Drugs / Rosnilimab
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06127043 | Dec 2023 → Jan 2026 overdue | ulcerative colitis | AnaptysBio, Inc. | Active not recruiting | Missed primary |
| Phase 2 | NCT06041269 | Aug 2023 → Nov 2024 overdue | rheumatoid arthritis | AnaptysBio, Inc. | Active not recruiting | Met primary |
| Phase 2 | NCT05205070 | Dec 2021 → Jan 2023 | alopecia areata | AnaptysBio, Inc. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-11-10 | AnaptysBio, Inc. | Results Anaptys Announces Phase 2 Trial of Rosnilimab Did Not Meet Primary or Secondary Endpoints at Week 12 in Moderate-to-Severe Ulcerative Colitis anaptysbio.com ↗
Given these results, this UC trial will be discontinued, resulting in at least $10 million in savings. |
| 2025-10-29 | AnaptysBio, Inc. | Results Anaptys Announces New Positive Phase 2b Trial Results for Rosnilimab in Rheumatoid Arthritis at ACR Late-Breaking Oral Presentation anaptysbio.com ↗
New study results showed that positive Week 12 data across multiple higher-order response measures continue to deepen into Week 28 regardless of prior treatment. |
| 2025-08-06 | AnaptysBio, Inc. | Results Anaptys Announces Second Quarter 2025 Financial Results and Provides Business Update anaptysbio.com ↗
Rosnilimab’s Phase 2b data in rheumatoid arthritis (RA) delivered a compelling safety and tolerability profile and JAK-like efficacy through six months that is durable for at least three months off-drug. |
| 2025-06-03 | AnaptysBio, Inc. | Results Anaptys Announces Positive Rosnilimab Data Updated Through Six Months in Robust Phase 2b Trial in RA anaptysbio.com ↗
In the robust, global 424-patient Phase 2b trial, rosnilimab achieved JAK-like efficacy on multiple clinically meaningful measures, including low disease activity (LDA) and remission on the Clinical Disease Activity Index (CDAI), as well as ACR70 response, over a six-month period. |
| 2025-02-27 | AnaptysBio, Inc. | Results Anaptys Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update anaptysbio.com ↗
Rosnilimab’s positive Phase 2b data in rheumatoid arthritis has revealed impressive safety, tolerability and three-month efficacy data that was sustained and surpasses six-month data from competitor all-active, head-to-head trials. |
| 2025-02-12 | AnaptysBio, Inc. | Results Anaptys Announces Rosnilimab Achieved Positive Results in RA Phase 2b Trial and Highest Ever Reported CDAI LDA Response Over 6 Months anaptysbio.com ↗
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced statistically significant Week 12 data from the global 424-patient Phase 2b RENOIR trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis (RA). |
| 2023-01-05 | AnaptysBio, Inc. | Results AnaptysBio Announces Portfolio Update Across Best-in-Class Immune Cell Modulating Antibodies anaptysbio.com ↗
Blinded interim review of alopecia areata Phase 2a data demonstrated rosnilimab “proof of mechanism” with robust reductions in peripheral PD-1 high and PD-1+ T cells and suggests administration was generally safe and well tolerated; |
| 2021-11-15 | AnaptysBio, Inc. | Results AnaptysBio Announces Positive Rosnilimab Healthy Volunteer Phase 1 Top-Line Data anaptysbio.com ↗
Top-line data demonstrated favorable safety, pharmacokinetics and pharmacodynamic results that support advancement of rosnilimab into subsequent patient trials. |
All press releases naming this drug 12 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rosnilimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06127043 ↗ |
| Known as | ANB-030 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095287 ↗ |
| Action | Activate | “PD-1 agonist antibody” NCT06041269 ↗ |
| Modality | Monoclonal antibody | “humanized monoclonal antibody” NCT05205070 ↗ |
| Route | Subcutaneous | “SC injections every 4 weeks” NCT05205070 ↗ |