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Stemgen
Stemgen is a Small molecule drug developed by National Heart, Lung, and Blood Institute (NHLBI). It is currently in Phase 2 development.
Stemgen, also known as Ancestim, is a recombinant methionyl human stem cell factor, a protein-based treatment. It has been studied in clinical trials for various conditions, including multiple myeloma, aplastic anemia, pancytopenia, myelodysplasia, and lymphoma.
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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 | Stemgen |
|---|---|
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma (PHASE3)
- Stem Cell Factor (SCF) Priming of Haematopoietic Stem Cell Grafts in Malignant Lymphoma (PHASE2)
- Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer (PHASE1)
- Lenalidomide and Recombinant Human Stem Cell Factor for Treatment of Myelodysplasia (EARLY_PHASE1)
- Comparing Treatments for Multiple Myeloma (PHASE2)
- A Phase I/II Trial of Recombinant-Methionyl Human Stem Cell Factor (SCF) in Adult Patients With Sickling Disorders (PHASE1)
- Stem Cell Factor Medication for Aplastic Anemia (PHASE1)
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:
- Stemgen CI brief — competitive landscape report
- Stemgen updates RSS · CI watch RSS
- National Heart, Lung, and Blood Institute (NHLBI) portfolio CI
Frequently asked questions about Stemgen
What is Stemgen?
Who makes Stemgen?
What development phase is Stemgen in?
Related
- Manufacturer: National Heart, Lung, and Blood Institute (NHLBI) — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing