Drug

Sargramostim

Approved · EMA

Emerging researchLate-stage development

Also known as Leukine, Sargramostatin.

RxNorm69634UNII5TAA004E22

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients With Unresectable Stage III or Stage IV Melanoma

Clinical trial2026-07-02Results expected Q2 2033 · ClinicalTrials.gov

A Comprehensive Safety Trial of Chimeric Antibody 14.18 (Ch14.18) With GM-CSF, IL-2 and Isotretinoin in High-Risk Neuroblastoma Patients Following Myeloablative Therapy

Clinical trial2026-06-24Results posted · ClinicalTrials.gov

A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma

Clinical trial2026-06-24Results posted · ClinicalTrials.gov

A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

Clinical trial2026-06-23Results expected Q1 2028 · ClinicalTrials.gov

A Phase II Study With a Safety Run-In of the Addition of N-803, a Novel IL-15 Super-Agonist, to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma

Clinical trial2026-06-04Results expected Q1 2028 · ClinicalTrials.gov

Evaluating the Feasibility of a Survivin Peptide Vaccine (SurVaxM) as an Interception Agent in Patients at High Risk for Lung Cancer

Clinical trial2026-06-03Results expected Q1 2029 · ClinicalTrials.gov

A Phase II Study of Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) in Patients With Progressing Metastatic Neuroendocrine Carcinomas (NECs)

Clinical trial2026-05-28Results expected Q4 2027 · ClinicalTrials.gov

Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease (SESAD)

Clinical trial2026-04-30Results expected Q4 2026 · ClinicalTrials.gov

A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer

Clinical trial2026-04-07Results expected Q2 2027 · ClinicalTrials.gov

A Phase II Randomized Study of Safety and Efficacy of a Multiple Antigen Vaccine (STEMVAC) in Non-Small-Cell Lung Cancer Patients

Clinical trial2026-04-03Results posted · ClinicalTrials.gov

Approval: Imreplys (EMA)

Regulatory2025-08-21EMA

Inhaled Sargramostim (Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor) for COVID-19-Associated Acute Hypoxemia: Results of the Phase 2, Randomized, Open-Label Trial (iLeukPulm).

Research2023-07-01Military medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Sargramostim

Aliases & brands

LeukineSargramostatin

RxNorm CUI

69634

UNII

5TAA004E22

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2025-08-21

Latest approval

2025-08-21

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2025-08-21Approval

Approval: Imreplys (EMA)

Indication: Imreplys is indicated for treatment of patients of all ages acutely exposed to myelosuppressive doses of radiation with Haematopoietic Sub-syndrome of Acute Radiation Syndrome… Show full indication

Imreplys is indicated for treatment of patients of all ages acutely exposed to myelosuppressive doses of radiation with Haematopoietic Sub-syndrome of Acute Radiation Syndrome (H-ARS). Imreplys should be used in accordance with official radiological/nuclear emergency recommendations.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.