Piperine
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Piperine: From an Unspecified Original Indication to Acne
One-Sentence Summary
Piperine is a pepper alkaloid whose only U.S. record is a single cancelled liquid product; no approved indication is documented in the data compiled for this report. The TxGNN model predicts it may be effective for Acne, but there are currently 0 clinical trials and 0 publications supporting this prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not documented (the license record has no approved indication text) |
| Predicted New Indication | Acne |
| TxGNN Prediction Score | 99.69% |
| Evidence Level | L5 |
| US Market Status | Cancelled only |
| Number of NDAs | 1 (cancelled) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Piperine is the main pungent alkaloid of black pepper. In preclinical settings it has been reported to have anti-inflammatory and antioxidant activity, which could plausibly relate to inflammatory acne.
This link is hypothetical. The data compiled for this report contain no clinical trials or literature, and no original indication is recorded, so the relationship between an original and a new indication cannot be assessed. The prediction rests only on the model score.
A second prediction, amenorrhea (score 99.39%), is also at the L5 level. No plausible mechanistic pathway to menstrual or hormonal regulation can be established from the available data, so it is not evaluated further.
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 |
|---|---|---|---|
| Not recorded (cancelled) | Piperine (Professional Complementary Health Formulas) | Liquid | Not recorded |
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found, and no knowledge-graph contraindications were identified. This does not mean the safety profile is clean; it is uncharacterized.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by a high model score (L5). There are no clinical trials or publications, the mechanism of action is unavailable, and the only U.S. product is cancelled. The safety profile is uncharacterized.
To proceed, the following is needed:
- Safety information from the FDA package insert (warnings and contraindications), which is a blocking gap for safety screening
- Mechanism of action data (e.g., from DrugBank)
- A literature and trial search for piperine in acne, covering preclinical and clinical studies
- Confirmation of the original or approved indication and the regulatory status of the product
- Assessment of route compatibility (topical vs. oral) for acne
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.