Revumenib, Intensive Chemotherapy Regimen
Acute Myeloid Leukemias
Phase III
Not Yet Recruiting
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
Sep 30, 2025
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Sndx-5613, Chemotherapy Regimen, Hidac
Acute Myeloid Leukemias
Phase I
Recruiting
A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias
Jan 12, 2024
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Axatilimab
Idiopathic Pulmonary Fibrosis
Phase II
Recruiting
MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Nov 09, 2023
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Chemotherapy, Revumenib
Solid Tumors, Colorectal Cancer
Phase I/II
Active Not Recruiting
Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors
Feb 07, 2023
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Revumenib
Acute Leukemia
Phase I
Completed
Study of Radiolabeled Revumenib in Adults With Acute Leukemia
Jun 01, 2022
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Axatilimab
Chronic Graft-Versus-Host-Disease
Phase II
Active Not Recruiting
A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
Jan 05, 2021
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Revumenib, Cobicistat
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Acute Leukemia Of Ambiguous Lineage, Mixed Phenotype Acute Leukemia
Phase I/II
Recruiting
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
Aug 16, 2019
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Axatilimab
Chronic Graft-Versus-Host-Disease
Phase I/II
Completed
A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD
Jul 10, 2018
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Atezolizumab, Entinostat
Breast Cancer
Phase I/II
Completed
Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In
Mar 09, 2016
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Pembrolizumab, Entinostat
Melanoma, Non-small Cell Lung Cancer, Mismatch Repair-Proficient Colorectal Cancer
Phase I/II
Completed
Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)
Apr 27, 2015
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Syndax Pharmaceuticals Inc (1T3) have in its pipeline
1T3 is currently developing the following drugs: Revumenib, Intensive Chemotherapy Regimen, Sndx-5613, Chemotherapy Regimen, Hidac, Axatilimab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.