Last reviewed · How we verify
Sagramostim
Sagramostim is a Small molecule drug developed by Vestre Viken Hospital Trust. It is currently in Phase 2 development. Also known as: leukine, Leukine, Granulocyte-Macrophage Colony-Stimulating Factor.
Sagramostim, also known as sargramostim, is a medication used to treat various conditions, including neuroblastoma, brain and central nervous system tumors, breast cancer, drug/agent toxicity by tissue/organ, and lung cancer. It is administered as part of a treatment regimen that may also include filgrastim and carboplatin.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Sagramostim |
|---|---|
| Also known as | leukine, Leukine, Granulocyte-Macrophage Colony-Stimulating Factor |
| Sponsor | Vestre Viken Hospital Trust |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Testing the SurVaxM Vaccine for Lung Cancer Prevention (PHASE2)
- A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma (PHASE2, PHASE3)
- Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse (PHASE1, PHASE2)
- NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (PHASE2)
- A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients (PHASE2)
- A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma (PHASE2)
- Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma (PHASE1)
- Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sagramostim CI brief — competitive landscape report
- Sagramostim updates RSS · CI watch RSS
- Vestre Viken Hospital Trust portfolio CI
Frequently asked questions about Sagramostim
What is Sagramostim?
Who makes Sagramostim?
Is Sagramostim also known as anything else?
What development phase is Sagramostim in?
Related
- Manufacturer: Vestre Viken Hospital Trust — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: leukine, Leukine, Granulocyte-Macrophage Colony-Stimulating Factor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing