Last reviewed · How we verify
Radiotracer Injection
Radiotracer Injection is a Small molecule drug developed by Massachusetts General Hospital. It is currently in Phase 2 development. Also known as: [11C]APP311, [11C]UCB-J.
Radiotracer injection is a method used in positron emission tomography (PET) imaging for detecting various types of cancer, including endometrial and ovarian cancers, as seen in the study "4FMFES-PET Imaging of Endometrial and Ovarian Cancers" (NCT04823065). The specific radiotracer used in this study is 11C-sarcosine, which is injected into the body to help identify cancerous tissues.
-
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 | Radiotracer Injection |
|---|---|
| Also known as | [11C]APP311, [11C]UCB-J |
| Sponsor | Massachusetts General Hospital |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Headache
- Flushing
- Dyspnoea
- Dizziness
- Chest discomfort
- Nausea
- Angina pectoris
- Hypertension
- Paresthesia
- Dysgeusia
- Transient Visual Disturbance
- Pain in Extremity
Key clinical trials
- Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors (PHASE2, PHASE3)
- High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy (PHASE2)
- CANF-Comb-II PET-MR in Atherosclerosis Multisite
- 64Cu-GRIP B in Patients With Acute Myocarditis (PHASE1)
- 64Cu-GRIP B in Patients With Advanced Malignancies (PHASE1, PHASE2)
- [18F]F-DOPA Imaging in Patients With Autonomic Failure (PHASE1)
- Study on the Application of ¹⁸F-FCOB04, a MAO-B Targeted PET Imaging Agent, in Neurodegenerative Diseases (EARLY_PHASE1)
- PET/MRI for Evaluation of Endometriosis
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:
- Radiotracer Injection CI brief — competitive landscape report
- Radiotracer Injection updates RSS · CI watch RSS
- Massachusetts General Hospital portfolio CI
Frequently asked questions about Radiotracer Injection
What is Radiotracer Injection?
Who makes Radiotracer Injection?
Is Radiotracer Injection also known as anything else?
What development phase is Radiotracer Injection in?
What are the side effects of Radiotracer Injection?
Related
- Manufacturer: Massachusetts General Hospital — full pipeline
- Also known as: [11C]APP311, [11C]UCB-J
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing