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endocrine-modulating drug therapy
endocrine-modulating drug therapy is a Endocrine modulator Small molecule drug developed by Fred Hutchinson Cancer Center. It is currently in Phase 3 development for Hormone receptor-positive breast cancer.
Endocrine-modulating drug therapy works by modulating the body's endocrine system to treat various conditions.
Endocrine-modulating drug therapy works by modulating the body's endocrine system to treat various conditions. Used for Hormone receptor-positive breast cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | endocrine-modulating drug therapy |
|---|---|
| Sponsor | Fred Hutchinson Cancer Center |
| Drug class | Endocrine modulator |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This type of therapy involves altering the body's hormonal balance to achieve therapeutic effects. By modulating the endocrine system, endocrine-modulating drug therapy can help regulate various bodily functions and treat conditions such as hormone-related cancers.
Approved indications
- Hormone receptor-positive breast cancer
Common side effects
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Nasopharyngeal Carcinoma Post IMRT
- Trifecta Research Study (PHASE2)
- Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy (PHASE2)
- Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp (NA)
- Evaluation of Metionac for the Modulation of Metabolic and Endocrine Parameters in Patients With PCOS. (PHASE4)
- Predictive Biomarkers of Response to Sunitinib in the Treatment of Poorly-differentiated NEURO-Endocrine Tumors (PHASE2)
- Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer (PHASE1, PHASE2)
- SWOG-8814 Tamoxifen With or Without Combination Chemotherapy in Postmenopausal Women Who Have Undergone Surgery for Breast Cancer (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:
- endocrine-modulating drug therapy CI brief — competitive landscape report
- endocrine-modulating drug therapy updates RSS · CI watch RSS
- Fred Hutchinson Cancer Center portfolio CI
Frequently asked questions about endocrine-modulating drug therapy
What is endocrine-modulating drug therapy?
How does endocrine-modulating drug therapy work?
What is endocrine-modulating drug therapy used for?
Who makes endocrine-modulating drug therapy?
What drug class is endocrine-modulating drug therapy in?
What development phase is endocrine-modulating drug therapy in?
What are the side effects of endocrine-modulating drug therapy?
Related
- Drug class: All Endocrine modulator drugs
- Manufacturer: Fred Hutchinson Cancer Center — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hormone receptor-positive breast cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing