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Novasoy
Novasoy is a Small molecule drug developed by University of Wisconsin, Madison. It is currently in Phase 2 development.
Novasoy is a soy phytoestrogen used in clinical trials to study its effects on various conditions, including menopause, hot flashes, breast cancer, pancreatic cancer, and prostate cancer. It has been studied in combination with estradiol and medroxyprogesterone acetate (MPA) in clinical trials, such as NCT00997893, which investigated its effects on menopausal symptoms.
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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 | Novasoy |
|---|---|
| Sponsor | University of Wisconsin, Madison |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study (PHASE2)
- Soy Isoflavones and Breast Cancer Risk Reduction (PHASE2)
- Soy Isoflavones Supplementation in Treating Women at High Risk For or With Breast Cancer (NA)
- Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer (PHASE2)
- Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer (PHASE2)
- Research Investigation of Soy and Estrogen (PHASE2)
- Alzheimer's Disease: Potential Benefit of Isoflavones (PHASE2)
- Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness (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:
- Novasoy CI brief — competitive landscape report
- Novasoy updates RSS · CI watch RSS
- University of Wisconsin, Madison portfolio CI
Frequently asked questions about Novasoy
What is Novasoy?
Who makes Novasoy?
What development phase is Novasoy in?
Related
- Manufacturer: University of Wisconsin, Madison — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing