Hydrocortisone Succinate
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
- Hydrocortisone Succinate
- Hydrocortisone Succinate: From Corticosteroid-Responsive Conditions to Allergic Asthma
Hydrocortisone Succinate: From Corticosteroid-Responsive Conditions to Allergic Asthma
One-Sentence Summary
Hydrocortisone succinate is an injectable glucocorticoid marketed in Singapore as Solu-Cortef, but the approved indication text is not available in the data compiled for this report. The TxGNN model predicts it may be effective for allergic asthma, with 0 registered clinical trials and 1 publication, a general review that gives no efficacy data. The prediction is biologically plausible because systemic corticosteroids are already used in acute asthma, but direct evidence for this specific indication is lacking.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (the licence record has no approved indication text) |
| Predicted New Indication | Allergic asthma |
| TxGNN Prediction Score | 97.04% |
| Evidence Level | L4 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the compiled data. Based on known pharmacology, hydrocortisone is a glucocorticoid with broad anti-inflammatory and immunosuppressive effects. These act through the glucocorticoid receptor and include suppression of Th2 cytokines, reduced eosinophil recruitment, and dampening of airway inflammation.
Allergic asthma is driven by this type of Th2 and eosinophilic inflammation. Systemic corticosteroids, including intravenous hydrocortisone, are already used in acute asthma exacerbations, so the predicted link is plausible. The high TxGNN score is probably driven by this known class effect rather than by new evidence.
The only supporting publication is a general review of cross-reacting drugs and chemicals, which touches on corticosteroid hypersensitivity. It does not show that hydrocortisone succinate works in allergic asthma.
Other predicted indications in the data (ranked by score) are intrinsic asthma, gout, migraine disorder, migraine with brainstem aura, uterine polyp, vocal cord polyp, middle ear polyp, epulis, and frontal sinus polyp. Most have no trial or literature support and are prediction-only signals. Several, such as epulis and uterine polyp, have no clear mechanistic rationale and are likely artifacts of the knowledge graph.
Clinical Trial Evidence
Currently no related clinical trials registered for allergic asthma.
For the second-ranked prediction, intrinsic asthma, one trial is linked:
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT04278404 | Phase N/A | Recruiting | 5000 | Pharmacokinetics and safety study of understudied drugs given to children. It is not designed to test efficacy, so it gives only indirect dosing and safety context. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 12668895 | 2003 | Review | Clin Rev Allergy Immunol | General review of cross-reacting drugs and chemicals, with a focus on aspirin and NSAIDs in aspirin-exacerbated respiratory disease. It gives no efficacy evidence for hydrocortisone in allergic asthma. |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN04791P | SOLU-CORTEF FOR INJECTION 100 mg/vial | Injection, powder, for solution | Not stated in the licence record |
The product is manufactured by Pfizer Manufacturing Belgium NV. It is the only registration, and it is valid and single-ingredient.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is mechanistically plausible, and systemic corticosteroids are already part of acute asthma care. However, no registered trials and only one non-specific review support hydrocortisone succinate in allergic asthma. Safety label data are also missing, so the evidence stays at L4 and the candidate cannot move beyond initial screening.
To proceed, the following is needed:
- The package insert warnings and contraindications from HSA, which are the blocking gap for safety screening
- The approved indications from the Singapore licence or package insert, to establish the original indication
- Mechanism of action data from DrugBank
- Indication-specific efficacy evidence, such as RCTs or guideline-level support for intravenous hydrocortisone in allergic asthma
- A route and dose compatibility assessment, since the injectable form must be matched to the intended asthma setting (for example acute exacerbation)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.