Teriparatide
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Teriparatide: From Osteoporosis to Duodenal Ulcer
One-Sentence Summary
Teriparatide is a parathyroid hormone (PTH 1-34) analog, used as a bone-building drug for osteoporosis. The TxGNN model ranks duodenal ulcer as its top prediction (score 99.86%), but there are 0 clinical trials and 0 publications supporting this direction, so it is a model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Osteoporosis (the license records contain no indication text; this comes from the pack’s mechanism notes) |
| Predicted New Indication | Duodenal ulcer |
| TxGNN Prediction Score | 99.86% |
| Evidence Level | L5 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 10 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Teriparatide is a PTH(1-34) analog that acts on bone remodeling through the PTH1 receptor. Detailed mechanism of action data is not available from DrugBank. Its established role is as a bone anabolic agent for osteoporosis.
No mechanistic link between this action and duodenal ulcer has been established. Duodenal ulcer is a gastrointestinal mucosal disease, and PTH1 receptor signaling in bone offers no clear rationale for treating it. The high TxGNN score reflects a pattern in the knowledge graph, not supporting trial or literature evidence. The prediction should be treated as a hypothesis-generating signal only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ANDA211097 | Teriparatide (Apotex Corp.) | Injection, solution | Not listed in the records |
| NDA216490 | Yorvipath (Ascendis Pharma) | Injection, solution | Not listed in the records |
| NDA021318 | Teriparatide (Prasco Laboratories) | Injection, solution | Not listed in the records |
| NDA211939 | Teriparatide (Alvogen, Inc.) | Injection, solution | Not listed in the records |
| ANDA213641 | Teriparatide (Amphastar Pharmaceuticals) | Injection | Not listed in the records |
Ten authorizations exist in total; the five above are the main ones listed. All are injectable products.
Safety Considerations
Please refer to the package insert for safety information. No drug interactions were found in the available data.
Conclusion and Next Steps
Decision: Hold
Rationale: The duodenal ulcer prediction rests on a graph-based score alone, with no clinical trials, no literature, and no plausible mechanistic link to PTH1 receptor signaling. It is not a candidate for further investment at this time.
To proceed, the following is needed:
- A plausible mechanistic hypothesis linking PTH signaling to duodenal ulcer, plus any preclinical evidence
- The FDA package insert (warnings, contraindications) and detailed MOA data
- Any registered clinical trials or peer-reviewed literature in this indication
Note on other predictions from the same pack: The strongest candidate is not the top-ranked one. Pregnancy-associated osteoporosis (TxGNN score 99.55%) has L3 evidence and a “Proceed with Guardrails” recommendation. It is supported by a multicenter retrospective cohort of teriparatide in pregnancy- and lactation-associated osteoporosis (PMID 34132853), a 47-patient series (PMID 35903718), and several systematic reviews. However, the 2025 meta-analysis found the treatment-response data inconclusive (PMID 40205203), and no Phase 2/3 RCT exists. It would be the more productive direction to evaluate first.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.