Parathyroid Hormone
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
- Parathyroid Hormone
- Parathyroid Hormone: From Hypoparathyroidism (Label Text Unavailable) to Migraine Disorder
Parathyroid Hormone: From Hypoparathyroidism (Label Text Unavailable) to Migraine Disorder
One-Sentence Summary
Parathyroid hormone (PTH) is a recombinant hormone product (NATPARA) that was formerly marketed as an injectable in the United States. The TxGNN model predicts it may be effective for migraine disorder, but there are no registered clinical trials and only 5 publications, all observational or genetic-association studies, and none tests PTH as a migraine treatment.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (the approved indication text on the US license record is empty) |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L4 |
| US Market Status | Cancelled only (no active license) |
| Number of NDAs | 1 (BLA125511, cancelled) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available for this drug. Parathyroid hormone is a hormone that regulates calcium and phosphate balance. The one US license on record is for the injectable product NATPARA, but its approved indication text is blank in the data compiled for this report.
The link to migraine is indirect. A 2025 genetic study (PMID 40297711) proposes that receptors for parathyroid hormone-related peptide (PTHrP), a close relative of PTH that acts on a shared receptor family, are genetic drivers of migraine susceptibility. This points to a plausible connection between PTH-family signalling and migraine. The other supporting papers only show associations between migraine and calcium, vitamin D, magnesium or bone status. No study shows that giving PTH treats migraine, so the very high TxGNN score is not backed by clinical data.
Other predicted indications were also reviewed. They are weaker: migraine with brainstem aura and migraine susceptibility rely on the same indirect genetic hint, and the remaining predictions (amenorrhea, Raynaud disease, esophageal disease, erectile dysfunction and others) rest on confounded associations, a single 1963 case report, or no literature at all.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 40297711 | 2025 | Genetic association/Review | Brain Communications | Proposes PTHrP receptors as genetic drivers of migraine susceptibility, based on Portuguese migraine patients |
| 31261815 | 2019 | Cohort | Medicina (Kaunas) | Vitamin D levels and response to vitamin D therapy in childhood migraine |
| 42340335 | 2026 | Case-control | Cephalalgia | Impaired bone status (vitamin D, calcium, PTH, densitometry) in women with frequent or chronic migraine |
| 42626018 | 2026 | Cross-sectional | Frontiers in Neurology | Serum calcium linked to neuropsychological symptoms in migraine patients in early pregnancy |
| 11425281 | 2001 | Review | Medical Hypotheses | Wide-ranging pathology of magnesium deficiency, including links to calcium metabolism |
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| BLA125511 (cancelled) | NATPARA (parathyroid hormone), Takeda Pharmaceuticals America | Injection, powder, lyophilized, for solution | Not available |
Safety Considerations
- Drug Interactions (5 found):
- Major: Digoxin, Digitoxin
- Moderate: Alendronic acid, Calcitriol (topical), Calcipotriol (topical)
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The migraine prediction has a high model score, but there are no clinical trials, and the literature shows only association and an indirect genetic hint. No study tests PTH as a migraine treatment. The only US license is cancelled, and the label’s warnings, contraindications and indication text are missing, so safety screening cannot proceed.
To proceed, the following is needed:
- The FDA package insert (warnings, contraindications, approved indication) for NATPARA
- Mechanism of action data, for example from DrugBank
- Preclinical or mechanistic studies on whether PTH or PTHrP receptor signalling can be modulated for migraine
- Evaluation of the calcium-raising effect of PTH and its Major interactions with digoxin and digitoxin before any study in migraine patients
- Confirmation of the feasibility of an injectable route for a chronic condition such as migraine
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.