At Ichnos Glenmark Innovation (IGI), we are committed to delivering breakthrough, curative therapies to improve and extend the lives of patients battling hematologic malignancies and solid tumors. Our primary focus is to conduct the clinical trials necessary to obtain regulatory approvals and ensure timely, broad, and safe access to our investigational medicines.

Expanded Access (also referred to as Compassionate Use) is a potential pathway for patients with serious or life-threatening conditions to gain access to investigational products outside of a clinical trial, when no satisfactory alternative treatment options exist.

At this time, IGI does not have any active Expanded Access programs and is not currently providing investigational products outside of clinical trials.

We believe that participation in a clinical trial is the most appropriate and reliable means of accessing our investigational therapies. Information about IGI’s ongoing clinical trials can be found in the Pipeline section of IGI’s website or by visiting ClinicalTrials.gov.

On April 24, 2025, the U.S. Food and Drug Administration granted Fast Track Designation to ISB 2001 for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. While Fast Track Designation does not require the establishment of an Expanded Access program, IGI is proactively publishing this policy in alignment with the transparency principles of the 21st Century Cures Act.

We continuously evaluate our development programs and may update this policy as new information becomes available. For inquiries regarding IGI’s investigational programs, please reach out via our Contact Us form.