Camylofin
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Camylofin: From Antispasmodic Use to Insomnia
One-Sentence Summary
Camylofin is an antispasmodic that is currently marketed in India in many single-ingredient products, although the data compiled for this report do not include an approved indication text. The TxGNN model predicts it may be effective for insomnia, but there are currently no clinical trials and no publications supporting this direction, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the licence data (the drug is generally known as an antispasmodic) |
| Predicted New Indication | Insomnia |
| TxGNN Prediction Score | 0.9939 |
| 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 general background knowledge (not part of the data compiled for this report), camylofin is an antispasmodic that combines anticholinergic (antimuscarinic) activity with direct smooth-muscle relaxation. Its use in smooth-muscle spasm is the likely original context, but no approved indication text was recorded in the licence data.
The link to insomnia is speculative. Central anticholinergic effects could in theory cause sedation, but they could equally impair cognition or worsen sleep quality. No mechanistic, clinical, or literature evidence in the compiled data confirms a benefit. The high TxGNN score (0.9939) is a model-based prediction only and should be treated as a hypothesis to test, not as proof of efficacy.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
Camylofin is registered in India under 20 valid single-ingredient licences (no cancelled licences). The licence data contain no approved indication text. Five main authorizations are listed below.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 498 | Anaspas 25mg Injection (Abbott) | Vial of 2 ml injection | Not stated |
| 25919 | Bigspas-P Tablet (Mankind Pharma Ltd) | Strip of 10 tablets | Not stated |
| 41 | Anafortan 25 mg/300 mg Tablet (Abbott) | Strip of 15 tablets | Not stated |
| 27172 | Bigspas 50mg Injection (Mankind Pharma Ltd) | Vial of 1 ml injection | Not stated |
| 42154 | Camifort Suspension (Intel Pharmaceuticals) | Bottle of 30 ml suspension | Not stated |
Available dosage forms include injections, tablets, and oral suspensions.
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found for this drug in the data compiled for this report, and no disease contraindications were identified in the knowledge graph.
Conclusion and Next Steps
Decision: Hold
Rationale: The only support for insomnia is a model prediction (L5), with no clinical trials or publications. The mechanism is unconfirmed, and the anticholinergic activity could plausibly worsen rather than improve sleep. Package insert safety information is also missing.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India Pharma website (a blocking gap for safety screening)
- Mechanism of action data from DrugBank to assess a plausible link to insomnia
- Confirmed original indication from the licence or label
- A targeted literature and trial search for camylofin and sleep outcomes
- Preclinical or early-phase evidence of benefit, with attention to central anticholinergic effects on cognition and sleep quality
- Assessment of route compatibility and similarity to the original indication (currently pending)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.