Product Description
NCA033989, a new anti-mutant calreticulin (CALR)-targeted monoclonal antibody, represents important research milestone in myelofibrosis (MF) and essential thrombocythemia (ET). INCA033989 binds with high affinity to mutant CALR and inhibits oncogenesis, the process of cells becoming cancerous, in cells expressing this oncoprotein. As described in our presentation, INCA033989 potently antagonizes CALR oncogenic function, resulting in selective inhibition of JAK/STAT signaling only in CALR-mutated cells with no effect on normal, non-oncogenic cells. This selectivity of action with INCA033989 results in the specific killing of tumor cells harboring the mutation and is suggestive of the potential to alter the course of disease in patients with CALR-mutant MF and ET. (Sourced from: https://investor.incyte.com/news-releases/news-release-details/incytes-novel-mutant-calr-antibody-unveiled-ash-2022-plenary)
Mechanisms of Action: CALR Antagonist
Novel Mechanism: Yes
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: Breakthrough Therapy - Thrombocytopenia *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Incyte
Company Location: Eastern America
Company Founding Year: 1991
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 5
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Incyte presented P1 Myeloproliferative Disorders results on 2025-12-08 for INCA-033989
- Clinical Outcomes Reported - Incyte presented P1 Myelofibrosis results on 2025-12-07 for INCA-033989
- Clinical Outcomes Reported - Incyte presented Unknown Thrombocythemia, Essential results on 2025-06-15 for INCA-033989
Highest Development Phases
Phase 3: Thrombocythemia, Essential
Phase 1: Healthy Volunteers|Myelofibrosis|Myeloproliferative Disorders|Oncology Unspecified
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06034002 |
INCA33989-102 | P1 |
Recruiting |
Myeloproliferative Disorders|Myelofibrosis|Thrombocythemia, Essential |
2028-10-29 |
50% |
2026-04-23 |
Patient Enrollment|Primary Endpoints|Treatments |
jRCT2031230426 |
jRCT2031230426 | P1 |
Recruiting |
Oncology Unspecified |
2028-02-29 |
|||
NCT05936359 |
INCA 33989-101 | P1 |
Active, not recruiting |
Myeloproliferative Disorders |
2028-02-29 |
12% |
2026-08-11 |
|
NCT07448155 |
INCA033989-103 | P1 |
Recruiting |
Healthy Volunteers |
2026-10-19 |
50% |
2026-07-09 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
NCT07623200 |
EXCALIBUR-ET2 | P3 |
Recruiting |
Thrombocythemia, Essential |
2029-06-15 |
14% |
2026-08-07 |
Primary Endpoints|Start Date |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
02/10/2026 |
News Article |
Incyte Reports Fourth Quarter and Full Year 2025 Financial Results |
|
12/18/2025 |
News Article |
Monoclonal Antibody Discovery Platform Market to Reach USD 11.93 Billion by 2035, Expanding at a 12.55% CAGR |
|
12/08/2025 |
News Article |
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 |
|
11/03/2025 |
News Article |
Incyte Announces More than 50 Abstracts Accepted for Presentation at the 2025 ASH Annual Meeting |