Secale Cereale Pollen
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Secale Cereale Pollen: From an Unspecified Original Indication to Alopecia
One-Sentence Summary
Secale cereale pollen (rye pollen extract) was marketed in the US as an allergenic extract solution, but no approved indication is recorded in the data compiled for this report. The TxGNN model predicts it may be effective for alopecia, but currently there are 0 clinical trials and 0 publications supporting this direction, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the available data |
| Predicted New Indication | Alopecia |
| TxGNN Prediction Score | 99.01% |
| Evidence Level | L5 |
| US Market Status | Cancelled only (no active license) |
| Number of NDAs | 1 (BLA101833, cancelled) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Secale cereale pollen is a complex botanical extract (rye pollen), and no original indication is recorded for it in the compiled data. A mechanistic link to alopecia therefore cannot be established.
The high TxGNN score (99.01%) is a model-based prediction only. Any plausible link, for example a hypothetical anti-inflammatory effect or a 5-alpha-reductase-related effect from plant sterols, would be speculative and unverified. Treat the prediction as a hypothesis to test, not as supported evidence.
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 |
|---|---|---|---|
| BLA101833 | Cultivated Rye (Greer Laboratories, Inc.) | Solution | Not recorded (license cancelled) |
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found for this substance.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no clinical, literature, or mechanistic support (Evidence Level L5). The only US license is cancelled, and safety and mechanism data are missing, so the project should not advance.
To proceed, the following is needed:
- Mechanism of action data (e.g., from DrugBank) and a plausible biological link to alopecia
- FDA package insert warnings and contraindications, to allow safety screening
- Confirmation of the original indication and a review of the cancelled license’s history
- Preclinical or literature evidence for hair-loss effects
- Assessment of route compatibility (the only known form is a solution, a non-topical allergenic extract) and of allergenicity risk for any new use
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.