Regramostim

Recombinant Human Granulocyte Macrophage Colony Stimulating Factor (rhu GM CSF)Rx: PrescriptionCompound: Withdrawn

Also known as: glycosylated GM-CSF, Regramostim, rhu GM-CSF (CHO-derived)

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Regramostim is a glycosylated recombinant human GM-CSF produced in Chinese hamster ovary (CHO) cells, differing from sargramostim (yeast-derived) and molgramostim (E. coli-derived). It was investigated for reduction of chemotherapy-induced neutropenia and acceleration of myeloid engraftment following bone marrow transplantation. It did not achieve widespread regulatory approval and has largely been superseded by other colony-stimulating factors.

Mechanism of Action

Binds to the GM-CSF receptor (CSF2R) on hematopoietic progenitor cells, stimulating proliferation, differentiation, and functional activation of granulocytes (neutrophils, eosinophils) and monocytes/macrophages, thereby accelerating myeloid recovery.

Routes of Administration

IntravenousSubcutaneous

Goals & Uses

  • Acceleration of myeloid engraftment post bone marrow transplantationHematology/transplantationModerate
  • Reduction of chemotherapy-induced neutropeniaHematology/oncologyModerate
  • Mobilization of hematopoietic progenitor cellsHematologyLow

Contraindications

  • Hypersensitivity to GM-CSF or CHO-derived productsImmunologicHigh
  • Autoimmune conditions with risk of cytokine-driven flareImmunologicModerate
  • Excessive leukemic myeloid blasts in bone marrow or peripheral bloodOncologicHigh

Adverse Effects

  • Fever and flu-like symptomsConstitutionalCommon
  • Injection site reactionsLocalCommon
  • Capillary leak syndromeVascularUncommonLeakage of fluid from blood vessels into tissues
  • Thromboembolic eventsCardiovascularRare
  • Pleural/pericardial effusionsCardiovascular/respiratoryUncommon
  • Bone pain / musculoskeletal painMusculoskeletalCommon

Drug Interactions

  • Cytotoxic chemotherapy agentsHigh
  • CorticosteroidsLow
  • LithiumModerate

Population Constraints

  • PregnancyReproductive SafetyRelative
  • Pediatric patientsAgeRelative
  • Renal or hepatic impairmentOrgan DysfunctionRelative

Regulatory Status

  • European UnionUnapprovedNo EMA marketing authorization; molgramostim was the EU-investigated GM-CSF variant.
  • United StatesUnapprovedRegramostim was not approved by the FDA; sargramostim (Leukine) is the approved GM-CSF in the US.
  • United KingdomUnapprovedNo MHRA approval on record for regramostim.

Regramostim was investigated in clinical trials but did not receive broad regulatory approval in major jurisdictions. It is distinct from sargramostim (Leukine, FDA-approved) and molgramostim. No current approved indications are on record in the US, EU, or UK.

Evidence & Sources

No sources recorded yet.

Browse All PeptidesBuild My Stack