Syndax Pharmaceuticals, Inc.

35 Gatehouse Drive
Building D, Floor 3
Waltham, Massachusetts United States of America

(646) 690-7620


  • SNDX-5613

Syndax Pharmaceuticals is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company's pipeline includes the Menin Inhibitor Program with SNDX-5613, a highly selective inhibitor of the Menin–MLL binding interaction. Pivotal trials of SNDX-5613 are ongoing.

Clinical Trials

Well-designed clinical trials are the cornerstone of how we develop medicines and are critical to the understanding of the safety and efficacy of new medicines. Patients entering clinical trials are required to meet specific criteria. At this time, Syndax Pharmaceuticals is enrolling patients to the AUGMENT-101 study, a phase 1-2 trial in patients with MLLr or mNPM1 acute leukemias. If you are interested in learning more about enrolling your patient to AUGMENT-101, contact SYNDAX at For those patients who are unable to participate in a clinical trial or in whome standard treatments have failed or who have been unable to tolerate already approved medications, they may seek access to investigational medications through what is often referred to as an expanded access program ("EAP").

Requesting Expanded Access

All requests for Expanded Access must be made by a treating physician on behalf of the patient.. Syndax will, in its sole discretion, evaluate requests for expanded access. Syndax may consider, without limitation, some or all of the following criteria:

  • Whether the patient suffers from a serious or immediately life-threatening disease or condition
  • Whether there are no comparable or satisfactory alternative therapies or clinical trials available
  • Whether sufficient preliminary efficacy and safety data exist to support an assessment that the benefit for the patient outweighs the potential risks and that the potential risks are not unreasonable in the context of the patient's diagnosis or condition being treated
  • Whether sufficient clinical data is available to identify an appropriate dose of the investigational drug in the context of the patient's diagnosis or condition being treated
  • Whether there is adequate drug supply to support the ongoing and necessary clinical trials as well as to support expanded access in a sustainable and equitable manner
  • Whether the patient is not eligible to participate in any ongoing clinical trials of the investigational drug
  • Whether expanded access will not adversely affect the clinical development program, including the initiation, conduct, or completion of the clinical trials that are required for regulatory approval
  • Whether the unsolicited request is made by a qualified and licensed physician
  • Whether the requesting physician has the expertise and facilities appropriate for the administration of the investigational drug and for monitoring, managing, and reporting any side effects and the patient's overall experience
  • Whether all required regulatory and institutional approvals have been obtained; and/or
  • Whether the patient has provided written informed consent

Patients, Caregivers and Patient Advocates: Requests for Expanded Access must be made by a qualified physician. Syndax encourages patients and caregivers to have a candid conversation about reasons for considering an investigational medicine. Your physician will be required to supervise the treatment and comply with safety reporting responsibilities. Your physician must make the written request on your behalf.

Physicians and Healthcare Professionals: Only appropriately licensed physicians may make a written request on behalf of a patient. The physician must be qualified to administer and oversee the investigational treatment and comply with Syndax safety reporting responsibilities. Investigational Review Board (IRB) approval for the use of the investigational medication is required. The physician must be willing to meet and follow all applicable legal and regulatory requirements. The physician will be required to provide adequate medical history and treatment information for a specific patient, obtain informed consent, and may be required to provide additional data on the progress and safety throughout the expanded access treatment interval.