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Brachytherapy
Brachytherapy is a Small molecule drug developed by The Methodist Hospital Research Institute. It is currently in Phase 2 development. Also known as: Brachytherapy pre surgery.
Brachytherapy is a form of radiation therapy where a sealed radiation source is placed inside or next to the area requiring treatment. It is commonly used to treat conditions such as prostate cancer, cervical cancer, skin cancer, and mucosal neoplasms of the oral cavity.
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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 | Brachytherapy |
|---|---|
| Also known as | Brachytherapy pre surgery |
| Sponsor | The Methodist Hospital Research Institute |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers (PHASE3)
- Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer (NA)
- Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda (PHASE2)
- To Observe the Benefit of Adding Brachytherapy After CCRT on Resectable Esophageal Cancer Patients Without Surgery (NA)
- Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer (PHASE3)
- Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma (PHASE3)
- Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer (PHASE3)
- Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment (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:
- Brachytherapy CI brief — competitive landscape report
- Brachytherapy updates RSS · CI watch RSS
- The Methodist Hospital Research Institute portfolio CI
Frequently asked questions about Brachytherapy
What is Brachytherapy?
Who makes Brachytherapy?
Is Brachytherapy also known as anything else?
What development phase is Brachytherapy in?
Related
- Manufacturer: The Methodist Hospital Research Institute — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Brachytherapy pre surgery
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing