Drugs / Emavusertib
Emavusertib
also known as
CA-4948 · AU-4948 · CA-4948 hydrochloride · CA-4948 maleate · CA-4948 mesylate · CA-4948 tosylate · CA-4948-phosphate · EMAVUSERTIB (CA-4948) · +5 more
Small molecule targets IRAK4 via inhibition
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT07107750 | Mar 2026 → Jun 2030 expected | biliary tract cancer | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT06696768 | Jun 2025 → Dec 2026 expected | colorectal adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT06439836 | May 2025 → Jun 2027 expected | urothelial carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT05685602 | Jun 2023 → Apr 2027 | pancreatic ductal adenocarcinoma | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 1 | NCT05187182 | Jun 2023 → Jul 2028 expected | esophageal cancer, gastric cancer, gastroesophageal cancer | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT05669352 | Apr 2025 → Aug 2026 | metastatic malignant neoplasm in the brain | University of Florida | Suspended | No outcome recorded |
| Phase 1/2 | NCT04278768 | Jul 2020 → Apr 2026 | acute myeloid leukemia, myelodysplastic syndrome | Curis, Inc. | Suspended | No outcome recorded |
| Phase 1/2 | NCT03328078 | Dec 2017 → Jul 2027 expected | primary central nervous system lymphoma | Curis, Inc. | Recruiting | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07463820 | Dec 2026 → Dec 2027 expected | myelodysplastic syndrome | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07271667 | Apr 2026 → Nov 2027 expected | B-cell chronic lymphocytic leukemia | Curis, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT05564390 | Jun 2024 → May 2029 expected | acute myeloid leukemia with multilineage dysplasia, myelodysplastic syndrome | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT05178342 | Jan 2022 → Jul 2024 | anemia, myelodysplastic syndrome | University of Leipzig | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Curis, Inc. | Results Curis Announces Positive Emavusertib Update curis.com ↗
The PCNSL update includes data for 7 BTK-naïve patients and 39 BTKi-experienced patients: |
| 2025-12-09 | Curis, Inc. | Results Curis Provides Updated Data from its Frontline AML Triplet Study curis.com ↗ |
| 2025-03-31 | Curis, Inc. | Results Curis Provides Fourth Quarter 2024 Business Update curis.com ↗
9 of these 13 patients demonstrated a reduction in tumor burden, including 6 objective responses, 4 complete responses (CR) and 2 partial responses (PR), with 3 of 4 CRs lasting more than six months. |
| 2024-12-10 | Curis, Inc. | Results Curis Announces Additional Data from TakeAim Leukemia Study curis.com ↗
Data show 10 objective responses in 19 response-evaluable patients: 6 complete remission (CR), 2 CR with either a complete remission with incomplete hematological recovery (CRi) or a partial hematological recovery (CRh) and 2 morphologic leukemia-free state (MLFS). |
| 2024-05-14 | Curis, Inc. | Results Curis Announces Additional Data from TakeAim Leukemia Study curis.com ↗
Preliminary data show 6 objective responses in 11 response-evaluable patients: 3 complete remission (CR), 1 CR with partial hematologic recovery (CRh) and 2 morphologic leukemia-free state (MLFS) with on-treatment duration range of 46-324 days. |
| 2023-12-12 | Curis, Inc. | Results Curis Announces Initial Combination Study Data from its TakeAim Lymphoma Study curis.com ↗
Patients with PCNSL who had a history of failed BTKi therapy showed a particularly noteworthy response: 3 out of 5 evaluable PCNSL patients achieved a Complete Response (CR), with durability ranging from 0.3 – 8.9 months. |
| 2023-12-11 | Curis, Inc. | Results Curis Presented Clinical Data from the TakeAim Leukemia Study at the 2023 ASH Conference curis.com ↗
Substantial reductions in blast counts were observed across all patient groups, irrespective of dose level, mutation status, or prior treatment history. |
| 2023-07-06 | Curis, Inc. | Regulatory FDA Removes Partial Clinical Hold on TakeAim Leukemia Study RP2D Established at 300 mg BID curis.com ↗
Curis, Inc., (Nasdaq: CRIS), a biotechnology company focused on the development of emavusertib, an orally available small molecule triple target inhibitor (IRAK4, FLT3 and CLK) for the treatment of hematologic malignancies, today announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on the TakeAim Leukemia Phase 1/2 study of emavusertib. |
| 2022-12-12 | Curis, Inc. | Results Curis Announces Additional Encouraging Clinical Data from TakeAim Leukemia Study of emavusertib (CA-4948) in Monotherapy R/R AML and hrMDS curis.com ↗
Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced positive updated clinical data from the ongoing open label Phase 1a dose escalation study of emavusertib (CA-4948), a novel, small molecule IRAK-4 inhibitor, as a monotherapy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) or high risk myelodysplastic syndromes (hrMDS) in both targeted and non-targeted populations. |
| 2022-08-30 | Curis, Inc. | Regulatory FDA Allows Patient Enrollment to Resume in Monotherapy Dose Escalation of Emavusertib in TakeAim Leukemia Study curis.com ↗
After review of the comprehensive data package submitted by Curis, the FDA has notified Curis that it may resume enrollment of additional patients in the monotherapy dose finding phase (Phase 1a) of the TakeAim Leukemia study, in which the company has agreed to enroll at least nine additional patients at the 200mg dose level. |
| 2022-08-18 | Curis, Inc. | Regulatory FDA Lifts Partial Clinical Hold on the TakeAim Lymphoma Study of Emavusertib curis.com ↗
With the partial clinical hold lifted on the TakeAim Lymphoma study, the Company is updating its timeline for clinical data release to reflect the availability of updated preliminary data from this study in 2023. |
| 2022-06-10 | Curis, Inc. | Results Curis Announces Presentations on Biomarker Development and Emavusertib Clinical Data at the 2022 European Hematology Association (EHA) Hybrid Congress curis.com ↗
It appears that when IRAK4 is found in the nucleus with active NF-kB proteins p50 and p65, using a technique which we refer to as 'triple staining,' this triple nuclear presence is associated with better responses to emavusertib, |
| 2022-06-04 | Curis, Inc. | Results Curis Announces Encouraging Emavusertib Data at the 2022 American Society of Clinical Oncology Annual Meeting (ASCO) curis.com ↗
TakeAim Lymphoma data for the combination of emavusertib plus ibrutinib show tumor reduction in 8 of 9 evaluable patients, including 2 complete responses and 2 partial responses |
| 2022-05-12 | Curis, Inc. | Results Curis Announces Abstracts Accepted for Presentation at the European Hematology Association 2022 Congress (EHA) curis.com ↗
Data in the abstract indicates that the combination has shown signs of early anti-cancer activity, including in patients with prior BTK inhibitor use, and the regimen appears to be well tolerated. |
| 2022-05-05 | Curis, Inc. | Regulatory Curis Reports First Quarter 2022 Financial Results and Business Update curis.com ↗
our two TakeAim studies were put on partial clinical hold by the U.S. Food and Drug Administration ("FDA") |
| 2022-04-11 | Curis, Inc. | Regulatory Curis Announces FDA Partial Clinical Hold for TakeAim Lymphoma Study of Emavusertib (CA-4948) curis.com ↗
The FDA has also placed a partial clinical hold on the TakeAim Lymphoma trial during which no new patients will be enrolled in the study, and current study participants benefiting from treatment may continue to be treated with emavusertib at doses of 300mg BID or lower after being reconsented. |
| 2022-04-04 | Curis, Inc. | Regulatory Curis Announces FDA Partial Clinical Hold for TakeAim Leukemia Study of Emavusertib (CA-4948) curis.com ↗
Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the Company's TakeAim Leukemia Phase 1/2a study (NCT04278768). |
| 2022-03-07 | Curis, Inc. | Results Curis Announces Gastroenterology Publication of Encouraging Preclinical Data of Emavusertib in Pancreatic Cancers curis.com ↗ |
| 2022-01-06 | Curis, Inc. | Results Curis Announces Updated Data with Additional Encouraging Clinical Activity in Phase 1/2 Study of CA-4948 Monotherapy in Targeted Patients with Relapsed or Refractory AML and MDS; and Initial Clinical Data from Phase 1 Study of CI-8993 in Patients with Relapsed or Refractory Solid Tumors curis.com ↗
We are especially pleased that these results demonstrate both a favorable safety profile and improved anti-cancer activity compared with standard of care therapies for these patients. |
| 2021-06-11 | Curis, Inc. | Results Curis Announces Positive Updated Data from Ongoing Phase 1/2 Study of CA-4948 Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes curis.com ↗
Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced updated data from its ongoing Phase 1/2 open-label, single arm, dose escalation and expansion trial of CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) at the European Hematology Association 2021 Virtual Congress (EHA). |
| 2021-05-12 | Curis, Inc. | Results Curis Reports Updated Data in Two Abstracts for CA-4948 Accepted for Presentation at the European Hematology Association 2021 Virtual Congress curis.com ↗
The abstracts include updated data from a February data-cut for its ongoing open-label, single arm, Phase 1/2 study of CA-4948 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS). |
| 2021-04-19 | Curis, Inc. | Regulatory Curis Receives FDA Orphan Drug Designation for CA-4948 for the Treatment of AML and MDS curis.com ↗
Receiving Orphan Drug designation for CA-4948 in AML and MDS represents a significant milestone in our mission of slowing or preventing the progression of disease in patients with these rare hematological malignancies. |
| 2020-12-08 | Curis, Inc. | Results Curis Announces Positive Preliminary Data from Ongoing Phase 1 Study of CA-4948 Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes curis.com ↗
We are highly encouraged by the breadth of clinical activity with CA-4948 seen with this early data, especially as this study is both monotherapy and in a late line, relapsed/refractory population. |
| 2020-12-07 | Curis, Inc. | Results Curis Announces Updated Preliminary Data from Ongoing Phase 1 Study of CA-4948 Showing Durable and Dose-Dependent Reductions in Tumor Burden in Patients with Relapsed or Refractory Non-Hodgkin's Lymphoma curis.com ↗
Anti-cancer activity was observed across multiple dose levels, which provides additional flexibility as we continue to develop CA-4948 for NHL. |
| 2017-11-07 | Curis, Inc. | Regulatory Curis Reports Third Quarter 2017 Financial Results curis.com ↗
We are pleased to announce the acceptance of our Investigational New Drug (IND) application for CA-4948, an inhibitor of IRAK4 kinase, which we expect to enter the clinic soon for the treatment of lymphomas with specific mutations, |
All press releases naming this drug 41 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Emavusertib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04278768 ↗ |
| Known as | AU-4948 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Known as | CA-4948 | “CA-4948” NCT03328078 ↗ |
| Known as | CA-4948 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Known as | CA-4948 maleate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Known as | CA-4948 mesylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Known as | CA-4948 tosylate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Known as | CA-4948-phosphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Known as | EMAVUSERTIB (CA-4948) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Known as | EMAVUSERTIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Known as | EMAVUSERTIB MALEATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Known as | EMAVUSERTIB MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Known as | EMAVUSERTIB PHOSPHATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Known as | EMAVUSERTIB TOSYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4783351 ↗ |
| Action | Inhibit | “Emavusertib is a novel small molecule inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4).” NCT04278768 ↗ |
| Modality | Small molecule | “Emavusertib is a novel small molecule inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4).” NCT04278768 ↗ |
| Route | Oral | “oral administration of emavusertib alone or in combination with ibrutinib” NCT03328078 ↗ |
| Target | IRAK4 | “Emavusertib is a novel small molecule inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4).” NCT04278768 ↗ |