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Recombinant-methionyl human stem cell factor
Recombinant-methionyl human stem cell factor is a Small molecule drug developed by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It is currently in Phase 1 development.
Recombinant-methionyl human stem cell factor is a treatment being studied in clinical trials for various types of acute myeloid leukemia, including those with specific genetic mutations. It is typically administered in combination with other treatments such as autologous bone marrow transplantation and busulfan.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Recombinant-methionyl human stem cell factor |
|---|---|
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Platelet count decreased
- Neutrophil count decreased
- 58300-Neutrophil count decreased
- Nausea
- Fatigue
- 65800-Platelet count decreased
- Lymphocyte count decreased
- Alanine aminotransferase increased
- Hemoglobin decreased
- White blood cell decreased
- Diarrhea
- Aspartate aminotransferase increased
Key clinical trials
- A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia (PHASE1)
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (PHASE2)
- CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia (PHASE1)
- Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies (PHASE2)
- A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT (PHASE2)
- Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PHASE3)
- Total Marrow and Lymphoid Irradiation Before Donor Transplant and Cyclophosphamide in Treating Patients With Acute Myeloid Leukemia (PHASE1)
- Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma (PHASE3)
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:
- Recombinant-methionyl human stem cell factor CI brief — competitive landscape report
- Recombinant-methionyl human stem cell factor updates RSS · CI watch RSS
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) portfolio CI
Frequently asked questions about Recombinant-methionyl human stem cell factor
What is Recombinant-methionyl human stem cell factor?
Who makes Recombinant-methionyl human stem cell factor?
What development phase is Recombinant-methionyl human stem cell factor in?
What are the side effects of Recombinant-methionyl human stem cell factor?
Related
- Manufacturer: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing