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Neoadjuvant Epigenetic Therapy
Neoadjuvant Epigenetic Therapy is a Small molecule drug developed by Edwin Posadas, MD. It is currently in Phase 1 development.
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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 | Neoadjuvant Epigenetic Therapy |
|---|---|
| Sponsor | Edwin Posadas, MD |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC) (PHASE1, PHASE2)
- Efficacy of Hypomethylating Agents vs. Intensive Chemotherapy in Acute Myeloid Leukemia Using 5hmC as a Blood-Based Minimal Residual Disease Marker (PHASE2)
- Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients
- A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer (EARLY_PHASE1)
- Zeprumetostat, Azacitidine Combined With Lipo-MIT in R/R PTCL (PHASE2)
- Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors (PHASE2)
- Pilot Study on Rutin Combined With Tislelizumab and GC (Gemcitabine and Cisplatin) as Neoadjuvant Therapy for Platinum-refractory Muscle-invasive Bladder Cancer (PHASE1)
- Biomarkers and Outcome Predictors of Pediatric Nephrotic Syndrome: A Genetic, Transcriptomic, and Secretome Multiomics Study
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:
- Neoadjuvant Epigenetic Therapy CI brief — competitive landscape report
- Neoadjuvant Epigenetic Therapy updates RSS · CI watch RSS
- Edwin Posadas, MD portfolio CI
Frequently asked questions about Neoadjuvant Epigenetic Therapy
What is Neoadjuvant Epigenetic Therapy?
Who makes Neoadjuvant Epigenetic Therapy?
What development phase is Neoadjuvant Epigenetic Therapy in?
Related
- Manufacturer: Edwin Posadas, MD — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing