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Syndax Pharmaceuticals

🇺🇸United States
Ownership
-
Employees
184
Market Cap
$1.7B
Website
Introduction

Syndax Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaged in the development of cancer therapies. Its product candidates include SNDX-5613 and SNDX-6352. The company was founded by Richard A. Heyman, Eckard Weber, Peter Ordentlich, Ronald M. Evans and Michael Downes on October 11, 2005 and is headquartered in Waltham, MA.

Clinical Trials

32

Active:6
Completed:18

Trial Phases

2 Phases

Phase 1:20
Phase 2:8

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (28 trials with phase data)• Click on a phase to view related trials

Phase 1
20 (71.4%)
Phase 2
8 (28.6%)

Phase 1 Study of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with AML Harboring Alterations in KMT2A/MLL, NPM1, or NUP98 Genes

Phase 1
Recruiting
Conditions
Acute Myeloid Leukemias
Interventions
Drug: Chemotherapy Regimen
Drug: HiDAC
First Posted Date
2025-02-03
Last Posted Date
2025-05-30
Lead Sponsor
Syndax Pharmaceuticals Inc.
Target Recruit Count
22
Registration Number
2024-514531-18-00
Locations
🇳🇱

Universitair Medisch Centrum Utrecht, Utrecht, Netherlands

🇳🇱

Universitair Medisch Centrum Groningen, Groningen, Netherlands

🇳🇱

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), Rotterdam, Netherlands

and more 9 locations

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2
Recruiting
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
Other: Placebo
First Posted Date
2023-11-15
Last Posted Date
2025-07-10
Lead Sponsor
Syndax Pharmaceuticals
Target Recruit Count
135
Registration Number
NCT06132256
Locations
🇦🇺

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

🇦🇺

Sunshine Coast University Hospital, Birtinya, Queensland, Australia

🇦🇺

Wallace Street Specialist Centre, Brisbane, Queensland, Australia

and more 70 locations

Expanded Access Program for Revumenib

Conditions
Relapsed/Refractory Acute Leukemia
First Posted Date
2023-06-26
Last Posted Date
2025-05-01
Lead Sponsor
Syndax Pharmaceuticals
Registration Number
NCT05918913
Locations
🇺🇸

UCLA, UCLA RRMC, Drug Information Center, Department of Pharmaceutical Services Drug Supply Shipment, Los Angeles, California, United States

🇺🇸

Rady Children's Hospital, San Diego, California, United States

🇺🇸

Alabama Center for Childhood Cancer And Blood Disorders, Children's of Alabama, Birmingham, Alabama, United States

and more 32 locations

Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors

Phase 1
Active, not recruiting
Conditions
Colorectal Cancer
Solid Tumors
Interventions
Drug: Chemotherapy
First Posted Date
2023-02-16
Last Posted Date
2025-05-13
Lead Sponsor
Syndax Pharmaceuticals
Target Recruit Count
42
Registration Number
NCT05731947
Locations
🇺🇸

Honor Health Research Institute, Scottsdale, Arizona, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, Manhattan, New York, United States

and more 3 locations

Study of Radiolabeled Revumenib in Adults With Acute Leukemia

Phase 1
Completed
Conditions
Acute Leukemia
Interventions
First Posted Date
2022-06-07
Last Posted Date
2025-01-10
Lead Sponsor
Syndax Pharmaceuticals
Target Recruit Count
9
Registration Number
NCT05406817
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

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News

Syndax Pharmaceuticals Appoints Dr. Nicholas Botwood as New R&D Head and Chief Medical Officer

Dr. Nicholas Botwood joins Syndax Pharmaceuticals from Bristol Myers Squibb, bringing 25 years of oncology drug development and commercialization experience to accelerate the company's cancer therapy pipeline.

Kura Oncology's Menin Inhibitor Ziftomenib Shows Promise in Mid-Stage Cancer Trial

Kura Oncology and Kyowa Kirin report positive results from their Phase 2 clinical trial evaluating ziftomenib, a novel menin inhibitor for cancer treatment.

Syndax Highlights FDA-Approved Therapies and Anticipated Milestones at J.P. Morgan Healthcare Conference

Syndax launched Revuforj (revumenib) for relapsed/refractory acute leukemia with KMT2A translocation, receiving NCCN guideline inclusion for AML and ALL.

Syndax's Revuforj Approved for Leukemia, Biosion Inks $940M Antibody Deal with Aclaris

• Syndax Pharmaceuticals' Revuforj (revumenib) received FDA approval as the first menin inhibitor for relapsed or refractory acute leukemia with specific genetic translocations. • Biosion granted Aclaris Therapeutics exclusive global rights to develop two antibodies, including BSI-045B (anti-TSLP) and BSI-502 (bispecific TSLP/IL4R), for up to $940 million. • Novartis expanded its radiopharma portfolio, licensing a somatostatin receptor 2 radiotherapeutic candidate from Ratio Therapeutics for cancer, potentially worth $745 million plus royalties.

Syndax's Revuforj (revumenib) Receives FDA Approval for KM2A-Rearranged Leukemia

Syndax Pharmaceuticals' Revuforj (revumenib) has gained FDA approval for treating adult and pediatric patients with relapsed or refractory KM2A-rearranged acute myeloid leukemia (AML).

FDA Approves Revuforj (revumenib) as First Menin Inhibitor for KMT2A-Rearranged Leukemia

The FDA has approved Revuforj (revumenib) as the first and only menin inhibitor for relapsed or refractory acute leukemia with KMT2A translocation in adults and children.

FDA Approves Syndax's Revuforj (axatilimab) as First Menin Inhibitor for Relapsed/Refractory AML

The FDA has granted accelerated approval to Revuforj (axatilimab), a first-in-class menin inhibitor, for adult patients with relapsed or refractory acute myeloid leukemia (AML).

FDA Approves Revuforj (axatilimab) for Relapsed or Refractory Chronic Graft-versus-Host Disease

The FDA has granted approval to Revuforj (axatilimab) for the treatment of adult and pediatric patients 12 years and older with relapsed or refractory chronic graft-versus-host disease (cGVHD) after failure of one or two prior lines of systemic therapy.

FDA Approves Syndax's Revuforj, a First-in-Class Menin Inhibitor for Acute Leukemia

The FDA has approved Syndax Pharmaceuticals' Revuforj (revumenib) for adults and children with relapsed or refractory acute leukemia with KMT2A rearrangement.

FDA Approves Revumenib for Relapsed or Refractory KMT2A-Rearranged Acute Leukemia

The FDA has approved revumenib (Revuforj) for adult and pediatric patients (≥1 year) with relapsed or refractory acute leukemia harboring a KMT2A translocation.

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