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Fludeoxyglucose PET CT
Fludeoxyglucose PET CT is a Radiopharmaceutical Small molecule drug developed by Michael C Roarke, MD. It is currently in Phase 2 development for Cancer diagnosis and staging. Also known as: F-18 FDG PET CT.
A positron-emitting glucose analog that accumulates in cancer cells, allowing for PET imaging.
A positron-emitting glucose analog that accumulates in cancer cells, allowing for PET imaging. Used for Cancer diagnosis and staging.
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| 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 | Fludeoxyglucose PET CT |
|---|---|
| Also known as | F-18 FDG PET CT |
| Sponsor | Michael C Roarke, MD |
| Drug class | Radiopharmaceutical |
| Target | Glucose transporter |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Fludeoxyglucose (18F-FDG) is a glucose analog that is taken up by cells with high metabolic rates, such as cancer cells. It is then detected by PET imaging, allowing for visualization of cancerous tissues.
Approved indications
- Cancer diagnosis and staging
Common side effects
Key clinical trials
- Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (PHASE2)
- Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors (PHASE2)
- Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer (PHASE3)
- Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer (PHASE1, PHASE2)
- Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment (PHASE1, PHASE2)
- Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial (PHASE2)
- Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin (PHASE1)
- De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer (PHASE2, 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:
- Fludeoxyglucose PET CT CI brief — competitive landscape report
- Fludeoxyglucose PET CT updates RSS · CI watch RSS
- Michael C Roarke, MD portfolio CI
Frequently asked questions about Fludeoxyglucose PET CT
What is Fludeoxyglucose PET CT?
How does Fludeoxyglucose PET CT work?
What is Fludeoxyglucose PET CT used for?
Who makes Fludeoxyglucose PET CT?
Is Fludeoxyglucose PET CT also known as anything else?
What drug class is Fludeoxyglucose PET CT in?
What development phase is Fludeoxyglucose PET CT in?
What does Fludeoxyglucose PET CT target?
Related
- Drug class: All Radiopharmaceutical drugs
- Target: All drugs targeting Glucose transporter
- Manufacturer: Michael C Roarke, MD — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Cancer diagnosis and staging
- Also known as: F-18 FDG PET CT
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing