Drugs / INCA033989
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07448155 | Mar → Oct 2026 expected | — | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT06034002 | Dec 2023 → Oct 2028 expected | myeloproliferative neoplasm | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 1 | NCT05936359 | Sep 2023 → Feb 2028 expected | myeloproliferative neoplasm | Incyte Corporation | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07623200 | Sep 2026 → Jun 2029 expected | essential thrombocythemia | Incyte Corporation | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-06-13 | Incyte Corporation | Results Incyte Announces New Positive Data at EHA 2026 Showed INCA033989 Achieved Rapid, Robust and Sustained Clinical and Molecular Responses and Was Well Tolerated in Patients with Myelofibrosis and Essential Thrombocythemia incyte.com ↗
INCA033989 demonstrated rapid, clinically meaningful responses and consistent molecular activity across both myelofibrosis (MF) and essential thrombocythemia (ET), with convergent evidence supporting the potential for disease modification. |
| 2025-12-08 | Incyte Corporation | Results Incyte Presents Updated Positive Data at ASH 2025 Reinforcing the Potential of INCA033989, its First-in-Class mutCALR-Targeted Monoclonal Antibody, in Patients with Essential Thrombocythemia incyte.com ↗
Nearly all (90%) of essential thrombocythemia (ET) patients treated with INCA033989 at the higher dose achieved a hematologic response (HR) with 83.3% achieving a complete HR |
| 2025-12-07 | Incyte Corporation | Regulatory Incyte’s First-in-Class mutCALR-Targeted Monoclonal Antibody, INCA033989, Granted Breakthrough Therapy Designation by U.S. FDA incyte.com ↗
the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to INCA033989 |
| 2025-12-07 | Incyte Corporation | Results Incyte Announces New Positive Data for INCA033989, its First-In-Class mutCALR-Targeted Monoclonal Antibody, in Patients with Myelofibrosis Presented at ASH 2025 incyte.com ↗
Rapid and robust reductions in spleen volume and symptoms, and improvements in anemia were observed with INCA033989 as monotherapy and in combination with ruxolitinib (Jakafi®) in patients with myelofibrosis (MF) harboring a CALR mutation (mutCALR) |
| 2025-06-15 | Incyte Corporation | Results Positive Late-Breaking Data for Incyte’s First-in-Class mutCALR-targeted therapy INCA033989 in Essential Thrombocythemia Presented at EHA2025 incyte.com ↗
In high-risk patients with essential thrombocythemia (ET) with a CALR mutation (mutCALR), 86% of INCA033989-treated patients at doses 400 mg and above achieved a complete or partial hematologic response with the majority (82%) realizing a complete response |
| 2025-06-03 | Incyte Corporation | Results Incyte Announces Multiple Presentations, Including New Late-Breaking Data for its mutCALR-Directed Monoclonal Antibody (INCA033989), Accepted for Presentation at EHA 2025 incyte.com ↗
INCA33989 is a Novel, First in Class, Mutant Calreticulin-Specific Monoclonal Antibody That Demonstrates Safety and Efficacy in Patients with Essential Thrombocythemia (ET) |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | INCA033989 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05936359 ↗ |
| Route | Subcutaneous | “administered as a SC injection” NCT07448155 ↗ |