Leridistim

Summary

Leridistim is an investigational chimeric cytokine designed to stimulate multilineage hematopoietic recovery, combining activities targeting G-CSF and IL-3 receptor pathways. It was studied in clinical trials for the treatment of chemotherapy-induced neutropenia and thrombocytopenia, particularly in patients undergoing myelosuppressive chemotherapy or bone marrow transplantation. Development was discontinued and it never received regulatory approval.

Mechanism of Action

Leridistim is a chimeric protein that simultaneously activates both the myeloid progenitor inhibitory factor-1 (MPIF-1/CCL23) receptor and the granulocyte colony-stimulating factor receptor (G-CSF-R), promoting hematopoietic progenitor cell expansion and neutrophil production while also activating the interleukin-3 receptor (IL-3R) pathway, thereby stimulating multilineage hematopoiesis.

Routes of Administration

Goals & Uses

• Multilineage hematopoietic recovery post-bone marrow transplantHematopoiesisLow
• Platelet recovery after chemotherapyHematopoiesisModerate
• Neutrophil recovery after chemotherapyHematopoiesisModerate
• Reduction of infection risk during myelosuppressionSupportive Oncology CareLow

Contraindications

• Known hypersensitivity to leridistim or related cytokinesAllergy/ImmunologyHigh
• Active malignant myeloid disease (e.g., AML, CML)OncologyHigh

Adverse Effects

• Bone painMusculoskeletalCommon
• Injection site reactionsLocalCommon
• HeadacheNeurologicCommonPain in the head or upper neck
• Fever/flu-like symptomsSystemicCommon
• SplenomegalyHematologicUncommon

Drug Interactions

• Other colony-stimulating factors (G-CSF, GM-CSF)Moderate
• Myelosuppressive chemotherapy agentsModerate

Population Constraints

• Pediatric patientsAgeRelative
• Pregnant or lactating womenReproductiveRelative
• Patients with pre-existing autoimmune conditionsImmunologicRelative

Regulatory Status

• European UnionInvestigationalNo EMA approval sought or granted; development discontinued before submission.
• United StatesInvestigationalStudied in Phase II/III trials but never approved by the FDA. Development discontinued.

Never received FDA, EMA, or other regulatory approval. Development was discontinued following clinical trials in the late 1990s and early 2000s. Investigated primarily by Immunex Corporation.

Evidence & Sources

No sources recorded yet.