Cabergoline
| Evidence Level: L4 | Predicted Indications: 5 |
Table of Contents
Cabergoline: From Hyperprolactinemic Disorders to Pituitary Adenocarcinoma
One-Sentence Summary
Cabergoline is a dopamine agonist widely used for prolactin-secreting pituitary tumors (prolactinoma) and hyperprolactinemia. The TxGNN model predicts it may be effective for pituitary adenocarcinoma, but there are 0 clinical trials and only 3 publications retrieved, all case reports that do not test cabergoline in this disease. The score is not backed by direct clinical evidence.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not listed in the US license data; the literature describes prolactinoma and hyperprolactinemia as its main use |
| Predicted New Indication | Pituitary adenocarcinoma |
| TxGNN Prediction Score | 99.06% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 12 licenses (ANDA/NDA) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available from DrugBank. Based on the analysis in the Evidence Pack, cabergoline is a dopamine D2 receptor agonist. It suppresses prolactin secretion and the growth of lactotroph cells, and it is standard therapy for prolactinoma.
Pituitary adenocarcinoma is a malignant tumor of the same organ and cell lineage. That makes a shared mechanism plausible, and it likely explains part of the model’s high score. However, the retrieved literature does not support the link directly. One paper is off-topic (pancreatic adenocarcinoma in a patient taking cabergoline for a pituitary adenoma). One is a case report on ectopic ACTH secretion, and one is a MEN1 case report. None tests cabergoline in pituitary carcinoma.
The pack also lists the related prediction pituitary cancer (rank 3, score 99.04%). It has much stronger support: reviews, a systematic review and meta-analysis of non-functioning pituitary adenoma studies, and preclinical work on new mechanisms. That evidence concerns pituitary adenomas, not carcinoma, so extrapolation to true carcinoma is still unproven.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 33569966 | 2021 | Case report (off-topic) | Rev Esp Enferm Dig | A 41-year-old woman on cabergoline for a pituitary adenoma was found to have pancreatic adenocarcinoma, first signaled by duodenal lymphangiectasia. Not about pituitary carcinoma. |
| 20497940 | 2010 | Case report | Endocr Pract | Long-term octreotide or cabergoline in a patient with ectopic corticotropin secretion after adrenalectomy. |
| 41760078 | 2026 | Case report | Medicine | Multiple endocrine neoplasia with an atypical course and a MEN1 gene variant of uncertain significance. |
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA076310 | Cabergoline | Tablet | Strides Pharma Science Limited |
| ANDA076310 | Cabergoline | Tablet | A-S Medication Solutions |
| ANDA204735 | Cabergoline | Tablet | A-S Medication Solutions |
| ANDA204735 | Cabergoline | Tablet | Ingenus Pharmaceuticals, LLC |
| NDA020664 | Cabergoline | Tablet | Mylan Pharmaceuticals Inc. |
The only route of administration is oral.
Safety Considerations
Please refer to the package insert for safety information.
Related literature in the pack notes that cardiac valvulopathy is a known concern with long-term or high-dose cabergoline use. Most studies found no significant association, but the question is still debated (PMID 25732645).
Conclusion and Next Steps
Decision: Hold
Rationale: The high TxGNN score (99.06%) has no direct clinical support. There are no trials, and the three retrieved publications are case reports that do not test cabergoline in pituitary carcinoma. The mechanistic plausibility rests on evidence from pituitary adenomas.
To proceed, the following is needed:
- The US package insert warnings and contraindications, which are currently missing and block safety screening
- Detailed mechanism of action data from DrugBank
- A targeted search for cabergoline in aggressive pituitary tumors and pituitary carcinoma specifically (case series, temozolomide combinations, and similar)
- A review of the related “pituitary cancer” prediction (rank 3, L3), which has stronger supporting evidence, as a possible better-defined candidate
- A long-term safety plan covering cardiac valve monitoring for high-dose use
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.