Ciclesonide
| Evidence Level: L5 | Predicted Indications: 5 |
Table of Contents
Ciclesonide: Inhaled corticosteroid prodrug → atopic eczema
One-Sentence Summary
Ciclesonide is an inhaled corticosteroid prodrug that is converted in the body to an active glucocorticoid receptor agonist. The TxGNN model predicts it may be useful for atopic eczema, but the data compiled for this report contain no clinical trials and no publications for this indication, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | atopic eczema |
| TxGNN Prediction Score | 0.9996 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (19 of 19) – CDSCO approval status is not included in this data |
| Number of Listed Products | 19 (valid: 19) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on general pharmacology, ciclesonide is an inhaled corticosteroid prodrug. Esterases activate it to des-ciclesonide, a glucocorticoid receptor agonist with anti-inflammatory activity.
Corticosteroids, applied to the skin or given systemically, are an established treatment for atopic eczema. A glucocorticoid-mediated anti-inflammatory effect is therefore mechanistically plausible.
There are important limits. No trials or literature were found for ciclesonide in this condition. The supplied data show no skin formulation or skin-specific pharmacology for ciclesonide. The score is a model prediction only. Two other entries in the prediction list, “dermatitis, atopic” (0.9973) and “atopic eczema”, describe essentially the same disease, so they should be treated as one candidate rather than as independent signals.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 215349 | Triohale Rotacap | packet of 30 rotacaps | Not recorded |
| 44473 | Ciclospray Nasal Spray | packet of 100 MDI Nasal Spray | Not recorded |
| 215625 | Trimium Transhaler | packet of 180 MDI Transhaler | Not recorded |
| 208034 | Simply One 6mcg/400mcg Rotacap | bottle of 30 rotacaps | Not recorded |
| 216181 | Trimium Transcaps | bottle of 15 transcaps | Not recorded |
Of 19 licences in total, all 19 are currently valid. Only the first five are listed here.
Safety Considerations
- Drug Interactions: 63 interactions were identified. Examples include:
- Major: cladribine.
- Moderate: clarithromycin, miconazole, cobicistat, atazanavir, fosamprenavir, amprenavir, boceprevir, ceritinib, conivaptan, fostamatinib, inhaled rapid-acting human insulin, topical abametapir.
- Minor: formoterol, salbutamol, arformoterol.
- Unknown level: omeprazole, lansoprazole, prednisolone, famotidine.
- Package insert warnings and contraindications are not available in the data compiled for this report. Please refer to the package insert for safety information.
- A related report for another prediction (contact dermatitis) describes a case of systemic allergic dermatitis from inhaled budesonide, with patch-test cross-reactivity to ciclesonide. This suggests corticosteroid hypersensitivity should be considered.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high, but no clinical trials or publications address atopic eczema for this drug. The evidence level is therefore L5. Ciclesonide is also marketed only in inhaled and nasal forms, with no skin formulation in the supplied data.
To proceed, the following is needed:
- Clinical or preclinical studies of ciclesonide in atopic eczema
- Mechanism of action data for ciclesonide and its active metabolite
- Assessment of whether a suitable skin formulation or route exists
- Package insert warnings and contraindications from the India regulator
- Review of the corticosteroid hypersensitivity and cross-reactivity risk
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.