutics | Regulatory Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. |
| 2024-10-29 | Nektar Therapeutics | Results Nektar Announces Publication in Nature Communications of Results from Phase 1b Studies of Rezpegaldesleukin in Two Inflammatory Skin Diseases nektar.com ↗
Results from the Phase 1b studies showed that rezpegaldesleukin safely and dose-dependently increased Tregs and rapidly improved measurable exploratory disease outcomes that are largely durable for at least 36 weeks after ceasing treatment. |
| 2024-09-25 | Nektar Therapeutics | Results Nektar Therapeutics Announces Multiple Presentations for Rezpegaldesleukin at EADV 2024 nektar.com ↗
The data show that REZPEG induces important immunoregulatory pathways, such as IL-10, a key anti-inflammatory cytokine. |
| 2023-10-13 | Nektar Therapeutics | Results Nektar Presents New Responder Data for Rezpegaldesleukin, a First-in-Class Selective Regulatory T-cell Therapy, in Late-Breaking News Oral Presentation at 2023 EADV Congress nektar.com ↗
Nektar Therapeutics (NASDAQ:NKTR) today announced new data for rezpegaldesleukin (REZPEG), a first-in-class selective regulatory T-cell (Treg) therapy, in patients with atopic dermatitis (AD) at the 2023 European Academy of Dermatology and Venereology (EADV) Congress . |
| 2023-09-13 | Nektar Therapeutics | Results Nektar Therapeutics Announces Promising New Data from Phase 1b Study of Rezpegaldesleukin in Moderate-to-Severe Atopic Dermatitis nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today announced new data for rezpegaldesleukin in patients with atopic dermatitis, including new clinical efficacy endpoints from the Phase 1b study. |
| 2023-08-07 | Nektar Therapeutics | Results Nektar Announces Promising New and Corrected Rezpegaldesleukin Efficacy Data Which Were Previously Reported in 2022 and Incorrectly Calculated by Former Collaborator Eli Lilly & Company nektar.com ↗
This efficacy benefit was also maintained for 36 weeks without additional treatment after the 12-week induction period. |
| 2023-02-23 | Nektar Therapeutics | Results Nektar Therapeutics Announces Phase 2 Topline Data for Rezpegaldesleukin in Patients with Systemic Lupus Erythematosus nektar.com ↗
Improvement in SLEDAI-2K score observed as compared to placebo, although study did not meet primary endpoint |
| 2022-09-07 | Nektar Therapeutics | Results Nektar Therapeutics Presents Data for Rezpegaldesleukin (LY3471851) in Patients with Atopic Dermatitis and Psoriasis from Two Separate Clinical Studies at 2022 European Academy of Dermatology (EADV) Congress nektar.com ↗
In atopic dermatitis, dose-dependent improvements in key efficacy measures were observed for an additional 36 weeks following the 12-week treatment period. |
| 2021-12-15 | Nektar Therapeutics | Results Nektar Therapeutics Announces Phase 1b Data for Novel T Regulatory Cell Stimulator NKTR-358 (LY3471851) in Patients with Atopic Dermatitis nektar.com ↗
The proof-of-concept data show that NKTR-358 (Q2W for 12-week treatment duration) resulted in a dose dependent reduction in Eczema Area and Severity Index (EASI) scores in patients with moderate-to-severe atopic dermatitis |
| 2021-05-20 | Nektar Therapeutics | Results Nektar Therapeutics Announces First Publication of NKTR-358, a Novel Molecule Designed to Selectively Stimulate Expansion and Selective Function of T Regulatory Cells, in the Journal of Translational Autoimmunity nektar.com ↗
These published data demonstrate that NKTR-358 has the ability to elicit sustained and preferential proliferation and activation of Tregs in vivo without corresponding increases in T effector cells. |
| 2020-11-04 | Nektar Therapeutics | Results New Clinical Data Presented from Phase 1b Study of NKTR-358, a Novel T Regulatory Cell Stimulator, at 2020 American College of Rheumatology (ACR) Congress nektar.com ↗
In our data presented at ACR 2020, we were excited to see that NKTR-358 demonstrated a dose-dependent reduction in CLASI-A composite clinical scores in patients with mild-to-moderate SLE after only 3 treatment cycles. |
| 2020-06-04 | Nektar Therapeutics | Results Data Presented from Phase 1b Study of NKTR-358, a Novel T Regulatory Cell Stimulator, at Annual European Congress of Rheumatology (EULAR 2020) nektar.com ↗
show that NKTR-358 was safe and well tolerated in patients with mild-to-moderate SLE and led to a marked and selective, dose-dependent expansion of regulatory T cells (Tregs) that was maintained over multiple administrations. |
| 2019-11-10 | Nektar Therapeutics | Results Nektar Therapeutics Presents Data from First-in-Human Phase 1a Study on Novel T Regulatory Cell Stimulator, NKTR-358 at 2019 Annual Meeting of the American College of Rheumatology nektar.com ↗
Nektar Therapeutics (NASDAQ: NKTR) today announced updated results from the first-in-human Phase 1a study of NKTR-358, a novel T regulatory (Treg) cell stimulator in development for the treatment of autoimmune and other chronic inflammatory conditions. |
| 2019-06-13 | Nektar Therapeutics | Results First-in-Human Data Presented from Phase 1a Study of NKTR-358, a Novel T Regulatory Cell Stimulator, at Annual European Congress of Rheumatology nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today announced the results of the first-in-human Phase 1a study evaluating single-ascending doses of NKTR-358, a first-in-class T regulatory cell stimulator in clinical development for the treatment of autoimmune and other chronic inflammatory conditions. |
| 2017-11-07 | Nektar Therapeutics | Results Nektar Therapeutics Presents Preclinical Data on NKTR-358, a First-in-Class Regulatory T Cell Stimulator, at 2017 American College of Rheumatology Annual Meeting nektar.com ↗
Data from these studies show that NKTR-358 drives the proliferation and sustained preferential activation of regulatory T cells, both of which are critically important to restore balance to the immune system, |
| 2017-07-10 | Nektar Therapeutics | Results Nektar Presents New Preclinical Data for NKTR-358, a First-in-Class Regulatory T Cell Stimulator, at 13th World Congress of Inflammation in London nektar.com ↗
today announced positive preclinical results for NKTR-358, a first-in-class resolution therapeutic for autoimmune disease. |
All press releases naming this drug 47 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rezpegaldesleukin | “Here we present clinical evidence for the Treg-selective interleukin-2 receptor agonist rezpegaldesleukin (REZPEG) in two randomized, double-blind, placebo-controlled Phase 1b...” PMID 39455575 ↗ Oct 2024 |
| Known as | Il-2 peg conjugate (nktr-358) | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095458 ↗ |
| Known as | LY3471851 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04380324 ↗ |
| Known as | NKTR-358 | “LY3471851 (NKTR-358) is a potential first-in-class therapeutic that may address an underlying immune system imbalance” NCT04677179 ↗ |
| Known as | REZPEG | “Here we present clinical evidence for the Treg-selective interleukin-2 receptor agonist rezpegaldesleukin (REZPEG) in two randomized, double-blind, placebo-controlled Phase 1b...” PMID 39455575 ↗ Oct 2024 |
| Known as | Rezpegaldesleukina | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095458 ↗ |
| Known as | Rezpegaldesleukine | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095458 ↗ |
| Action | Activate | “By activating these cells, LY3471851 may act to bring the immune system back into balance.” NCT03556007 ↗ |
| Modality | Protein / enzyme biologic | “pegylated-recombinant-human interleukin-2 (rezpegaldesleukin)” NCT06136741 ↗ |
| Route | Subcutaneous | “multiple subcutaneous (SC) doses of LY3471851” NCT03556007 ↗ |