NETSPOT
Peak68ga-dotatate
NDAINTRAVENOUSPOWDERPriority Review
Approved
Jun 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
NETSPOT (68ga-dotatate) is 68 dotatate binds to somatostatin receptors, with highest affinity for subtype 2 receptors (sstr2). First approved in 2016.
Drug data last refreshed 40m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NETSPOT is a gallium-68 (68Ga) labeled somatostatin receptor agonist (DOTATATE) used for PET imaging of neuroendocrine tumors and other somatostatin receptor-positive malignancies. It binds with high affinity to somatostatin receptor subtype 2 (SSTR2), which is overexpressed on neuroendocrine tumor cells, enabling precise localization and staging via positron emission tomography.
Peak6.1 years to LOE
As a peak-stage diagnostic imaging agent with no direct competitors, the brand team is likely stable or contracting, with focus on market penetration and operational efficiency rather than growth initiatives.
Mechanism of Action
68 dotatate binds to somatostatin receptors, with highest affinity for subtype 2 receptors (SSTR2). It binds to cells that express somatostatin receptors, including malignant cells, which overexpress SSTR2. Gallium-68 is a β+ emitting radionuclide with an emission yield that allows PET imaging.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Comparison of Al18F-NOTA-LM3 With 68Ga-DOTATATE and 68Ga-NODAGA-LM3 PET/CT in Patients With Well-differentiated Neuroendocrine Tumors
Started Mar 2023
80 enrolled
Neuroendocrine Tumors
68Ga-DOTATATE PET/CT in Neuroendocrine Tumor
Started Apr 2014
100 enrolled
Neuroendocrine Tumors
68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)
Started Mar 2013
169 enrolled
Neuroendocrine Carcinoma
68Ga-DOTATATE PET/CT in Oncogenic Osteomalacia
Started Dec 2011
100 enrolled
Oncogenic OsteomalaciaMesenchymal Tumor
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.