Liminatus Pharma (LIMN) FDA Approvals

Liminatus Pharma's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Liminatus Pharma (LIMN). Over the past two years, Liminatus Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as IBA101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

IBA101 FDA Regulatory Events

IBA101 is a drug developed by Liminatus Pharma for the following indication: next-generation CD47 antibody. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Initiation - March 17,2026

Phase 1

• Drug: IBA101
• Announced Date: March 17, 2026
• Indication: next-generation CD47 antibody

Liminatus announced plans to initiate a Phase 1 clinical trial evaluating IBA101, a next-generation CD47-blocking monoclonal antibody designed to engage innate immune pathways and complement established immuno-oncology therapies.

Liminatus plans to start a Phase 1 clinical trial of IBA101, a next-generation CD47-blocking monoclonal antibody designed to engage innate immune pathways and work alongside PD-1/PD-L1 checkpoint inhibitors. IBA101 targets the CD47 "don't-eat-me" signal that helps tumor cells evade macrophages. By boosting macrophage-mediated tumor clearance and improving antigen presentation, the drug aims to increase the depth and durability of responses to established immuno-oncology treatments in solid tumors.

The planned Phase 1 is a seamless program beginning with monotherapy dose escalation to assess safety, tolerability and pharmacokinetics, then moving into combination cohorts with PD-1/PD-L1 therapies under the same protocol. Lung cancer is the initial focus. The study, led by Dr. Se-Hoon Lee, will include translational analyses to measure immune activity and identify markers associated with benefit. Liminatus expects to complete manufacturing, nonclinical work and regulatory planning before advancing the program.

Provided Update - June 24,2025

• Drug: IBA101
• Announced Date: June 24, 2025
• Indication: next-generation CD47 antibody

Liminatus announced that it has been preparing to redefine the immune-oncology landscape with IBA101, a novel CD47 checkpoint inhibitor engineered to eliminate the anemia and thrombocytopenia that halted earlier candidates.

Liminatus Pharma is preparing to redefine the immune-oncology landscape with its novel CD47 checkpoint inhibitor, IBA101. Unlike earlier candidates, IBA101 is engineered to avoid side effects such as anemia and thrombocytopenia by sparing red blood cells and platelets. This is achieved through precise epitope selection and Fc engineering, allowing for higher dosing levels and potentially a more effective anti‑tumor response. Preclinical studies in non‑human primates have shown promising safety, with no significant reductions in hemoglobin or platelet counts. By blocking the “don’t‑eat‑me” signal on tumor cells, IBA101 reactivates the body’s immune clearance system, which may lead to more robust immune responses against cancer. Liminatus’ progress marks an important step toward safer and more potent immunotherapy, with upcoming clinical trials planned in both the United States and Korea.