Urofollitropin
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Urofollitropin: From Ovulation Induction and Ovarian Stimulation to Migraine Disorder
One-Sentence Summary
Urofollitropin is a urinary-derived follicle-stimulating hormone (FSH) preparation, used for ovulation induction and ovarian stimulation in fertility treatment. The TxGNN model predicts it may be effective for migraine disorder, but there are currently no clinical trials and no publications supporting this prediction, so it rests on model output alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the licence records compiled for this report (ovulation induction and ovarian stimulation, based on the drug class) |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 0.9985 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, urofollitropin is a gonadotropin (FSH) preparation derived from urine. Its efficacy in ovarian stimulation is established, but no mechanistic route to migraine has been demonstrated.
The link between the two conditions is weak. A hormonal-fluctuation hypothesis, such as menstrual-related migraine, is conceivable. However, gonadotropin stimulation would more plausibly provoke headache than treat it. The high score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.
Other top-ranked predictions are similarly unsupported. These include migraine with brainstem aura, cauda equina syndrome, His bundle tachycardia, restless legs syndrome, and Raynaud disease. None has clinical or literature data, and none has an identified mechanistic link to FSH receptor signalling.
India Market Information
Twenty single-ingredient injectable registrations are valid. The licence records compiled for this report contain no approved indication text. The main authorisations are listed below.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 74798 | Euvifol-HP 150IU Injection | Vial of 1 ml injection | Not stated |
| 166561 | Ovitropin FSH 150IU Injection | Box of 1 injection | Not stated |
| 86785 | Follicare 150IU HP Injection | Vial of 1 injection | Not stated |
| 85292 | Fostine 75 Injection | Vial of 2 ml injection | Not stated |
| 127791 | Lupi Rfsh 900IU Injection | Vial of 1 ml injection | Not stated |
Safety Considerations
- Drug Interactions: One interaction is recorded. Ganirelix has a Moderate-level interaction with urofollitropin (source: DDInter).
Please refer to the package insert for other safety information, including warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The migraine prediction has a very high model score but no supporting clinical trials or publications, and no plausible mechanism. Gonadotropin stimulation may instead worsen headache. The evidence level is L5 (model prediction only).
To proceed, the following is needed:
- Package insert warnings and contraindications from the Indian regulatory sources
- Approved indication text for the registered products
- Detailed mechanism of action data
- A mechanistic hypothesis and preclinical or observational data linking FSH to migraine, for example in menstrual-related migraine
- A safety assessment of headache or migraine as a known adverse effect of gonadotropins
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.