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Gallium Ga 68-DOTATATE
Gallium Ga 68-DOTATATE is a Small molecule drug developed by Mayo Clinic. It is currently in Phase 2 development for Positron emission tomography. Also known as: (68)Ga-DOTA-TATE, 68Ga-DOTA-0-Tyr3-Octreotate, 68Ga-DOTATATE, Gallium Ga 68 Oxodotreotide.
Gallium Ga 68-DOTATATE works by binding to specific targets in the body, allowing for diagnostic imaging.
Gallium Ga 68-DOTATATE is used in PET/CT scans to study and diagnose various conditions, including Neuroendocrine Tumors, Carcinoid Tumors, Medullary Thyroid Carcinoma, and Tumor-Induced Osteomalacia. It is also being investigated for its potential use in Breast Cancer imaging, as seen in a prospective study comparing it to 18F FDG PET/CT.
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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 | Gallium Ga 68-DOTATATE |
|---|---|
| Also known as | (68)Ga-DOTA-TATE, 68Ga-DOTA-0-Tyr3-Octreotate, 68Ga-DOTATATE, Gallium Ga 68 Oxodotreotide, Gallium Oxodotreotide Ga-68 |
| Sponsor | Mayo Clinic |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Mechanism of action
Imagine a key that fits into a specific lock. Gallium Ga 68-DOTATATE is like that key, designed to bind to specific molecules in the body. This binding allows doctors to use imaging tests to see where the key is located, which can help diagnose and monitor certain conditions.
Approved indications
- Positron emission tomography
Common side effects
Key clinical trials
- Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome (PHASE2)
- Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells (PHASE2)
- 177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer (PHASE1,PHASE2)
- Studies on Tumors of the Thyroid
- Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumors (NA)
- The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer (PHASE2)
- Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging
- NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (PHASE1)
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:
- Gallium Ga 68-DOTATATE CI brief — competitive landscape report
- Gallium Ga 68-DOTATATE updates RSS · CI watch RSS
- Mayo Clinic portfolio CI
Frequently asked questions about Gallium Ga 68-DOTATATE
What is Gallium Ga 68-DOTATATE?
How does Gallium Ga 68-DOTATATE work?
What is Gallium Ga 68-DOTATATE used for?
Who makes Gallium Ga 68-DOTATATE?
Is Gallium Ga 68-DOTATATE also known as anything else?
What development phase is Gallium Ga 68-DOTATATE in?
Related
- Manufacturer: Mayo Clinic — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Positron emission tomography
- Also known as: (68)Ga-DOTA-TATE, 68Ga-DOTA-0-Tyr3-Octreotate, 68Ga-DOTATATE, Gallium Ga 68 Oxodotreotide, Gallium Oxodotreotide Ga-68
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing