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Embospheres
Embospheres is a Small molecule drug developed by Memorial Sloan Kettering Cancer Center. It is currently in Phase 1 development.
Embospheres are used in the treatment of Prostate Cancer, Benign Prostatic Hyperplasia, and other conditions such as Uterine Myoma and Uterine Fibroid, through interventions like Prostatic artery embolization. They are also studied in combination with other treatments, including the HoLEP Procedure, for conditions like Prostate Cancer and Lower Urinary Tract Symptoms.
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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 | Embospheres |
|---|---|
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Painful urination
- Burning micturition
- Fatigue
- Hematuria
- Pelvic pain
- Frequency urinary
- Bloody semen
- Urgency urination
- Incontinence urinary
- Bladder spasm
- Abdominal spasm
- Urinary retention
Key clinical trials
- A Single Center, Non-randomized Study to Evaluate the Safety and Efficacy of Left Gastric Artery Embolization in Obese Patients With Hepatocellular Carcinoma to Achieve Appropriate Weight Loss That Ma (NA)
- Safety and Efficacy of TACE With Thermosensitive Nanogel Embolic Agent Versus Embosphere for Hepatocellular Carcinoma: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial (NA)
- Randomized Controlled Trial of Uterine Artery Embolization (UAE) Versus High-Intensity-Focused-Ultrasound (HIFU) for Treatment of Patients With Uterine Fibroids (NA)
- Phase I Study of Transarterial Chemoembolization of Lung Metastases (Phase 1)
- Safety and Efficacy of Embozene® Microspheres for Uterine Fibroid Embolization Compared to Embosphere® Microspheres for Symptomatic Relief From Uterine Fibroids (NA)
- Feasibility Evaluation of the Embolic Agent BeadBlock™ in the Treatment of Uterine Fibroids With Uterine Artery Embolization With Comparison of Study Endpoints to Embosphere® (Phase 1)
- Prospective, Single Arm Investigation to Assess Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Kn (NA)
- Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH) (Phase 1)
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:
- Embospheres CI brief — competitive landscape report
- Embospheres updates RSS · CI watch RSS
- Memorial Sloan Kettering Cancer Center portfolio CI
Frequently asked questions about Embospheres
What is Embospheres?
Who makes Embospheres?
What development phase is Embospheres in?
What are the side effects of Embospheres?
Related
- Manufacturer: Memorial Sloan Kettering Cancer Center — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing