Wednesday, July 8, 2026

Drug profile · INN

sargramostim

sargramostim (IMREPLYS) is a granulocyte-macrophage colony-stimulating factor receptor agonist. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved Antineoplastic and immunomodulating agents (L03) L03AA09
US status approved
Patents linked 0
Pipeline programs 8
News articles 0
Drug details — sargramostim
US status
approved
Class
Antineoplastic and immunomodulating agents (L03)
Route
Patents
0
Programs
8
Data quality
0.83

Quick answer

sargramostim (IMREPLYS) is a granulocyte-macrophage colony-stimulating factor receptor agonist. Current US regulatory status: approved.

Key facts

INN sargramostim
Brand IMREPLYS
Mechanism Granulocyte-macrophage colony-stimulating factor receptor agonist
Target Granulocyte-macrophage colony-stimulating factor receptor
Therapeutic class Antineoplastic and immunomodulating agents (L03)
Formulation VIAL
ATC code L03AA09

Mechanism of action

Granulocyte-macrophage colony-stimulating factor receptor agonist

Primary target: Granulocyte-macrophage colony-stimulating factor receptor

Approval history

Authority Status Date
FDA approved
EMA approved
PMDA approved

Pipeline programs

  1. 201 Phase 2 · Y-mAbs Therapeutics · Treatment of high-risk neuroblastoma patients with primary r
  2. BreAK CRC 001 Phase 2 · Anaxis Pharma · Unresectable locally advanced or metastatic colorectal cance
  3. Leukine for Ovarian cancer Phase 2 · Nordic Bioscience · Ovarian cancer
  4. Sargramostim Phase 2 · United Therapeutics Europe · Covid19
  5. Sargramostim Phase 2 · United Therapeutics Europe · COVID-19
  6. Sargramostim Phase 2 · Hospital Authority · COVID
  7. Sargramostim Phase 2 · Hospital Authority · Pulmonary Alveolar Proteinosis, Autoimmune
  8. Sargramostim Phase 1 · Ultragenyx UK · Autoimmune Pulmonary Alveolar Proteinosis

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is sargramostim?

sargramostim (IMREPLYS) is a granulocyte-macrophage colony-stimulating factor receptor agonist. Current US regulatory status: approved.

What is the brand name for sargramostim?

IMREPLYS is a marketed brand name for sargramostim. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of sargramostim?

sargramostim has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.